Aumolertinib With Chemotherapy or Alone Compared With Osimertinib in Patients With Epidermal Growth Factor Receptor-Mutant Non-Small Cell Lung Cancer

• ClinicalTrials.gov Identifier: NCT05493501
• Recruitment Status: Terminated
• First Posted: August 9, 2022
• Results First Posted: May 2, 2024
• Last Update Posted: May 2, 2024
• Sponsor: EQRx International, Inc.
• Information provided by (Responsible Party): EQRx International, Inc.

• Study Type: Interventional
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: NSCLC
• Interventions: Drug: Aumolertinib monotherapy; Drug: Osimertinib monotherapy; Drug: Pemetrexed; Drug: Cisplatin; Drug: Carboplatin; Drug: Paclitaxel; Drug: Nab paclitaxel; Drug: Gemcitabine
• Enrollment: 8

Participant Flow

Recruitment Details
Pre-assignment Details

Arm/Group Title	Aumolertinib Monotherapy	Aumolertinib + Platinum-based Doublet Chemotherapy	Osimertinib Monotherapy
Arm/Group Description	Aumolertinib monotherapy: Administered orally, once daily as two 55-mg tablets for a total dose of 110 mg.	For adenocarcinoma, either: Aumolertinib + cisplatin with pemetrexed, or; Aumolertinib + carboplatin with pemetrexed For squamous cell carcinoma, one of the following: Aumolertinib + cisplatin or carboplatin with paclitaxel;; Aumolertinib + cisplatin or carboplatin with albumin-bound paclitaxel; or; Aumolertinib + cisplatin or carboplatin with gemcitabine Aumolertinib monotherapy: Administered orally, once daily as two 55-mg tablets for a total dose of 110 mg. Pemetrexed: Administered by IV Infusion per prescribing information. Maybe be continued as maintenance therapy Cisplatin: Administered by IV Infusion given over 4 fixed cycles (q3wk × 4 cycles) per prescribing information. Carboplatin: Administered by IV Infusion given over 4 fixed cycles (q3wk × 4 cycles) per prescribing information. Paclitaxel: Administered by IV Infusion given over 4 -6 fixed cycles per prescribing information. Nab paclitaxel: Administered by IV Infusion given over 4 fixed cycles per prescribing information. Gemcitabine: Administered by IV Infusion over 4 fixed cycles per prescribing information.	Osimertinib monotherapy: 80 mg tablet administered orally, once daily
Period Title: Overall Study
Started	1	2	5
Completed	0	0	0
Not Completed	1	2	5

Baseline Characteristics

Arm/Group Title		Aumolertinib Monotherapy	Aumolertinib + Platinum-based Doublet Chemotherapy	Osimertinib Monotherapy	Total
Arm/Group Description		Aumolertinib monotherapy: Administered orally, once daily as two 55-mg tablets for a total dose of 110 mg.	For adenocarcinoma, either: Aumolertinib + cisplatin with pemetrexed, or; Aumolertinib + carboplatin with pemetrexed For squamous cell carcinoma, one of the following: Aumolertinib + cisplatin or carboplatin with paclitaxel;; Aumolertinib + cisplatin or carboplatin with albumin-bound paclitaxel; or; Aumolertinib + cisplatin or carboplatin with gemcitabine Aumolertinib monotherapy: Administered orally, once daily as two 55-mg tablets for a total dose of 110 mg. Pemetrexed: Administered by IV Infusion per prescribing information. Maybe be continued as maintenance therapy Cisplatin: Administered by IV Infusion given over 4 fixed cycles (q3wk × 4 cycles) per prescribing information. Carboplatin: Administered by IV Infusion given over 4 fixed cycles (q3wk × 4 cycles) per prescribing information. Paclitaxel: Administered by IV Infusion given over 4 -6 fixed cycles per prescribing information. Nab paclitaxel: Administered by IV Infusion given over 4 fixed cycles per prescribing information. Gemcitabine: Administered by IV Infusion over 4 fixed cycles per prescribing information.	Osimertinib monotherapy: 80 mg tablet administered orally, once daily	Total of all reporting groups
Overall Number of Baseline Participants		1	2	5	8
Baseline Analysis Population Description		Study terminated early, no participants completed the study, no participants were analyzed.
Age, Continuous; Mean (Full Range); Unit of measure: Years
	Number Analyzed	1 participants	2 participants	5 participants	8 participants
		69; (69 to 69)	71; (66 to 75)	63; (52 to 74)	66; (52 to 75)
Sex: Female, Male; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	1 participants	2 participants	5 participants	8 participants
	Female	1 100.0%	2 100.0%	4 80.0%	7 87.5%
	Male	0 0.0%	0 0.0%	1 20.0%	1 12.5%
Ethnicity (NIH/OMB); Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	1 participants	2 participants	5 participants	8 participants
	Hispanic or Latino	0 0.0%	0 0.0%	1 20.0%	1 12.5%
	Not Hispanic or Latino	1 100.0%	2 100.0%	4 80.0%	7 87.5%
	Unknown or Not Reported	0 0.0%	0 0.0%	0 0.0%	0 0.0%
Race (NIH/OMB); Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	1 participants	2 participants	5 participants	8 participants
	American Indian or Alaska Native	0 0.0%	0 0.0%	0 0.0%	0 0.0%
	Asian	0 0.0%	0 0.0%	0 0.0%	0 0.0%
	Native Hawaiian or Other Pacific Islander	0 0.0%	0 0.0%	0 0.0%	0 0.0%
	Black or African American	0 0.0%	0 0.0%	0 0.0%	0 0.0%
	White	1 100.0%	2 100.0%	5 100.0%	8 100.0%
	More than one race	0 0.0%	0 0.0%	0 0.0%	0 0.0%
	Unknown or Not Reported	0 0.0%	0 0.0%	0 0.0%	0 0.0%

Outcome Measures

1. Primary Outcome

Title	Progression Free Survival (PFS) as Assessed by Blinded Independent Central Review (BICR) Per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
Description	PFS is defined as the time from date of randomization until date of disease progression or death due to any cause, whichever occurs first.
Time Frame	Up to 5 years

Outcome Measure Data

Analysis Population Description

data not collected, 0 participants analyzed

Arm/Group Title	Aumolertinib Monotherapy	Aumolertinib + Platinum-based Doublet Chemotherapy	Osimertinib Monotherapy
Arm/Group Description:	Aumolertinib monotherapy: Administered orally, once daily as two 55-mg tablets for a total dose of 110 mg.	For adenocarcinoma, either: Aumolertinib + cisplatin with pemetrexed, or; Aumolertinib + carboplatin with pemetrexed For squamous cell carcinoma, one of the following: Aumolertinib + cisplatin or carboplatin with paclitaxel;; Aumolertinib + cisplatin or carboplatin with albumin-bound paclitaxel; or; Aumolertinib + cisplatin or carboplatin with gemcitabine Aumolertinib monotherapy: Administered orally, once daily as two 55-mg tablets for a total dose of 110 mg. Pemetrexed: Administered by IV Infusion per prescribing information. Maybe be continued as maintenance therapy Cisplatin: Administered by IV Infusion given over 4 fixed cycles (q3wk × 4 cycles) per prescribing information. Carboplatin: Administered by IV Infusion given over 4 fixed cycles (q3wk × 4 cycles) per prescribing information. Paclitaxel: Administered by IV Infusion given over 4 -6 fixed cycles per prescribing information. Nab paclitaxel: Administered by IV Infusion given over 4 fixed cycles per prescribing information. Gemcitabine: Administered by IV Infusion over 4 fixed cycles per prescribing information.	Osimertinib monotherapy: 80 mg tablet administered orally, once daily
Overall Number of Participants Analyzed	0	0	0

No data displayed because Outcome Measure has zero total analyzed.

2. Secondary Outcome

Title	Overall Survival (OS)
Description	OS is defined as the time from date of randomization until death from any cause.
Time Frame	Up to 6 years

Outcome Measure Data

Analysis Population Description

data not collected, 0 participants analyzed

Arm/Group Title	Aumolertinib Monotherapy	Aumolertinib + Platinum-based Doublet Chemotherapy	Osimertinib Monotherapy
Arm/Group Description:	Aumolertinib monotherapy: Administered orally, once daily as two 55-mg tablets for a total dose of 110 mg.	For adenocarcinoma, either: Aumolertinib + cisplatin with pemetrexed, or; Aumolertinib + carboplatin with pemetrexed For squamous cell carcinoma, one of the following: Aumolertinib + cisplatin or carboplatin with paclitaxel;; Aumolertinib + cisplatin or carboplatin with albumin-bound paclitaxel; or; Aumolertinib + cisplatin or carboplatin with gemcitabine Aumolertinib monotherapy: Administered orally, once daily as two 55-mg tablets for a total dose of 110 mg. Pemetrexed: Administered by IV Infusion per prescribing information. Maybe be continued as maintenance therapy Cisplatin: Administered by IV Infusion given over 4 fixed cycles (q3wk × 4 cycles) per prescribing information. Carboplatin: Administered by IV Infusion given over 4 fixed cycles (q3wk × 4 cycles) per prescribing information. Paclitaxel: Administered by IV Infusion given over 4 -6 fixed cycles per prescribing information. Nab paclitaxel: Administered by IV Infusion given over 4 fixed cycles per prescribing information. Gemcitabine: Administered by IV Infusion over 4 fixed cycles per prescribing information.	Osimertinib monotherapy: 80 mg tablet administered orally, once daily
Overall Number of Participants Analyzed	0	0	0

No data displayed because Outcome Measure has zero total analyzed.

3. Secondary Outcome

Title	Objective Response Rate (ORR) as Assessed by BICR Per RECIST v1.1
Description	ORR is defined as proportion of participants who achieve a complete response or partial response at any time before progressive disease or initiating a subsequent anticancer therapy.
Time Frame	Up to 5 years

Outcome Measure Data

Analysis Population Description

data not collected, 0 participants analyzed

Arm/Group Title	Aumolertinib Monotherapy	Aumolertinib + Platinum-based Doublet Chemotherapy	Osimertinib Monotherapy
Arm/Group Description:	Aumolertinib monotherapy: Administered orally, once daily as two 55-mg tablets for a total dose of 110 mg.	For adenocarcinoma, either: Aumolertinib + cisplatin with pemetrexed, or; Aumolertinib + carboplatin with pemetrexed For squamous cell carcinoma, one of the following: Aumolertinib + cisplatin or carboplatin with paclitaxel;; Aumolertinib + cisplatin or carboplatin with albumin-bound paclitaxel; or; Aumolertinib + cisplatin or carboplatin with gemcitabine Aumolertinib monotherapy: Administered orally, once daily as two 55-mg tablets for a total dose of 110 mg. Pemetrexed: Administered by IV Infusion per prescribing information. Maybe be continued as maintenance therapy Cisplatin: Administered by IV Infusion given over 4 fixed cycles (q3wk × 4 cycles) per prescribing information. Carboplatin: Administered by IV Infusion given over 4 fixed cycles (q3wk × 4 cycles) per prescribing information. Paclitaxel: Administered by IV Infusion given over 4 -6 fixed cycles per prescribing information. Nab paclitaxel: Administered by IV Infusion given over 4 fixed cycles per prescribing information. Gemcitabine: Administered by IV Infusion over 4 fixed cycles per prescribing information.	Osimertinib monotherapy: 80 mg tablet administered orally, once daily
Overall Number of Participants Analyzed	0	0	0

No data displayed because Outcome Measure has zero total analyzed.

4. Secondary Outcome

Title	Disease Control Rate (DCR) as Assessed by BICR Per RECIST v1.1
Description	DCR is defined as the proportion of participants who have a best overall response of complete response or partial response or stable disease.
Time Frame	Up to 5 years

Outcome Measure Data

Analysis Population Description

data not collected, 0 participants analyzed

Arm/Group Title	Aumolertinib Monotherapy	Aumolertinib + Platinum-based Doublet Chemotherapy	Osimertinib Monotherapy
Arm/Group Description:	Aumolertinib monotherapy: Administered orally, once daily as two 55-mg tablets for a total dose of 110 mg.	For adenocarcinoma, either: Aumolertinib + cisplatin with pemetrexed, or; Aumolertinib + carboplatin with pemetrexed For squamous cell carcinoma, one of the following: Aumolertinib + cisplatin or carboplatin with paclitaxel;; Aumolertinib + cisplatin or carboplatin with albumin-bound paclitaxel; or; Aumolertinib + cisplatin or carboplatin with gemcitabine Aumolertinib monotherapy: Administered orally, once daily as two 55-mg tablets for a total dose of 110 mg. Pemetrexed: Administered by IV Infusion per prescribing information. Maybe be continued as maintenance therapy Cisplatin: Administered by IV Infusion given over 4 fixed cycles (q3wk × 4 cycles) per prescribing information. Carboplatin: Administered by IV Infusion given over 4 fixed cycles (q3wk × 4 cycles) per prescribing information. Paclitaxel: Administered by IV Infusion given over 4 -6 fixed cycles per prescribing information. Nab paclitaxel: Administered by IV Infusion given over 4 fixed cycles per prescribing information. Gemcitabine: Administered by IV Infusion over 4 fixed cycles per prescribing information.	Osimertinib monotherapy: 80 mg tablet administered orally, once daily
Overall Number of Participants Analyzed	0	0	0

No data displayed because Outcome Measure has zero total analyzed.

5. Secondary Outcome

Title	Tumor Growth Rate (TGR) as Assessed by BICR Per RECIST v1.1
Description	TGR is defined as the constant exponential growth rate estimated using the sum of longest diameters based on radiological tumor assessment per RECIST v1.1.
Time Frame	Up to 5 years

Outcome Measure Data

Analysis Population Description

data not collected, 0 participants analyzed

Arm/Group Title	Aumolertinib Monotherapy	Aumolertinib + Platinum-based Doublet Chemotherapy	Osimertinib Monotherapy
Arm/Group Description:	Aumolertinib monotherapy: Administered orally, once daily as two 55-mg tablets for a total dose of 110 mg.	For adenocarcinoma, either: Aumolertinib + cisplatin with pemetrexed, or; Aumolertinib + carboplatin with pemetrexed For squamous cell carcinoma, one of the following: Aumolertinib + cisplatin or carboplatin with paclitaxel;; Aumolertinib + cisplatin or carboplatin with albumin-bound paclitaxel; or; Aumolertinib + cisplatin or carboplatin with gemcitabine Aumolertinib monotherapy: Administered orally, once daily as two 55-mg tablets for a total dose of 110 mg. Pemetrexed: Administered by IV Infusion per prescribing information. Maybe be continued as maintenance therapy Cisplatin: Administered by IV Infusion given over 4 fixed cycles (q3wk × 4 cycles) per prescribing information. Carboplatin: Administered by IV Infusion given over 4 fixed cycles (q3wk × 4 cycles) per prescribing information. Paclitaxel: Administered by IV Infusion given over 4 -6 fixed cycles per prescribing information. Nab paclitaxel: Administered by IV Infusion given over 4 fixed cycles per prescribing information. Gemcitabine: Administered by IV Infusion over 4 fixed cycles per prescribing information.	Osimertinib monotherapy: 80 mg tablet administered orally, once daily
Overall Number of Participants Analyzed	0	0	0

No data displayed because Outcome Measure has zero total analyzed.

6. Secondary Outcome

Title	Duration of Response (DOR) as Assessed by BICR Per RECIST v1.1
Description	DOR is defined as date of first response (complete response or partial response) until date of disease progression or death due to any cause, whichever occurs first
Time Frame	Up to 5 years

Outcome Measure Data

Analysis Population Description

data not collected, 0 participants analyzed

Arm/Group Title	Aumolertinib Monotherapy	Aumolertinib + Platinum-based Doublet Chemotherapy	Osimertinib Monotherapy
Arm/Group Description:	Aumolertinib monotherapy: Administered orally, once daily as two 55-mg tablets for a total dose of 110 mg.	For adenocarcinoma, either: Aumolertinib + cisplatin with pemetrexed, or; Aumolertinib + carboplatin with pemetrexed For squamous cell carcinoma, one of the following: Aumolertinib + cisplatin or carboplatin with paclitaxel;; Aumolertinib + cisplatin or carboplatin with albumin-bound paclitaxel; or; Aumolertinib + cisplatin or carboplatin with gemcitabine Aumolertinib monotherapy: Administered orally, once daily as two 55-mg tablets for a total dose of 110 mg. Pemetrexed: Administered by IV Infusion per prescribing information. Maybe be continued as maintenance therapy Cisplatin: Administered by IV Infusion given over 4 fixed cycles (q3wk × 4 cycles) per prescribing information. Carboplatin: Administered by IV Infusion given over 4 fixed cycles (q3wk × 4 cycles) per prescribing information. Paclitaxel: Administered by IV Infusion given over 4 -6 fixed cycles per prescribing information. Nab paclitaxel: Administered by IV Infusion given over 4 fixed cycles per prescribing information. Gemcitabine: Administered by IV Infusion over 4 fixed cycles per prescribing information.	Osimertinib monotherapy: 80 mg tablet administered orally, once daily
Overall Number of Participants Analyzed	0	0	0

No data displayed because Outcome Measure has zero total analyzed.

7. Secondary Outcome

Title	Depth of Response (DepOR) as Assessed by BICR Per RECIST v1.1
Description	DepOR is defined as the relative change in target lesion tumor size (calculated as the sum of the longest diameters of the target lesions, in the absence of new lesions or progression of nontarget lesions) as compared to baseline.
Time Frame	Up to 5 years

Outcome Measure Data

Analysis Population Description

data not collected, 0 participants analyzed

Arm/Group Title	Aumolertinib Monotherapy	Aumolertinib + Platinum-based Doublet Chemotherapy	Osimertinib Monotherapy
Arm/Group Description:	Aumolertinib monotherapy: Administered orally, once daily as two 55-mg tablets for a total dose of 110 mg.	For adenocarcinoma, either: Aumolertinib + cisplatin with pemetrexed, or; Aumolertinib + carboplatin with pemetrexed For squamous cell carcinoma, one of the following: Aumolertinib + cisplatin or carboplatin with paclitaxel;; Aumolertinib + cisplatin or carboplatin with albumin-bound paclitaxel; or; Aumolertinib + cisplatin or carboplatin with gemcitabine Aumolertinib monotherapy: Administered orally, once daily as two 55-mg tablets for a total dose of 110 mg. Pemetrexed: Administered by IV Infusion per prescribing information. Maybe be continued as maintenance therapy Cisplatin: Administered by IV Infusion given over 4 fixed cycles (q3wk × 4 cycles) per prescribing information. Carboplatin: Administered by IV Infusion given over 4 fixed cycles (q3wk × 4 cycles) per prescribing information. Paclitaxel: Administered by IV Infusion given over 4 -6 fixed cycles per prescribing information. Nab paclitaxel: Administered by IV Infusion given over 4 fixed cycles per prescribing information. Gemcitabine: Administered by IV Infusion over 4 fixed cycles per prescribing information.	Osimertinib monotherapy: 80 mg tablet administered orally, once daily
Overall Number of Participants Analyzed	0	0	0

No data displayed because Outcome Measure has zero total analyzed.

8. Secondary Outcome

Title	PFS as Assessed by the Investigator Per RECIST v1.1
Description	PFS is defined as the time from date of randomization until date of disease progression or death due to any cause, whichever occurs first.
Time Frame	Up to 5 years

Outcome Measure Data

Analysis Population Description

data not collected, 0 participants analyzed

Arm/Group Title	Aumolertinib Monotherapy	Aumolertinib + Platinum-based Doublet Chemotherapy	Osimertinib Monotherapy
Arm/Group Description:	Aumolertinib monotherapy: Administered orally, once daily as two 55-mg tablets for a total dose of 110 mg.	For adenocarcinoma, either: Aumolertinib + cisplatin with pemetrexed, or; Aumolertinib + carboplatin with pemetrexed For squamous cell carcinoma, one of the following: Aumolertinib + cisplatin or carboplatin with paclitaxel;; Aumolertinib + cisplatin or carboplatin with albumin-bound paclitaxel; or; Aumolertinib + cisplatin or carboplatin with gemcitabine Aumolertinib monotherapy: Administered orally, once daily as two 55-mg tablets for a total dose of 110 mg. Pemetrexed: Administered by IV Infusion per prescribing information. Maybe be continued as maintenance therapy Cisplatin: Administered by IV Infusion given over 4 fixed cycles (q3wk × 4 cycles) per prescribing information. Carboplatin: Administered by IV Infusion given over 4 fixed cycles (q3wk × 4 cycles) per prescribing information. Paclitaxel: Administered by IV Infusion given over 4 -6 fixed cycles per prescribing information. Nab paclitaxel: Administered by IV Infusion given over 4 fixed cycles per prescribing information. Gemcitabine: Administered by IV Infusion over 4 fixed cycles per prescribing information.	Osimertinib monotherapy: 80 mg tablet administered orally, once daily
Overall Number of Participants Analyzed	0	0	0

No data displayed because Outcome Measure has zero total analyzed.

9. Secondary Outcome

Title	ORR as Assessed by the Investigator Per RECIST v1.1
Description	ORR is defined as the proportion of participants who achieve a complete response or partial response at any time before disease progression or initiating a subsequent anticancer therapy.
Time Frame	Up to 5 years

Outcome Measure Data

Analysis Population Description

data not collected, 0 participants analyzed

Arm/Group Title	Aumolertinib Monotherapy	Aumolertinib + Platinum-based Doublet Chemotherapy	Osimertinib Monotherapy
Arm/Group Description:	Aumolertinib monotherapy: Administered orally, once daily as two 55-mg tablets for a total dose of 110 mg.	For adenocarcinoma, either: Aumolertinib + cisplatin with pemetrexed, or; Aumolertinib + carboplatin with pemetrexed For squamous cell carcinoma, one of the following: Aumolertinib + cisplatin or carboplatin with paclitaxel;; Aumolertinib + cisplatin or carboplatin with albumin-bound paclitaxel; or; Aumolertinib + cisplatin or carboplatin with gemcitabine Aumolertinib monotherapy: Administered orally, once daily as two 55-mg tablets for a total dose of 110 mg. Pemetrexed: Administered by IV Infusion per prescribing information. Maybe be continued as maintenance therapy Cisplatin: Administered by IV Infusion given over 4 fixed cycles (q3wk × 4 cycles) per prescribing information. Carboplatin: Administered by IV Infusion given over 4 fixed cycles (q3wk × 4 cycles) per prescribing information. Paclitaxel: Administered by IV Infusion given over 4 -6 fixed cycles per prescribing information. Nab paclitaxel: Administered by IV Infusion given over 4 fixed cycles per prescribing information. Gemcitabine: Administered by IV Infusion over 4 fixed cycles per prescribing information.	Osimertinib monotherapy: 80 mg tablet administered orally, once daily
Overall Number of Participants Analyzed	0	0	0

No data displayed because Outcome Measure has zero total analyzed.

10. Secondary Outcome

Title	DCR as Assessed by the Investigator Per RECIST v1.1
Description	DCR is defined as the proportion of participants who have a best overall response of complete response or partial response or stable disease.
Time Frame	Up to 5 years

Outcome Measure Data

Analysis Population Description

data not collected, 0 participants analyzed

Arm/Group Title	Aumolertinib Monotherapy	Aumolertinib + Platinum-based Doublet Chemotherapy	Osimertinib Monotherapy
Arm/Group Description:	Aumolertinib monotherapy: Administered orally, once daily as two 55-mg tablets for a total dose of 110 mg.	For adenocarcinoma, either: Aumolertinib + cisplatin with pemetrexed, or; Aumolertinib + carboplatin with pemetrexed For squamous cell carcinoma, one of the following: Aumolertinib + cisplatin or carboplatin with paclitaxel;; Aumolertinib + cisplatin or carboplatin with albumin-bound paclitaxel; or; Aumolertinib + cisplatin or carboplatin with gemcitabine Aumolertinib monotherapy: Administered orally, once daily as two 55-mg tablets for a total dose of 110 mg. Pemetrexed: Administered by IV Infusion per prescribing information. Maybe be continued as maintenance therapy Cisplatin: Administered by IV Infusion given over 4 fixed cycles (q3wk × 4 cycles) per prescribing information. Carboplatin: Administered by IV Infusion given over 4 fixed cycles (q3wk × 4 cycles) per prescribing information. Paclitaxel: Administered by IV Infusion given over 4 -6 fixed cycles per prescribing information. Nab paclitaxel: Administered by IV Infusion given over 4 fixed cycles per prescribing information. Gemcitabine: Administered by IV Infusion over 4 fixed cycles per prescribing information.	Osimertinib monotherapy: 80 mg tablet administered orally, once daily
Overall Number of Participants Analyzed	0	0	0

No data displayed because Outcome Measure has zero total analyzed.

11. Secondary Outcome

Title	TGR as Assessed by the Investigator Per RECIST v1.1
Description	TGR is defined as the constant exponential growth rate estimated using the sum of longest diameters based on radiological tumor assessment per RECIST v1.1.
Time Frame	Up to 5 years

Outcome Measure Data

Analysis Population Description

data not collected, 0 participants analyzed

Arm/Group Title	Aumolertinib Monotherapy	Aumolertinib + Platinum-based Doublet Chemotherapy	Osimertinib Monotherapy
Arm/Group Description:	Aumolertinib monotherapy: Administered orally, once daily as two 55-mg tablets for a total dose of 110 mg.	For adenocarcinoma, either: Aumolertinib + cisplatin with pemetrexed, or; Aumolertinib + carboplatin with pemetrexed For squamous cell carcinoma, one of the following: Aumolertinib + cisplatin or carboplatin with paclitaxel;; Aumolertinib + cisplatin or carboplatin with albumin-bound paclitaxel; or; Aumolertinib + cisplatin or carboplatin with gemcitabine Aumolertinib monotherapy: Administered orally, once daily as two 55-mg tablets for a total dose of 110 mg. Pemetrexed: Administered by IV Infusion per prescribing information. Maybe be continued as maintenance therapy Cisplatin: Administered by IV Infusion given over 4 fixed cycles (q3wk × 4 cycles) per prescribing information. Carboplatin: Administered by IV Infusion given over 4 fixed cycles (q3wk × 4 cycles) per prescribing information. Paclitaxel: Administered by IV Infusion given over 4 -6 fixed cycles per prescribing information. Nab paclitaxel: Administered by IV Infusion given over 4 fixed cycles per prescribing information. Gemcitabine: Administered by IV Infusion over 4 fixed cycles per prescribing information.	Osimertinib monotherapy: 80 mg tablet administered orally, once daily
Overall Number of Participants Analyzed	0	0	0

No data displayed because Outcome Measure has zero total analyzed.

12. Secondary Outcome

Title	DOR as Assessed by the Investigator Per RECIST v1.1
Description	DOR is defined as date of first response (complete response or partial response) until the date of disease progression or death due to any cause, whichever occurs first.
Time Frame	Up to 5 years

Outcome Measure Data

Analysis Population Description

data not collected, 0 participants analyzed

Arm/Group Title	Aumolertinib Monotherapy	Aumolertinib + Platinum-based Doublet Chemotherapy	Osimertinib Monotherapy
Arm/Group Description:	Aumolertinib monotherapy: Administered orally, once daily as two 55-mg tablets for a total dose of 110 mg.	For adenocarcinoma, either: Aumolertinib + cisplatin with pemetrexed, or; Aumolertinib + carboplatin with pemetrexed For squamous cell carcinoma, one of the following: Aumolertinib + cisplatin or carboplatin with paclitaxel;; Aumolertinib + cisplatin or carboplatin with albumin-bound paclitaxel; or; Aumolertinib + cisplatin or carboplatin with gemcitabine Aumolertinib monotherapy: Administered orally, once daily as two 55-mg tablets for a total dose of 110 mg. Pemetrexed: Administered by IV Infusion per prescribing information. Maybe be continued as maintenance therapy Cisplatin: Administered by IV Infusion given over 4 fixed cycles (q3wk × 4 cycles) per prescribing information. Carboplatin: Administered by IV Infusion given over 4 fixed cycles (q3wk × 4 cycles) per prescribing information. Paclitaxel: Administered by IV Infusion given over 4 -6 fixed cycles per prescribing information. Nab paclitaxel: Administered by IV Infusion given over 4 fixed cycles per prescribing information. Gemcitabine: Administered by IV Infusion over 4 fixed cycles per prescribing information.	Osimertinib monotherapy: 80 mg tablet administered orally, once daily
Overall Number of Participants Analyzed	0	0	0

No data displayed because Outcome Measure has zero total analyzed.

13. Secondary Outcome

Title	DepOR as Assessed by the Investigator Per RECIST v1.1
Description	DepOR is defined as the relative change in target lesion tumor size (calculated as the sum of the longest diameters of the target lesions, in the absence of new lesions or progression of nontarget lesions) as compared to baseline.
Time Frame	Up to 5 years

Outcome Measure Data

Analysis Population Description

data not collected, 0 participants analyzed

Arm/Group Title	Aumolertinib Monotherapy	Aumolertinib + Platinum-based Doublet Chemotherapy	Osimertinib Monotherapy
Arm/Group Description:	Aumolertinib monotherapy: Administered orally, once daily as two 55-mg tablets for a total dose of 110 mg.	For adenocarcinoma, either: Aumolertinib + cisplatin with pemetrexed, or; Aumolertinib + carboplatin with pemetrexed For squamous cell carcinoma, one of the following: Aumolertinib + cisplatin or carboplatin with paclitaxel;; Aumolertinib + cisplatin or carboplatin with albumin-bound paclitaxel; or; Aumolertinib + cisplatin or carboplatin with gemcitabine Aumolertinib monotherapy: Administered orally, once daily as two 55-mg tablets for a total dose of 110 mg. Pemetrexed: Administered by IV Infusion per prescribing information. Maybe be continued as maintenance therapy Cisplatin: Administered by IV Infusion given over 4 fixed cycles (q3wk × 4 cycles) per prescribing information. Carboplatin: Administered by IV Infusion given over 4 fixed cycles (q3wk × 4 cycles) per prescribing information. Paclitaxel: Administered by IV Infusion given over 4 -6 fixed cycles per prescribing information. Nab paclitaxel: Administered by IV Infusion given over 4 fixed cycles per prescribing information. Gemcitabine: Administered by IV Infusion over 4 fixed cycles per prescribing information.	Osimertinib monotherapy: 80 mg tablet administered orally, once daily
Overall Number of Participants Analyzed	0	0	0

No data displayed because Outcome Measure has zero total analyzed.

14. Secondary Outcome

Title	Quality of Life as Assessed by the National Cancer Institute Patient Reported Outcomes Common Terminology Criteria for Adverse Events (NCI PRO-CTCAE) Questionnaire
Description	NCI PRO-CTCAE questionnaire responses are scored from 0 to 4, wherein lower values represent a better outcome. For this trial, the burden of symptoms that will be captured by this questionnaire comprises nausea, diarrhea, and rash.
Time Frame	Up to 5 years

Outcome Measure Data

Analysis Population Description

data not collected, 0 participants analyzed

Arm/Group Title	Aumolertinib Monotherapy	Aumolertinib + Platinum-based Doublet Chemotherapy	Osimertinib Monotherapy
Arm/Group Description:	Aumolertinib monotherapy: Administered orally, once daily as two 55-mg tablets for a total dose of 110 mg.	For adenocarcinoma, either: Aumolertinib + cisplatin with pemetrexed, or; Aumolertinib + carboplatin with pemetrexed For squamous cell carcinoma, one of the following: Aumolertinib + cisplatin or carboplatin with paclitaxel;; Aumolertinib + cisplatin or carboplatin with albumin-bound paclitaxel; or; Aumolertinib + cisplatin or carboplatin with gemcitabine Aumolertinib monotherapy: Administered orally, once daily as two 55-mg tablets for a total dose of 110 mg. Pemetrexed: Administered by IV Infusion per prescribing information. Maybe be continued as maintenance therapy Cisplatin: Administered by IV Infusion given over 4 fixed cycles (q3wk × 4 cycles) per prescribing information. Carboplatin: Administered by IV Infusion given over 4 fixed cycles (q3wk × 4 cycles) per prescribing information. Paclitaxel: Administered by IV Infusion given over 4 -6 fixed cycles per prescribing information. Nab paclitaxel: Administered by IV Infusion given over 4 fixed cycles per prescribing information. Gemcitabine: Administered by IV Infusion over 4 fixed cycles per prescribing information.	Osimertinib monotherapy: 80 mg tablet administered orally, once daily
Overall Number of Participants Analyzed	0	0	0

No data displayed because Outcome Measure has zero total analyzed.

15. Secondary Outcome

Title	Rate of Circulating Tumor DNA (ctDNA) Clearance
Description	ctDNA clearance is defined as when a detectable EGFR mutation in ctDNA at baseline becomes undetectable or drops below a predetermined threshold. Rate of ctDNA clearance is defined as 100 × number of participants who are ctDNA-negative at 6 weeks divided by number of participants who are ctDNA-positive at baseline.
Time Frame	6 weeks

Outcome Measure Data

Analysis Population Description

data not collected, 0 participants analyzed

Arm/Group Title	Aumolertinib Monotherapy	Aumolertinib + Platinum-based Doublet Chemotherapy	Osimertinib Monotherapy
Arm/Group Description:	Aumolertinib monotherapy: Administered orally, once daily as two 55-mg tablets for a total dose of 110 mg.	For adenocarcinoma, either: Aumolertinib + cisplatin with pemetrexed, or; Aumolertinib + carboplatin with pemetrexed For squamous cell carcinoma, one of the following: Aumolertinib + cisplatin or carboplatin with paclitaxel;; Aumolertinib + cisplatin or carboplatin with albumin-bound paclitaxel; or; Aumolertinib + cisplatin or carboplatin with gemcitabine Aumolertinib monotherapy: Administered orally, once daily as two 55-mg tablets for a total dose of 110 mg. Pemetrexed: Administered by IV Infusion per prescribing information. Maybe be continued as maintenance therapy Cisplatin: Administered by IV Infusion given over 4 fixed cycles (q3wk × 4 cycles) per prescribing information. Carboplatin: Administered by IV Infusion given over 4 fixed cycles (q3wk × 4 cycles) per prescribing information. Paclitaxel: Administered by IV Infusion given over 4 -6 fixed cycles per prescribing information. Nab paclitaxel: Administered by IV Infusion given over 4 fixed cycles per prescribing information. Gemcitabine: Administered by IV Infusion over 4 fixed cycles per prescribing information.	Osimertinib monotherapy: 80 mg tablet administered orally, once daily
Overall Number of Participants Analyzed	0	0	0

No data displayed because Outcome Measure has zero total analyzed.

16. Secondary Outcome

Title	Plasma Concentration of Aumolertinib
Description	Plasma concentration is defined as the measured drug concentration of aumolertinib.
Time Frame	Up to approximately 5 months

Outcome Measure Data

Analysis Population Description

data not collected, 0 participants analyzed

Arm/Group Title	Aumolertinib Monotherapy	Aumolertinib + Platinum-based Doublet Chemotherapy	Osimertinib Monotherapy
Arm/Group Description:	Aumolertinib monotherapy: Administered orally, once daily as two 55-mg tablets for a total dose of 110 mg.	For adenocarcinoma, either: Aumolertinib + cisplatin with pemetrexed, or; Aumolertinib + carboplatin with pemetrexed For squamous cell carcinoma, one of the following: Aumolertinib + cisplatin or carboplatin with paclitaxel;; Aumolertinib + cisplatin or carboplatin with albumin-bound paclitaxel; or; Aumolertinib + cisplatin or carboplatin with gemcitabine Aumolertinib monotherapy: Administered orally, once daily as two 55-mg tablets for a total dose of 110 mg. Pemetrexed: Administered by IV Infusion per prescribing information. Maybe be continued as maintenance therapy Cisplatin: Administered by IV Infusion given over 4 fixed cycles (q3wk × 4 cycles) per prescribing information. Carboplatin: Administered by IV Infusion given over 4 fixed cycles (q3wk × 4 cycles) per prescribing information. Paclitaxel: Administered by IV Infusion given over 4 -6 fixed cycles per prescribing information. Nab paclitaxel: Administered by IV Infusion given over 4 fixed cycles per prescribing information. Gemcitabine: Administered by IV Infusion over 4 fixed cycles per prescribing information.	Osimertinib monotherapy: 80 mg tablet administered orally, once daily
Overall Number of Participants Analyzed	0	0	0

No data displayed because Outcome Measure has zero total analyzed.

17. Secondary Outcome

Title	Plasma Concentration of Aumolertinib Metabolite
Description	Plasma concentration is defined as the measured drug concentration of aumolertinib metabolite.
Time Frame	Up to approximately 5 months

Outcome Measure Data

Analysis Population Description

data not collected, 0 participants analyzed

Arm/Group Title	Aumolertinib Monotherapy	Aumolertinib + Platinum-based Doublet Chemotherapy	Osimertinib Monotherapy
Arm/Group Description:	Aumolertinib monotherapy: Administered orally, once daily as two 55-mg tablets for a total dose of 110 mg.	For adenocarcinoma, either: Aumolertinib + cisplatin with pemetrexed, or; Aumolertinib + carboplatin with pemetrexed For squamous cell carcinoma, one of the following: Aumolertinib + cisplatin or carboplatin with paclitaxel;; Aumolertinib + cisplatin or carboplatin with albumin-bound paclitaxel; or; Aumolertinib + cisplatin or carboplatin with gemcitabine Aumolertinib monotherapy: Administered orally, once daily as two 55-mg tablets for a total dose of 110 mg. Pemetrexed: Administered by IV Infusion per prescribing information. Maybe be continued as maintenance therapy Cisplatin: Administered by IV Infusion given over 4 fixed cycles (q3wk × 4 cycles) per prescribing information. Carboplatin: Administered by IV Infusion given over 4 fixed cycles (q3wk × 4 cycles) per prescribing information. Paclitaxel: Administered by IV Infusion given over 4 -6 fixed cycles per prescribing information. Nab paclitaxel: Administered by IV Infusion given over 4 fixed cycles per prescribing information. Gemcitabine: Administered by IV Infusion over 4 fixed cycles per prescribing information.	Osimertinib monotherapy: 80 mg tablet administered orally, once daily
Overall Number of Participants Analyzed	0	0	0

No data displayed because Outcome Measure has zero total analyzed.

18. Secondary Outcome

Title	Number of Participants With Treatment Emergent Adverse Events (TEAEs)
Description	This outcome will evaluate the incidence of participants with TEAEs, graded according to NCI CTCAE V5.
Time Frame	From date of treatment initiation until discontinuation from treatment (plus 28 days for TEAEs), up to 5 years

Outcome Measure Data

Analysis Population Description

data not collected, 0 participants analyzed

Arm/Group Title	Aumolertinib Monotherapy	Aumolertinib + Platinum-based Doublet Chemotherapy	Osimertinib Monotherapy
Arm/Group Description:	Aumolertinib monotherapy: Administered orally, once daily as two 55-mg tablets for a total dose of 110 mg.	For adenocarcinoma, either: Aumolertinib + cisplatin with pemetrexed, or; Aumolertinib + carboplatin with pemetrexed For squamous cell carcinoma, one of the following: Aumolertinib + cisplatin or carboplatin with paclitaxel;; Aumolertinib + cisplatin or carboplatin with albumin-bound paclitaxel; or; Aumolertinib + cisplatin or carboplatin with gemcitabine Aumolertinib monotherapy: Administered orally, once daily as two 55-mg tablets for a total dose of 110 mg. Pemetrexed: Administered by IV Infusion per prescribing information. Maybe be continued as maintenance therapy Cisplatin: Administered by IV Infusion given over 4 fixed cycles (q3wk × 4 cycles) per prescribing information. Carboplatin: Administered by IV Infusion given over 4 fixed cycles (q3wk × 4 cycles) per prescribing information. Paclitaxel: Administered by IV Infusion given over 4 -6 fixed cycles per prescribing information. Nab paclitaxel: Administered by IV Infusion given over 4 fixed cycles per prescribing information. Gemcitabine: Administered by IV Infusion over 4 fixed cycles per prescribing information.	Osimertinib monotherapy: 80 mg tablet administered orally, once daily
Overall Number of Participants Analyzed	0	0	0

No data displayed because Outcome Measure has zero total analyzed.

19. Secondary Outcome

Title	Number of Participants With Serious Adverse Events (SAEs)
Description	This outcome will evaluate incidence of participants with SAEs, be graded according to NCI CTCAE V5.
Time Frame	From date of treatment initiation until discontinuation from treatment (plus 28 days for TEAEs), up to 5 years

Outcome Measure Data

Analysis Population Description

data not collected, 0 participants analyzed

Arm/Group Title	Aumolertinib Monotherapy	Aumolertinib + Platinum-based Doublet Chemotherapy	Osimertinib Monotherapy
Arm/Group Description:	Aumolertinib monotherapy: Administered orally, once daily as two 55-mg tablets for a total dose of 110 mg.	For adenocarcinoma, either: Aumolertinib + cisplatin with pemetrexed, or; Aumolertinib + carboplatin with pemetrexed For squamous cell carcinoma, one of the following: Aumolertinib + cisplatin or carboplatin with paclitaxel;; Aumolertinib + cisplatin or carboplatin with albumin-bound paclitaxel; or; Aumolertinib + cisplatin or carboplatin with gemcitabine Aumolertinib monotherapy: Administered orally, once daily as two 55-mg tablets for a total dose of 110 mg. Pemetrexed: Administered by IV Infusion per prescribing information. Maybe be continued as maintenance therapy Cisplatin: Administered by IV Infusion given over 4 fixed cycles (q3wk × 4 cycles) per prescribing information. Carboplatin: Administered by IV Infusion given over 4 fixed cycles (q3wk × 4 cycles) per prescribing information. Paclitaxel: Administered by IV Infusion given over 4 -6 fixed cycles per prescribing information. Nab paclitaxel: Administered by IV Infusion given over 4 fixed cycles per prescribing information. Gemcitabine: Administered by IV Infusion over 4 fixed cycles per prescribing information.	Osimertinib monotherapy: 80 mg tablet administered orally, once daily
Overall Number of Participants Analyzed	0	0	0

No data displayed because Outcome Measure has zero total analyzed.

20. Secondary Outcome

Title	Number of Participants With Electrocardiogram (ECG) Abnormalities
Description	This outcome will evaluate incidence of participants with ECG abnormalities
Time Frame	From date of treatment initiation until discontinuation from treatment (plus 28 days for TEAEs), up to 5 years

Outcome Measure Data

Analysis Population Description

data not collected, 0 participants analyzed

Arm/Group Title	Aumolertinib Monotherapy	Aumolertinib + Platinum-based Doublet Chemotherapy	Osimertinib Monotherapy
Arm/Group Description:	Aumolertinib monotherapy: Administered orally, once daily as two 55-mg tablets for a total dose of 110 mg.	For adenocarcinoma, either: Aumolertinib + cisplatin with pemetrexed, or; Aumolertinib + carboplatin with pemetrexed For squamous cell carcinoma, one of the following: Aumolertinib + cisplatin or carboplatin with paclitaxel;; Aumolertinib + cisplatin or carboplatin with albumin-bound paclitaxel; or; Aumolertinib + cisplatin or carboplatin with gemcitabine Aumolertinib monotherapy: Administered orally, once daily as two 55-mg tablets for a total dose of 110 mg. Pemetrexed: Administered by IV Infusion per prescribing information. Maybe be continued as maintenance therapy Cisplatin: Administered by IV Infusion given over 4 fixed cycles (q3wk × 4 cycles) per prescribing information. Carboplatin: Administered by IV Infusion given over 4 fixed cycles (q3wk × 4 cycles) per prescribing information. Paclitaxel: Administered by IV Infusion given over 4 -6 fixed cycles per prescribing information. Nab paclitaxel: Administered by IV Infusion given over 4 fixed cycles per prescribing information. Gemcitabine: Administered by IV Infusion over 4 fixed cycles per prescribing information.	Osimertinib monotherapy: 80 mg tablet administered orally, once daily
Overall Number of Participants Analyzed	0	0	0

No data displayed because Outcome Measure has zero total analyzed.

21. Secondary Outcome

Title	Number of Participants With Laboratory Abnormalities
Description	This outcome will evaluate incidence of participants with laboratory abnormalities, graded according to NCI CTCAE V5.
Time Frame	From date of treatment initiation until discontinuation from treatment (plus 28 days for TEAEs), up to 5 years

Outcome Measure Data

Analysis Population Description

data not collected, 0 participants analyzed

Arm/Group Title	Aumolertinib Monotherapy	Aumolertinib + Platinum-based Doublet Chemotherapy	Osimertinib Monotherapy
Arm/Group Description:	Aumolertinib monotherapy: Administered orally, once daily as two 55-mg tablets for a total dose of 110 mg.	For adenocarcinoma, either: Aumolertinib + cisplatin with pemetrexed, or; Aumolertinib + carboplatin with pemetrexed For squamous cell carcinoma, one of the following: Aumolertinib + cisplatin or carboplatin with paclitaxel;; Aumolertinib + cisplatin or carboplatin with albumin-bound paclitaxel; or; Aumolertinib + cisplatin or carboplatin with gemcitabine Aumolertinib monotherapy: Administered orally, once daily as two 55-mg tablets for a total dose of 110 mg. Pemetrexed: Administered by IV Infusion per prescribing information. Maybe be continued as maintenance therapy Cisplatin: Administered by IV Infusion given over 4 fixed cycles (q3wk × 4 cycles) per prescribing information. Carboplatin: Administered by IV Infusion given over 4 fixed cycles (q3wk × 4 cycles) per prescribing information. Paclitaxel: Administered by IV Infusion given over 4 -6 fixed cycles per prescribing information. Nab paclitaxel: Administered by IV Infusion given over 4 fixed cycles per prescribing information. Gemcitabine: Administered by IV Infusion over 4 fixed cycles per prescribing information.	Osimertinib monotherapy: 80 mg tablet administered orally, once daily
Overall Number of Participants Analyzed	0	0	0

No data displayed because Outcome Measure has zero total analyzed.

Adverse Events

Time Frame	Adverse events were collected until the study reached early termination. Adverse events were collected from date of treatment initiation until discontinuation from treatment (plus 28 days for TEAEs), approximately 8 months, 17 days.
Adverse Event Reporting Description	The trial was discontinued at 8 months. No patients were analyzed.
Arm/Group Title	Aumolertinib Monotherapy	Aumolertinib + Platinum-based Doublet Chemotherapy	Osimertinib Monotherapy
Arm/Group Description	Aumolertinib monotherapy: Administered orally, once daily as two 55-mg tablets for a total dose of 110 mg.	For adenocarcinoma, either: Aumolertinib + cisplatin with pemetrexed, or; Aumolertinib + carboplatin with pemetrexed For squamous cell carcinoma, one of the following: Aumolertinib + cisplatin or carboplatin with paclitaxel;; Aumolertinib + cisplatin or carboplatin with albumin-bound paclitaxel; or; Aumolertinib + cisplatin or carboplatin with gemcitabine Aumolertinib monotherapy: Administered orally, once daily as two 55-mg tablets for a total dose of 110 mg. Pemetrexed: Administered by IV Infusion per prescribing information. Maybe be continued as maintenance therapy Cisplatin: Administered by IV Infusion given over 4 fixed cycles (q3wk × 4 cycles) per prescribing information. Carboplatin: Administered by IV Infusion given over 4 fixed cycles (q3wk × 4 cycles) per prescribing information. Paclitaxel: Administered by IV Infusion given over 4 -6 fixed cycles per prescribing information. Nab paclitaxel: Administered by IV Infusion given over 4 fixed cycles per prescribing information. Gemcitabine: Administered by IV Infusion over 4 fixed cycles per prescribing information.	Osimertinib monotherapy: 80 mg tablet administered orally, once daily
All-Cause Mortality
	Aumolertinib Monotherapy	Aumolertinib + Platinum-based Doublet Chemotherapy	Osimertinib Monotherapy
	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)
Total	0/1 (0.00%)	0/2 (0.00%)	0/5 (0.00%)
Serious Adverse Events
	Aumolertinib Monotherapy	Aumolertinib + Platinum-based Doublet Chemotherapy	Osimertinib Monotherapy
	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)
Total	0/1 (0.00%)	0/2 (0.00%)	0/5 (0.00%)
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	0%
	Aumolertinib Monotherapy	Aumolertinib + Platinum-based Doublet Chemotherapy	Osimertinib Monotherapy
	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)
Total	1/1 (100.00%)	2/2 (100.00%)	5/5 (100.00%)
Gastrointestinal disorders
Abdominal pain upper *	0/1 (0.00%)	2/2 (100.00%)	0/5 (0.00%)
Diarrhoea *	1/1 (100.00%)	0/2 (0.00%)	3/5 (60.00%)
Gastro-oesophageal reflux disease *	0/1 (0.00%)	1/2 (50.00%)	0/5 (0.00%)
Nausea *	1/1 (100.00%)	2/2 (100.00%)	1/5 (20.00%)
Vomiting *	0/1 (0.00%)	1/2 (50.00%)	0/5 (0.00%)
General disorders
Fatigue *	0/1 (0.00%)	2/2 (100.00%)	1/5 (20.00%)
Infections and infestations
Skin Infection *	0/1 (0.00%)	0/2 (0.00%)	1/5 (20.00%)
Investigations
Neutrophil count decreased *	0/1 (0.00%)	1/2 (50.00%)	1/5 (20.00%)
White blood cell count decreased *	0/1 (0.00%)	0/2 (0.00%)	1/5 (20.00%)
Metabolism and nutrition disorders
Dehydration *	0/1 (0.00%)	0/2 (0.00%)	1/5 (20.00%)
Musculoskeletal and connective tissue disorders
Muscular weakness *	0/1 (0.00%)	1/2 (50.00%)	0/5 (0.00%)
Myalgia *	0/1 (0.00%)	0/2 (0.00%)	1/5 (20.00%)
Pain in extremity *	1/1 (100.00%)	0/2 (0.00%)	0/5 (0.00%)
Nervous system disorders
Dizziness *	0/1 (0.00%)	0/2 (0.00%)	1/5 (20.00%)
Headache *	0/1 (0.00%)	0/2 (0.00%)	1/5 (20.00%)
Respiratory, thoracic and mediastinal disorders
Dyspnoea *	0/1 (0.00%)	1/2 (50.00%)	0/5 (0.00%)
Skin and subcutaneous tissue disorders
Dermatitis acneiform *	1/1 (100.00%)	0/2 (0.00%)	0/5 (0.00%)
Dry skin *	0/1 (0.00%)	0/2 (0.00%)	1/5 (20.00%)
Pruritis *	0/1 (0.00%)	0/2 (0.00%)	1/5 (20.00%)
Vascular disorders
Hypertension *	0/1 (0.00%)	0/2 (0.00%)	2/5 (40.00%)
Hypotension *	0/1 (0.00%)	1/2 (50.00%)	0/5 (0.00%)
* Indicates events were collected by non-systematic assessment

Limitations and Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact

• Name/Title: EQRx Clinical Trials
• Organization: EQRx International
• Phone: (650) 779-2300
• EMail: clinicalstudies@eqrx.com

• Responsible Party: EQRx International, Inc.
• ClinicalTrials.gov Identifier: NCT05493501
• Other Study ID Numbers: EQ143-301; 2022-002674-93 ( EudraCT Number )
• First Submitted: June 24, 2022
• First Posted: August 9, 2022
• Results First Submitted: November 1, 2023
• Results First Posted: May 2, 2024
• Last Update Posted: May 2, 2024