Study Comparing Cobolimab, Dostarlimab, and Docetaxel Combinations for Advanced Non-Small Cell Lung Cancer
Sponsor: GlaxoSmithKline
ClinicalTrials ID:NCT04655976
This clinical trial is testing different combinations of the drugs cobolimab, dostarlimab, and docetaxel to see which is most effective for treating advanced non-small cell lung cancer (NSCLC) in patients who have not responded to previous treatments.
Patient Parameters
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Program Overview
This study is being conducted at multiple centers and involves testing different drug combinations to treat advanced non-small cell lung cancer (NSCLC) in patients whose cancer has progressed despite previous treatments with anti-PD-(L)1 therapy and chemotherapy. The trial aims to find out which combination of cobolimab, dostarlimab, and docetaxel works best.
Eligibility Criteria
Inclusion Criteria
- Have advanced or metastatic non-small cell lung cancer (NSCLC) confirmed by lab tests.
- Have received no more than two previous treatments for advanced cancer, including a platinum-based chemotherapy and an anti-PD-1 or anti-PD-(L)1 therapy.
- Have cancer that can be measured by scans.
- Have shown disease progression after previous treatments.
- Agree to provide a tumor sample from a previous biopsy or undergo a new biopsy if needed.
- Have a performance status score of 0 or 1, indicating full activity or some restriction in strenuous activities.
- Have a life expectancy of at least 3 months.
- Have adequate organ function based on medical tests.
- Have recovered from any side effects of previous treatments.
- Agree to use effective contraception during the study.
Exclusion Criteria
- Have previously stopped anti-PD-(L)1 or anti-PD-L2 treatment due to severe side effects.
- Have been treated with certain other immune therapies or docetaxel before.
- Have specific genetic mutations (EGFR, ALK, ROS-1) unless tested and confirmed negative.
- Experienced rapid disease progression within 8 weeks of starting previous anti-PD-1 or anti-PD-L1 therapy.
- Have received high-dose lung radiation within 6 months or palliative radiation within 7 days before starting the study.
- Have certain liver conditions or abnormal liver function tests.
- Have untreated or progressing brain metastases unless stable after treatment.
- Test positive for hepatitis B, hepatitis C, or HIV.
- Have active autoimmune diseases requiring treatment in the past 2 years.
- Have symptomatic fluid buildup in the abdomen or around the lungs unless stable after treatment.
- Have lung diseases like pneumonitis or interstitial lung disease.
- Have severe nerve damage.
- Have received a live vaccine within 30 days before starting the study.
- Cannot stop taking certain medications like aspirin before a biopsy if needed.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| GSK Investigational Site | 92708 | Fountain Valley | California |
| GSK Investigational Site | 94596 | Walnut Creek | California |
| GSK Investigational Site | 06360 | Norwich | Connecticut |
| GSK Investigational Site | 20422 | Washington D.C. | District of Columbia |
| GSK Investigational Site | 96819 | Honolulu | Hawaii |
| GSK Investigational Site | 52242 | Iowa City | Iowa |
| GSK Investigational Site | 41017 | Edgewood | Kentucky |
| GSK Investigational Site | 89144 | Las Vegas | Nevada |
| GSK Investigational Site | 11501 | Mineola | New York |
| GSK Investigational Site | 10016 | New York | New York |
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