Anlotinib Combined With Nivolumab for Non-Small Cell Lung Cancer

Sponsor
The First Affiliated Hospital with Nanjing Medical University
Study ID
NCT04211896
Phase
PHASE2
Status
Unknown

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Anlotinib — DRUG
    Anlotinib will be given at a dose of 12mg once daily on days 1-14 of a 21-day cycle.
  • Nivolumab — DRUG
    Nivolumab will be given at a dose of 240 mg every 2 weeks (Odd Cycles: Days 1 and 15 and Even Cycles Day 8) per 21 day Cycle.

Study Details

This study evaluates the safety and efficacy of anlotinib in combination with nivilumab as second-line treatment in advanced NSCLC patients. The primary endpoint of the study is progression-free survival (PFS);the secondary endpoints are disease control rate (DCR), objective response rate (ORR), overall survival (OS) and safety.

Key Dates

Start date
Jan 1, 2020
Status verified
Dec 2019
Primary completion
Jul 1, 2021
Completion
Jan 1, 2022

Study Design

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

Arms

  • Experimental: anlotinib plus nivolumab

Primary Outcome Measure

Progression-Free Survival (PFS) [ Time Frame: 6 months ]

Central Contacts

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