An Expanded Access Program to Provide Divarasib to Participants With Previously Treated KRAS G12c-Positive Advanced or Metastatic Non-Small Cell Lung Cancer
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Keep this study
Lead
Genentech, Inc.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible 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 be 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)
Treatment with anti-cancer therapy (e.g., chemotherapy, immunotherapy, biologic therapy, or an investigational anti-cancer agent) within 28 days prior to initiation of EAP treatment
More than 30 Gy of radiotherapy to the lung within 6 months prior to initiation of EAP treatment
Uncontrolled tumor-related pain where palliative care or hospice admission is planned, or where active pain management interventions are insufficient to alleviate symptoms
Unresolved toxicities from prior anti-cancer therapy, defined as not having resolved to CTCAE v6.0 Grade 1 or better, or to levels dictated in the eligibility criteria or toxicities from prior anti-cancer therapy or palliative radiation therapy that are considered irreversible
Treatment with strong CYP3A4 inhibitors or inducers within 14 days or 5 half-lives of the drug or its major active metabolite, whichever is longer, prior to initiation of EAP treatment
Any serious medical condition or abnormality in clinical laboratory tests that precludes an individual's safe participation in and completion of the EAP
Blood or platelet transfusion within 14 days prior to initiation of EAP treatment
History or presence of an abnormal ECG that is deemed clinically significant (e.g., complete left bundle branch block, second- or third-degree atrioventricular heart block) or evidence of prior myocardial infarction
History of active malignancy that is currently receiving treatment or not well controlled
Significant cardiovascular disease, within 6 months of initiation of EAP treatment
History of ventricular dysrhythmias or risk factors for ventricular dysrhythmias such as structural heart disease (e.g., severe left ventricular systolic dysfunction, left ventricular hypertrophy), coronary heart disease (symptomatic or with ischemia demonstrated by diagnostic testing), clinically significant electrolyte abnormalities (e.g., hypokalemia, hypomagnesemia, hypocalcemia), or family history of sudden unexplained death or long QT syndrome
Clareo Health | An Expanded Access Program to Provide Divarasib to Participants With Previously Treated KRAS G12c-Positive Advanced or Metastatic Non-Small Cell Lung Cancer
