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NCT06472076 (Belrestotug in PDL1 high Non-small-cell Lung Cancer): BVCT ex-ante prediction vs. reported outcome

On 30 Jan 2025, BioinvestGPT's BVCT predicted technical failure and commercial failure for this trial. The 13 May 2025 readout is classified on the dashboard as True Negative (TN), a correct prediction. Recorded clinical-benefit conclusion: statistically insignificant (PFS) and commercially insufficient.

Clinical Trial

NCTID
NCT06472076
Acronym
GALAXIES Lung-301
Drug Name
Belrestotug
Drug MoA
anti-TIGIT inhibitor
Drug Modality
monoclonal antibody
Drug Class
First-In-Class
Therapeutic Area
Neoplasms
Indication
PDL1 high Non-small-cell Lung Cancer (NSCLC)
Human Patients
1000
Sponsor
GlaxoSmithKline / iTeos Therapeutics
Phase
Phase 3

Prediction of , index 1895

Prospective Prediction
Prediction Index
1895
Prediction Date
Commercial Prediction
FAILURE (commercially insufficient additive clinical benefit in OS inferior to pembrolizumab monotherapy)
Technical Prediction
FAILURE (statistically insignificant additive clinical benefit in ORR/PFS non-superior to pembrolizumab monotherapy)

Readout of

Prediction Validation
Readout Date
Prediction To Readout
103 days in advance
Readout Data Interpretation
belrestotug + dostarlimab failed to achieve statistically significant clinical benefit in PFS compared with dostarlimab mono therapy
Press Release
Prediction Result
Prediction Accuracy
Correct Prediction
Clinical Benefit Conclusion
statistically insignificant (PFS) and commercially insufficient
Prediction Classification
True Negative (TN)

ClinicalTrials.gov record

ClinicalTrials.gov record, retrieved 2026-09-24. Third-party data.

Official title
A Randomized, Multicenter, Double-blind, Phase 3 Study to Investigate the Safety and Efficacy of Belrestotug in Combination With Dostarlimab Compared With Placebo in Combination With Pembrolizumab in Participants With Previously Untreated, Unresectable, Locally Advanced or Metastatic PD-L1 Selected Non-small Cell Lung Cancer (GALAXIES Lung-301)
Phase
Phase 3
Status
Active not recruiting
Enrollment
88
Lead sponsor
GlaxoSmithKline
Conditions
Lung Cancer, Non-Small Cell
Interventions
BIOLOGICAL: Dostarlimab; BIOLOGICAL: Belrestotug; BIOLOGICAL: Pembrolizumab; DRUG: Placebo
Design
Randomized · Parallel · Quadruple
Primary purpose
Treatment
Start
2024-06-10
Primary completion
2026-06-30
Completion
2027-08-30
Primary outcomes
  • Number of Participants with Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) (Up to approximately 138 weeks)
  • Number of Participants with TEAEs or SAEs leading to dose withdrawals or treatment discontinuation (Up to approximately 138 weeks)

NCT06472076 on ClinicalTrials.gov

Return to the dashboardClinicalTrials.gov

How to read these records: evidence · methodology · all trials