Anlotinib Combined With Nivolumab for Non-Small Cell Lung Cancer

NCT ID: NCT04211896

Last Updated: 2019-12-26

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-01-01
• Study Completion Date: 2022-01-01

Brief Summary

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.

Conditions

Non Small Cell Lung Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

anlotinib plus nivolumab

Group Type: EXPERIMENTAL

Anlotinib

Intervention Type: DRUG

Anlotinib will be given at a dose of 12mg once daily on days 1-14 of a 21-day cycle.

Nivolumab

Intervention Type: 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.

Interventions

Anlotinib

Anlotinib will be given at a dose of 12mg once daily on days 1-14 of a 21-day cycle.

Intervention Type: DRUG

Nivolumab

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.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Male or female patients aged 18-75 years old;

2. ECOG PS：0-1,Expected Survival Time: Over 3 months;

3. Subjects with histologically or cytologically confirmed locally advanced and/or advanced NSCLC, with measurable nidus(using RECIST 1.1);

4. For local advanced or advanced NSCLC, disease progression occurred after first-line systemic treatment previously;

5. The negative patients in EGFR&ALK can participate or who positive in EGFR&ALK, have or have not drug tolerance after the treatment with relative targeted drugs;

6. main organs function is normal;

7. Signed and dated informed consent.

Exclusion Criteria

1. have used Anlotinib before;

2. Small Cell Lung Cancer (including small cell cancer and other kinds of cancer mixed with non-small cell cancer);

3. examined as positive in EGFR&ALK mutation detection and never take the treatment of TKIs;

4. Previously (within 5 years) or presently suffering from other malignancies;

5. Symptomatic or uncontrolled brain metastases;

6. Unstable systemic disease, including active infection, uncontrolled hypertension, unstable angina, congestive heart failure, or myocardial infarction within 6 months or serious cardiac arrhythmia requiring medication;

7. Pregnancy or lactation.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The First Affiliated Hospital with Nanjing Medical University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Renhua Guo, MD

Role: CONTACT

Phone: 025-68136360

Email: rhguo@njmu.edu.cn

Other Identifiers

ANPD1-001

Identifier Type: -

Identifier Source: org_study_id