Trial results for the Phase 2 study (NCT04925986) investigating pembrolizumab combined with sitravatinib for advanced treatment-naïve PD-L1+ non-squamous NSCLC were posted on ClinicalTrials.gov on 2025-04-17. The study, which enrolled 9 participants, was terminated, with objective response rates showing only 0 to 2 participants achieving a response across various groups.
Background
The study aimed to evaluate the efficacy of pembrolizumab combined with the investigational drug sitravatinib in the frontline treatment of advanced, non-squamous PD-L1 positive NSCLC.
Trial design
The study (NCT04925986) was a Phase 2 multicohort trial that enrolled 9 participants and was ultimately terminated. It investigated the combination of sitravatinib plus pembrolizumab in patients with advanced treatment-naïve PD-L1+ non-squamous non-small cell lung cancer (NSCLC), including metastatic lung non-small cell carcinoma and Stage IV lung non-small cell cancer.
Key results
The trial evaluated Objective Response Rate (ORR) across different groups. For the outcome of "Objective Response Rate (ORR)", measured as the count of participants achieving a response, the results were consistently low:
- For Sitravatinib: Group 1A, objective responses were observed in 0, 0, and 1 participant(s) across different measurements.
- For Sitravatinib: Group 2A, objective responses were observed in 0, 0, and 2 participant(s) across different measurements.
- For Sitravatinib: Group 1B, objective responses were observed in 0, 1, and 0 participant(s) across different measurements.
- For Sitravatinib: Group 2B, objective responses were observed in 0, 1, and 2 participant(s) across different measurements.
What this means
The termination of this Phase 2 study and the consistently low objective response rates (ranging from 0 to 2 participants per group) suggest that the combination of pembrolizumab and sitravatinib may not offer sufficient clinical benefit for advanced treatment-naïve PD-L1+ non-squamous NSCLC under the conditions of this trial. These results indicate a lack of efficacy that likely led to the trial's early cessation.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for study NCT04925986, titled "Sitravatinib Plus Pembrolizumab in Patients With Advanced Treatment-Naïve PD-L1+ Non-Squamous NSCLC," were posted on 2025-04-17 on clinicaltrials.gov.