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

Guangdong Association of Clinical Trials106 enrolled

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

106

Conditions

Advanced Non-squamous NSCLC

Interventions

Anlotinib plus PemetrexedDRUG

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

PemetrexedDRUG

Pemetrexed 500 mg/m2 every 21 days for 4-6 cycles or unacceptable toxic effects

Eligibility

Sex: ALLMin age: 18 YearsMax age: 120 Years

Medical Language ↔ Plain English

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

Locations (1)

Beijing Chest Hospital

Beijing, Beijing Municipality, China

RECRUITING

Outcomes

Primary Outcomes

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.