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Unknown status
Verified  2018-11 by Guangdong Association of Clinical Trials
Last known status was: Recruiting

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

ClinicalTrials.gov ID NCT03768037
Sponsor Guangdong Association of Clinical Trials
Information provided by Guangdong Association of Clinical Trials (Responsible Party)
Last Update Posted 2018-12-07
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Study Overview

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.
Official Title
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
Advanced Non-squamous NSCLC
Intervention / Treatment
  • Drug: Anlotinib plus Pemetrexed
  • Drug: Pemetrexed
  • Drug: Anlotinib plus Pemetrexed
  • Drug: Pemetrexed
Other Study ID Numbers
  • CTONG1801
Study Start (Estimated)
2018-11-26
Primary Completion (Estimated)
2019-11-26
Study Completion (Estimated)
2020-11-26
Enrollment (Estimated)
106
Study Type
Interventional
Phase
Phase 4

Contacts and Locations

This section provides contact details for people who can answer questions about joining this study, and information on where this study is taking place.

To learn more, please see the Contacts and Locations section in How to Read a Study Record(https://clinicaltrials.gov/study-basics/how-to-read-study-record#contacts-and-locations).

Study Contact

Name: Xiaoqing Liu

Phone Number: 86-010-89509324

Email: liuxiaoqing@csco.org.cn

Study Contact Backup

Name: Shucai Zhang

Phone Number: 86-010-89509324

Email: sczhang6304@163.com

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies(https://clinicaltrials.gov/study-basics/learn-about-studies).
Eligibility Criteria
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
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Ages Eligible for Study
18 Years to 120 Years (AdultOlder Adult )
Sexes Eligible for Study
All
Accepts Healthy Volunteers
No

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

Arms and Interventions

Participant Group/Arm Intervention/Treatment
Participant Group/Arm Experimental: Anlotinib plus Pemetrexed
Anlotinib plus Pemetrexed
Intervention/Treatment 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

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

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 causeEstimated 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 treatmentEstimated 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 treatmentEstimated to be from baseline up to 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.
Sponsor
Guangdong Association of Clinical Trials

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Registration Dates
First Submitted
2018-11-30
First Submitted that Met QC Criteria
2018-12-05
First Posted
2018-12-07
Study Record Updates
Last Update Submitted that met QC Criteria
2018-12-05
Last Update Posted
2018-12-07
Last Verified
2018-11

More Information

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Additional Relevant MeSH Terms