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Tests treatment safety and results for Non-Small Cell Lung Cancer
Official title 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
ClinicalTrials.gov ID: NCT05789082
What this study is testing
What is Divarasib?
Divarasib is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for non-small cell lung cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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).
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Confirmation of Biomarker eligibility
- Pre-treatment tumor tissue along with an associated pathology report is required for all participants enrolled on study. Representative tumor...
- 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...
- No prior systemic treatment for advanced unresectable or metastatic NSCLC
You likely can't join if
- 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...
- History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, or idiopathic pneumonitis...
See the full eligibility 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...
- 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...
- 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...
- 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Duarte, California, United States
- Huntington Beach, California, United States
- Irvine, California, United States
- La Jolla, California, United States
- Long Beach, California, United States
- New Haven, Connecticut, United States
- Fort Myers, Florida, United States
- St. Petersburg, Florida, United States
- West Palm Beach, Florida, United States
- Mineola, New York, United States
- New York, New York, United States
- The Bronx, New York, United States
- Houston, Texas, United States
- Blacksburg, Virginia, United States
- Norfolk, Virginia, United States
- Buenos Aires, Argentina
- Ciudad Autonoma Buenos Aires, Argentina
- La Rioja, Argentina
- Concord, New South Wales, Australia
- Melbourne, Victoria, Australia
+ 44 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Duarte, California, United States; Huntington Beach, California, United States; Irvine, California, United States; La Jolla, California, United States; Long Beach, California, United States; New Haven, Connecticut, United States and 58 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.