Combination Chemotherapy With or Without Anlotinib in the Maintenance Treatment of Non-Squamous Non-Small Cell Lung Cancer.

Study Overview
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Brief Summary
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This study will compare maintenance therapy with anlotinib plus pemetrexed versus pemetrexed or anlotinib alone, in patients with Non-squamous Non-small cell lung cancer who have not progressed during first-line therapy with anlotinib + pemetrexed + carboplatin. The primary endpoint of the study is progression-free survival (PFS); the secondary endpoints are disease control rate (DCR), objective response rate (ORR) and overall survival (OS).

Official Title
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A Study of the Effect of Anlotinib, Pemetrexed or the Combination As Maintenance Therapy for Patients With Non-Squamous Non-Small Cell Lung Cancer.

Conditions
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Non-squamous Non-small-cell Lung Cancer

Intervention / Treatment
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* Drug: Anlotinib + Pemetrexed+Carboplatin
* Drug: Pemetrexed
* Drug: Anlotinib + Pemetrexed
* Drug: Anlotinib


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥ 18 years and ≤ 75, ECOG PS: 0 1, estimated survival duration more than 3 months; Subjects with histologically or cytologically confirmed locally advanced and/or advanced Non-squamous NSCLC; Signed and dated informed consent; adequate hematological, liver and renal function Exclusion Criteria: prior chemotherapy or treatment with another systemic anti-cancer agent malignancies other than NSCLC within 5 years prior to randomization, except for adequately treated carcinoma in situ of the cervix, basal or squamous cell skin cancer, localized prostate cancer or DCIS evidence of tumor invading major blood vessels current or recent use of aspirin (>325mg/day) or full-dose anticoagulants or thrombolytic agents for therapeutic purposes history of haemoptysis >/=grade 2 clinically significant cardiovascular disease

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: First-line Treatment<br> | Drug: Anlotinib + Pemetrexed+Carboplatin<br>* Anlotinib: 12mg, QD, PO, d1-14, 21 days per cycle Carboplatin: AUC 5 on day 1 of 21 days per cycle Pemetrexed: 500mg/m2 iv on day 1 of 21 days per cycle<br>|
| Experimental: Maintenance Treatment A<br> | Drug: Pemetrexed<br>* 500mg/m2 iv on day 1 of 21 days per cycle(maintenance phase)<br>|
| Experimental: Maintenance Treatment B<br> | Drug: Anlotinib + Pemetrexed<br>* Anlotinib:12mg, QD, PO, d1-14, 21 days per cycle(maintenance phase) Pemetrexed:500mg/m2 iv on day 1 of 21 days per cycle(maintenance phase)<br>|
| Experimental: Maintenance Treatment C<br> | Drug: Anlotinib<br>* 12mg, QD, PO, d1-14, 21 days per cycle(maintenance phase)<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective Response Rate (ORR) | 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). | each 42 days up to intolerance the toxicity or PD (up to 12 months) | 
| Disease control rate (DCR) | 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). | each 42 days up to intolerance the toxicity or PD (up to 12 months) | 
| Overall Survival (OS) | OS is calculated from diagnosis to death or last follow-up time. | 12 months | 
| Number of Participants with Adverse Events as a Measure of Safety and Tolerability | Number of Participants with Adverse Events as a Measure of Safety and Tolerability | Until 30 day safety follow-up visit |