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

Sponsor
Shanghai Pulmonary Hospital, Shanghai, China
Study ID
NCT04762030
Phase
PHASE2
Status
Unknown

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Durvalumab Anlotinib Carboplatin Nab-paclitaxel — DRUG
    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.

Study Details

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.

Key Dates

Start date
Feb 8, 2021
Status verified
Feb 2021
Primary completion
Dec 30, 2023
Completion
Dec 30, 2025

Study Design

Enrollment
39 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Experimental Group

Primary Outcome Measure

PFS at 24 months [ Time Frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 months ]

Central Contacts

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