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

PHASE2RecruitingINTERVENTIONAL
Enrollment

39

Participants

Timeline

Start Date

February 8, 2021

Primary Completion Date

December 30, 2023

Study Completion Date

December 30, 2025

Conditions
Non Small Cell Lung Cancer
Interventions
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."

Trial Locations (1)

200092

RECRUITING

Shanghai Pulmonary Hospital, Shanghai

All Listed Sponsors
lead

Shanghai Pulmonary Hospital, Shanghai, China

OTHER