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

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ClinicalTrials.gov Identifier: NCT03768037
Recruitment Status : Unknown
Verified November 2018 by Guangdong Association of Clinical Trials.
Recruitment status was:  Recruiting
First Posted : December 7, 2018
Last Update Posted : December 7, 2018
Sponsor:
Information provided by (Responsible Party):
Guangdong Association of Clinical Trials

Study Description
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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.

Condition or disease Intervention/treatment Phase
Advanced Non-squamous NSCLC Drug: Anlotinib plus Pemetrexed Drug: Pemetrexed Phase 4

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 106 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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.
Estimated Study Start Date : November 26, 2018
Estimated Primary Completion Date : November 26, 2019
Estimated Study Completion Date : November 26, 2020

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Anlotinib plus Pemetrexed
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
Pemetrexed
Pemetrexed
 Drug: Pemetrexed
Pemetrexed 500 mg/m2 every 21 days for 4-6 cycles or unacceptable toxic effects


Outcome Measures
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Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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)

  2. Overall Survival(OS) [ Time Frame: Estimated to be from baseline up to 2 years ]
    the time from randomization to death from any cause

  3. 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

  4. 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


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 120 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03768037


Contacts
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Contact: Xiaoqing Liu 86-010-89509324 liuxiaoqing@csco.org.cn
Contact: Shucai Zhang 86-010-89509324 sczhang6304@163.com

Locations
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China, Beijing
Beijing Chest Hospital Recruiting
Beijing, Beijing, China, 101149
Contact: Shucai Zhang    86-010-89509324    sczhang6304@163.com   
Contact: Zhe Liu    86-010-89509323    liuzhe1968@aliyun.com   
Sponsors and Collaborators
Guangdong Association of Clinical Trials
More Information
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Responsible Party: Guangdong Association of Clinical Trials
ClinicalTrials.gov Identifier: NCT03768037    
Other Study ID Numbers: CTONG1801
First Posted: December 7, 2018    Key Record Dates
Last Update Posted: December 7, 2018
Last Verified: November 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Carcinoma, Non-Small-Cell Lung
Carcinoma, Bronchogenic
Bronchial Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
 Lung Diseases
Respiratory Tract Diseases
Pemetrexed
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Folic Acid Antagonists
Nucleic Acid Synthesis Inhibitors