Recruiting NCT06890598

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

Phase III Interventional Carcinoma, Non-Small-Cell Lung

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied: The protocol lists: Olomorasib, Pembrolizumab, Durvalumab, Placebo.
Who it may be relevant to: Registry conditions: Carcinoma, Non-Small-Cell Lung. Basic parameters: from 18 years · All.
What needs checking: Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place: United States, Australia, Austria, Belgium, Brazil +24
Next step: Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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

Overview

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.

Interventions

Drug Olomorasib
Administered orally.
Drug Pembrolizumab
Administered intravenously (IV).
Drug Durvalumab
Administered IV.
Drug Placebo
Administered orally.

Primary outcome measures

Part A: Disease-Free Survival (DFS) by Investigator Assessment [Time frame: Randomization to disease recurrence or death from any cause (Estimated as approximately 4 years).]
Part B: Progression-Free Survival (PFS) by BICR [Time frame: Randomization to disease progression or death from any cause (Estimated as approximately 3 years).]

Secondary outcome measures (11)

Part A & B: Overall Survival (OS) [Time frame: Randomization to disease progression or death from any cause (Estimated as approximately 5 years).]
Part A & B: Change from baseline in health-related quality of life (HRQoL), measured by European Organization for Research & Treatment of CancerQualityofLifeQuestionnaire-Core 30 (EORTC QLQ-C30) [Time frame: Randomization through end of treatment (Estimated as approximately 3 years).]
Part B: PFS by Investigator [Time frame: Randomization to disease progression or death from any cause (Estimated as approximately 3 years)]
Part B: Objective Response Rate (ORR) per RECIST 1.1 by BICR and Investigator [Time frame: Randomization to disease progression or death from any cause (Estimated as approximately 3 years).]
Part B: Duration of Response (DOR) per RECIST 1.1 by BICR and Investigator [Time frame: Randomization to disease progression or death from any cause (Estimated as approximately 3 years).]
Part B: Disease Control Rate (DCR) per RECIST 1.1 by BICR and Investigator [Time frame: Randomization to disease progression or death from any cause (Estimated as approximately 3 years).]
Part B: Time to Response (TTR) per RECIST 1.1 by BICR and Investigator [Time frame: Randomization until the date that measurement criteria for CR or PR (whichever is first recorded) are first met (Estimated as approximately 3 years).]
Part B: Progression-Free Survival 2 (PFS2) by investigator assessment [Time frame: Randomization to disease progression on next line of treatment or death from any cause (Estimated as approximately 3 years).]]
Part B: Changes in Non-Small Cell Lung Cancer (NSCLC)-related symptoms, measured by the NSCLC-Symptom Assessment Questionnaire (SAQ) [Time frame: Randomization through end of treatment (Estimated as approximately 3 years).]
Part B: Time to worsening of NSCLC-related symptoms, as measured by NSCLC-SAQ [Time frame: Randomization through end of treatment (Estimated as approximately 3 years).]
Part B: Changes in patient-reported pulmonary symptoms of cough, chest pain, and dyspnea, measured by NSCLC-SAQ [Time frame: Randomization through end of treatment (Estimated as approximately 3 years).]

Eligibility criteria

Inclusion criteria

Histological or cytological confirmation of NSCLC.

Part A

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.
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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation: Randomized
Model: Parallel assignment
Masking: Double blind
Primary purpose: Treatment