Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at Los Angeles, California and other locations
Dates
study started
completion around
Principal Investigator
by Jay Lee

Description

Summary

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.

Official Title

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

Keywords

Carcinoma, Non-Small-Cell Lung, Non-Small-Cell Lung Carcinoma, Pembrolizumab, Durvalumab, Olomorasib, Olomorasib + Pembrolizumab, Olomorasib + Durvalumab

Eligibility

You can join if…

Open to people ages 18 years and up

  • Histological or cytological confirmation of NSCLC.
    • Part A
      1. Clinical Stage II-IIIB (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 (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

You CAN'T join if...

  • Have known changes in the EGFR or ALK genes.
  • Have another type of cancer that is progressing or required active treatment within the past 3 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.

Locations

  • UCLA Hematology/Oncology - Santa Monica
    Los Angeles California 90404 United States
  • Profound Research LLC
    Oceanside California 92056 United States

Lead Scientist at UCLA

Details

Status
not yet accepting patients
Start Date
Completion Date
(estimated)
Sponsor
Eli Lilly and Company
ID
NCT06890598
Phase
Phase 3 research study
Study Type
Interventional
Participants
Expecting 700 study participants
Last Updated