Trial results for a Phase 1/2 study (NCT04216316) investigating pembrolizumab in combination with berzosertib, carboplatin, and gemcitabine for patients with advanced squamous cell non-small cell lung cancer were posted on ClinicalTrials.gov on 2026-03-24. The study reported a median progression-free survival of 9.00 months for the total population.
Background
Pembrolizumab (Keytruda) is an immune checkpoint inhibitor. This Phase 1/2 trial investigated a combination therapy including pembrolizumab, berzosertib, carboplatin, and gemcitabine for patients with advanced squamous cell non-small cell lung cancer. Berzosertib is an anti-cancer drug, and carboplatin and gemcitabine are chemotherapy drugs.
Trial design
The Phase 1/2 trial, NCT04216316, enrolled 12 participants with Stage IV squamous cell non-small cell lung cancer. It evaluated the combination of berzosertib, carboplatin, gemcitabine, and pembrolizumab. The study aimed to determine the best dose of carboplatin in this regimen and assess its efficacy.
Key results
Key results from the trial included findings on dose-limiting toxicities (DLT) and progression-free survival (PFS).
- For patients who experienced a DLT, the percentage was 0% in the Dose Level -1 group and 33.3% in the Dose Level 1 group. The recommended Phase 2 dose (RP2D) for Dose Level -1 was 4 mg/mL*min.
For the total population receiving berzosertib, carboplatin, gemcitabine, and pembrolizumab:
- The median PFS was 9.00 months.
- The 12-month PFS rate was 28%, and the 24-month PFS rate was 18%.
- The best overall response was 0%.
PFS results by dose level showed a median PFS of 9.00 months for Dose Level -1 (12-month PFS: 20%) and 8.00 months for Dose Level 1 (12-month PFS: 33%, 24-month PFS: 17%).
What this means
The results from this Phase 1/2 trial provide initial insights into the safety and efficacy of combining pembrolizumab with berzosertib, carboplatin, and gemcitabine for advanced squamous cell non-small cell lung cancer. The observed median progression-free survival of 9.00 months suggests potential activity for this regimen. While the 0% best overall response rate for the total population is a notable finding, the PFS data offers a preliminary indication of disease control, warranting further investigation.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for study NCT04216316, titled "Testing the Addition of an Anti-cancer Drug, Berzosertib (M6620, VX-970), to the Usual Treatments (Carboplatin and Gemcitabine) and to Pembrolizumab for Patients With Advanced Squamous Cell Non-small Cell Lung Cancer," were posted on 2026-03-24 on clinicaltrials.gov.