Testing LY3537982 against a placebo for non-small-cell lung carcinoma
Official title: A Study of First-Line Olomorasib (LY3537982) and Pembrolizumab With or Without Chemotherapy in Patients With Advanced KRAS G12C-Mutant Non-small Cell Lung Cancer
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
- Phase 3
- 8 groups
- Sites in Abbotsford British Columbia, Chicoutimi and 1 more city
- Recruiting
Interventions (6)
- Medication
LY3537982
Administered orally.
- Medication
Pembrolizumab
Administered IV.
- Medication
Placebo
Administered orally.
- Medication
Cisplatin
Administered IV.
- Medication
Carboplatin
Administered IV.
- Medication
Pemetrexed
Administered IV.
Canadian Sites (3)
3 of 3 recruiting
- Recruiting
BC Cancer Abbotsford
Abbotsford British Columbia
- Recruiting
CIUSSS- saguenay-Lac-Saint-Jean
Chicoutimi
- Recruiting
BC Cancer Vancouver
Vancouver
Eligibility Criteria
See who this study is looking for25 criteria
The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.
Inclusion
- +Must have disease with evidence of KRAS G12C mutation.
- +Must have known programmed death-ligand 1 (PD-L1) expression
- +Must have adequate laboratory parameters.
- +Part B and Safety Lead-In Part B: the histology of the tumor must be predominantly non-squamous (in line with pemetrexed label).
- +Part A: Greater than or equal to (≥)50 percent (%).
- +Part B: 0% to 100%.
- +Part C: \<50%.
- +Must have measurable disease per RECIST v1.1.
- +Estimated life expectancy ≥12 weeks.
- +Ability to swallow capsules.
- +Must have an ECOG performance status of 0 or 1.
- +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
- +Histologically or cytologically confirmed NSCLC with Stage IIIB-IIIC or Stage IV disease, not suitable for curative intent radical surgery or radiation therapy.
Exclusion
- −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 randomizationRandomisedWhich group you go into is decided by chance, not by you or your doctor.Read more →:
- −\--- 1 cycle of standard-of-care treatment prior to study enrollmentEnrolmentThe number of participants a study plans to include, or has included.Read more → will be allowed for cases where immediate treatment is clinically indicated:
- −Have known active central nervous system metastases and/or carcinomatous meningitis.
- −Exclusion CriteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → for Participants receiving Pemetrexed and Platinum (Part B and Safety Lead-In Part B)
- −Have predominantly squamous cell histology for NSCLC
- −Only for participants with mild to moderate renal insufficiency: Unable to avoid aspirin, ibuprofen, or other nonsteroidal anti-inflammatory drugs (NSAIDs) two days before (5 days for long acting NSAIDs), day of, and two days after administration of pemetrexed
- −Is unable or unwilling to take folic acid or vitamin B12 supplementation.
- −\-- Prior systemic therapy (chemotherapy, immunotherapy, targeted therapy, or biological therapy) for advanced or metastatic NSCLC.
In plain language
Assembled directly from this trial’s registry record. Every sentence traces to a field below — nothing here is generated or interpreted.
What this study is
This study is testing a treatment for a condition.
Phase 3Phase 3A large study comparing a treatment against the current standard.Read more → — a large study comparing this against the current standard, usually across many hospitals.
From the trial registry
Built from these fields:
- designModule.designInfo.primaryPurpose
- designModule.phases
Who receives what
There are 8 groups in this study.
Groups A, B, D and H receive LY3537982 and Pembrolizumab.
Registry label: A: Dose Optimization: LY3537982 Dose Level 1 plus Pembrolizumab · B: Dose Optimization: LY3537982 Dose Level 2 plus Pembrolizumab · D: Part A: LY3537982 plus Pembrolizumab · H: Part C: LY3537982 plus Pembrolizumab
Groups C and F receive LY3537982, Pembrolizumab and Pemetrexed, together with one or more of: Cisplatin and Carboplatin.
Registry label: C: Safety Lead In: LY3537982 plus Pembrolizumab, Pemetrexed and Platinum · F: Part B: LY3537982 plus Pembrolizumab, Pemetrexed, and Platinum
Group E, the placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group, receives Placebo and Pembrolizumab.
Registry label: E: Part A: Placebo plus Pembrolizumab
Group G, the placebo group, receives Placebo, Pembrolizumab and Pemetrexed, together with one or more of: Cisplatin and Carboplatin.
Registry label: G: Part B: Placebo plus Pembrolizumab, Pemetrexed, and Platinum
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].label
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
How the study is run
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
Neither you nor the study team would know which group you are in until the study ends.
From the trial registry
Built from these fields:
- designModule.designInfo.allocation
- designModule.designInfo.maskingInfo.masking
Is there a placebo?
One group receives a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → — a dummy treatment with no active medicine in it.
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
Who the study is looking for
The study lists a minimum age of 18 years, with no upper limit given.
The study is open to people of any sex.
The study does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
These are the criteria the study lists. Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part.
From the trial registry
Built from these fields:
- eligibilityModule.minimumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How big and how long
The study aims to enrol about 1,264 people.
The study is currently expected to finish around January 2031.
The main measurement is taken over: RandomizationRandomisedWhich group you go into is decided by chance, not by you or your doctor.Read more → to first documented progression of disease or death from any cause. (Estimated as approximately 1 year).
From the trial registry
Built from these fields:
- designModule.enrollmentInfo.count
- statusModule.completionDateStruct.date
- outcomesModule.primaryOutcomes[].timeFrame
What the study measures
Dose Optimization and Safety Lead-In Part B: Number of Participants with a Treatment Emergent Adverse EventAdverse eventAny medical problem that happens during a study, whether or not the treatment caused it.Read more →(s) (TEAE) — measured over RandomizationRandomisedWhich group you go into is decided by chance, not by you or your doctor.Read more → to first documented progression of disease or death from any cause. (Estimated as approximately 1 year).
Part A and Part B: Progression-Free Survival (PFS) — measured over Randomization to first documented progression of disease or death from any cause. (Estimated as approximately 1 year).
From the trial registry
Built from these fields:
- outcomesModule.primaryOutcomes[].measure
- outcomesModule.primaryOutcomes[].timeFrame
Source: NCT06119581 on ClinicalTrials.gov. The full registry text is further down this page — this summary never replaces it.
Not medical advice. What do these terms mean?
What is being tested — in plain terms
About LY3537982Drug
Administered orally.
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
About PembrolizumabDrug
Administered IV.
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
About PlaceboDrug
Administered orally.
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
About CisplatinDrug
Administered IV.
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
About CarboplatinDrug
Administered IV.
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
About PemetrexedDrug
Administered IV.
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
Common questions
Answered from this trial’s registry record. Where the record doesn’t say, these answers say so rather than filling the gap.
Am I eligible for this trial?
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part. Concord cannot make that determination, and neither can any tool that has not examined you.
What the study lists: a minimum age of 18 years.
The full inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more → and exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → are published on this page, exactly as the study team wrote them.
The useful next step is to bring this trial to your doctor. Answering a few questions first gives them something concrete to review.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.eligibilityCriteria
Is there a placebo?
Yes. This study includes a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group — a dummy treatment with no active medicine in it.
From the trial registry
- armsInterventionsModule.armGroups[].type
Would I know which treatment I am getting?
Neither you nor the study team would know which group you are in until the study ends.
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
From the trial registry
- designModule.designInfo.maskingInfo.masking
- designModule.designInfo.allocation
Who can join?
The study lists a minimum age of 18 years, with no upper limit given.
It is open to people of any sex.
It does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can confirm whether a particular person can take part.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How long would this take?
The study's main measurement is taken over: RandomizationRandomisedWhich group you go into is decided by chance, not by you or your doctor.Read more → to first documented progression of disease or death from any cause. (Estimated as approximately 1 year).
The study as a whole is currently expected to finish around 2031-01.
How long any one person takes part can differ from the study length. The study team can tell you what the schedule looks like in practice.
From the trial registry
- outcomesModule.primaryOutcomes[].timeFrame
- statusModule.completionDateStruct.date
How many people are taking part?
The study aims to enrol about 1,264 people.
From the trial registry
- designModule.enrollmentInfo.count
Where is this happening?
This study lists 15 locations, including: Abbotsford British Columbia, Canada; Chicoutimi, Canada; Vancouver, Canada; Ann Arbor, Michigan, United States; Grand Rapids, Michigan, United States; Minneapolis, Minnesota, United States, and 9 more.
Sites can open and close during a study, so confirm with the team before travelling.
From the trial registry
- trial_locations
About This Trial
The purpose of this study is to assess if adding LY3537982 (olomorasib) 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.
Other Sites (15)
University of Michigan
Ann Arbor, Michigan, United States
The Cancer & Hematology Centers
Grand Rapids, Michigan, United States
Allina Health Cancer Institute - Abbott Northwestern Hospital
Minneapolis, Minnesota, United States
HealthPartners Cancer Research Center
Saint Paul, Minnesota, United States
Maimonides Cancer Center
Brooklyn, New York, United States
Northwell Health/ RJ Zuckerberg Cancer Center
Lake Success, New York, United States
Perlmutter Cancer Center at NYU Langone Hospital - Long Island
Mineola, New York, United States
Laura and Isaac Perlmutter Cancer Center
New York, New York, United States
Manhattan Eye, Ear and Throat Hospital
New York, New York, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
Swedish Cancer Institute - Edmonds
Edmonds, Washington, United States
Kadlec Clinic Hematology and Oncology
Kennewick, Washington, United States
Swedish Medical Center
Seattle, Washington, United States
VA Puget Sound Health Care System
Seattle, Washington, United States
USO - Northwest Cancer Specialists
Vancouver, Washington, United States
If this study interests you
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This page is for informational purposes only and does not constitute medical advice. Clinical trial eligibility can only be determined by the trial site after proper screening. Trial information is sourced from ClinicalTrials.gov and may not reflect the most current status. Always consult your healthcare provider before making decisions about clinical trial participation.