Efficacy Comparison of Dostarlimab Plus Chemotherapy Versus Pembrolizumab Plus Chemotherapy in Participants With Metastatic Non-squamous Non-small Cell Lung Cancer (NSCLC)
TerminatedPhase 2Results postedLast updated 8 August 2025
What this trial tests
Phase 2 trial testing Dostarlimab in Lung Cancer, Non-Small Cell in 243 participants. Terminated before completion.
18 and older, any sex, with Lung Cancer, Non-Small Cell. 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.
Overall Survival (OS)Secondary· Up to approximately 46 months
OS was defined as the time from the date of randomization to the date of death by any cause.
Group
Value
95% CI
Dostarlimab + Chemotherapy
20.2
14.5 – 27.3
Pembrolizumab + Chemotherapy
15.9
11.6 – 19.3
Progression-free Survival (PFS)Secondary· Up to approximately 46 months
PFS was defined as the time from the date of randomization to the date of disease progression (PD) or death by any cause, whichever occurs first. PFS was evaluated using Response Evaluation Criteria in Solid Tumors Criteria (RECIST) version 1.1 based on Investigator assessment. PD is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as a reference, the smallest sum of diameters recorded since the treatment started (e.g., percent change from nadir, where nadir is defined as the smallest sum of diameters recorded since treatment start).
Group
Value
95% CI
Dostarlimab + Chemotherapy
8.8
6.9 – 11.0
Pembrolizumab + Chemotherapy
6.8
4.9 – 7.1
Number of Participants With Treatment-emergent Adverse Event (TEAEs), TEAEs Leading to Death and TEAEs Leading to Treatment DiscontinuationSecondary· Up to 46 months
AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. A TEAE is an event that emerges during treatment having been absent pretreatment or worsens relative to the pretreatment state. Number of participants with TEAEs, TEAEs leading to death, and TEAEs leading to treatment discontinuation are presented. AEs were coded using the Medical Dictionary for Regulatory Affairs (MedDRA dictionary).
TEAEs
Group
Value
95% CI
Dostarlimab + Chemotherapy
119
Pembrolizumab + Chemotherapy
119
TEAEs leading to death
Group
Value
95% CI
Dostarlimab + Chemotherapy
17
Pembrolizumab + Chemotherapy
12
TEAEs leading to treatment discontinuation
Group
Value
95% CI
Dostarlimab + Chemotherapy
35
Pembrolizumab + Chemotherapy
46
Number of Participants With Treatment Emergent Immune-related Adverse Event (irAE)Secondary· Up to 46 months
The irAEs are events which are severe or fatal and can occur in participants treated with monoclonal antibodies directed against immune checkpoints, including pembrolizumab and dostarlimab. While irAEs (eg, diarrhea/colitis, pneumonitis, nephritis, hypophysitis, adrenalitis, thyroiditis, severe skin reactions, uveitis, myocarditis, and hepatotoxicity) usually occur during treatment, symptoms can also manifest after discontinuation of treatment. AEs were coded using the MedDRA dictionary.
Group
Value
95% CI
Dostarlimab + Chemotherapy
38
Pembrolizumab + Chemotherapy
47
Number of Participants With Serious AEsSecondary· Up to approximately 46 months
An SAE is any untoward medical occurrence that, at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly/birth defect or is an important medical event that may jeopardize the participant or may require medical or surgical intervention to prevent one of the above outcomes. SAEs are subset of AEs. AEs were coded using the MedDRA dictionary.
Group
Value
95% CI
Dostarlimab + Chemotherapy
51
Pembrolizumab + Chemotherapy
61
Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to BaselineSecondary· Up to approximately 46 months
Normal ranges were 30 to 110 units per liter (U/L) (Amylase); 4. 5 to 5. 6 milligram/deciliters (mg/dL) (Calcium); 96 to 100 milliequivalents (mEq)/ L (Chloride); 2. 5 to 4.5 mg/dL (Phosphate); 6 to 8.3 grams/L (protein); 6 to 24 millimoles/L (Urea) and 7 to 20 mg/dL (Urea nitrogen). Participants were counted in worst case category that their value changes to low, normal or no change \[NC\] or high), unless there is NC in their category. Participants whose laboratory value category was unchanged (e.g. High to High) or whose value became normal, were recorded in "To Normal or No Change" categor
Amylase, To Low
Group
Value
95% CI
Dostarlimab + Chemotherapy
8
Pembrolizumab + Chemotherapy
11
Amylase, To Normal or No Change
Group
Value
95% CI
Dostarlimab + Chemotherapy
76
Pembrolizumab + Chemotherapy
76
Amylase, To High
Group
Value
95% CI
Dostarlimab + Chemotherapy
34
Pembrolizumab + Chemotherapy
30
Calcium, To Low
Group
Value
95% CI
Dostarlimab + Chemotherapy
42
Pembrolizumab + Chemotherapy
39
Calcium, To Normal or No Change
Group
Value
95% CI
Dostarlimab + Chemotherapy
60
Pembrolizumab + Chemotherapy
65
Calcium, To High
Group
Value
95% CI
Dostarlimab + Chemotherapy
25
Pembrolizumab + Chemotherapy
16
Chloride, To Low
Group
Value
95% CI
Dostarlimab + Chemotherapy
34
Pembrolizumab + Chemotherapy
26
Chloride, To Normal or No Change
Group
Value
95% CI
Dostarlimab + Chemotherapy
65
Pembrolizumab + Chemotherapy
69
Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to BaselineSecondary· Up to approximately 46 months
Normal ranges were 0.01 to 0.3\*10\^9 cells/L (basophils); 41 to 50 percentage of red blood cells (RBC) in blood (hematocrit); 80-100 femtoliters (fl) (erythrocytes \[referred as Ery\] mean corpuscular volume (EMCV)); 2 to 8 percentage of WBC (monocytes); and Women: 4.2 to 5.4 million RBC/ microliter (mcL) of blood and Men: 4.7 to 6.1 million RBC/ mcL (erythrocytes). Participants were counted in worst case category that their value changes to low, normal or no change \[NC\] or high), unless there is NC in their category. Participants whose laboratory value category was unchanged (e.g. High to
Basophils, To Low
Group
Value
95% CI
Dostarlimab + Chemotherapy
12
Pembrolizumab + Chemotherapy
9
Basophils, To Normal or No Change
Group
Value
95% CI
Dostarlimab + Chemotherapy
72
Pembrolizumab + Chemotherapy
75
Basophils, To High
Group
Value
95% CI
Dostarlimab + Chemotherapy
19
Pembrolizumab + Chemotherapy
19
Hematocrit, To Low
Group
Value
95% CI
Dostarlimab + Chemotherapy
73
Pembrolizumab + Chemotherapy
64
Hematocrit, To Normal or No Change
Group
Value
95% CI
Dostarlimab + Chemotherapy
43
Pembrolizumab + Chemotherapy
50
Hematocrit, To High
Group
Value
95% CI
Dostarlimab + Chemotherapy
3
Pembrolizumab + Chemotherapy
1
EMCV, To Low
Group
Value
95% CI
Dostarlimab + Chemotherapy
6
Pembrolizumab + Chemotherapy
11
EMCV, To Normal or No Change
Group
Value
95% CI
Dostarlimab + Chemotherapy
59
Pembrolizumab + Chemotherapy
54
Number of Participants With Worst Case Urinalysis Results Post-Baseline Relative to BaselineSecondary· Up to approximately 46 months
Urine samples were collected to assess urine Bilirubin, glucose, ketones, Leukocyte Esterase, Nitrite, occult blood and Protein using dipstick method. The dipstick test gave results in a semi-quantitative manner, and results for urinalysis parameters were recorded as No Change/Decreased, Increase to TRACE, Increase to +, Increase to ++, Increase to +++ and Increase to ++++. Baseline (Day 1) was defined as the most recent, non-missing value prior to or on the first study treatment dose date.
Bilirubin, No Change/Decreased
Group
Value
95% CI
Dostarlimab + Chemotherapy
86
Pembrolizumab + Chemotherapy
66
Bilirubin, Increase to TRACE
Group
Value
95% CI
Dostarlimab + Chemotherapy
0
Pembrolizumab + Chemotherapy
0
Bilirubin, Increase to +
Group
Value
95% CI
Dostarlimab + Chemotherapy
4
Pembrolizumab + Chemotherapy
3
Bilirubin, Increase to ++
Group
Value
95% CI
Dostarlimab + Chemotherapy
0
Pembrolizumab + Chemotherapy
0
Bilirubin, Increase to +++
Group
Value
95% CI
Dostarlimab + Chemotherapy
0
Pembrolizumab + Chemotherapy
0
Bilirubin, Increase to ++++
Group
Value
95% CI
Dostarlimab + Chemotherapy
0
Pembrolizumab + Chemotherapy
0
Glucose, No Change/Decreased
Group
Value
95% CI
Dostarlimab + Chemotherapy
79
Pembrolizumab + Chemotherapy
57
Glucose, Increase to TRACE
Group
Value
95% CI
Dostarlimab + Chemotherapy
2
Pembrolizumab + Chemotherapy
1
Change From Baseline (CFB) in Thyroid Functions: Free Triiodothyronine (T3) and Free Thyroxine (T4)Secondary· Up to approximately 46 months
Blood samples were collected for the assessment Free Triiodothyronine (T3) and Free Thyroxine (T4).
Triiodothyronine, Free, Baseline
Group
Value
95% CI
Dostarlimab + Chemotherapy
4.48026
± 1.638746
Pembrolizumab + Chemotherapy
4.48540
± 1.066597
Triiodothyronine, Free, CFB to Cycle 2 Day 1
Group
Value
95% CI
Dostarlimab + Chemotherapy
-0.12423
± 2.071042
Pembrolizumab + Chemotherapy
-0.24330
± 1.026993
Triiodothyronine, Free, CFB to Cycle 4 Day 1
Group
Value
95% CI
Dostarlimab + Chemotherapy
-0.00187
± 2.206972
Pembrolizumab + Chemotherapy
-0.11796
± 1.413190
Triiodothyronine, Free, CFB to Cycle 6 Day 1
Group
Value
95% CI
Dostarlimab + Chemotherapy
-0.15030
± 2.128584
Pembrolizumab + Chemotherapy
-0.37705
± 1.117516
Triiodothyronine, Free, CFB to Cycle 8 Day 1
Group
Value
95% CI
Dostarlimab + Chemotherapy
0.11483
± 2.738875
Pembrolizumab + Chemotherapy
-0.43073
± 1.123017
Triiodothyronine, Free, CFB to Cycle 10 Day 1
Group
Value
95% CI
Dostarlimab + Chemotherapy
-0.25993
± 2.187046
Pembrolizumab + Chemotherapy
-0.23819
± 1.273369
Triiodothyronine, Free, CFB to Cycle 12 Day 1
Group
Value
95% CI
Dostarlimab + Chemotherapy
-0.04347
± 2.817465
Pembrolizumab + Chemotherapy
5.82171
± 34.328615
Triiodothyronine, Free, CFB to Cycle 14 Day 1
Group
Value
95% CI
Dostarlimab + Chemotherapy
-0.61895
± 2.558169
Pembrolizumab + Chemotherapy
-0.33501
± 1.597219
Change From Baseline in Thyroid Function: Thyrotropin (TSH)Secondary· Up to approximately 46 months
Blood samples were collected for the assessment of Thyroid Function Thyrotropin (TSH).
Baseline
Group
Value
95% CI
Dostarlimab + Chemotherapy
1.853
± 1.8354
Pembrolizumab + Chemotherapy
1.904
± 1.7421
CFB to Cycle 2 Day 1
Group
Value
95% CI
Dostarlimab + Chemotherapy
0.225
± 3.7642
Pembrolizumab + Chemotherapy
-0.497
± 1.7405
CFB to Cycle 4 Day 1
Group
Value
95% CI
Dostarlimab + Chemotherapy
1.285
± 9.4283
Pembrolizumab + Chemotherapy
-0.622
± 1.7892
CFB to Cycle 6 Day 1
Group
Value
95% CI
Dostarlimab + Chemotherapy
1.123
± 8.4596
Pembrolizumab + Chemotherapy
2.006
± 21.0213
CFB to Cycle 8 Day 1
Group
Value
95% CI
Dostarlimab + Chemotherapy
2.454
± 9.7235
Pembrolizumab + Chemotherapy
2.648
± 22.9952
CFB to Cycle 10 Day 1
Group
Value
95% CI
Dostarlimab + Chemotherapy
3.233
± 12.1571
Pembrolizumab + Chemotherapy
1.986
± 12.8377
CFB to Cycle 12 Day 1
Group
Value
95% CI
Dostarlimab + Chemotherapy
2.448
± 9.8590
Pembrolizumab + Chemotherapy
1.138
± 10.9780
CFB to Cycle 14 Day 1
Group
Value
95% CI
Dostarlimab + Chemotherapy
1.282
± 4.2566
Pembrolizumab + Chemotherapy
1.734
± 9.0539
Change From Baseline in Thyroid Functions: Triiodothyronine (T3) and Thyroxine (T4)Secondary· Up to approximately 46 months
Blood samples were collected for the assessment of Triiodothyronine (T3) and Thyroxine (T4).
Triiodothyronine, Baseline
Group
Value
95% CI
Dostarlimab + Chemotherapy
1.68399
± 0.308404
Pembrolizumab + Chemotherapy
1.48287
± 0.526037
Triiodothyronine, CFB to Cycle 2 Day 1
Group
Value
95% CI
Dostarlimab + Chemotherapy
0.06903
± 0.172873
Pembrolizumab + Chemotherapy
-0.58292
Triiodothyronine, CFB to Cycle 4 Day 1
Group
Value
95% CI
Dostarlimab + Chemotherapy
-0.41878
± 0.353613
Triiodothyronine, CFB to Cycle 6 Day 1
Group
Value
95% CI
Dostarlimab + Chemotherapy
-0.21476
Thyroxine, Baseline
Group
Value
95% CI
Dostarlimab + Chemotherapy
72.72912
± 46.845564
Pembrolizumab + Chemotherapy
85.29069
± 38.027652
Thyroxine, CFB to Cycle 2 Day 1
Group
Value
95% CI
Dostarlimab + Chemotherapy
16.06393
± 38.489073
Pembrolizumab + Chemotherapy
-3.12689
± 11.544100
Thyroxine, CFB to Cycle 4 Day 1
Group
Value
95% CI
Dostarlimab + Chemotherapy
10.16002
± 47.746764
Pembrolizumab + Chemotherapy
12.22592
± 30.578995
Thyroxine, CFB to Cycle 6 Day 1
Group
Value
95% CI
Dostarlimab + Chemotherapy
9.83083
± 30.658114
Pembrolizumab + Chemotherapy
-2.45916
± 27.497527
Number of Participants With Worst-case Grade Change From Baseline in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)Secondary· Up to approximately 46 months
DBP and SBP were measured in a semi-supine position after 5 minutes rest. Grades were derived based on numeric criteria as defined in Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Systolic Blood Pressure (SBP): Grade 0 (\<120 Millimetre of mercury (mmHg)), Grade 1 (120-139 mmHg), Grade 2 (140-159 mmHg), Grade 3 (\>=160 mmHg). Diastolic Blood Pressure (DBP): Grade 0 (\<80 mmHg), Grade 1 (80-89 mmHg), Grade 2 (90-99 mmHg), Grade 3 (\>=100 mmHg). An increase is defined as an increase in the CTCAE grade relative to the Baseline grade. Only those participants with grade increa
DBP, Increase to Grade 1
Group
Value
95% CI
Dostarlimab + Chemotherapy
36
Pembrolizumab + Chemotherapy
27
DBP, Increase to Grade 2
Group
Value
95% CI
Dostarlimab + Chemotherapy
35
Pembrolizumab + Chemotherapy
25
DBP, Increase to Grade 3
Group
Value
95% CI
Dostarlimab + Chemotherapy
6
Pembrolizumab + Chemotherapy
7
SBP, Increase to Grade 1
Group
Value
95% CI
Dostarlimab + Chemotherapy
24
Pembrolizumab + Chemotherapy
18
SBP, Increase to Grade 2
Group
Value
95% CI
Dostarlimab + Chemotherapy
34
Pembrolizumab + Chemotherapy
24
SBP, Increase to Grade 3
Group
Value
95% CI
Dostarlimab + Chemotherapy
8
Pembrolizumab + Chemotherapy
11
Adverse events — posted to ClinicalTrials.gov
Time frame: All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 and up to approximately 46 months..
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
NSCLC comprises of approximately 84 percent (%) of all lung cancers and is often diagnosed at advanced stage due to poor prognosis. Dostarlimab is an immunoglobulin G (IgG)4 kappa humanized monoclonal antibody (mAb) that binds with high affinity to programmed cell death protein 1 (PD 1), resulting in inhibition of binding to programmed death ligand 1 (PD L1) and programmed death ligand 2 (PD L2). This study aims to compare the efficacy and safety PD-1 inhibitors dostarlimab and pembrolizumab, when administered in combination with chemotherapy (pemetrexed, cisplatin and carboplatin), in participants with non-squamous NSCLC without a known sensitizing epidermal growth factor receptor (EGFR), anaplastic lymphoma kinase (ALK), or receptor tyrosine kinase-1 (ROS-1) mutation, BRAF V600E mutation, or other genomic aberration for which an approved targeted therapy is available. A total of approximately 240 participants will be enrolled in the study for a period of 5 years.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
NCT07408063 — A Comprehensive Multiomic Biomarker Evaluation Across Two Single-arm Cohorts to Elucidate Mechanisms of Response and Res
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NCT07381777 — XELOX Plus DoSTARlimab Versus XELOX Alone as Consolidation Treatment After Standard Chemoradiation in pMMR/MSS or MSI-Lo
· Phase 2
· not yet recruiting
NCT06405230 — Evaluation of Programmed Death Ligand 1 (PDL1) Response to Treatment in Extracellular Vesicles (EVs), Patient-derived Or
· Phase 1, PHASE2
· recruiting
NCT07336147 — Dostarlimab, Cisplatin and Etoposide in Combination With Radiotherapy in Sandwich Sequence for Small Cell Neuroendocrine
· Phase 2
· recruiting
NCT07108270 — A Study of Dostarlimab in Combination With Carboplatin-paclitaxel in Chinese Participants With Primary Advanced or Recur
· Phase 2
· recruiting
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
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: 8 August 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/NCT04581824.