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Trial record 1 of 1 for:    J3M-MC-JZQB
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A Study of LY3537982 Plus Immunotherapy With or Without Chemotherapy in Participants With Non-Small Cell Lung Cancer (NSCLC) With a Change in a Gene Called KRAS G12C (SUNRAY-01)

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ClinicalTrials.gov Identifier: NCT06119581
Recruitment Status : Recruiting
First Posted : November 7, 2023
Last Update Posted : April 26, 2024
Sponsor:
Collaborator:
Loxo Oncology, Inc.
Information provided by (Responsible Party):
Eli Lilly and Company

Study Description
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Brief Summary:
The purpose of this study is to assess if adding LY3537982 in combination with standard of care anti-cancer drugs is more effective than standard of care in participants with untreated advanced NSCLC. NSCLC must have a change in a gene called KRAS G12C. Study participation, including follow-up, could last up to 3 years, depending on how you and your lung cancer are doing.

Condition or disease Intervention/treatment Phase
Carcinoma, Non-Small-Cell Lung Neoplasm Metastasis Drug: LY3537982 Drug: Pembrolizumab Drug: Placebo Drug: Cisplatin Drug: Carboplatin Drug: Pemetrexed Phase 3

Detailed Description:
Dose Optimization, Part A, and Part B are randomized. Safety Lead-In for Part B is single arm, non-randomized.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1016 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: SUNRAY-01, A Global Pivotal Study in Participants With KRAS G12C-Mutant, Locally Advanced or Metastatic Non-Small Cell Lung Cancer Comparing First-Line Treatment of LY3537982 and Pembrolizumab vs Placebo and Pembrolizumab in Those With PD-L1 Expression ≥50% or LY3537982 and Pembrolizumab, Pemetrexed, Platinum vs Placebo and Pembrolizumab, Pemetrexed, Platinum Regardless of PD-L1 Expression
Actual Study Start Date : December 21, 2023
Estimated Primary Completion Date : October 2026
Estimated Study Completion Date : October 2029

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Dose Optimization: LY3537982 Dose Level 1 plus Pembrolizumab
LY3537982 Dose level 1 administered orally in combination with pembrolizumab administered intravenously (IV) in 21-day cycles. Participants may continue to receive treatment until discontinuation criteria are met.
 Drug: LY3537982
Administered orally.

Drug: Pembrolizumab
Administered IV.
Experimental: Dose Optimization: LY3537982 Dose Level 2 plus Pembrolizumab
LY3537982 Dose level 2 administered orally in combination with pembrolizumab administered IV in 21-day cycles. Participants may continue to receive treatment until discontinuation criteria are met.
 Drug: LY3537982
Administered orally.

Drug: Pembrolizumab
Administered IV.
Experimental: Safety Lead In: LY3537982 plus Pembrolizumab, Pemetrexed and Platinum
LY3537982 administered orally in combination with pembrolizumab, pemetrexed, and platinum (cisplatin or carboplatin) administered IV in 21-day cycles. Participants may continue to receive treatment until discontinuation criteria are met.
 Drug: LY3537982
Administered orally.

Drug: Pembrolizumab
Administered IV.

Drug: Cisplatin
Administered IV.

Drug: Carboplatin
Administered IV.

Drug: Pemetrexed
Administered IV.
Experimental: Part A: LY3537982 plus Pembrolizumab
LY3537982 administered orally in combination with pembrolizumab administered IV in 21-day cycles. Participants may continue to receive treatment until discontinuation criteria are met.
 Drug: LY3537982
Administered orally.

Drug: Pembrolizumab
Administered IV.
Placebo Comparator: Part A: Placebo plus Pembrolizumab
Placebo administered orally in combination with pembrolizumab administered IV in 21-day cycles. Participants may continue to receive treatment until discontinuation criteria are met.
 Drug: Pembrolizumab
Administered IV.

Drug: Placebo
Administered orally.
Experimental: Part B: LY3537982 plus Pembrolizumab, Pemetrexed, and Platinum
LY3537982 administered orally in combination with pembrolizumab, pemetrexed, and platinum (cisplatin or carboplatin) administered IV in 21-day cycles. Participants may continue to receive treatment until discontinuation criteria are met.
 Drug: LY3537982
Administered orally.

Drug: Pembrolizumab
Administered IV.

Drug: Cisplatin
Administered IV.

Drug: Carboplatin
Administered IV.

Drug: Pemetrexed
Administered IV.
Placebo Comparator: Part B: Placebo plus Pembrolizumab, Pemetrexed, and Platinum
Placebo administered orally in combination with pembrolizumab, pemetrexed, and platinum (cisplatin or carboplatin) administered IV in 21-day cycles. Participants may continue to receive treatment until discontinuation criteria are met.
 Drug: Pembrolizumab
Administered IV.

Drug: Placebo
Administered orally.

Drug: Cisplatin
Administered IV.

Drug: Carboplatin
Administered IV.

Drug: Pemetrexed
Administered IV.


Outcome Measures
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Primary Outcome Measures :
  1. Dose Optimization and Safety Lead-In Part B: Number of Participants with a Treatment Emergent Adverse Event(s) (TEAE) [ Time Frame: Randomization to first documented progression of disease or death from any cause. (Estimated as approximately 1 year) ]
    Dose Optimization and Safety Lead-In Part B: Number of Participants with a TEAE

  2. Part A and Part B: Progression-Free Survival (PFS) [ Time Frame: Randomization to first documented progression of disease or death from any cause. (Estimated as approximately 1 year) ]
    PFS per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 by blinded independent central review (BICR)


Secondary Outcome Measures :
  1. Part A and Part B: Overall Survival (OS) [ Time Frame: Randomization to date of death from any cause. (Estimated as up to 3 years) ]
    Part A and Part B: OS

  2. Part A and Part B: Overall Response Rate (ORR): Percentage of Participants who Achieve a Best Overall Response (BOR) of Complete Response (CR) or Partial Response (PR) [ Time Frame: Randomization to disease progression or death. (Estimated as approximately 1 year) ]
    ORR per RECIST v1.1 by BICR

  3. Part A and Part B: Duration of Response (DOR) [ Time Frame: Date of first evidence of CR or PR to date of disease progression or death from any cause. (Estimated as approximately 1 year) ]
    DOR per RECIST v1.1 by BICR

  4. Part A and Part B: Disease Control Rate (DCR): Percentage of Participants who Achieve a BOR of CR, PR, or Stable Disease (SD) [ Time Frame: Randomization to disease progression or death from any cause. (Estimated as approximately 1 year) ]
    DCR per RECIST v1.1 by BICR

  5. Part A and Part B: Time to Response (TTR) [ Time Frame: Time from randomization until the date that measurement criteria for CR or PR (whichever is first recorded) are first met (Estimated as approximately 1 year) ]
    TTR per RECIST v1.1 by BICR

  6. Part A and Part B: PFS2 [ Time Frame: Randomization to disease progression on next line of treatment or death from any cause (Estimated as approximately 1 year ]
    Part A and Part B: PFS2 by Investigator

  7. Part A and Part B: Time to Worsening of NSCLC-related Symptoms as Measured by NSCLC Symptom Assessment Questionnaire (NSCLC-SAQ) [ Time Frame: Randomization through end of treatment (Estimated as approximately 1 year) ]
    NSCLC symptoms will be assessed using the 7-item NSCLC-SAQ. The NSCLC-SAQ measures overall symptom severity of NSCLC, including cough, pain, dyspnea, fatigue, and poor appetite. Response options range from 0) "Not at all" to 4) "Always" or from 0) "Never" to 4) "Always." The total score ranges from 0-20. Higher scores represent worse symptoms.

  8. Part A and Part B: Time to Deterioration in Physical Function, as Measured by the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Core Questionnaire (EORTC QLQ-C30) Physical Functioning Subscale [ Time Frame: Randomization through end of treatment (Estimated as approximately 1 year) ]
    The EORTC QLQ-C30 is a 30-question patient-reported instrument used to assess multidimensional health-related quality of life (HRQoL) in cancer patients. Physical functioning is measured by the EORTC-QLQ-30 Physical Function Scale (five items). Response options range from 1) "Not at all" to 4) "Very much." The sum score is linearly transformed to the range 0 - 100. Higher scores represent better physical function.

  9. Part A and Part B: Proportion of Time with High Side-Effect Burden, as Measured by Functional Assessment of Cancer Therapy - General Item 5 (FACT-GP5) [ Time Frame: Randomization through end of treatment (Estimated as approximately 1 year) ]
    FACT-GP5 is a single-item, patient-reported instrument for assessing overall treatment side-effect burden. Response options range from 0) "Not at all" to 4) "Very much." Higher scores represent higher symptom burden.

  10. Part A and Part B: Change from Baseline in Overall Health-related Quality of Life, as Measured by the EORTC QLQ-C30 Global Health Status/Quality of Life Subscale [ Time Frame: Randomization through end of treatment (Estimated as approximately 1 year) ]
    The EORTC QLQ-C30 is a 30-question patient-reported instrument used to assess multidimensional HRQoL in cancer patients. Overall HRQoL is measured by the EORTC QLQ-30 Global Health Status/Quality of Life Subscale (two items). Response options range from 1) "very poor" to 7) "excellent." Scores are linearly transformed to the range 0 - 100. Higher scores represent better overall HRQoL.


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histologically or cytologically confirmed NSCLC with Stage IIIB-IIIC or Stage IV disease, not suitable for curative intent radical surgery or radiation therapy.
  • Part B and Safety Lead-In Part B: the histology of the tumor must be predominantly non-squamous (in line with pemetrexed label).
  • Must have disease with evidence of KRAS G12C mutation.

  • Must have known programmed death-ligand 1 (PD-L1) expression

    • Part A: Greater than or equal to (≥)50 percent (%).
    • Part B: 0% to 100%.
  • Must have measurable disease per RECIST v1.1.
  • Must have an ECOG performance status of 0 or 1.
  • Estimated life expectancy ≥12 weeks.
  • Ability to swallow capsules.
  • Must have adequate laboratory parameters.
  • Contraceptive use should be consistent with local regulations for those participating in clinical studies.

  • Women of childbearing potential must

    • Have a negative pregnancy test.
    • Not be breastfeeding during treatment and after study intervention for at least 180 days.

Exclusion Criteria:

  • Have a documented additional validated targetable oncogenic driver mutation or alteration in genes such as epidermal growth factor receptor (EGFR), anaplastic lymphoma kinase (ALK), BRAF (V600E), human epidermal growth factor receptor 2 (HER2), MET (exon 14), ROS1, rearranged during transfection (RET), or neurotrophic tyrosine receptor kinase (NTRK)1/2/3.

  • Have had any of the following prior to randomization:

    -- Prior systemic therapy (chemotherapy, immunotherapy, targeted therapy, or biological therapy) for advanced or metastatic NSCLC.

    --- 1 cycle of standard-of-care treatment prior to study enrollment will be allowed for cases where immediate treatment is clinically indicated:

  • Have known active central nervous system metastases and/or carcinomatous meningitis.

Exclusion Criteria for Participants receiving Pemetrexed and Platinum (Part B and Safety Lead-In Part B)

  • Squamous cell and/or mixed small cell/nonsmall cell histology is not permitted.
  • Is unable to interrupt aspirin or other nonsteroidal anti-inflammatory drugs (NSAIDs)
  • Is unable or unwilling to take folic acid or vitamin B12 supplementation.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06119581


Contacts
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Contact: There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 ClinicalTrials.gov@lilly.com

Locations
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Sponsors and Collaborators
Eli Lilly and Company
Loxo Oncology, Inc.
Investigators
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Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST) Eli Lilly and Company
More Information
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Additional Information:

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Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT06119581    
Other Study ID Numbers: 18612
J3M-MC-JZQB ( Other Identifier: Eli Lilly and Company )
U1111-1288-0565 ( Other Identifier: Universal Trial Number )
2023-503412-33-00 ( Other Identifier: EU Trial Number )
First Posted: November 7, 2023    Key Record Dates
Last Update Posted: April 26, 2024
Last Verified: April 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
Time Frame: Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.
Access Criteria: A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
URL: https://vivli.org/

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Carcinoma, Non-Small-Cell Lung
Neoplasm Metastasis
Carcinoma, Bronchogenic
Bronchial Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Neoplastic Processes
 Pathologic Processes
Carboplatin
Pembrolizumab
Pemetrexed
Antineoplastic Agents
Antineoplastic Agents, Immunological
Immune Checkpoint Inhibitors
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors
Folic Acid Antagonists
Nucleic Acid Synthesis Inhibitors