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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
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.
Official title: Phase II Randomized Controlled Trial of Neoadjuvant Pembrolizumab or Pembrolizumab With Histology-Specific Chemotherapy for Operable Stage IA3 to IIA Non-Small Cell Lung Cancer (NSCLC)
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
6
Start Date
2022-08-28
Completion Date
2026-04-14
Last Updated
2026-04-17
Healthy Volunteers
Yes
Conditions
Interventions
Pembrolizumab
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
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
Paclitaxel 200 mg/m2 IV every 3 weeks, given on cycle day 1. Only given to participants with squamous cell carcinoma.
Pemetrexed
Pemetrexed 500 mg/m2 every 3 weeks, given on cycle day 1. Only given to participants with non-squamous cell carcinoma.
Locations (1)
McGill University Health Center
Montreal, Quebec, Canada