Efficacy Comparison of Cobolimab + Dostarlimab + Docetaxel to Dostarlimab + Docetaxel to Docetaxel Alone in Participants With Advanced Non-small Cell Lung Cancer Who Have Progressed on Prior Anti-PD-(L)1 Therapy and Chemotherapy

Part of paid clinical trials in Fountain Valley, California.

Sponsor
GlaxoSmithKline
Study ID
NCT04655976
Phase
PHASE3
Status
Active Not Recruiting

Conditions

  • Lung Cancer, Non-Small Cell

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Cobolimab — BIOLOGICAL
    Cobolimab will be administered.
  • Dostarlimab — BIOLOGICAL
    Dostarlimab will be administered.
  • Docetaxel — DRUG
    Docetaxel will be administered.

Study Details

This is a multi-center, parallel group treatment, Phase 2/3 open label study evaluating cobolimab in combination with dostarlimab and docetaxel in participants with advanced non-small cell Lung Cancer (NSCLC) who have progressed on prior anti-PD-(L)1 therapy and chemotherapy.

Key Dates

Start date
Dec 8, 2020
Status verified
Sep 2025
Primary completion
Jun 5, 2025
Completion
Mar 30, 2027

Study Design

Enrollment
758 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Participants receiving cobolimab+ dostarlimab+ docetaxel
  • Experimental: Participants receiving dostarlimab+ docetaxel
  • Active Comparator: Participants receiving docetaxel

Primary Outcome Measure

Overall survival (OS) in participants receiving cobolimab + dostarlimab + docetaxel relative to participants receiving docetaxel alone [ Time Frame: Up to approximately 52 months ]

Locations (17)

FacilityCityStateZIPSite coordinators
GSK Investigational SiteFountain ValleyCalifornia92708-
GSK Investigational SiteWalnut CreekCalifornia94596-
GSK Investigational SiteNorwichConnecticut06360-
GSK Investigational SiteWashington D.C.District of Columbia20422-
GSK Investigational SiteHonoluluHawaii96819-
GSK Investigational SiteIowa CityIowa52242-
GSK Investigational SiteEdgewoodKentucky41017-
GSK Investigational SiteLas VegasNevada89144-
GSK Investigational SiteMineolaNew York11501-
GSK Investigational SiteNew YorkNew York10016-
GSK Investigational SiteWhite PlainsNew York10601-
GSK Investigational SitePittsburghPennsylvania15224-
GSK Investigational SitePittsburghPennsylvania15232-
GSK Investigational SiteSioux FallsSouth Dakota57105-
GSK Investigational SiteHoustonTexas77030-
GSK Investigational SiteFredericksburgVirginia22408-
GSK Investigational SiteTacomaWashington98405-

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GSK Investigational Site· Fountain Valley, CAGSK Investigational Site· Walnut Creek, CAGSK Investigational Site· Norwich, CTGSK Investigational Site· Washington D.C., DCGSK Investigational Site· Honolulu, HIGSK Investigational Site· Iowa City, IA

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