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Studieoverzicht

Study name: J3M-MC-JZQH: 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

Histology NSCLC, all subtypes
Tumor stage Stage I - III
NCT Id NCT06890598
Host / recruiting site 1 Amsterdam UMC Enrollment Recruiting
Host / recruiting site 2 Amphia Enrollment Recruiting
Host / recruiting site 3 St. Antonius Ziekenhuis Enrollment Recruiting
Host / recruiting site 4 Isala Zwolle Enrollment Recruiting
Host / recruiting site 5 ETZ Elisabeth Enrollment Recruiting
Host / recruiting site 6 Ziekenhuis St.Jansdal Enrollment Recruiting
Design

Both Part A and B are randomized, double-blind, placebo-controlled.
Intervention

Experimental: Part A: Olomorasib + Pembrolizumab
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.

Placebo Comparator: Part A: Placebo + Pembrolizumab
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.

Experimental: Part B: Olomorasib + Durvalumab
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.

Placebo Comparator: Part B: Placebo + Durvalumab
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.
Key outcome parameters

Part A: Disease-Free Survival (DFS) by Investigator Assessment
Part B: Progression-Free Survival (PFS)
Part A & B: Overall Survival (OS)
Key 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
Key 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.
Contact information