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Study of Anlotinib Combined With Docetaxel in Non-Driver Mutation Non-squamous NSCLC: the Save Study

NCT ID: NCT03646968

Last Updated: 2023-12-27

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

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

43 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-08-01

Study Completion Date

2025-06-01

Brief Summary

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The purpose of this study is to evaluate the Effectiveness and Safety of Anlotinib combined with Docetaxel in Progress after First line Standard Cheomotherapy in advanced non-driver mutation non- squamous non-small cell lung cancer

Detailed Description

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The purpose of this study is to evaluate the Effectiveness and Safety of Anlotinib combined with Docetaxel in Progress after First line Standard Cheomotherapy in advanced non-driver mutation non- squamous non-small cell lung cancer .According to the result of TAX317,the ORR of second line standard chemotherapy was 5- 8%. We expect the ORR was 20%. Using PASS11, we calculated the sample size of this study was 39 , according to 10% censoring,the expected sample size is 43.

Conditions

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Non-Squamous Non Small Cell Lung Cancer

Keywords

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Anlotinib Combined With Docetaxel

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Cohorts

Phase II Study to evaluate the Effectiveness and Safety of Anlotinib combined with Docetaxel in Progress after First line Standard Cheomotherapy in advanced non-driver mutation non- squamous non-small cell lung cancer

Group Type EXPERIMENTAL

Anlotinib and Docetaxel

Intervention Type DRUG

Patients who was Progress after First line Standard Cheomotherapy in advanced non-driver mutation non- squamous non-small cell lung cancer recieved the treatment of Anlotinib and Docetaxel (Anlotinib, 12mg, po,qd and Docetaxel 175mg/m2, ivgtt, every 21day)

Interventions

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Anlotinib and Docetaxel

Patients who was Progress after First line Standard Cheomotherapy in advanced non-driver mutation non- squamous non-small cell lung cancer recieved the treatment of Anlotinib and Docetaxel (Anlotinib, 12mg, po,qd and Docetaxel 175mg/m2, ivgtt, every 21day)

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 18，Pathologically proven Non squamous non small cell lung cancer

* No-drive gene mutaion (EGFR、ALK、ROS1） by NGS
* Progress after second line
* PS score 0-2

Exclusion Criteria

* Patients received second line treatment
* Patients received treatment of Anlotinib or Docetaxel
* Patients with contraindication of chemotherapy
* Pregnant or breast feeding women
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Yongchang Zhang

OTHER

Sponsor Role lead

Responsible Party

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Yongchang Zhang

Professor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Yongchang Zhang, MD

Role: PRINCIPAL_INVESTIGATOR

Hunan Cancer Hospital

Locations

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Hunan Cancer Hospital

Changsha, Hunan, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Yongchang Zhang, MD

Role: CONTACT

Phone: +8613873123436

Email: [email protected]

Yongchang Zhang, MD

Role: CONTACT

Phone: +8613873123436

Email: [email protected]

Facility Contacts

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Yongchang Zhang, MD

Role: primary

Yongchang Zhang, MD

Role: backup

Other Identifiers

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SAVE

Identifier Type: -

Identifier Source: org_study_id