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)
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT06119581 |
Recruitment Status :
Recruiting
First Posted : November 7, 2023
Last Update Posted : May 6, 2024
|
Sponsor:
Eli Lilly and Company
Collaborator:
Loxo Oncology, Inc.
Information provided by (Responsible Party):
Eli Lilly and Company
Tracking Information | |||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
First Submitted Date ICMJE | November 1, 2023 | ||||||||||||||||
First Posted Date ICMJE | November 7, 2023 | ||||||||||||||||
Last Update Posted Date | May 6, 2024 | ||||||||||||||||
Actual Study Start Date ICMJE | December 21, 2023 | ||||||||||||||||
Estimated Primary Completion Date | October 2026 (Final data collection date for primary outcome measure) | ||||||||||||||||
Current Primary Outcome Measures ICMJE |
|
||||||||||||||||
Original Primary Outcome Measures ICMJE | Same as current | ||||||||||||||||
Change History | |||||||||||||||||
Current Secondary Outcome Measures ICMJE |
|
||||||||||||||||
Original Secondary Outcome Measures ICMJE | Same as current | ||||||||||||||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||||||||||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||||||||||||
Descriptive Information | |||||||||||||||||
Brief Title ICMJE | 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 | ||||||||||||||||
Official Title ICMJE | 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 | ||||||||||||||||
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. | ||||||||||||||||
Detailed Description | Dose Optimization, Part A, and Part B are randomized. Safety Lead-In for Part B is single arm, non-randomized. | ||||||||||||||||
Study Type ICMJE | Interventional | ||||||||||||||||
Study Phase ICMJE | Phase 3 | ||||||||||||||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double (Participant, Investigator) Primary Purpose: Treatment |
||||||||||||||||
Condition ICMJE |
|
||||||||||||||||
Intervention ICMJE |
|
||||||||||||||||
Study Arms ICMJE |
|
||||||||||||||||
Publications * | Not Provided | ||||||||||||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||||||||||||||
Recruitment Information | |||||||||||||||||
Recruitment Status ICMJE | Recruiting | ||||||||||||||||
Estimated Enrollment ICMJE |
1016 | ||||||||||||||||
Original Estimated Enrollment ICMJE | Same as current | ||||||||||||||||
Estimated Study Completion Date ICMJE | October 2029 | ||||||||||||||||
Estimated Primary Completion Date | October 2026 (Final data collection date for primary outcome measure) | ||||||||||||||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
Exclusion Criteria for Participants receiving Pemetrexed and Platinum (Part B and Safety Lead-In Part B)
|
||||||||||||||||
Sex/Gender ICMJE |
|
||||||||||||||||
Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||||||||||||||
Accepts Healthy Volunteers ICMJE | No | ||||||||||||||||
Contacts ICMJE |
|
||||||||||||||||
Listed Location Countries ICMJE | Australia, Austria, Belgium, Brazil, Canada, China, Czechia, Denmark, France, Germany, Greece, Hungary, India, Italy, Japan, Korea, Republic of, Mexico, Netherlands, Norway, Poland, Portugal, Romania, Spain, Sweden, Switzerland, Taiwan, Turkey, United Kingdom, United States | ||||||||||||||||
Removed Location Countries | |||||||||||||||||
Administrative Information | |||||||||||||||||
NCT Number ICMJE | NCT06119581 | ||||||||||||||||
Other Study ID Numbers ICMJE | 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 ) |
||||||||||||||||
Has Data Monitoring Committee | Yes | ||||||||||||||||
U.S. FDA-regulated Product |
|
||||||||||||||||
IPD Sharing Statement ICMJE |
|
||||||||||||||||
Current Responsible Party | Eli Lilly and Company | ||||||||||||||||
Original Responsible Party | Same as current | ||||||||||||||||
Current Study Sponsor ICMJE | Eli Lilly and Company | ||||||||||||||||
Original Study Sponsor ICMJE | Same as current | ||||||||||||||||
Collaborators ICMJE | Loxo Oncology, Inc. | ||||||||||||||||
Investigators ICMJE |
|
||||||||||||||||
PRS Account | Eli Lilly and Company | ||||||||||||||||
Verification Date | May 2024 | ||||||||||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |