Divarasib for Advanced Non-Small Cell Lung Cancer

A Study Evaluating the Safety, Activity, and Pharmacokinetics of Divarasib as a Single Agent or in Combination With Other Anti-Cancer Therapies in Participants With Previously Untreated Advanced or Metastatic Non-Small Cell Lung Cancer With a KRAS G12C Mutation

Recruiting Phase 1 Phase 2 Interventional Study
Non-Small Cell Lung Cancer
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
Ready to participate?

Review the details below, then apply to join this clinical trial.

At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 1/2
Study type
Interventional
Purpose
Treatment
Participants needed
320 (estimated)
Sponsor
Hoffmann-La Roche · Industry
Who this trial is looking for

This trial is looking for people with advanced non-small cell lung cancer who have not received treatment before. Participants will take divarasib alone or with other cancer therapies.

Are You a Good Fit for This Trial?

You may be able to join if

  • I have a confirmed KRAS G12C mutation.
  • I have measurable disease that has not been treated before.
  • I have been diagnosed with advanced or metastatic non-small cell lung cancer.
  • I have a performance status of 0 or 1.
  • I can provide tumor tissue samples.
  • I have no prior systemic treatment for my lung cancer.
  • I have brain metastases that meet specific size criteria, if applicable.

You may not be able to join if

  • I have another active cancer with available treatment.
  • I have symptomatic brain metastases that need treatment.
  • I have a history of severe lung diseases.
  • I have had treatment with a KRAS G12C inhibitor before.
  • I am allergic to divarasib or any of its components.
  • I have uncontrolled cancer-related symptoms like pain or fluid buildup.
  • I cannot take corticosteroids or other required medications.
  • I have had another type of cancer in the last 5 years, apart from certain low-risk types.

Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.

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About This Trial

The purpose of this study is to evaluate the safety, pharmacokinetics (PK), and activity of single-agent divarasib or combined with other anti-cancer therapies in participants with previously untreated, advanced or metastatic non-small cell lung cancer (NSCLC).

Trial Locations
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Eligibility Criteria
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 unstaine…
Contacts

Reference Study ID Number: BO44426 https://forpatients.roche.com/ No attachments to email below.

888-662-6728 (U.S. and Canada)

global-roche-genentech-trials@gene.com

CONTACT

Fastest response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry

CONTACT