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RecruitingPhase 3

Study of Olomorasib (LY3537982) in Combination With Standard of Care in Participants With Resected or Unresectable KRAS G12C-mutant Non-Small Cell Lung Cancer

A Phase 3, Multicenter, Double-Blind, Placebo-controlled Study Assessing the Efficacy and Safety of Olomorasib in Combination With Standard of Care Immunotherapy in Participants With Resected or Unresectable KRAS G12C-Mutant, Non-Small Cell Lung Cancer - SUNRAY-02

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 3 years

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "The study may last up to 3 years for each participant."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether adding olomorasib works better than adding a placebo (a pill with no active drug) to pembrolizumab or durvalumab. It is for people with non-small cell lung cancer with a KRAS G12C gene change, either removed by surgery or unable to be removed by surgery. Each person may be in the study for up to 3 years.

The main purpose of this study is to assess if olomorasib in combination with pembrolizumab is more effective than the pembrolizumab and placebo combination in part A in participants with resected KRAS G12C-mutant NSCLC and to assess if olomorasib in combination with durvalumab is more effective than the durvalumab and placebo combination in part B in participants with unresectable KRAS G12C-mutant non-small cell lung cancer. The study may last up to 3 years for each participant.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Have non-small cell lung cancer confirmed by a tissue or cell test.
  • Part A: Have stage II–IIIB cancer removed by surgery. If chemotherapy and immune treatment were given before surgery, some cancer must still have been present at surgery.
  • Part B: Have stage III cancer that cannot be removed by surgery and did not get worse during platinum-based chemotherapy given with radiation.
  • Have a KRAS G12C gene change and a known level of PD-L1, a protein on cells.
  • Be fully active or able to do light work, even if hard physical activity is limited.
  • Be able to swallow medicine and have lab test results that meet study requirements.
  • Follow local birth control rules for people in clinical studies.
  • If able to become pregnant, have a negative pregnancy test and do not breastfeed during treatment.

Who can't join

  • Have a known EGFR or ALK gene change that can be targeted with treatment.
  • Have another cancer that is getting worse or needed active treatment in the 2 years before screening.
  • Have an active autoimmune disease, where the immune system attacks the body, that needed whole-body treatment in the past 2 years. Hormone replacement treatment is allowed.
  • Had a severe immune-related side effect or allergic reaction from past immune treatment, or still have an immune-related side effect that is more than mild. Hormone-related diseases controlled with stable hormone replacement treatment are an exception.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: * Histological or cytological confirmation of NSCLC. * Part A 1. Clinical Stage II-IIIB (N0, N1, N2) treated with presurgical chemoimmunotherapy, with residual tumor present at time of surgery. Patients with a pathologic complete response are not eligible. 2. Pathologic Stage II-IIIB (N0, N1, N2) NSCLC treated with initial upfront resection. * Part B - Clinical Stage III, unresectable NSCLC, without progression on concurrent platinum-based chemoradiotherapy. * Must have disease with evidence of KRAS G12C mutation. * Must have known programmed death-ligand 1 (PD-L1) expression * Must have an ECOG performance status of 0 or 1. * Able to swallow oral medication. * 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 Exclusion Criteria: * Have known, actionable changes in the EGFR or ALK genes. * Have another type of cancer that is progressing or required active treatment within the past 2 years before screening. * Have an active autoimmune disease that required systemic treatment in the past 2 years. Endocrine replacement therapy is allowed. * Had any immune-related side effect or allergic reaction (Grade 3 or higher) from a previous immunotherapy medicine, or any immune-related side effect greater than Grade 1 that has not resolved. This does not apply for people with hormone-related diseases who are now on stable hormone replacement therapy.

Study sites (91)

AL

AR

AZ

CA

CT

DC

FL

GA

  • University Cancer & Blood Center, LLC · Athens, GA 30607 · Study contact · 706-353-2990Frederick Flynt · Principal investigatorMore trials in Athens
  • Winship Cancer Institute · Atlanta, GA 30322Jennifer Carlisle · Principal investigatorMore trials in Atlanta
  • City of Hope National Medical Center, Atlanta Cancer Center · Newnan, GA 30265Evan Pisick · Principal investigatorMore trials in Newnan

IL

IN

KY

LA

MA

MD

ME

MI

MO

NC

NH

NJ

  • Jefferson Health - Cherry Hill · Cherry Hill, NJ 08002Sarah Gordon · Principal investigatorMore trials in Cherry Hill
  • Sidney Kimmel Cancer Center - Washington Township · Sewell, NJ 08080Sarah Gordon · Principal investigatorMore trials in Sewell

NY

OH

OR

PA

  • Thomas Jefferson University, Sidney Kimmel Cancer Center - Clinical Trials Office · Philadelphia, PA 19107Sarah Gordon · Principal investigatorMore trials in Philadelphia
  • Jefferson Hospital Northeast · Philadelphia, PA 19114Sarah Gordon · Principal investigatorMore trials in Philadelphia
  • AHN Allegheny General Hospital · Pittsburgh, PA 15212Ariel Lopez-Chavez · Principal investigatorMore trials in Pittsburgh

SC

SD

TN

TX

VA

VT

  • The University of Vermont Medical Center Inc. · Burlington, VT 05405Rohit Singh · Principal investigatorMore trials in Burlington

WA

WI