18 and older, any sex, with Neoplasms. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Part 1: Number of Participants With Any Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) (Arm 4)Primary· Up to approximately 97 weeks
An AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE is defined as any untoward medical occurrence that, at any dose resulted in death, is life threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/ incapacity, is a congenital anomaly/ birth defect, other situations and is associated with liver injury or impaired liver function. SAEs are subset of AEs. A TEAE is any event that w
Any TEAEs
Group
Value
95% CI
Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)]
6
Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)]
9
Arm 4: Dostarlimab + Belrestotug [High Dose (HD)]
8
Any SAEs
Group
Value
95% CI
Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)]
0
Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)]
3
Arm 4: Dostarlimab + Belrestotug [High Dose (HD)]
2
Part 1: Number of Participants With Any TEAEs and SAEs (Arm 5)Primary· Up to approximately 107 weeks
An AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE is defined as any untoward medical occurrence that, at any dose resulted in death, is life threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/ incapacity, is a congenital anomaly/ birth defect, other situations and is associated with liver injury or impaired liver function. SAEs are subset of AEs. A TEAE is any event that w
Arm 5 Randomized Part: Belrestotug MD + Dostarlimab + Nelistotug HD
3
Part 1: Number of Participants With Dose Limiting Toxicity (DLT) (Arm 4 and Arm 5)Primary· Up to 21 days
A DLT is an AE meeting criteria such as, hematologic toxicities of Grade (G) 4 neutropenia/anemia/thrombocytopenia (G3 if bleeding). Non-hematological toxicities include persistent G2 eye events, colitis/diarrhea (G2 unresolved to ≤ G1 within 7 days despite immunosuppressive therapy, G3 for ≥ 72 hours, any G4), G3 pneumonitis, rash (unresolved to ≤ G2 within 2 weeks despite treatment), hypersensitivity/IRR, liver events meeting Hy's Law criteria. G3 toxicity unresolved to ≤G1 or baseline within 3 days with supportive care, or any G4 toxicity. Exclusions include G3 events of electrolyte imbalan
Group
Value
95% CI
Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)]
Arm 5 Randomized Part: Belrestotug MD + Dostarlimab + Nelistotug HD
0
Part 1: Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status (Arm 4)Primary· Up to approximately 97 weeks
Performance Status was assessed using the ECOG scale (Grades 0-5), where 0: Fully active, able to carry on all pre-disease performance without restriction. Grade 1: Restricted in physically strenuous activity but ambulatory \& able to carry out work of light or sedentary nature; Grade 2 - Ambulatory \& capable of all self-care but unable to carry out any work activities. Up and about more than (\>) 50% of waking hours; Grade 3 -Capable of only limited self-care, confined to bed or chair \> 50% of waking hours; Grade 4 -Completely disabled. Cannot carry on any self-care. Totally confined to bed
Baseline, Grade 0
Group
Value
95% CI
Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)]
0
Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)]
5
Arm 4: Dostarlimab + Belrestotug [High Dose (HD)]
3
Baseline, Grade 1
Group
Value
95% CI
Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)]
6
Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)]
4
Arm 4: Dostarlimab + Belrestotug [High Dose (HD)]
6
Week 4, Grade 0
Group
Value
95% CI
Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)]
1
Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)]
4
Arm 4: Dostarlimab + Belrestotug [High Dose (HD)]
3
Week 4, Grade 1
Group
Value
95% CI
Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)]
3
Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)]
3
Arm 4: Dostarlimab + Belrestotug [High Dose (HD)]
4
Week 4, Grade 2
Group
Value
95% CI
Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)]
2
Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)]
1
Arm 4: Dostarlimab + Belrestotug [High Dose (HD)]
1
Week 7, Grade 0
Group
Value
95% CI
Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)]
1
Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)]
2
Arm 4: Dostarlimab + Belrestotug [High Dose (HD)]
1
Week 7, Grade 1
Group
Value
95% CI
Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)]
1
Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)]
1
Arm 4: Dostarlimab + Belrestotug [High Dose (HD)]
5
Week 10, Grade 0
Group
Value
95% CI
Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)]
1
Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)]
2
Arm 4: Dostarlimab + Belrestotug [High Dose (HD)]
1
Part 1: Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status (Arm 5)Primary· Up to approximately 107 weeks
Performance Status was assessed using the ECOG scale (Grades 0-5), where 0: Fully active, able to carry on all pre-disease performance without restriction. Grade 1: Restricted in physically strenuous activity but ambulatory \& able to carry out work of light or sedentary nature; Grade 2 - Ambulatory \& capable of all self-care but unable to carry out any work activities. Up and about more than (\>) 50% of waking hours; Grade 3 -Capable of only limited self-care, confined to bed or chair \> 50% of waking hours; Grade 4 -Completely disabled. Cannot carry on any self-care. Totally confined to bed
Arm 5 Randomized Part: Belrestotug MD + Dostarlimab + Nelistotug HD
10
Part 1: Number of Participants With Worst-case Post Baseline Relative to Baseline Electrocardiogram (ECG) Findings (Arm 4)Primary· Up to approximately 97 weeks
Number of participants with worst-case post baseline (WCPB) from baseline ECG findings is summarized as clinically significant. Data is summarized as Normal, Abnormal - Not Clinically Significant (NCS) and Abnormal - Clinically Significant (CS). Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Worst Case Post-Baseline includes all scheduled and unscheduled visits post baseline.
Baseline
Group
Value
95% CI
Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)]
4
Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)]
2
Arm 4: Dostarlimab + Belrestotug [High Dose (HD)]
4
Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)]
2
Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)]
6
Arm 4: Dostarlimab + Belrestotug [High Dose (HD)]
3
Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)]
0
Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)]
0
Arm 4: Dostarlimab + Belrestotug [High Dose (HD)]
2
Worst-case post baseline
Group
Value
95% CI
Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)]
2
Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)]
2
Arm 4: Dostarlimab + Belrestotug [High Dose (HD)]
3
Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)]
3
Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)]
1
Arm 4: Dostarlimab + Belrestotug [High Dose (HD)]
2
Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)]
0
Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)]
1
Arm 4: Dostarlimab + Belrestotug [High Dose (HD)]
3
Adverse events — posted to ClinicalTrials.gov
Time frame: All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5..
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)]
Serious: 0/6 (0%)
Deaths: 4/6
Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)]
Serious: 3/9 (33%)
Deaths: 5/9
Arm 4: Dostarlimab + Belrestotug [High Dose (HD)])
This study is a sub-study of the master protocol 205801 (NCT03739710). This sub study will assess safety and pharmacokinetics and pharmacodynamics (PK/PD) of novel regimens (Dostarlimab plus belrestotug , and Dostarlimab plus belrestotug plus nelistotug) in participants with previously treated NSCLC.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
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Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by GlaxoSmithKline
Last refreshed: 3 July 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06926673.