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

Trial Title: 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

NCT ID: NCT04655976

Condition: Lung Cancer, Non-Small Cell

Conditions: Official terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Docetaxel
Dostarlimab

Conditions: Keywords:
GSK4069889A
GSK4057190A
Cobolimab
Dostarlimab
Docetaxel
Chemotherapy

Study type: Interventional

Study phase: Phase 3

Overall status: Active, not recruiting

Study design:

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Biological
Intervention name: Cobolimab
Description: Cobolimab will be administered.
Arm group label: Participants receiving cobolimab+ dostarlimab+ docetaxel

Intervention type: Biological
Intervention name: Dostarlimab
Description: Dostarlimab will be administered.
Arm group label: Participants receiving cobolimab+ dostarlimab+ docetaxel
Arm group label: Participants receiving dostarlimab+ docetaxel

Intervention type: Drug
Intervention name: Docetaxel
Description: Docetaxel will be administered.
Arm group label: Participants receiving cobolimab+ dostarlimab+ docetaxel
Arm group label: Participants receiving docetaxel
Arm group label: Participants receiving dostarlimab+ docetaxel

Summary: 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.

Criteria for eligibility:
Criteria:
Inclusion Criteria: - 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 measurable disease. - Participant has documented radiographic disease progression on prior platinum based chemotherapy and on or after prior anti-PD-(L)1 therapy. - Participant agrees to submit an archival formalin-fixed paraffin-embedded (FFPE) tumor tissue specimen that was collected on or after diagnosis of metastatic disease. If archival tissue is not available, the participant must undergo biopsy prior to study entry. - Participant has an ECOG performance status score of 0 or 1. - Participant has a life expectancy of at least 3 months. - Participant has adequate Baseline organ function. - Participant has recovered from any prior treatment related toxicities. - Participant agrees to use contraception. Exclusion Criteria: - 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. - Participant has a documented sensitizing epidermal growth factor receptor (EGFR), anaplastic lymphoma kinase (ALK), or c-ros oncogene 1 (ROS-1) mutation. Participants whose tumors have not been tested for these driver mutations and therefore who have unknown driver mutation status are not eligible. Participants with squamous histology do not need to be tested for these driver mutations. - Participant had radiological or clinical disease progression (i.e., worsening performance status, clinical symptoms, and laboratory data) <=8 weeks after initiation of prior anti-programmed cell death protein 1 (anti-PD-1) or anti-PD-L1 antibody. The clinical disease progression should have been confirmed by a subsequent radiological scan. - Participant has received radiation to the lung that is >30 gray (Gy) within 6 months prior to the first dose of study treatment. - Participant has completed palliative radiotherapy within 7 days prior to the first dose of study treatment. - Participant is ineligible if any of the following hepatic characteristics are present: a. Alanine aminotransferase (ALT) >2.5 times upper limit normal (ULN) b. ALT and/or aspartate aminotransferase (AST) >1.5 times ULN concomitant with alkaline phosphatase (ALP) >2.5 times ULN; c. Bilirubin >1 times ULN; d. Current active liver or biliary disease (with the exception of Gilbert's syndrome or asymptomatic gallstones, liver metastases, or otherwise stable chronic liver disease per the Investigator's assessment). - Participant has known new or progressive brain metastases and/or leptomeningeal metastases. Participants who have received prior therapy for their brain metastases and have radiographically stable central nervous system disease may participate, provided they are neurologically stable for at least 4 weeks before study entry and are off corticosteroids within 3 days prior to the first dose of study treatment. - Participant has tested positive for the following at Screening or within 3 months before the first dose of study treatment: a. Presence of hepatitis B surface antigen. b. Presence of hepatitis C antibody in the absence of a ribonucleic acid (RNA) test for hepatitis C virus. If a confirmatory RNA test is available, a positive test result will exclude a participant, while a negative test result (indicating absence of active infection) will allow the participant to enter into the study. - Participant has known human immunodeficiency virus (HIV) (positive for HIV 1 or HIV 2 antibodies). - Participant has active autoimmune disease that required systemic treatment in the past 2 years, is immunocompromised in the opinion of the Investigator, or is receiving systemic immunosuppressive treatment. - Participant has symptomatic ascites or pleural effusion. A participant who is clinically stable following treatment of these conditions (including therapeutic thoracentesis or paracentesis) is eligible. - Participant has current interstitial lung disease, current pneumonitis, or a history of pneumonitis that required the use of glucocorticoids to assist with management. - Participant has pre-existing peripheral neuropathy that is Grade >=2 by National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0 criteria. - Participant has received a live vaccine within 30 days of the first dose of study treatment. Seasonal flu vaccines that do not contain live virus and Coronavirus Disease 2019 (COVID-19) vaccines. - Participant is unable to interrupt aspirin or other non-steroidal anti-inflammatory drugs (NSAIDs) for undergoing a biopsy procedure (in cases when a participant does not have an archival biopsy), other than an aspirin dose <=1.3 grams (g) per day, for a 5-day period (8-day) period for long-acting agents, such as piroxicam).

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: GSK Investigational Site

Address:
City: Fountain Valley
Zip: 92708
Country: United States

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Name: GSK Investigational Site

Address:
City: Walnut Creek
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City: Norwich
Zip: 06360
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Address:
City: Washington
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City: Honolulu
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City: Iowa City
Zip: 52242
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Address:
City: Edgewood
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Address:
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City: White Plains
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Address:
City: Pittsburgh
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City: Pittsburgh
Zip: 15232
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Address:
City: Sioux Falls
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Address:
City: Houston
Zip: 77030
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Name: GSK Investigational Site

Address:
City: Fredericksburg
Zip: 22408
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Facility:
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Address:
City: Tacoma
Zip: 98405
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Address:
City: Buenos Aires
Zip: C1426ABP
Country: Argentina

Facility:
Name: GSK Investigational Site

Address:
City: Cipoletti Rio Negro
Zip: R8324CVE
Country: Argentina

Facility:
Name: GSK Investigational Site

Address:
City: Ciudad Autonoma de Buenos Aire
Zip: 1425
Country: Argentina

Facility:
Name: GSK Investigational Site

Address:
City: Florida
Zip: 1602
Country: Argentina

Facility:
Name: GSK Investigational Site

Address:
City: La Rioja
Zip: F5300COE
Country: Argentina

Facility:
Name: GSK Investigational Site

Address:
City: Pergamino
Zip: B2700CPM
Country: Argentina

Facility:
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Address:
City: Rosario
Zip: S2000DBS
Country: Argentina

Facility:
Name: GSK Investigational Site

Address:
City: Viedma
Zip: R8500ACE
Country: Argentina

Facility:
Name: GSK Investigational Site

Address:
City: South Brisbane
Zip: 4101
Country: Australia

Facility:
Name: GSK Investigational Site

Address:
City: Ashford
Zip: 5037
Country: Australia

Facility:
Name: GSK Investigational Site

Address:
City: Hobart
Zip: 7000
Country: Australia

Facility:
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Address:
City: Ballarat
Zip: 3350
Country: Australia

Facility:
Name: GSK Investigational Site

Address:
City: Melbourne
Zip: 3004
Country: Australia

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Name: GSK Investigational Site

Address:
City: Mount Waverley
Zip: 3350
Country: Australia

Facility:
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Address:
City: Aalst
Zip: 9300
Country: Belgium

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Address:
City: Hasselt
Zip: 3500
Country: Belgium

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Name: GSK Investigational Site

Address:
City: Kortrijk
Zip: 8500
Country: Belgium

Facility:
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Address:
City: Blumenau
Zip: 89010340
Country: Brazil

Facility:
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Address:
City: Fortaleza
Zip: 60336-232
Country: Brazil

Facility:
Name: GSK Investigational Site

Address:
City: Porto Alegre
Zip: 90610000
Country: Brazil

Facility:
Name: GSK Investigational Site

Address:
City: Rio de Janeiro
Zip: 22061080
Country: Brazil

Facility:
Name: GSK Investigational Site

Address:
City: Rio de Janeiro
Zip: 22250-905
Country: Brazil

Facility:
Name: GSK Investigational Site

Address:
City: Salvador
Zip: 40170-110
Country: Brazil

Facility:
Name: GSK Investigational Site

Address:
City: SAo Paulo
Zip: 04014-002
Country: Brazil

Facility:
Name: GSK Investigational Site

Address:
City: Kingston
Zip: K7L 2V7
Country: Canada

Facility:
Name: GSK Investigational Site

Address:
City: Oshawa
Zip: L1G 2B9
Country: Canada

Facility:
Name: GSK Investigational Site

Address:
City: Sudbury
Zip: P3E 5J1
Country: Canada

Facility:
Name: GSK Investigational Site

Address:
City: Greenfield Park
Zip: J4V 2H1
Country: Canada

Facility:
Name: GSK Investigational Site

Address:
City: Montreal
Zip: H3T 1E2
Country: Canada

Facility:
Name: GSK Investigational Site

Address:
City: Helsinki
Zip: 00180
Country: Finland

Facility:
Name: GSK Investigational Site

Address:
City: Kuopio
Zip: 70210
Country: Finland

Facility:
Name: GSK Investigational Site

Address:
City: CrEteil cedex
Zip: 94010
Country: France

Facility:
Name: GSK Investigational Site

Address:
City: Grenoble cedex 9
Zip: 38043
Country: France

Facility:
Name: GSK Investigational Site

Address:
City: Marseille
Zip: 13009
Country: France

Facility:
Name: GSK Investigational Site

Address:
City: Nice Cedex 2
Zip: 06189
Country: France

Facility:
Name: GSK Investigational Site

Address:
City: Quimper cedex
Zip: 29107
Country: France

Facility:
Name: GSK Investigational Site

Address:
City: Rennes
Zip: 35033
Country: France

Facility:
Name: GSK Investigational Site

Address:
City: Tours cedex 9
Zip: 37044
Country: France

Facility:
Name: GSK Investigational Site

Address:
City: Augsburg
Zip: 86156
Country: Germany

Facility:
Name: GSK Investigational Site

Address:
City: Bad Berka
Zip: 99437
Country: Germany

Facility:
Name: GSK Investigational Site

Address:
City: Berlin
Zip: 12200
Country: Germany

Facility:
Name: GSK Investigational Site

Address:
City: Bonn
Zip: 53113
Country: Germany

Facility:
Name: GSK Investigational Site

Address:
City: Dresden
Zip: 01307
Country: Germany

Facility:
Name: GSK Investigational Site

Address:
City: Essen
Zip: 45147
Country: Germany

Facility:
Name: GSK Investigational Site

Address:
City: Frankfurt
Zip: 60488
Country: Germany

Facility:
Name: GSK Investigational Site

Address:
City: Frankfurt
Zip: 60590
Country: Germany

Facility:
Name: GSK Investigational Site

Address:
City: Halle
Zip: 06120
Country: Germany

Facility:
Name: GSK Investigational Site

Address:
City: Heidelberg
Zip: 69126
Country: Germany

Facility:
Name: GSK Investigational Site

Address:
City: Karlsruhe
Zip: 76137
Country: Germany

Facility:
Name: GSK Investigational Site

Address:
City: Koeln
Zip: 51109
Country: Germany

Facility:
Name: GSK Investigational Site

Address:
City: Muenchen
Zip: 81925
Country: Germany

Facility:
Name: GSK Investigational Site

Address:
City: MUnchen
Zip: 80336
Country: Germany

Facility:
Name: GSK Investigational Site

Address:
City: Oldenburg
Zip: 26121
Country: Germany

Facility:
Name: GSK Investigational Site

Address:
City: Athens
Zip: 115 27
Country: Greece

Facility:
Name: GSK Investigational Site

Address:
City: Athens
Zip: 11526
Country: Greece

Facility:
Name: GSK Investigational Site

Address:
City: Athens
Zip: 11528
Country: Greece

Facility:
Name: GSK Investigational Site

Address:
City: Athens
Zip: 12462
Country: Greece

Facility:
Name: GSK Investigational Site

Address:
City: Larissa
Zip: 41100
Country: Greece

Facility:
Name: GSK Investigational Site

Address:
City: Pylaia Thessaloniki
Zip: 570 01
Country: Greece

Facility:
Name: GSK Investigational Site

Address:
City: Rio Patras
Zip: 26504
Country: Greece

Facility:
Name: GSK Investigational Site

Address:
City: Thessaloniki
Zip: 55236
Country: Greece

Facility:
Name: GSK Investigational Site

Address:
City: Thessaloniki
Zip: 57010
Country: Greece

Facility:
Name: GSK Investigational Site

Address:
City: Ancona
Zip: 60126
Country: Italy

Facility:
Name: GSK Investigational Site

Address:
City: Avellino
Zip: 83100
Country: Italy

Facility:
Name: GSK Investigational Site

Address:
City: Firenze
Zip: 50134
Country: Italy

Facility:
Name: GSK Investigational Site

Address:
City: Milano
Zip: 20132
Country: Italy

Facility:
Name: GSK Investigational Site

Address:
City: Milano
Zip: 20133
Country: Italy

Facility:
Name: GSK Investigational Site

Address:
City: Monza
Zip: 20900
Country: Italy

Facility:
Name: GSK Investigational Site

Address:
City: Napoli
Zip: 80131
Country: Italy

Facility:
Name: GSK Investigational Site

Address:
City: Orbassano TO
Zip: 10043
Country: Italy

Facility:
Name: GSK Investigational Site

Address:
City: Perugia
Zip: 06156
Country: Italy

Facility:
Name: GSK Investigational Site

Address:
City: Siena
Zip: 53100
Country: Italy

Facility:
Name: GSK Investigational Site

Address:
City: Kyoto
Zip: 612-8555
Country: Japan

Facility:
Name: GSK Investigational Site

Address:
City: Miyagi
Zip: 981-1293
Country: Japan

Facility:
Name: GSK Investigational Site

Address:
City: Osaka
Zip: 591-8555
Country: Japan

Facility:
Name: GSK Investigational Site

Address:
City: Yamaguchi
Zip: 755-0241
Country: Japan

Facility:
Name: GSK Investigational Site

Address:
City: Cheongju Chungcheongbuk-do
Zip: 28644
Country: Korea, Republic of

Facility:
Name: GSK Investigational Site

Address:
City: Daegu
Zip: 42601
Country: Korea, Republic of

Facility:
Name: GSK Investigational Site

Address:
City: Gyeonggi-do
Zip: 10408
Country: Korea, Republic of

Facility:
Name: GSK Investigational Site

Address:
City: Pusan
Zip: 49241
Country: Korea, Republic of

Facility:
Name: GSK Investigational Site

Address:
City: Seongnam-si Gyeonggi-do
Zip: 13620
Country: Korea, Republic of

Facility:
Name: GSK Investigational Site

Address:
City: Seoul
Zip: 03722
Country: Korea, Republic of

Facility:
Name: GSK Investigational Site

Address:
City: Seoul
Zip: 05505
Country: Korea, Republic of

Facility:
Name: GSK Investigational Site

Address:
City: Seoul
Zip: 06351
Country: Korea, Republic of

Facility:
Name: GSK Investigational Site

Address:
City: Seoul
Zip: 08308
Country: Korea, Republic of

Facility:
Name: GSK Investigational Site

Address:
City: Suwon Kyunggi-do
Zip: 443-721
Country: Korea, Republic of

Facility:
Name: GSK Investigational Site

Address:
City: Guadalajara
Zip: 44280
Country: Mexico

Facility:
Name: GSK Investigational Site

Address:
City: Mexico City
Zip: 03100
Country: Mexico

Facility:
Name: GSK Investigational Site

Address:
City: Mexico City
Zip: 03810
Country: Mexico

Facility:
Name: GSK Investigational Site

Address:
City: Mexico City
Zip: 06700
Country: Mexico

Facility:
Name: GSK Investigational Site

Address:
City: Mexico City
Zip: CP 14080
Country: Mexico

Facility:
Name: GSK Investigational Site

Address:
City: Monterrey
Zip: 64460
Country: Mexico

Facility:
Name: GSK Investigational Site

Address:
City: Puebla Puebla
Zip: 72560
Country: Mexico

Facility:
Name: GSK Investigational Site

Address:
City: Amersfoort
Zip: 3813 TZ
Country: Netherlands

Facility:
Name: GSK Investigational Site

Address:
City: Enschede
Zip: 7512 KZ
Country: Netherlands

Facility:
Name: GSK Investigational Site

Address:
City: Groningen
Zip: 9713 GZ
Country: Netherlands

Facility:
Name: GSK Investigational Site

Address:
City: Harderwijk
Zip: 3844 DG
Country: Netherlands

Facility:
Name: GSK Investigational Site

Address:
City: Nijmegen
Zip: 6525 GA
Country: Netherlands

Facility:
Name: GSK Investigational Site

Address:
City: Utrecht
Zip: 3543 AZ
Country: Netherlands

Facility:
Name: GSK Investigational Site

Address:
City: Zwolle
Zip: 8025 AB
Country: Netherlands

Facility:
Name: GSK Investigational Site

Address:
City: Bydgoszcz
Zip: 85-796
Country: Poland

Facility:
Name: GSK Investigational Site

Address:
City: Gdynia
Zip: 81-519
Country: Poland

Facility:
Name: GSK Investigational Site

Address:
City: Lodz
Zip: 90-338
Country: Poland

Facility:
Name: GSK Investigational Site

Address:
City: Olsztyn
Zip: 10-357
Country: Poland

Facility:
Name: GSK Investigational Site

Address:
City: Pila
Zip: 64-920
Country: Poland

Facility:
Name: GSK Investigational Site

Address:
City: Poznan
Zip: 60-693
Country: Poland

Facility:
Name: GSK Investigational Site

Address:
City: Bucuresti
Zip: 013812
Country: Romania

Facility:
Name: GSK Investigational Site

Address:
City: Craiova Dolj
Zip: 200385
Country: Romania

Facility:
Name: GSK Investigational Site

Address:
City: Craiova
Zip: 200347
Country: Romania

Facility:
Name: GSK Investigational Site

Address:
City: Otopeni
Zip: 075100
Country: Romania

Facility:
Name: GSK Investigational Site

Address:
City: Timisoara
Zip: 300239
Country: Romania

Facility:
Name: GSK Investigational Site

Address:
City: Chelyabinsk
Zip: 454048
Country: Russian Federation

Facility:
Name: GSK Investigational Site

Address:
City: Moscow Region
Zip: 143423
Country: Russian Federation

Facility:
Name: GSK Investigational Site

Address:
City: Pushkin
Zip: 196603
Country: Russian Federation

Facility:
Name: GSK Investigational Site

Address:
City: Saint-Petersburg
Zip: 197022
Country: Russian Federation

Facility:
Name: GSK Investigational Site

Address:
City: A CoruNa
Zip: 15006
Country: Spain

Facility:
Name: GSK Investigational Site

Address:
City: Badalona
Zip: 08916
Country: Spain

Facility:
Name: GSK Investigational Site

Address:
City: Barcelona
Zip: 08035
Country: Spain

Facility:
Name: GSK Investigational Site

Address:
City: Barcelona
Zip: 08036
Country: Spain

Facility:
Name: GSK Investigational Site

Address:
City: Burgos
Zip: 09006
Country: Spain

Facility:
Name: GSK Investigational Site

Address:
City: Cordoba
Zip: 140044
Country: Spain

Facility:
Name: GSK Investigational Site

Address:
City: Las Palmas De Gran Canar
Zip: 35016
Country: Spain

Facility:
Name: GSK Investigational Site

Address:
City: Madrid
Zip: 28007
Country: Spain

Facility:
Name: GSK Investigational Site

Address:
City: Madrid
Zip: 28034
Country: Spain

Facility:
Name: GSK Investigational Site

Address:
City: Madrid
Zip: 28041
Country: Spain

Facility:
Name: GSK Investigational Site

Address:
City: Madrid
Zip: 28046
Country: Spain

Facility:
Name: GSK Investigational Site

Address:
City: Madrid
Zip: 28050
Country: Spain

Facility:
Name: GSK Investigational Site

Address:
City: Madrid
Zip: 28222
Country: Spain

Facility:
Name: GSK Investigational Site

Address:
City: Malaga
Zip: 29010
Country: Spain

Facility:
Name: GSK Investigational Site

Address:
City: Valencia
Zip: 46026
Country: Spain

Facility:
Name: GSK Investigational Site

Address:
City: Gavle
Zip: SE-801 87
Country: Sweden

Facility:
Name: GSK Investigational Site

Address:
City: Stockholm
Zip: 171 64
Country: Sweden

Facility:
Name: GSK Investigational Site

Address:
City: Uppsala
Zip: SE-751 85
Country: Sweden

Facility:
Name: GSK Investigational Site

Address:
City: HsinChu
Zip: 300
Country: Taiwan

Facility:
Name: GSK Investigational Site

Address:
City: Taichung
Zip: 407
Country: Taiwan

Facility:
Name: GSK Investigational Site

Address:
City: Taipei
Zip: 11217
Country: Taiwan

Facility:
Name: GSK Investigational Site

Address:
City: Taipei
Zip: 23561
Country: Taiwan

Facility:
Name: GSK Investigational Site

Address:
City: Bangkok
Zip: 10210
Country: Thailand

Facility:
Name: GSK Investigational Site

Address:
City: Dusit
Zip: 10300
Country: Thailand

Facility:
Name: GSK Investigational Site

Address:
City: Kho Hong Hat Yai
Zip: 90110
Country: Thailand

Facility:
Name: GSK Investigational Site

Address:
City: Khon Kaen
Zip: 40002
Country: Thailand

Facility:
Name: GSK Investigational Site

Address:
City: Pathumthani
Zip: 12120
Country: Thailand

Facility:
Name: GSK Investigational Site

Address:
City: Adana
Zip: 1120
Country: Turkey

Facility:
Name: GSK Investigational Site

Address:
City: Antalya
Zip: 07020
Country: Turkey

Facility:
Name: GSK Investigational Site

Address:
City: Izmir
Zip: 35600
Country: Turkey

Facility:
Name: GSK Investigational Site

Address:
City: Cardiff
Zip: CF14 2TL
Country: United Kingdom

Facility:
Name: GSK Investigational Site

Address:
City: Edinburgh
Zip: EH4 2XU
Country: United Kingdom

Facility:
Name: GSK Investigational Site

Address:
City: London
Zip: SE1 9RT
Country: United Kingdom

Facility:
Name: GSK Investigational Site

Address:
City: London
Zip: W1G 6AD
Country: United Kingdom

Facility:
Name: GSK Investigational Site

Address:
City: Manchester
Zip: M20 4BX
Country: United Kingdom

Start date: December 8, 2020

Completion date: October 31, 2025

Lead sponsor:
Agency: GlaxoSmithKline
Agency class: Industry

Source: GlaxoSmithKline

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT04655976