Non Small Cell Lung Cancer
Conditions
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.
Interventions
DRUGAnlotinib
Anlotinib will be given at a dose of 12mg once daily on days 1-14 of a 21-day cycle.
DRUGNivolumab
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.
Sponsors
The First Affiliated Hospital with Nanjing Medical University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| Number of Participants with Adverse Events as a Measure of Safety and Tolerability | Until 30 day safety follow-up visit | — |
Contacts
Primary ContactRenhua Guo, MD
Outcome results
None listed