Last updated: 09/25/2025 11:40:59

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 ChemotherapyCOSTAR Lung

GSK study ID
213410
Clinicaltrials.gov ID
EudraCT ID
EU CT Number
Not applicable
Trial status
Active, not recruiting
Active, not recruiting
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: A Randomized, Open Label Phase 2/3 Study Comparing 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 (COSTAR Lung)
Trial description: 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.
Primary purpose:
Treatment
Trial design:
Parallel
Masking:
None (Open Label)
Allocation:
Randomized
Primary outcomes:

Overall survival (OS) in participants receiving cobolimab + dostarlimab + docetaxel relative to participants receiving docetaxel alone

Timeframe: Up to approximately 52 months

OS in participants receiving dostarlimab + docetaxel relative to participants receiving docetaxel alone

Timeframe: Up to approximately 52 months

Secondary outcomes:

OS in participants receiving cobolimab + dostarlimab + docetaxel relative to participants receiving dostarlimab + docetaxel

Timeframe: Up to approximately 52 months

Objective response rate (ORR)

Timeframe: Up to approximately 52 months

Progression free survival (PFS)

Timeframe: Up to approximately 52 months

Duration of response (DOR)

Timeframe: Up to approximately 52 months

Time to deterioration (TTD)

Timeframe: Up to approximately 52 months

Change from Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30 item Core Module (EORTC QLQ-C30) assessment

Timeframe: Baseline (Day 1) and up to approximately 52 months

Change from Baseline in the EORTC QLQ LC13 assessment

Timeframe: Baseline (Day 1) and up to approximately 52 months

Number of participants with serious adverse events (SAEs)

Timeframe: From consent signature (Day -28) until the 90 day post last dose follow-up

Number of participants with treatment-emergent adverse events (TEAEs) and immune related adverse event (irAEs)

Timeframe: From consent signature (Day -28) until the 30 day post last dose follow-up

Number of participants with TEAEs leading to death

Timeframe: From consent signature (Day -28) until the 90 day post last dose follow-up

Number of participants with adverse events (AEs) leading to discontinuation

Timeframe: From consent signature (Day -28) until the 30 day post last dose follow-up

Number of participants with clinically significant changes in hematology, clinical chemistry, thyroid function and urinalysis lab parameters

Timeframe: From consent signature (Day -28) until the 90 day post last dose follow-up

Number of participants with clinically significant changes in vital signs and Electrocardiogram (ECG) Parameters

Timeframe: From consent signature (Day -28) until the 90 day post last dose follow-up

Number of participants with indicated Eastern Cooperative Oncology Group (ECOG) performance status

Timeframe: From consent signature (Day -28) until the 90 day post last dose follow-up

Number of participants with usage of concomitant medications

Timeframe: From consent signature (Day -28) until the 90 day post last dose follow-up

Number of participants with abnormal physical examinations

Timeframe: From consent signature (Day -28) until the 90 day post last dose follow-up

Interventions:
Biological/vaccine: Cobolimab
Biological/vaccine: Dostarlimab
Drug: Docetaxel
Enrollment:
758
Observational study model:
Not applicable
Primary completion date:
2025-05-06
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Lung Cancer, Non-Small Cell
Product
Not applicable
Collaborators
NA
Study date(s)
December 2020 to March 2027
Type
Interventional
Phase
3

Participation criteria

Sex
Female & Male
Age
18+ years
Accepts healthy volunteers
No
  • Participant has histologically or cytologically proven advanced or metastatic NSCLC and only squamous or non-squamous cell carcinoma.
  • Participant has received no more than 2 prior lines of therapy for advanced or metastatic disease, which must only include a platinum based (e.g., cisplatin, carboplatin) doublet chemotherapy regimen and an anti-PD-1 or an anti-PD-(L)1 antibody.
  • Participant has been previously treated with an anti-PD-[L]1 or anti-programmed death-ligand 2 (anti-PD-[L]2) agent that resulted in permanent discontinuation due to an AE.
  • Participant has been previously treated with an anti-T cell immunoglobulin and mucin domain containing 3 (anti-TIM-3) or anti-cytotoxic T lymphocyte associated protein 4 (CTLA 4) agent or docetaxel.

Trial location(s)

Location
Status
Contact us
Contact us
Location
GSK Investigational Site
Seoul, South Korea, 05505
Status
Study Complete
Location
GSK Investigational Site
Seongnam-si Gyeonggi-do, South Korea, 13620
Status
Recruitment Complete
Location
GSK Investigational Site
Orbassano TO, Italy, 10043
Status
Recruitment Complete
Location
GSK Investigational Site
Ashford, SA, Australia, 5037
Status
Study Complete
Location
GSK Investigational Site
Olsztyn, Poland, 10-357
Status
Recruitment Complete
Location
GSK Investigational Site
Bydgoszcz, Poland, 85-796
Status
Recruitment Complete
Location
GSK Investigational Site
Pushkin, Russia, 196603
Status
Study Complete
Location
GSK Investigational Site
Sioux Falls, SD, United States, 57105
Status
Recruitment Complete
Location
GSK Investigational Site
White Plains, NY, United States, 10601
Status
Study Complete
Location
GSK Investigational Site
Gdynia, Poland, 81-519
Status
Recruitment Complete
Location
GSK Investigational Site
Rennes, France, 35033
Status
Recruitment Complete
Location
GSK Investigational Site
Frankfurt, Germany, 60488
Status
Recruitment Complete
Location
GSK Investigational Site
Barcelona, Spain, 08036
Status
Recruitment Complete
Location
GSK Investigational Site
Barcelona, Spain, 08035
Status
Recruitment Complete
Location
GSK Investigational Site
Madrid, Spain, 28046
Status
Study Complete
Location
GSK Investigational Site
Berlin, Germany, 12200
Status
Study Complete
Location
GSK Investigational Site
Sudbury, ON, Canada, P3E 5J1
Status
Recruitment Complete
Location
GSK Investigational Site
Koeln, Germany, 51109
Status
Recruitment Complete
Location
GSK Investigational Site
Karlsruhe, Germany, 76137
Status
Study Complete
Location
GSK Investigational Site
Essen, Germany, 45147
Status
Recruitment Complete
Location
GSK Investigational Site
Las Vegas, NV, United States, 89144
Status
Study Complete
Location
GSK Investigational Site
Bonn, Germany, 53113
Status
Recruitment Complete
Location
GSK Investigational Site
Pittsburgh, PA, United States, 15232
Status
Study Complete
Location
GSK Investigational Site
Frankfurt, Germany, 60590
Status
Study Complete
Location
GSK Investigational Site
Oshawa, ON, Canada, L1G 2B9
Status
Recruitment Complete
Location
GSK Investigational Site
Viedma, Argentina, R8500ACE
Status
Recruitment Complete
Location
GSK Investigational Site
Iowa City, IA, United States, 52242
Status
Study Complete
Location
GSK Investigational Site
Mexico City, Mexico, 06700
Status
Recruitment Complete
Location
GSK Investigational Site
Rosario, Argentina, S2000DBS
Status
Study Complete
Location
GSK Investigational Site
Craiova Dolj, Romania, 200385
Status
Recruitment Complete
Location
GSK Investigational Site
Craiova, Romania, 200347
Status
Recruitment Complete
Location
GSK Investigational Site
Otopeni, Romania, 075100
Status
Study Complete
Location
GSK Investigational Site
Oldenburg, Germany, 26121
Status
Study Complete
Location
GSK Investigational Site
Las Palmas De Gran Canar, Spain, 35016
Status
Recruitment Complete
Location
GSK Investigational Site
AMERSFOORT, Netherlands, 3813 TZ
Status
Study Complete
Location
GSK Investigational Site
Milano, Italy, 20132
Status
Recruitment Complete
Location
GSK Investigational Site
SAo Paulo, Brazil, 04014-002
Status
Recruitment Complete
Location
GSK Investigational Site
Ancona, Italy, 60126
Status
Recruitment Complete
Location
GSK Investigational Site
Cardiff, United Kingdom, CF14 2TL
Status
Recruitment Complete
Location
GSK Investigational Site
Edgewood, KY, United States, 41017
Status
Recruitment Complete
Location
GSK Investigational Site
Pittsburgh, PA, United States, 15224
Status
Study Complete
Location
GSK Investigational Site
Porto Alegre, Brazil, 90610000
Status
Recruitment Complete
Location
GSK Investigational Site
STOCKHOLM, Sweden, 171 64
Status
Study Complete
Location
GSK Investigational Site
Houston, TX, United States, 77030
Status
Study Complete
Location
GSK Investigational Site
Burgos, Spain, 09006
Status
Study Complete
Location
GSK Investigational Site
Cordoba, Spain, 140044
Status
Recruitment Complete
Location
GSK Investigational Site
HARDERWIJK, Netherlands, 3844 DG
Status
Study Complete
Location
GSK Investigational Site
London, United Kingdom, SE1 9RT
Status
Recruitment Complete
Location
GSK Investigational Site
Rio de Janeiro, Brazil, 22061080
Status
Study Complete
Location
GSK Investigational Site
UPPSALA, Sweden, SE-751 85
Status
Study Complete
Location
GSK Investigational Site
Adana, Turkey, 1120
Status
Study Complete
Location
GSK Investigational Site
Antalya, Turkey, 07020
Status
Study Complete
Location
GSK Investigational Site
Athens, Greece, 115 27
Status
Recruitment Complete
Location
GSK Investigational Site
Athens, Greece, 11526
Status
Recruitment Complete
Location
GSK Investigational Site
Athens, Greece, 11528
Status
Study Complete
Location
GSK Investigational Site
Athens, Greece, 12462
Status
Recruitment Complete
Location
GSK Investigational Site
Dusit, Thailand, 10300
Status
Recruitment Complete
Location
GSK Investigational Site
GRONINGEN, Netherlands, 9713 GZ
Status
Recruitment Complete
Location
GSK Investigational Site
Hasselt, Belgium, 3500
Status
Recruitment Complete
Location
GSK Investigational Site
Kho Hong Hat Yai, Thailand, 90110
Status
Recruitment Complete
Location
GSK Investigational Site
Heidelberg, Germany, 69126
Status
Study Complete
Location
GSK Investigational Site
Honolulu, HI, United States, 96819
Status
Study Complete
Location
GSK Investigational Site
Pathumthani, Thailand, 12120
Status
Study Complete
Location
GSK Investigational Site
Kortrijk, Belgium, 8500
Status
Recruitment Complete
Location
GSK Investigational Site
Kyoto, Japan, 612-8555
Status
Recruitment Complete
Location
GSK Investigational Site
Larissa, Greece, 41100
Status
Study Complete
Location
GSK Investigational Site
Malaga, Spain, 29010
Status
Recruitment Complete
Location
GSK Investigational Site
Miyagi, Japan, 981-1293
Status
Study Complete
Location
GSK Investigational Site
Khon Kaen, Thailand, 40002
Status
Recruitment Complete
Location
GSK Investigational Site
Muenchen, Germany, 81925
Status
Study Complete
Location
GSK Investigational Site
NIJMEGEN, Netherlands, 6525 GA
Status
Study Complete
Location
GSK Investigational Site
Osaka, Japan, 591-8555
Status
Study Complete
Location
GSK Investigational Site
Rio Patras, Greece, 26504
Status
Recruitment Complete
Location
GSK Investigational Site
Perugia, Italy, 06156
Status
Study Complete
Location
GSK Investigational Site
Rio de Janeiro, Brazil, 22250-905
Status
Recruitment Complete
Location
GSK Investigational Site
Suwon Kyunggi-do, South Korea, 443-721
Status
Study Complete
Location
GSK Investigational Site
Tacoma, WA, United States, 98405
Status
Study Complete
Location
GSK Investigational Site
Pylaia Thessaloniki, Greece, 570 01
Status
Recruitment Complete
Location
GSK Investigational Site
Walnut Creek, CA, United States, 94596
Status
Study Complete
Location
GSK Investigational Site
Yamaguchi, Japan, 755-0241
Status
Recruitment Complete
Location
GSK Investigational Site
ZWOLLE, Netherlands, 8025 AB
Status
Study Complete
Location
GSK Investigational Site
Mexico City, Mexico, 03810
Status
Study Complete
Location
GSK Investigational Site
Daegu, South Korea, 42601
Status
Recruitment Complete
Location
GSK Investigational Site
Gyeonggi-do, South Korea, 10408
Status
Recruitment Complete
Location
GSK Investigational Site
A CoruNa, Spain, 15006
Status
Recruitment Complete
Location
GSK Investigational Site
La Rioja, Argentina, F5300COE
Status
Recruitment Complete
Location
GSK Investigational Site
MADRID, Spain, 28222
Status
Recruitment Complete
Location
GSK Investigational Site
Marseille, France, 13009
Status
Recruitment Complete
Location
GSK Investigational Site
Mexico City, Mexico, CP 14080
Status
Study Complete
Location
GSK Investigational Site
Milano, Italy, 20133
Status
Recruitment Complete
Location
GSK Investigational Site
Montreal, QC, Canada, H3T 1E2
Status
Recruitment Complete
Location
GSK Investigational Site
Monza, Italy, 20900
Status
Recruitment Complete
Location
GSK Investigational Site
MUnchen, Germany, 80336
Status
Recruitment Complete
Location
GSK Investigational Site
Quimper cedex, France, 29107
Status
Recruitment Complete
Location
GSK Investigational Site
Aalst, Belgium, 9300
Status
Recruitment Complete
Location
GSK Investigational Site
Augsburg, Germany, 86156
Status
Study Complete
Location
GSK Investigational Site
Avellino, Italy, 83100
Status
Recruitment Complete
Location
GSK Investigational Site
Bad Berka, Germany, 99437
Status
Study Complete
Location
GSK Investigational Site
Badalona, Spain, 08916
Status
Study Complete
Location
GSK Investigational Site
Ballarat, VIC, Australia, 3350
Status
Recruitment Complete
Location
GSK Investigational Site
Mount Waverley, VIC, Australia, 3350
Status
Study Complete
Location
GSK Investigational Site
Blumenau, Brazil, 89010340
Status
Recruitment Complete
Location
GSK Investigational Site
Bucuresti, Romania, 013812
Status
Recruitment Complete
Location
GSK Investigational Site
Pusan, South Korea, 49241
Status
Recruitment Complete
Location
GSK Investigational Site
Chelyabinsk, Russia, 454048
Status
Study Complete
Location
GSK Investigational Site
Cheongju Chungcheongbuk-do, South Korea, 28644
Status
Recruitment Complete
Location
GSK Investigational Site
Cipoletti Rio Negro, Argentina, R8324CVE
Status
Recruitment Complete
Location
GSK Investigational Site
Ciudad Autonoma de Buenos Aire, Argentina, 1425
Status
Recruitment Complete
Location
GSK Investigational Site
BUENOS AIRES, Argentina, C1426ABP
Status
Recruitment Complete
Location
GSK Investigational Site
CrEteil cedex, France, 94010
Status
Recruitment Complete
Location
GSK Investigational Site
Dresden, Germany, 01307
Status
Recruitment Complete
Location
GSK Investigational Site
ENSCHEDE, Netherlands, 7512 KZ
Status
Study Complete
Location
GSK Investigational Site
Edinburgh, United Kingdom, EH4 2XU
Status
Recruitment Complete
Location
GSK Investigational Site
Firenze, Italy, 50134
Status
Recruitment Complete
Location
GSK Investigational Site
Florida, Argentina, 1602
Status
Recruitment Complete
Location
GSK Investigational Site
Fortaleza, Brazil, 60336-232
Status
Recruitment Complete
Location
GSK Investigational Site
Fountain Valley, CA, United States, 92708
Status
Recruitment Complete
Location
GSK Investigational Site
Fredericksburg, VA, United States, 22408
Status
Recruitment Complete
Location
GSK Investigational Site
Greenfield Park, QC, Canada, J4V 2H1
Status
Recruitment Complete
Location
GSK Investigational Site
GRENOBLE CEDEX 9, France, 38043
Status
Recruitment Complete
Location
GSK Investigational Site
Guadalajara, Mexico, 44280
Status
Study Complete
Location
GSK Investigational Site
GAVLE, Sweden, SE-801 87
Status
Study Complete
Location
GSK Investigational Site
Halle, Germany, 06120
Status
Study Complete
Location
GSK Investigational Site
Helsinki, Finland, 00180
Status
Study Complete
Location
GSK Investigational Site
Hobart, TAS, Australia, 7000
Status
Recruitment Complete
Location
GSK Investigational Site
Izmir, Turkey, 35600
Status
Study Complete
Location
GSK Investigational Site
Kingston, ON, Canada, K7L 2V7
Status
Recruitment Complete
Location
GSK Investigational Site
Kuopio, Finland, 70210
Status
Study Complete
Location
GSK Investigational Site
Lodz, Poland, 90-338
Status
Study Complete
Location
GSK Investigational Site
London, United Kingdom, W1G 6AD
Status
Recruitment Complete
Location
GSK Investigational Site
Madrid, Spain, 28007
Status
Recruitment Complete
Location
GSK Investigational Site
Madrid, Spain, 28034
Status
Recruitment Complete
Location
GSK Investigational Site
Madrid, Spain, 28041
Status
Recruitment Complete
Location
GSK Investigational Site
Madrid, Spain, 28050
Status
Recruitment Complete
Location
GSK Investigational Site
Manchester, United Kingdom, M20 4BX
Status
Recruitment Complete
Location
GSK Investigational Site
Melbourne, VIC, Australia, 3004
Status
Recruitment Complete
Location
GSK Investigational Site
Mexico City, Mexico, 03100
Status
Recruitment Complete
Location
GSK Investigational Site
Mineola, NY, United States, 11501
Status
Recruitment Complete
Location
GSK Investigational Site
Monterrey, Mexico, 64460
Status
Study Complete
Location
GSK Investigational Site
Moscow Region, Russia, 143423
Status
Study Complete
Location
GSK Investigational Site
Napoli, Italy, 80131
Status
Recruitment Complete
Location
GSK Investigational Site
New York, NY, United States, 10016
Status
Recruitment Complete
Location
GSK Investigational Site
NICE CEDEX 2, France, 06189
Status
Recruitment Complete
Location
GSK Investigational Site
Norwich, CT, United States, 06360
Status
Recruitment Complete
Location
GSK Investigational Site
Salvador, Brazil, 40170-110
Status
Recruitment Complete
Location
GSK Investigational Site
Pergamino, Argentina, B2700CPM
Status
Study Complete
Location
GSK Investigational Site
Pila, Poland, 64-920
Status
Recruitment Complete
Location
GSK Investigational Site
Poznan, Poland, 60-693
Status
Study Complete
Location
GSK Investigational Site
Puebla Puebla, Mexico, 72560
Status
Study Complete
Location
GSK Investigational Site
Saint-Petersburg, Russia, 197022
Status
Recruitment Complete
Location
GSK Investigational Site
Siena, Italy, 53100
Status
Recruitment Complete
Location
GSK Investigational Site
South Brisbane, QLD, Australia, 4101
Status
Recruitment Complete
Location
GSK Investigational Site
Taipei, Taiwan, 11217
Status
Study Complete
Location
GSK Investigational Site
Thessaloniki, Greece, 55236
Status
Recruitment Complete
Location
GSK Investigational Site
Thessaloniki, Greece, 57010
Status
Study Complete
Location
GSK Investigational Site
Timisoara, Romania, 300239
Status
Recruitment Complete
Location
GSK Investigational Site
Tours cedex 9, France, 37044
Status
Recruitment Complete
Location
GSK Investigational Site
UTRECHT, Netherlands, 3543 AZ
Status
Study Complete
Location
GSK Investigational Site
Valencia, Spain, 46026
Status
Recruitment Complete
Location
GSK Investigational Site
Washington, DC, United States, 20422
Status
Study Complete
Location
GSK Investigational Site
Bangkok, Thailand, 10210
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Billings, MT, United States, 59102
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Bronx, NY, United States, 10461
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Bronx, NY, United States, 10468
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Chicago, IL, United States, 60612
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Gera, Germany, 07548
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Gunma, Japan, 377-0280
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Hiroshima, Japan, 737-0023
Status
Terminated/Withdrawn
Location
GSK Investigational Site
HsinChu, Taiwan, 300
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Hyogo, Japan, 670-8520
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Knoxville, TN, United States, 37916
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Leipzig, Germany, 04103
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Los Angeles, CA, United States, 90034
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Louisville, KY, United States, 40206
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Memphis, TN, United States, 38104
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Mie, Japan, 515-8544
Status
Terminated/Withdrawn
Location
GSK Investigational Site
New York, NY, United States, 10010
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Northport, NY, United States, 11768
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Oakland, CA, United States, 94611
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Okayama, Japan, 700-8558
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Orange City, FL, United States, 32763
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Osaka, Japan, 560-8552
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Roseville, CA, United States, 95661
Status
Terminated/Withdrawn
Location
GSK Investigational Site
San Francisco, CA, United States, 94115
Status
Terminated/Withdrawn
Location
GSK Investigational Site
San Francisco, CA, United States, 94121
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Santa Clara, CA, United States, 95051
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Taichung, Taiwan, 407
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Tampere, Finland, 33520
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Tottori, Japan, 683-8504
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Turku, Finland, 20520
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Vallejo, CA, United States, 94589
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Whittier, CA, United States, 90703
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Woolangabba, QLD, Australia, 4102
Status
Terminated/Withdrawn

Study documents

No study documents available.

Results overview

Study Results yet to be posted

Recruitment status
Active, not recruiting
Actual primary completion date
2025-05-06
Actual study completion date
Not applicable

Plain language summaries

Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.

Additional information about the trial

Additional information
Not applicable
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