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

Overview

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.

Full Title of Study: “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.”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: November 26, 2019

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.

Interventions

  • Drug: Anlotinib plus Pemetrexed
    • 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
  • Drug: Pemetrexed
    • Pemetrexed 500 mg/m2 every 21 days for 4-6 cycles or unacceptable toxic effects

Arms, Groups and Cohorts

  • Experimental: Anlotinib plus Pemetrexed
    • Anlotinib plus Pemetrexed
  • Other: Pemetrexed
    • Pemetrexed

Clinical Trial Outcome Measures

Primary Measures

  • Proportion of patients alive and progression free at 6 months (APF6)
    • Time Frame: 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 Measures

  • Progression Free Survival(PFS)
    • Time Frame: 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)
  • Overall Survival(OS)
    • Time Frame: Estimated to be from baseline up to 2 years
    • the time from randomization to death from any cause
  • Disease Control Rate(DCR)
    • Time Frame: 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
  • Objective Response Rate(ORR)
    • Time Frame: Estimated to be from baseline up to 2 years
    • the total proportion of patients who demonstrate a response(complete responses + partial responses) to treatment

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 120 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Guangdong Association of Clinical Trials
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Contact(s)
    • Xiaoqing Liu, 86-010-89509324, liuxiaoqing@csco.org.cn

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