CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 12 enrolled
Drug / intervention
Pembrolizumab +2 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03217071
NCT03217071Phase 2Completed
CompareCT.gov

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

Sue Yom·interventional·Posted Jul 13, 2017·Updated Oct 23, 2024

In Brief

A Phase 2 clinical trial evaluating Pembrolizumab, stereotactic radiation therapy (SRT), and 1 other intervention for Non Small Cell Lung Cancer. Completed, enrolled 12 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsNon Small Cell Lung Cancer
CountriesUnited States
CollaboratorsMerck Sharp & Dohme LLC

Timeline

Phase 2CompletedFinished
201820192020202120222023202420252026
First PostedJul 13, 2017
Enrollment StartOct 4, 2017
Primary CompletionMar 31, 2022
TodayJul 2, 2026
Enrollment to primary: 4.5 yearsPosted 9.0 years ago

Interventions

Pembrolizumabdrug

All study participants will receive pembrolizumab every 3 weeks, for 2 cycles.

stereotactic radiation therapy (SRT)radiation

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.

Surgery (Non-interventional, standard of care)procedure

Standard of care surgery to remove cancer