Study Comparing Sotorasib with Chemotherapy to Pembrolizumab with Chemotherapy for Advanced Non-Small Cell Lung Cancer
Sponsor: Amgen
Sponsor score: 60
ClinicalTrials ID:NCT05920356
This clinical trial is comparing two different treatment combinations for patients with advanced non-small cell lung cancer (NSCLC). The study aims to see which combination helps patients live longer without the cancer getting worse.
Patient Parameters
| Parameter | Options |
|---|
Program Overview
The main goal of this study is to compare how long patients with advanced non-small cell lung cancer (NSCLC) can live without their cancer progressing when treated with either sotorasib combined with chemotherapy or pembrolizumab combined with chemotherapy.
Eligibility Criteria
Inclusion Criteria
- Diagnosed with advanced non-small cell lung cancer (NSCLC) that is not squamous type and has a specific KRAS mutation (G12C).
- Cancer must be at stage IV or advanced stage IIIB/C.
- Tested negative for PD-L1 expression.
- Have not received any previous systemic treatment for cancer that has spread or cannot be cured.
- Be in good overall health with an ECOG performance status of 0 or 1, meaning fully active or restricted in physically strenuous activity but ambulatory.
Exclusion Criteria
- Have a type of lung cancer that includes small-cell or large-cell neuroendocrine cells, or mainly squamous cells.
- Have tumors with specific genetic changes that have approved targeted treatments.
- Have brain metastases that are causing symptoms, whether treated or not.
- Have digestive system issues that prevent taking oral medication.
- Have had a heart attack in the last 6 months, or have unstable heart rhythms or chest pain.
- Have previously been treated with a KRAS G12C inhibitor.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| University of Illinois Chicago | 60612 | Chicago | Illinois |
| Norton Cancer Institute - Brownsboro | 40241 | Louisville | Kentucky |
| Reliant Medical Group Inc | 01606 | Worcester | Massachusetts |
| University of New Mexico Cancer Center | 87131 | Albuquerque | New Mexico |
| Memorial Sloan Kettering Cancer Center | 10065 | New York | New York |
| Duke University | 27710 | Durham | North Carolina |
| FirstHealth Cancer Center | 28374 | Pinehurst | North Carolina |
| University of Pittsburgh Medical Center | 15232 | Pittsburgh | Pennsylvania |
| University of Tennessee Medical Center Knoxville | 37920 | Knoxville | Tennessee |
| Sarah Cannon Research Institute | 37203 | Nashville | Tennessee |
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