Study of Olomorasib (LY3537982) in Combination With Standard of Care in Participants With Resected or Unresectable KRAS G12C-mutant Non-Small Cell Lung Cancer (SUNRAY-02)

Lilly

Status and phase: Enrolling; Phase 3

Conditions: Carcinoma, Non-Small-Cell Lung

Treatments: Drug: Olomorasib; Drug: Placebo; Drug: Pembrolizumab; Drug: Durvalumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT06890598

18763

J3M-MC-JZQH (Other Identifier)

2024-512302-25-00 (EU Trial (CTIS) Number)

Details and patient eligibility

About

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.

Enrollment: 700 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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700 participants in 4 patient groups, including a placebo group

Part A: Olomorasib + Pembrolizumab

Experimental group

Description:

Participants will receive olomorasib administered orally in combination with pembrolizumab intravenously (IV) for up to 1 year followed by olomorasib alone for up to 3 years of total treatment.

Treatment:

Drug: Pembrolizumab

Drug: Olomorasib

Part A: Placebo + Pembrolizumab

Placebo Comparator group

Description:

Participants will receive placebo administered orally in combination with pembrolizumab administered IV for up to 1 year followed by placebo alone for up to 3 years of total treatment.

Treatment:

Drug: Pembrolizumab

Drug: Placebo

Part B: Olomorasib + Durvalumab

Experimental group

Description:

Participants will receive olomorasib administered orally in combination with durvalumab administered IV for up to 1 year followed by olomorasib alone for up to 3 years of total treatment.

Treatment:

Drug: Durvalumab

Drug: Olomorasib

Part B: Placebo + Durvalumab

Placebo Comparator group

Description:

Participants will receive placebo administered orally in combination with durvalumab administered IV for up to 1 year followed by placebo alone for up to 3 years of total treatment.

Treatment:

Drug: Durvalumab

Drug: Placebo