MedTrace Logo

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

NCT03217071 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2024-10-23

Study results available
· View outcomes & findings →

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.

Conditions

  • Non Small Cell Lung Cancer

Interventions

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

Sponsors & Collaborators

Principal Investigators

  • Sue Yom, MD · University of California, San Francisco

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-10-04
Primary Completion
2022-03-31
Completion
2022-03-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03217071 on ClinicalTrials.gov