NCT04762030

Neoadjuvant Durvalumab/Anlotinib /Chemotherapy Plus Curative Resection in Stage III Non-Small-Cell Lung Cancer : A Single-arm Phase II Study

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 39 (estimated)
• Sponsor: Shanghai Pulmonary Hospital, Shanghai, China · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a randomized, open label study designed to evaluate the efficacy and safety of neoadjuvant Durvalumab/Anlotinib/Chemotherapy followed by surgery in resectable stage III non-small cell lung cancer.

Conditions

• Non Small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	Durvalumab Anlotinib Carboplatin Nab-paclitaxel	Neoadjuvant treatment (durvalumab+carboplatin+nab-paclitaxel + anlotinib) will start within 1-3 days from enrollment. 2 cycles will be administered at 21-day (+/- 3 days) intervals (QW3). Then, two cycles of combined durvalumab and anlotinib (QW3) will be administered prior to surgery. Before surgery, a tumor assessment will be done. Patients with stable disease or partial response may be considered for surgery. Surgery: Surgery must be done within the 5rd-7th week from day 1 cycle 4 of neoadjuvant treatment (day 35-49 after day 1 of cycle 4). Adjuvant treatment: Patients that are R0 confirmed by surgical pathology evaluation will receive the first adjuvant administration within the 2rd to 8th week from surgery. Twelve cycles of durvalumab adjuvant treatment (Q4W) will be administered.

Timeline

• Start date: 2021-02-08
• Primary completion: 2023-12-30
• Completion: 2025-12-30
• First posted: 2021-02-21
• Last updated: 2021-02-21

Locations

1 site across 1 country: China