Anlotinib Plus Pemetrexed or Pemetrexed for Previously Untreated Elderly (>=70) or PS=2 Non-squamous NSCLC

Study Overview
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Brief Summary
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Evaluate the efficacy and safety of Anlotinib plus Pemetrexed as the 1-line treatment of patients with Platinum intolerant advanced non-squamous NSCLC, with Pemetrexed control.

Detailed Description
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Anlotinib (AL3818) is a kind of innovative medicines approved by State Food and Drug Administration（SFDA:2011L00661） which was researched by Jiangsu Chia-tai Tianqing Pharmaceutical Co., Ltd. Anlotinib is a kinase inhibitor of receptor tyrosine with multi-targets, especially for VEGFR1、VEGFR2、VEGFR3、FGFR1/2/3、PDGFRa/β c-Kit and MET.

Official Title
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A Study to Evaluate the Efficacy and Safety of Anlotinib Plus Pemetrexed as the 1-line Treatment of Patients With Platinum Intolerant Advanced Non-squamous NSCLC, With Pemetrexed Control.

Conditions
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Advanced Non-squamous NSCLC

Intervention / Treatment
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* Drug: Anlotinib plus Pemetrexed
* Drug: Pemetrexed


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ≥70 years old and ECOG PS=0-2 or ≥18 years old and ECOG PS=2 Diagnosed with advanced or recurrent non-squamous NSCLC (phase IIIB/IV) through pathology, with measurable nidus(using RECIST 1.1) No prior systemic treatment for non-squamous NSCLC Negative in EGFR&ALK&ROS1 Main organs function is normal Exclusion Criteria: Have any habitus or medical history of hemorrhage, however severe it is; the patients who have non healing wounds, ulcer or fracture after any events with hemorrhage or bleeding Symptoms of brain metastases cannot be controlled and treated within less than 21 days Have participated in other clinical trials of anti-tumor medicine within 4 weeks Get any severe diseases or the ones that cannot be controlled

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 120 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: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Anlotinib plus Pemetrexed<br>Anlotinib plus Pemetrexed | Drug: Anlotinib plus Pemetrexed<br>* Anlotinib p.o, qd and it should be continued until disease progress or unacceptable toxic effects. Pemetrexed 500 mg/m2 every 21 days for 4-6 cycles or unacceptable toxic effects<br>|
| Other: Pemetrexed<br>Pemetrexed | Drug: Pemetrexed<br>* Pemetrexed 500 mg/m2 every 21 days for 4-6 cycles or unacceptable toxic effects<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients alive and progression free at 6 months (APF6) | the number (%) of patients who are alive and progression free per RECIST 1.1 at 6 months after randomization per Kaplan-Meier estimate of progression free survival at 6 months. | Estimated to be from baseline up to 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression Free Survival(PFS) | the time from randomization until the date of objective disease progression (RECIST 1.1) or death (by any cause in the absence of progression) | Estimated to be from baseline up to 2 years | 
| Overall Survival(OS) | the time from randomization to death from any cause | Estimated to be from baseline up to 2 years | 
| Disease Control Rate(DCR) | the total proportion of patients who demonstrate a response(complete responses + partial responses + stable disease ) to treatment | Estimated to be from baseline up to 2 years | 
| Objective Response Rate(ORR) | the total proportion of patients who demonstrate a response(complete responses + partial responses) to treatment | Estimated to be from baseline up to 2 years |