Trial results for pembrolizumab (Keytruda) in combination with concurrent chemoradiotherapy or radiation therapy for small cell lung cancer (SCLC) were posted on ClinicalTrials.gov on 2026-03-10. The study, NCT02402920, showed a median overall survival (OS) of 39.5 months in patients with limited-stage SCLC (LS-SCLC).
Background
Pembrolizumab (Keytruda) is an immunotherapy used in various cancers. This trial investigated its use in patients with small cell lung cancer (SCLC), specifically those with extensive stage small cell lung carcinoma (ES-SCLC) and limited stage small cell lung carcinoma (LS-SCLC), as well as neuroendocrine neoplasm.
Trial design
The Phase 1 trial, NCT02402920, enrolled 83 participants to study the side effects and best dose of pembrolizumab when given with chemoradiotherapy or radiation therapy. The study included patients with extensive stage small cell lung carcinoma, limited stage small cell lung carcinoma, and neuroendocrine neoplasm. Interventions included carboplatin, cisplatin, etoposide, and pembrolizumab.
Key results
Key results from the trial included assessments of dose-limiting toxicities (DLTs), progression-free survival (PFS), overall survival (OS), and overall response rate (ORR).
For limited-stage small cell lung cancer (LS-SCLC):
- Only 1 dose-limiting toxicity (DLT) was observed.
- Median progression-free survival (PFS) was 19.7 months (95% Confidence Interval).
- Median overall survival (OS) was 39.5 months (95% Confidence Interval).
- The overall response rate (ORR) was 79% (95% Confidence Interval).
For extensive-stage small cell lung cancer (ES-SCLC):
- 0 dose-limiting toxicities (DLTs) were observed.
- Median progression-free survival (PFS) was 6.1 months (95% Confidence Interval).
- Median overall survival (OS) was 8.4 months (95% Confidence Interval).
- The overall response rate (ORR) was 15.20% (95% Confidence Interval).
What this means
The results of this Phase 1 trial suggest that pembrolizumab in combination with concurrent chemoradiotherapy or radiation therapy is generally tolerable, with a low number of dose-limiting toxicities observed across both LS-SCLC and ES-SCLC groups. The reported median overall survival of 39.5 months and an overall response rate of 79% in the LS-SCLC cohort are notable findings for this difficult-to-treat cancer, especially for an early-phase study. While these are exploratory endpoints in a Phase 1 trial, they provide preliminary insights into the potential efficacy of this combination in small cell lung cancer.
Source
The information for this article was sourced from ClinicalTrials.gov, a public database of clinical studies. The results for study NCT02402920, titled 'Pembrolizumab and Concurrent Chemoradiotherapy or Radiation Therapy in Treating Patients With Small Cell Lung Cancer,' were posted on 2026-03-10 on clinicaltrials.gov.