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

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.

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 Overview

• Status: Unknown
• Conditions: Advanced Non-squamous NSCLC
• Intervention / Treatment: Drug: Anlotinib plus Pemetrexed; Drug: Pemetrexed

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 Type: Interventional
• Enrollment (Anticipated): 106
• Phase: Phase 4

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 101149
      • Recruiting
      • Beijing Chest Hospital
      • Contact: Shucai Zhang; Phone Number: 86-010-89509324; Email: sczhang6304@163.com
      • Contact: Zhe Liu; Phone Number: 86-010-89509323; Email: liuzhe1968@aliyun.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 120 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Anlotinib plus Pemetrexed	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
Other: Pemetrexed	Drug: Pemetrexed; Pemetrexed 500 mg/m2 every 21 days for 4-6 cycles or unacceptable toxic effects

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Guangdong Association of Clinical Trials

Study record dates

Study Major Dates

• Study Start (Anticipated): November 26, 2018
• Primary Completion (Anticipated): November 26, 2019
• Study Completion (Anticipated): November 26, 2020

Study Registration Dates

• First Submitted: November 30, 2018
• First Submitted That Met QC Criteria: December 5, 2018
• First Posted (Actual): December 7, 2018

Study Record Updates

• Last Update Posted (Actual): December 7, 2018
• Last Update Submitted That Met QC Criteria: December 5, 2018
• Last Verified: November 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Molecular Mechanisms of Pharmacological Action; Nucleic Acid Synthesis Inhibitors; Enzyme Inhibitors; Antineoplastic Agents; Folic Acid Antagonists; Pemetrexed
• Other Study ID Numbers: CTONG1801

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No