Study Comparing Cobolimab, Dostarlimab, and Docetaxel Combinations for Advanced Non-Small Cell Lung Cancer

Sponsor: GlaxoSmithKline

Sponsor score: 60

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

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

FACILITYZIPCITYSTATE
GSK Investigational Site92708Fountain ValleyCalifornia
GSK Investigational Site94596Walnut CreekCalifornia
GSK Investigational Site06360NorwichConnecticut
GSK Investigational Site20422Washington D.C.District of Columbia
GSK Investigational Site96819HonoluluHawaii
GSK Investigational Site52242Iowa CityIowa
GSK Investigational Site41017EdgewoodKentucky
GSK Investigational Site89144Las VegasNevada
GSK Investigational Site11501MineolaNew York
GSK Investigational Site10016New YorkNew York

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