drugset
drugset / Trial / NCT04638582

Pembrolizumab as Neoadjuvant Therapy for Resectable Stage IA3 to IIA Non-Small Cell Lung Cancer (NSCLC)

NCT04638582 ↗

Phase 2 Terminated 6 enrolled McGill University Health Centre/Research Institute of the McGill University Health Centre
RandomizedParallel-groupOpen-labelTreatment

Summary

This is a prospective, randomized, single-site, open-label Phase II trial of neoadjuvant pembrolizumab (3 cycles) followed by surgery, versus concomitant neoadjuvant pembrolizumab with platinum doublet chemotherapy (3 cycles) followed by surgery for participants with Stage IA3, IB and IIA non-small-cell lung cancer (NSCLC). Participants will be offered pembrolizumab (6 cycles), and standard of care adjuvant chemotherapy (4 cycles) if applicable.

Timeline

Start
2022-08-28
Primary completion
2026-04-14
Completion
2026-04-14

Outcome

Outcome not reported

Stopped (Enrollment): “Study was terminated due to low recruitment.”

Drugs

EvaluationDrugModalityDoseRoute
Subject Carboplatin Small molecule 5 unknown Intravenous
Subject Carboplatin Small molecule 6 unknown Intravenous
Subject Paclitaxel Small molecule 200 mg/m2 Intravenous
Subject Paclitaxel Small molecule 500 mg/m2 Intravenous
Subject Pembrolizumab Monoclonal antibody 400 mg Intravenous
Subject Pemetrexed Small molecule 500 mg/m2 —

Indications

non-small cell lung carcinoma