RecruitingNon-Small Cell Lung CancerKRAS G12C Lung Cancer

A Study Evaluating the Efficacy and Safety of Divarasib and Pembrolizumab Versus Pembrolizumab and Pemetrexed and Carboplatin or Cisplatin in Participants With Previously Untreated, KRAS G12C-Mutated, Advanced or Metastatic Non-Squamous Non-Small Cell Lung Cancer

Eligible age

18+ yrs

Accepts

All genders

Locations

25 states

Healthy volunteers

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About this study

The purpose of this study is to evaluate the efficacy and safety of divarasib and pembrolizumab compared with pembrolizumab and pemetrexed and carboplatin or cisplatin, for the first-line treatment of adult participants with KRAS G12C-mutated, advanced or metastatic non squamous non-small cell lung cancer (NSCLC).

Sponsor: Hoffmann-La Roche

You may qualify if…

✓ Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
✓ Histologically or cytologically confirmed diagnosis of advanced or metastatic non squamous NSCLC that is not eligible for curative surgery and/or definitive chemoradiotherapy
✓ Measurable disease, as defined by RECIST v1.1
✓ No prior systemic treatment for advanced or metastatic NSCLC
✓ Documentation of the presence of a KRAS G12C mutation
✓ Documentation of known PD-L1 expression status in tumor tissue
✓ Availability of a representative tumor specimen
✓ Adequate end-organ function

You may not qualify if…

✕ Known concomitant second oncogenic driver with available targeted treatment
✕ Symptomatic, untreated, or actively progressing central nervous system (CNS) metastases
✕ Spinal cord compression not definitively treated with surgery and/or radiation or previously diagnosed and treated spinal cord compression without evidence that disease has been clinically stable for \>=2 weeks prior to randomization
✕ History of leptomeningeal disease
✕ Uncontrolled tumor-related pain
✕ Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures (once a month or more frequently)
✕ Any anti-cancer systemic therapy, including hormonal therapy, within 21 days prior to randomization, or is expected to require any other form of antineoplastic therapy while in the study
✕ Radiation therapy including palliative RT to bone metastases within 2 weeks prior to randomization and RT to the lung \>30Gy within 6 months prior to randomization