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

Sponsor
McGill University Health Centre/Research Institute of the McGill University Health Centre
Study ID
NCT04638582
Phase
PHASE2
Status
Terminated

Conditions

  • Lung Cancer, Nonsmall Cell

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Pembrolizumab — DRUG
    Neoadjuvant pembrolizumab 200 mg IV every 3 weeks, given on cycle day 1. Adjuvant pembrolizumab 400 mg IV every 6 weeks, given on cycle day 1.
  • Carboplatin — DRUG
    Carboplatin AUC 6 IV (maximum dose: 900 mg) for squamous cell carcinoma, and AUC 5 IV (maximum dose: 750 mg) for non-squamous cell carcinoma, every 3 weeks, given on cycle day 1.
  • Paclitaxel — DRUG
    Paclitaxel 200 mg/m2 IV every 3 weeks, given on cycle day 1. Only given to participants with squamous cell carcinoma.
  • Pemetrexed — DRUG
    Pemetrexed 500 mg/m2 every 3 weeks, given on cycle day 1. Only given to participants with non-squamous cell carcinoma.

Study Details

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.

Key Dates

Start date
Aug 28, 2022
Status verified
Apr 2026
Primary completion
Apr 14, 2026
Completion
Apr 14, 2026

Study Design

Enrollment
6 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Neoadjuvant pembrolizumab + adjuvant pembrolizumab +/- adjuvant chemotherapy
    Neoadjuvant: Participants receive pembrolizumab \[200 mg, intravenous (IV)\] every 3 weeks for 3 cycles. Adjuvant: Participants receive pembrolizumab \[400 mg IV\] every 6 weeks for 6 cycles, and may receive histology-specific adjuvant chemotherapy \[consisting of carboplatin AUC 6 and paclitaxel 200 mg/m2, or carboplatin AUC 5 and paclitaxel 500 mg/m2\] every 3 weeks for 4 cycles, if indicated.
  • Experimental: Neoadjuvant pembrolizumab and chemotherapy + adjuvant pembrolizumab +/- adjuvant chemotherapy
    Neoadjuvant: Participants receive pembrolizumab \[200 mg, intravenous (IV)\] every 3 weeks for 3 cycles in combination with standard of care histology-specific chemotherapy \[consisting of carboplatin AUC 6 and paclitaxel 200 mg/m2, or carboplatin AUC 5 and paclitaxel 500 mg/m2\] every 3 weeks for 3 cycles. Adjuvant: Participants receive pembrolizumab \[400 mg IV\] every 6 weeks for 6 cycles, and may receive histology-specific adjuvant chemotherapy \[consisting of carboplatin AUC 6 and paclitaxel 200 mg/m2, or carboplatin AUC 5 and paclitaxel 500 mg/m2\] every 3 weeks for 4 cycles, if indicated.

Primary Outcome Measure

ctDNA resolution [ Time Frame: Up to 2 years ]

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