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Compares treatment options for Non-Small Cell Lung Cancer (NSCLC)
Official title A Study Evaluating Sotorasib Platinum Doublet Combination Versus Pembrolizumab Platinum Doublet Combination as a Front-Line Therapy in Participants With Stage IV or Advanced Stage IIIB/C Nonsquamous Non-Small Cell Lung Cancers (CodeBreaK 202)
ClinicalTrials.gov ID: NCT05920356
What this study is testing
What is Sotorasib?
Sotorasib is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for non-small cell lung cancer (nsclc).
Also referred to as AMG 510, LUMYKRAS ®.
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 primary objectives are to compare progression-free survival (PFS) and overall survival (OS) in participants who receive sotorasib with platinum doublet chemotherapy versus participants who receive pembrolizumab with platinum doublet chemotherapy.
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 100
You may be able to join if
- Histologically or cytologically confirmed diagnosis of nonsquamous stage IV or advanced Stage IIIB or IIIC NSCLC with KRAS p. G12C mutation and...
- No history of systemic anticancer therapy in metastatic/non-curable settings
- Eastern Cooperative Oncology Group (ECOG) ≤ 1
You likely can't join if
- Mixed histology NSCLC with either small-cell or large-cell neuroendocrine cell component or predominant squamous cell histology
- Participants with tumors known to harbor molecular alterations for which targeted therapy is locally approved as a front-line therapy
- Symptomatic (treated or untreated) brain metastases
- Gastrointestinal (GI) tract disease causing the inability to take oral medication
- Myocardial infarction within 6 months of randomization, unstable arrhythmias, or unstable angina
- Prior therapy with a KRAS G12C inhibitor
The study team makes the final eligibility decision.
Where it's taking place
- Santa Barbara, California, United States
- Newark, Delaware, United States
- Chicago, Illinois, United States
- Niles, Illinois, United States
- Louisville, Kentucky, United States
- Worcester, Massachusetts, United States
- Albuquerque, New Mexico, United States
- New York, New York, United States
- Asheville, North Carolina, United States
- Durham, North Carolina, United States
- Pinehurst, North Carolina, United States
- Media, Pennsylvania, United States
- Pittsburgh, Pennsylvania, United States
- Knoxville, Tennessee, United States
- Memphis, Tennessee, United States
- Nashville, Tennessee, United States
- Houston, Texas, United States
- Irving, Texas, United States
- Olympia, Washington, United States
- Janesville, Wisconsin, United States
+ 297 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 to 100 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Santa Barbara, California, United States; Newark, Delaware, United States; Chicago, Illinois, United States; Niles, Illinois, United States; Louisville, Kentucky, United States; Worcester, Massachusetts, United States and 311 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.