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

Phase 4

• Conditions: Advanced Non-squamous NSCLC
• Interventions: Drug: Anlotinib plus Pemetrexed; Drug: Pemetrexed

• Registration Number: NCT03768037
• Lead Sponsor: Guangdong Association of Clinical Trials

Brief Summary

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

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.

Study Timeline

• Status Verified: 2018-11
• Study Start: 2018-11-26
• Study First Submitted: 2018-11-30
• Study First Submitted QC: 2018-12-05
• Last Update Submitted: 2018-12-05
• Study First Posted: 2018-12-07
• Last Update Posted: 2018-12-07
• Primary Completion: 2019-11-26
• Study Completion: 2020-11-26

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 106

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Anlotinib plus Pemetrexed	Anlotinib plus Pemetrexed	Anlotinib plus Pemetrexed
Pemetrexed	Pemetrexed	Pemetrexed

Primary Outcome Measures

Name	Time	Method
Proportion of patients alive and progression free at 6 months (APF6)	Estimated to be from baseline up to 2 years	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.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Beijing Chest Hospital; 🇨🇳 Beijing, Beijing, China