A Study of DZD9008 Versus Platinum-Based Doublet Chemotherapy in Local Advanced or Metastatic Non-small Cell Lung Cancer

• ClinicalTrials.gov Identifier: NCT05668988
• Recruitment Status: Recruiting
• First Posted: December 30, 2022
• Last Update Posted: September 22, 2023
• Sponsor: Dizal Pharmaceuticals
• Information provided by (Responsible Party): Dizal Pharmaceuticals

Tracking Information

• First Submitted Date: December 20, 2022
• First Posted Date: December 30, 2022
• Last Update Posted Date: September 22, 2023
• Actual Study Start Date: December 13, 2022
• Estimated Primary Completion Date: February 28, 2026 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: December 20, 2022): Progression Free Survival (PFS) as assessed by Blinded Independent Central Review (BICR) per RECIST 1.1 [ Time Frame: Up to approximately 34 months after the first participant is randomized ]
• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures (submitted: December 20, 2022): Overall Survival [ Time Frame: Up to approximately 34 months after the first participant is randomized ]
• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: A Study of DZD9008 Versus Platinum-Based Doublet Chemotherapy in Local Advanced or Metastatic Non-small Cell Lung Cancer
• Official Title: A Phase 3, Open-Label, Randomized, Multi-Center Study of DZD9008 Versus Platinum-Based Doublet Chemotherapy as First-Line Treatment for Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer Harboring Epidermal Growth Factor Receptor Exon 20 Insertion Mutation

Brief Summary

This is a phase 3, open-label, randomized, multi-center study assessing the efficacy and safety of DZD9008 versus platinum-based doublet chemotherapy in participants with locally advanced or metastatic NSCLC with EGFR Exon20ins mutation, who are newly diagnosed or have not received prior systemic therapy in advanced stage.

Primary objective of this study is to assess the efficacy of DZD9008 versus platinum-based doublet chemotherapy using by BICR-assessed PFS per RECIST 1.1 as primary endpoint. Approximately 320 participants are estimated to be randomized into the study. Participants enrolled will be randomized to DZD9008 or platinum-based doublet chemotherapy in a 1:1 manner, stratified by baseline brain metastasis (with/without).

• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Non-small Cell Lung Cancer

Intervention

• Drug: DZD9008
  orally, 300 mg, once daily until a treatment discontinuation criterion is met.
• Drug: Pemetrexed+carboplatin
  Participants randomized into chemotherapy arm can receive up to 6 cycles of pemetrexed + carboplatin (pemetrexed 500 mg/m2 + carboplatin area under the plasma concentration-time curve 5 mg/ml per minute (AUC5), IV infusion, every 3 weeks) as the initial treatment. Participants whose disease has not progressed after 4 cycles of first-line platinum-based doublet chemotherapy may receive pemetrexed maintenance monotherapy until a treatment discontinuation criterion is met.

Study Arms

• Experimental: DZD9008
  Intervention: Drug: DZD9008
• Active Comparator: Platinum-based Chemotherapy
  Intervention: Drug: Pemetrexed+carboplatin

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: December 20, 2022): 320
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: October 31, 2027
• Estimated Primary Completion Date: February 28, 2026 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

1. Aged at least 18 years old (or per local regulatory/IRB requirement).
2. Histologically or cytologically confirmed diagnosis of non-squamous NSCLC, locally advanced (Stage IIIB and IIIC according to the 8th edition of the AJCC TNM staging criteria) or metastatic (Stage IV), not suitable for curative therapy.
3. Adequate tumor tissue available, for central laboratory confirmation of EGFR exon 20 insertion mutation
4. At least 1 measurable lesion per RECIST Version 1.1
5. Life expectancy ≥ 12 weeks
6. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1
7. Adequate organ and hematologic function

Exclusion Criteria:

1. Prior treatment with any systemic anti-cancer therapy for locally advanced or metastatic NSCLC.
2. Spinal cord compression or leptomeningeal metastasis.
3. Concurrent EGFR mutations: exon 19 deletion, L858R, T790M, G719X, S768I, or L861Q.
4. History of stroke or intracranial hemorrhage within 6 months before randomization.
5. As judged by the investigator, any evidence of severe or uncontrolled systemic diseases, including uncontrolled hypertension and active bleeding diatheses (i.e., hemophilia and Von Willebrand disease).

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

Contact: Cyrus Cai, M.D.; +86 21 6109 5805; cyrus.cai@dizalpharma.com

• Listed Location Countries: China

Administrative Information

• NCT Number: NCT05668988
• Other Study ID Numbers: DZ2022E0005
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Dizal Pharmaceuticals
• Original Responsible Party: Same as current
• Current Study Sponsor: Dizal Pharmaceuticals
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Caicun Zhou; Shanghai Pulmonary Hospital, Shanghai, China

• PRS Account: Dizal Pharmaceuticals
• Verification Date: September 2023