Study Comparing Zimberelimab and Domvanalimab with Chemotherapy to Pembrolizumab with Chemotherapy in Patients with Untreated Metastatic Non-Small Cell Lung Cancer
Sponsor: Gilead Sciences
ClinicalTrials ID:NCT05502237
This clinical trial is testing two different combinations of drugs with chemotherapy to see which is more effective in improving survival for patients with untreated metastatic non-small cell lung cancer (NSCLC) that does not have certain genetic changes.
Patient Parameters
| Parameter | Options |
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Program Overview
The main goal of this study is to compare the effectiveness of two different drug combinations, both used with chemotherapy, in treating patients with metastatic non-small cell lung cancer (NSCLC) that has not been treated before and does not have specific genetic changes. One group will receive zimberelimab and domvanalimab with chemotherapy, while the other group will receive pembrolizumab with chemotherapy. Researchers aim to find out which combination helps patients live longer.
Eligibility Criteria
Inclusion Criteria
- Life expectancy of at least 3 months.
- Diagnosed with Stage IV non-small cell lung cancer (NSCLC) without certain genetic changes.
- No previous treatment for metastatic NSCLC.
- Cancer must be measurable by standard criteria.
- Good overall health with a performance status score of 0 or 1.
- Adequate organ function as determined by medical tests.
Exclusion Criteria
- Have a mix of small-cell and non-small cell lung cancer.
- Pregnant, breastfeeding, or planning to breastfeed during the study.
- Previous treatment with certain immune-targeting drugs.
- Allergic to the study drugs or their ingredients.
- Have another active cancer or had one in the last 3 years.
- Have an active autoimmune disease needing treatment in the past 2 years.
- Taking long-term steroids.
- Have significant fluid retention in the body.
- Have untreated cancer spread to the brain or spinal cord.
- Have active inflammatory bowel disease or recent gastrointestinal perforation.
- Have a history of lung inflammation needing steroids.
- Have had a tissue or organ transplant.
- Received a live-virus vaccine within 30 days before starting treatment.
- Have active hepatitis B or C infection.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Palo Verde Hematology Oncology Ltd | 85304 | Glendale | Arizona |
| California Cancer Associates for Research and Excellence | 92069 | San Marcos | California |
| Texas Oncology | 93105 | Santa Barbara | California |
| Innovative Clinical Research Institute | 90606 | Whittier | California |
| Eastern CT Hematology and Oncology Associates | 06360 | Norwich | Connecticut |
| Lake City Cancer Care | 32024 | Lake City | Florida |
| Florida Cancer Specialists | 34232 | Sarasota | Florida |
| Moffitt Cancer Center | 33612 | Tampa | Florida |
| Peachtree Hematology Oncology Consultants | 30318 | Atlanta | Georgia |
| Illinois Cancer Care | 61615 | Peoria | Illinois |
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