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

Yongchang Zhang

Status and phase: Enrolling; Phase 2

Conditions: Non-Squamous Non Small Cell Lung Cancer

Treatments: Drug: Anlotinib and Docetaxel

Study type: Interventional

Funder types: Other

Identifiers

NCT03646968

SAVE

Details and patient eligibility

About

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

Full description

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.

Enrollment: 43 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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43 participants in 1 patient group

Cohorts

Experimental group

Description:

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

Treatment:

Drug: Anlotinib and Docetaxel