An Expanded Access Program to Provide Divarasib to Participants With Previously Treated KRAS G12c-Positive Advanced or Metastatic Non-Small Cell Lung Cancer

NCT07783009 | Unknown

• 1 other identifier: AL46650
• Study Type: expanded_access
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this expanded access program (EAP) is to provide early access to divarasib to participants with KRAS G12C-positive (KRAS G12C+) advanced or metastatic non-small cell lung cancer (NSCLC), prior to divarasib becoming commercially available in the United States.

Conditions

Non-Small Cell Lung Cancer

Interventions

Divarasib DRUG

Participants will self-administer divarasib as per the schedule in the protocol.

Also known as: RO7435846

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Locally advanced or metastatic NSCLC not amenable to treatment with surgical resection or combined chemoradiation
• Disease progression during or after treatment with at least one prior standard of care systemic therapy but no more than three lines of prior systemic therapy in the advanced or metastatic setting, with the exceptions for adjuvant/neoadjuvant therapies
• Documentation of the presence of a KRAS G12C mutation obtained at any timepoint during the course of the disease
• Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-2
• Life expectancy of greater than or equal to 12 weeks
• Ability to swallow tablets intact, without chewing or crushing

You may not qualify if:

• Previous enrollment in Roche- or Genentech-sponsored study of divarasib
• Prior treatment with a pan-KRAS/RAS inhibitor
• Prior treatment with a KRAS G12C inhibitor, unless specific criteria are met
• Pregnant or breastfeeding, or intending to become pregnant during the EAP or within the timeframe in which contraception is required
• Known hypersensitivity to any of the components of divarasib
• Malabsorption syndrome or other condition that would interfere with enteral absorption
• Mixed small-cell lung cancer
• Known and untreated, or active CNS metastases (progressing or requiring anticonvulsants or corticosteroids for symptomatic control)
• Leptomeningeal disease or carcinomatous meningitis
• Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures biweekly or more frequently
• Clinically significant history of liver disease, including viral or other hepatitis, or cirrhosis
• Known clinically significant history of liver disease consistent with Child-Pugh Class B or C, including active viral or other hepatitis (ex: hepatitis B \[HBV\] or hepatitis C \[HCV\]) virus, current alcohol abuse or cirrhosis
• Known positive HIV infection
• Significant traumatic injury or major surgical procedure within 4 weeks prior to initiation of EAP treatment
• Chronic diarrhea, short bowel syndrome, or significant upper gastrointestinal surgery including gastric resection, a history of inflammatory bowel disease (e.g., Crohn's disease or ulcerative colitis) or any active bowel inflammation (including diverticulitis)

Sponsors & Collaborators

• Genentech, Inc.: lead

Related Links

• Please use this form to submit your questions for a faster response: https://www.gene.com/contact-us/submit-medical-inquiry. Do not include or attach any medical records when emailing or completing the form. A nurse will respond within 24 business hours.

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Central Study Contacts

Reference Study ID Number: AL46650 https://forpatients.roche.com/ No attachments to email below.

CONTACT

888-662-6728; global-roche-genentech-trials@gene.com

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

CONTACT

Study Design

• Study Type: expanded access
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 18, 2026
• First Posted: August 24, 2026
• Last Updated: August 24, 2026

Record last verified: 2026-08