Evaluating divarasib with other cancer therapies for advanced lung cancer with a KRAS mutation

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study evaluates the safety, pharmacokinetics, and activity of divarasib when combined with other anti-cancer therapies in patients with previously untreated advanced or metastatic non-small cell lung cancer (NSCLC) that has a KRAS G12C mutation. Participants will receive divarasib alongside treatments such as pembrolizumab, carboplatin, cisplatin, and pemetrexed. The study aims to determine how well this combination works and its safety profile in this specific patient population.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Confirmation of Biomarker eligibility
* Pre-treatment tumor tissue along with an associated pathology report is required for all participants enrolled on study. Representative tumor specimens must be in formalin-fixed, paraffin embedded (FFPE) blocks (preferred) or 15 unstained, freshly cut, serial slides. Although 15 slides are required, if only 10 slides are available, the participant may be eligible for the study following consultation with the Sponsor.
* Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1
* Histologically or cytologically documented locally advanced unresectable or metastatic NSCLC that is not eligible for curative surgery and/or definitive chemoradiotherapy
* No prior systemic treatment for advanced unresectable or metastatic NSCLC
* Measurable disease, as defined by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. Additionally, for participants in cohort D, measurable brain metastases defined as at least 5 millimeters and twice the slice thickness, but less than 20 mm, that is asymptomatic and does not require local therapy at the time of enrollment.

Exclusion Criteria:

* Known concomitant second oncogenic driver with available targeted treatment
* Squamous cell histology NSCLC
* Symptomatic, untreated, or actively progressing CNS metastases (Cohorts A, B, and C)
* Prior treatment with a KRAS G12C inhibitor
* Known hypersensitivity to any of the components of divarasib or pembrolizumab; or known hypersensitivity to pemetrexed, carboplatin, or cisplatin (Cohort B only)
* History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis, active tuberculosis, significant cardiovascular disease within 3 months prior to initiation of study treatment
* History of malignancy other than NSCLC within 5 years prior to initiation of study treatment, with the exception of malignancies with a negligible risk of metastasis or death (e.g., 5-year OS rate more \>90%), such as adequately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, localized prostate cancer, ductal breast carcinoma in situ, or Stage I uterine cancer
* Uncontrolled tumor related pain, pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures, uncontrolled or symptomatic hypercalcemia
* Co-morbid condition that is an absolute contraindication to treatment with corticosteroids
* Inability or unwillingness to take prophylactic treatments such as corticosteroids, anti-emetics, folic acid, or vitamin B12 supplementation.
* Participants with brain metastases for whom complete surgical resections is clinically appropriate

Where it's running

• Yale Cancer Center
  New Haven, Connecticut, United States Recruiting
• Florida Cancer Specialists - SOUTH - SCRI - PPDS
  Fort Myers, Florida, United States Recruiting
• Florida Cancer Specialists - NORTH - SCRI - PPDS
  St. Petersburg, Florida, United States Recruiting
• Florida Cancer Specialists - EAST - SCRI - PPDS
  West Palm Beach, Florida, United States Recruiting
• NYU Langone Hospital - Long Island
  Mineola, New York, United States Recruiting
• NYU Cancer Center
  New York, New York, United States Recruiting

+21 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: Reference Study ID Number: BO44426 https://forpatients.roche.com/ No attachments to email below.
• Email: global-roche-genentech-trials@gene.com
• Phone: 888-662-6728 (U.S. and Canada)

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.