NCT03217071

Pembrolizumab With and Without Radiotherapy for Non-Small Cell Lung Cancer

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 Biomarkers

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Sue Yom · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a randomized single-institution, phase II, open-label clinical trial of neoadjuvant pembrolizumab with or without low-dose stereotactic radiation therapy (SRT) in stage I-IIIA non-small lung cancer (NSCLC) patients who are planned to undergo surgical resection of their lung cancer.

Detailed description

Two consecutive run-in cohorts will administer pembrolizumab or pembrolizumab with SRT of 12 Gy to the lateral aspect of the primary tumor. Patients will receive pembrolizumab for 2 cycles prior to surgery or SRT and surgery. Surgical resection of all involved areas of tumor will occur within 6 weeks of the last administration of pembrolizumab. It should be noted that surgery is expected to occur within a much shorter window and 6 weeks would represent the greatest allowable amount of delay. If during the run-in, only the pembrolizumab-alone cohort meets pre-specified safety parameters, subsequently enrolled patients will enter a larger expansion cohort, with treatment given according to that cohort only. If during the run-in both cohorts meet pre-specified safety parameters, subsequently enrolled patients will enter the expansion cohort and be randomized between preoperative pembrolizumab versus pembrolizumab with SRT of 12 Gy.

Conditions

• Non Small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	Pembrolizumab	All study participants will receive pembrolizumab every 3 weeks, for 2 cycles.
RADIATION	stereotactic radiation therapy (SRT)	Patients in Cohort 2 of the Safety run-in and patients in the expansion cohort who are randomized to the 'pembrolizumab +radiation arm' will receive one dose of SRT within 1 week (+/- 3 days) following the second administration of pembrolizumab.
PROCEDURE	Surgery (Non-interventional, standard of care)	Standard of care surgery to remove cancer

Timeline

• Start date: 2017-10-04
• Primary completion: 2022-03-31
• Completion: 2022-03-31
• First posted: 2017-07-13
• Last updated: 2024-10-23
• Results posted: 2024-10-23

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study