Anlotinib Combined With Nivolumab for Non-Small Cell Lung Cancer

Phase 2

• Conditions: Non Small Cell Lung Cancer
• Interventions: Drug: Anlotinib; Drug: Nivolumab

• Registration Number: NCT04211896
• Lead Sponsor: The First Affiliated Hospital with Nanjing Medical University

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2019-12
• Study First Submitted: 2019-12-23
• Study First Submitted QC: 2019-12-24
• Last Update Submitted: 2019-12-24
• Study First Posted: 2019-12-26
• Last Update Posted: 2019-12-26
• Study Start: 2020-01-01
• Primary Completion: 2021-07-01
• Study Completion: 2022-01-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 70

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
anlotinib plus nivolumab	Anlotinib	-
anlotinib plus nivolumab	Nivolumab	-

Primary Outcome Measures

Name	Time	Method
Progression-Free Survival (PFS)	6 months	PFS is defined as the time from the date of treatment to the first date of disease progression or death from any cause.

Secondary Outcome Measures

Name	Time	Method
Number of Participants with Adverse Events as a Measure of Safety and Tolerability	Until 30 day safety follow-up visit
Objective Response Rate (ORR)	each 42 days up to intolerance the toxicity or PD (up to 12 months)	Treatment response are defined as complete response (CR), partial response (PR), stable disease (SD) and progression disease (PD) according to Response Evaluation Criteria in Solid Tumor (RECISIT criteria, version 1.1). The percentage of patients who achieved CR and PR was defined as objective response rate (ORR)
Disease control rate (DCR)	each 42 days up to intolerance the toxicity or PD (up to 12 months)	Treatment response are defined as complete response (CR), partial response (PR), stable disease (SD) and progression disease (PD) according to Response Evaluation Criteria in Solid Tumor (RECISIT criteria, version 1.1) and the percentage of patients who achieved CR, PR and SD was defined as disease control rate (DCR).
Overall Survival (OS)	12 months	OS is calculated from diagnosis to death or last follow-up time.