18 and older, any sex, with Carcinoma, Non-Small-Cell Lung or Lung Diseases. 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.
Objective Response Rate (ORR)Primary· up to 267 days
The Objective Response Rate (ORR): The primary endpoint for this study will be ORR as defined by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) in the main study population. Presented are counts of participants in the following RECIST categories: Complete Response (CR), Partial Response (PR), Stable Disease (SD), Progressive Disease (PD)
Group
Value
95% CI
Sitravatinib: Group 1A
0
Sitravatinib: Group 2A
0
Sitravatinib: Group 1B
0
Sitravatinib: Group 2B
0
Sitravatinib: Group 1A
0
Sitravatinib: Group 2A
0
Sitravatinib: Group 1B
1
Sitravatinib: Group 2B
1
Sitravatinib: Group 1A
1
Sitravatinib: Group 2A
2
Sitravatinib: Group 1B
0
Sitravatinib: Group 2B
2
Sitravatinib: Group 1A
0
Sitravatinib: Group 2A
0
Sitravatinib: Group 1B
1
Sitravatinib: Group 2B
0
Overall Survival (OS)Secondary· until death or date of last contact, up to 2 years
Overall Survival (OS) in the main study populations (ie groups 1A and 2A) is a secondary endpoint for this study. OS in groups 1B and 2B is an exploratory endpoint. Defined as the time from date of treatment start to death due to any cause
Group
Value
95% CI
Sitravatinib: Group 1A
246
NA – NA
Sitravatinib: Group 2A
210
24 – NA
Progression Free Survival (PFS)Secondary· Until progressive disease, death, or last contact, up to 2 years
Progression Free Survival (PFS) in the main study populations (ie groups 1A and 2A) is a secondary endpoint for this study. PFS in groups 1B and 2B is an exploratory endpoint. Defined as time from first dose to first progressive disease (PD) or death due to any cause in the absence of documented PD.
Group
Value
95% CI
Sitravatinib: Group 1A
246
NA – NA
Sitravatinib: Group 2A
210
24 – NA
Clinical Benefit Rate (CBR)Secondary· up to 2 years
Clinical Benefit Rate (CBR) in Group A is a secondary endpoints for this study, while CBR in Group B is an exploratory endpoint. Defined as percent of patients documented to have a confirmed Complete Response (CR), confirmed Partial Response (PR), or Stable Disease (SD) documented on at least 1 on-study assessment and including at least 5 weeks on study
Group
Value
95% CI
Sitravatinib: Group 1A
100
Sitravatinib: Group 2A
66.7
Number of Participants That Experienced at Least 1 Adverse EventSecondary· 2 years
Evaluation of the safety and toxicity profile of the combination of sitravatinib and pembrolizumab in the first-line treatment of patients with non-squamous metastatic NSCLC is a secondary objective in this study. Secondary endpoint is adverse events as per CTCAE v.5. The Safety population is defined as all patients who received any dose of study treatment (i.e., sitravatinib and/or pembrolizumab) and will be used for all safety analyses. Number of participants that experienced at least 1 adverse event.
Group
Value
95% CI
Sitravatinib: Group 1A
1
Sitravatinib: Group 2A
3
Sitravatinib: Group 1B
2
Sitravatinib: Group 2B
3
Adverse events — posted to ClinicalTrials.gov
Time frame: Up to 450 days.
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
This is a multicohort phase 2 study to evaluate the efficacy of pembrolizumab combined with the investigational drug sitravatinib in the frontline treatment of advanced, non-squamous PD-L1 positive NSCLC.
Publications & conference data
7 peer-reviewed publications reference this trial (live from Europe PMC):
NCT05564338 — Efficacy and Safety of Sitravatinib Plus Tislelizumab or Placebo Plus Tislelizumab Versus Placebo as Adjuvant Treatment
· Phase 3
· withdrawn
NCT05461794 — Study To Investigate the Efficacy and Safety of Sitravatinib in Combination With Tislelizumab in Participants With Esoph
· Phase 2
· terminated
NCT04904302 — Sitravatinib and Nivolumab for the Treatment of Metastatic or Advanced Clear Cell Renal Cell Cancer
· Phase 2
· terminated
NCT05228496 — A Study to Investigate the Efficacy and Safety of Tislelizumab Combined With Sitravatinib as Maintenance Therapy for ES-
· Phase 2
· unknown
NCT04123704 — Sitravatinib in Metastatic Breast Cancer
· Phase 2
· terminated
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· NA
· 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 Sarah Goldberg
Last refreshed: 17 April 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/NCT04925986.