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)
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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.
• Able to undergo protocol therapy, including necessary surgery.
• If female: may participate if no active pregnancy, not breastfeeding, and at least one of the following: is not a woman of childbearing potential (WOCBP), or is a WOCBP using contraceptive methods.
• If male: must agree to refrain from donating sperm, and must either be abstinent or agree to use contraception.
• ECOG 0-1
• Available formalin-fixed paraffin embedded (FFPE) tumor tissue samples
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.
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.