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Cobolimab

Phase 2

Lung Cancer, Non-Small Cell | Monoclonal antibody | Oncology |GSK plc|Last Updated: Jul 1, 2026

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLEDDMC
Total Trials1
Total Enrollment758

FDA Designations

No designations recorded

Clinical trial landscape

Cobolimab · 2 trials · 13 indications

Phase 2 1Phase 1 1
NCT04655976Efficacy 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 ChemotherapyLung Cancer, Non-Small Cell
ACTIVE NOT_RECRUITING758 Analytics
PHASE2ACTIVE NOT_RECRUITING
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
Lung Cancer, Non-Small CellUnlock trial analytics

Study Endpoints

Primary Endpoints

Overall Survival (OS) (Arm A Versus Arm C)
Up to approximately 234 weeks

OS is defined as the time from the date of randomization to the date of death due to any cause.

Overall Survival (OS) (Arm B Versus Arm C)
Up to approximately 234 weeks

OS is defined as the time from the date of randomization to the date of death due to any cause.

Part 1- Number of participants with Dose Limiting Toxicities (DLTs)
Up to 42 days
Part 1- Number of participants with treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), immune-mediated adverse events (imAEs) and adverse events (AEs) leading to discontinuation occurring during the study
Up to approximately 46 months
Part 1- Serum concentration of Cobolimab
1±0.5 hours (h) post-dose on Cycle 1 Day 1; 168±12 h post-dose Cycle 1Day 8; Pre-dose and 1±0.5 h post-dose on Cycle 2 Day 1; Cycle 4 Day 1 and Cycle 6 Day 1(Each cycle is of 21 days)
Part 1- Serum concentration of Dostarlimab
1±0.5 h post start of cobolimab infusion on Cycle 1 Day 1; Pre-dose on Cycle 2 Day 1; Cycle 4 Day 1 and Cycle 6 Day 1(Each cycle is of 21 days)
Part 1- Recommended Phase 2 Dose (RP2D) of Cobolimab and Dostarlimab combination
Up to approximately 12 months
Part 2- Confirmed Objective Response Rate (ORR)
Up to approximately 46 months

Confirmed ORR is defined as the proportion of participants who have achieved confirmed complete response (CR) or confirmed partial response (PR), evaluated using disease-specific tumor assessment criteria based on Investigator assessment

Part 2- Number of participants with TEAEs, SAEs, imAEs, TEAEs leading to death and AEs leading to discontinuation
Up to approximately 46 months
Part 2-Number of participants with changes in laboratory parameters, vital signs and cardiac parameters
Up to approximately 46 months

Secondary Endpoints

Overall Survival (OS) (Arm A Versus Arm B)
Up to approximately 234 weeks
Overall Response Rate (ORR)
Up to approximately 234 weeks
Progression Free Survival (PFS)
Up to approximately 234 weeks
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Participants receiving cobolimab+ dostarlimab+ docetaxelEXPERIMENTAL -
Participants receiving dostarlimab+ docetaxelEXPERIMENTAL -
Participants receiving docetaxelACTIVE_COMPARATOR -
Part 1- Dose determinationEXPERIMENTAL -
Part 2- Dose expansionEXPERIMENTAL -

Interventions

NameTypeDescription
CobolimabBIOLOGICALCobolimab will be administered.
DostarlimabBIOLOGICALDostarlimab will be administered.
DocetaxelDRUGDocetaxel will be administered.
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites163

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 (...

Countries:United StatesArgentinaAustraliaBelgiumBrazilCanadaFinlandFranceGermanyGreeceItalyJapanMexicoNetherlandsPolandRomaniaRussiaSouth KoreaSpainSwedenTaiwanThailandTurkey (Türkiye)United KingdomCzechiaDenmark
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Recent Changes (Last 90 Days)

LOWJul 2, 2026NCT04655976Phase: PHASE3 → PHASE2
LOWJul 2, 2026NCT04655976Phase: PHASE3 → PHASE2
LOWJul 2, 2026NCT04655976Phase: PHASE3 → PHASE2
LOWJul 2, 2026NCT04655976Phase: PHASE3 → PHASE2

Frequently asked questions about Cobolimab

What is Cobolimab used for?

Cobolimab is an investigational monoclonal antibody being studied for use in oncology, specifically in non-small cell lung cancer, melanoma, and other cancers. It is currently in Phase 2 clinical development for advanced non-small cell lung cancer and Phase 1 for pediatric and young adult cancers.

What does Cobolimab target?

Cobolimab is a monoclonal antibody, a type of -mab antibody. Its specific molecular target is not disclosed in available information. It is being studied in combination with other therapies for the treatment of various cancers.

Who makes Cobolimab?

Cobolimab is being developed by GSK plc, a global biopharma company listed on the stock exchange under the ticker GSK. GSK is conducting clinical trials to evaluate the safety and efficacy of Cobolimab in multiple cancer indications.

What phase is Cobolimab in?

Cobolimab is in Phase 2 clinical development for advanced non-small cell lung cancer. It is also being studied in a Phase 1 trial for pediatric and young adult cancers. Cobolimab is investigational and has not been approved by regulatory authorities.

What clinical trials is Cobolimab in?

Cobolimab is being evaluated in two active clinical trials. NCT04655976 is a Phase 2 study comparing Cobolimab plus dostarlimab and docetaxel to other combinations in advanced non-small cell lung cancer. NCT06521567 is a Phase 1 study of Cobolimab plus dostarlimab in pediatric and young adult cancer patients.

Is Cobolimab the same as dostarlimab?

No, Cobolimab is not the same as dostarlimab. They are distinct investigational drugs being studied together in combination. In clinical trials, Cobolimab is combined with dostarlimab and docetaxel to evaluate its efficacy in treating advanced non-small cell lung cancer.