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

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

Status
UNKNOWN
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03646968
Acronym
SAVE
Enrollment
43
Registered
2018-08-24
Start date
2018-08-01
Completion date
2025-06-01
Last updated
2023-12-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non-Squamous Non Small Cell Lung Cancer

Keywords

Anlotinib Combined With Docetaxel

Brief summary

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

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.

Interventions

DRUGAnlotinib 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)

Sponsors

Yongchang Zhang
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
ORRmay 2018- may 2019 (1 year)overall response rate

Secondary

MeasureTime frameDescription
PFSmay 2018- may 2019 (1 year)Progression survival time
OSmay 2018- may 2019 (1 year)overall survival time

Countries

China

Contacts

Primary ContactYongchang Zhang, MD
yangnong0217@163.com+8613873123436
Backup ContactYongchang Zhang, MD
zhangyongchang@csu.edu.cn+8613873123436

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026