J3M-MC-JZQH - SUNRAY-02 - 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

Studio Clinico

Patologia: Neoplasie del polmone

Osservazionale-Sperimentale: Sperimentale

Monocentrico-Multicentrico: Multicentrico

Randomizzato: Sì

Fase di studio: III

Linee di trattamento: Adiuvante/neoadiuvante

Criteri di inclusione: 

- Histological or cytological confirmed resected Stages II to IIIB KRAS G12C mutant NSCLC as confirmed by test performed in a CLIA, ISO/IEC, CAP, or similarly certified laboratory as per local guidelines. EU Laboratories to also have IVDR certification.
- Stage II-IIIB (N2) NSCLC (AJCC 8th edition) including either:
    - Clinical Stage II-IIIB (N2) treated with pre-surgical chemo-immunotherapy, with residual tumor present at time of surgery (i.e. patients with a pathologic complete response are ineligible)
    - Pathologic Stage II-IIIB (N2) NSCLC treated with initial upfront resection
- ECOG 0-1
- Have known PD-L1 expression (0-100%) of tumor cells as determined by an IHC assay performed in a CLIA, ISO/IEC, CAP, or similarly certified laboratory as per local guidelines. EU Laboratories to also have IVDR certification.

Criteri di esclusione: 

- Have known EGFR of ALK mutations
- Have clinically significant active cardiovascular disease or history of myocardial infarction within 6 months prior to planned start of study treatment.  QTcF >470 msec as outlined in the protocol
- Have active autoimmune disease that has required systemic anti-autoimmune treatment in the past 2 years (i.e., with use of disease modifying agents, corticosteroids, or immunosuppressive drugs). 
- Have an active uncontrolled infection requiring systemic therapy. HBV or HCV patients permitted under certain circumstances as outlined in the protocol.
- Has a diagnosis of primary immunodeficiency or is receiving systemic theroid therapy (dose more than 10mg daily of prednisone equivalent) or any form of immunosuppressive therapy within 7 days prior to first dose of study intervention.
- Have received a live vaccine within 30 days prior to the first dose of trial treatment.  
Exceptions: Seasonal flu vaccines that do not contain live virus are permitted. Any licensed COVID-19 vaccine (including for Emergency Use) in a particular country is allowed as long as they are messenger ribonucleic acid (mRNA) vaccines, adenoviral vaccines, or inactivated vaccines. 

Trattamento sperimentale: 

LY3537982

Trattamento di controllo: 

Pembrolizumab + Placebo

Centri partecipanti

Nord Italia

Centro Italia

Sud Italia e isole

Informazioni Generali

Protocollo

Numero di iscrizione a registro: 2024-512302-25-00

Data di inserimento: 01.08.2025

Data di aggiornamento: 19.02.2026

Promotore

Eli Lilly and Company

Principal Investigator ITALIA

Riferimento: Dr. Info non applicabile

Telefono: 00000

Email: na@na.it

Localita: na