Phase 2 Study of Neoadjuvant Pembrolizumab With or Without Radiation for NSCLC
Researchers are assessing the efficacy of neoadjuvant pembrolizumab with or without low-dose SRT among patients with stage I to IIIA NSCLC who plan to undergo surgical resection.
Title: PembroX: Enhancing the Immunogenicity of Non-Small Cell Lung Cancer With Pembrolizumab +/- Stereotactic Radiotherapy Delivered in the Preoperative Window, A Randomized Phase II Study With Correlative Biomarkers1
Principal Investigators: Sue Yom, MD, University of California, San Francisco
Description: For this randomized, open-label phase 2 study, researchers are assessing the efficacy of neoadjuvant pembrolizumab with or without low-dose stereotactic radiation therapy (SRT) among patients with stage I to IIIA non–small cell lung cancer (NSCLC) who plan to undergo surgical resection.
Patients will receive intravenous pembrolizumab 200 mg on day 1 of each 3 week cycle for 2 cycles. Patients in the SRT arm will receive a single 12 Gy dose of SRT within a week of initiating the second cycle of pembrolizumab. Patients will undergo surgical resection within 6 weeks after the last dose of pembrolizumab.
The primary outcome measure of the study is the change in number of infiltrating CD3+ T cells over 25 months. Secondary outcome measures include 1-year overall survival, 1-year relapse free survival, 1-year distant metastases, 25-month progression to unresectability, and 25-month incidence of treatment-related adverse events.
The estimated study enrollment is 40 patients.
For more study information, including exclusion and inclusion criteria, study locations, and contact information, visit https://clinicaltrials.gov/ct2/show/NCT03217071.
Status: Open and recruiting patients as of November 29, 2017.
This study is sponsored by Sue Yom, in collaboration with Merck Sharp & Dohme Corp.
- ClinicalTrials.gov. Pembrolizumab with and without radiotherapy for non-small cell lung cancer. NCT03217071. https://clinicaltrials.gov/ct2/show/NCT03217071 . Accessed November 29, 2017.