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

NCT ID: NCT03768037

Last Updated: 2018-12-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

106 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-11-26

Study Completion Date

2020-11-26

Brief Summary

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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

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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.

Conditions

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Advanced Non-squamous NSCLC

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Anlotinib plus Pemetrexed

Anlotinib plus Pemetrexed

Group Type EXPERIMENTAL

Anlotinib plus Pemetrexed

Intervention Type DRUG

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

Group Type OTHER

Pemetrexed

Intervention Type DRUG

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

Interventions

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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

Intervention Type DRUG

Pemetrexed

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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

120 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Guangdong Association of Clinical Trials

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Beijing Chest Hospital

Beijing, Beijing Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Xiaoqing Liu

Role: CONTACT

Phone: 86-010-89509324

Email: [email protected]

Shucai Zhang

Role: CONTACT

Phone: 86-010-89509324

Email: [email protected]

Facility Contacts

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Shucai Zhang

Role: primary

Zhe Liu

Role: backup

Other Identifiers

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CTONG1801

Identifier Type: -

Identifier Source: org_study_id