Health Trials

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

ConditionCarcinoma, Non-Small-Cell Lung
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorEli Lilly and Company

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Olomorasib

    Drug

    Administered orally.

  • Pembrolizumab

    Drug

    Administered intravenously (IV).

  • Durvalumab

    Drug

    Administered IV.

  • Placebo

    Drug

    Administered orally.

Treatment groups

700 Participants
are divided into 4 treatment groups
Group A: Part A: Olomorasib + PembrolizumabExperimental treatment 2 interventions
Group B: Part A: Placebo + PembrolizumabPlacebo comparator 2 interventions
Group C: Part B: Olomorasib + DurvalumabExperimental treatment 2 interventions
Group D: Part B: Placebo + DurvalumabPlacebo comparator 2 interventions

Trial outcomes

Primary outcomes

1

Part A: Disease-Free Survival (DFS) by Investigator Assessment

DFS by Investigator Assessment

Time frame
Randomization to disease recurrence or death from any cause (Estimated as approximately 4 years).
2

Part B: Progression-Free Survival (PFS) by BICR

PFS per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 by blinded independent central review (BICR)

Time frame
Randomization to disease progression or death from any cause (Estimated as approximately 3 years).

Secondary outcomes

1

Part A & B: Overall Survival (OS)

OS

Time frame
Randomization to disease progression or death from any cause (Estimated as approximately 5 years).
2

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)

Change from baseline in HRQoL, measured by the EORTC QLQ-C30

Time frame
Randomization through end of treatment (Estimated as approximately 3 years).
3

Part B: PFS by Investigator

PFS per RECIST v1.1 by Investigator

Time frame
Randomization to disease progression or death from any cause (Estimated as approximately 3 years)
4

Part B: Objective Response Rate (ORR) per RECIST 1.1 by BICR and Investigator

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).

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Eli Lilly and Company

Lead sponsor

AstraZeneca

Collaborator

Source ClinicalTrials.gov
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