NCT03799601

Docetaxel Combined With Carboplatin Plus Anlotinib as First Line Treatment in NSCLC

A Single Arm, Multi-center Study to Assess the Efficacy and Safety of Docetaxel Combined With Carboplatin Plus Anlotinib as First Line Treatment in Non-squamous Non-small-cell Lung Cancer (NSCLC)

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 45 (estimated)
• Sponsor: Tongji Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

Anlotinib which has shown an affirmatory efficacy in ALTER0303 controlled trial as a 3rd-line treatment on advanced NSCLC is a tyrosine kinase inhibitor with a favorable safety profile in phase I trial which mainly targets VEGFR1/2/3, FGFR, PDGFR and c-kit. The purpose of this trail is to establish whether advanced non-squamous NSCLC patients could benefit from the combination treatment of docetaxel, carboplatin and anlotinib as the first-line and maintenance treatment.

Detailed description

First-line patients (or postoperative recurrence) with locally advanced or metastatic NSCLC were enrolled in this trail. The patients (clinical stage ⅢB/Ⅳ, with no sensitizing mutation of the epidermal growth factor receptor gene or translocation of the anaplastic lymphoma kinase gene) were confirmed by histological or cytological diagnosis. The primary endpoint is PFS; secondary endpoint includes OS, DCR and ORR. The study was single-arm, conducted at 8 centers in China mainland. The primary end point was PFS (time from enrollment to first RECIST1.1-defined PD or death). 45 patients were planned for enrollment. This estimate was based on 80% power, with a two-sided 5% significance level. We analyzed PFS and OS using Kaplan-Meier methodology. The research protocol was approved by the relevant ethics committees, and the study was conducted according to the Declaration of Helsinki and Good Clinical Practice guidelines. Patients gave written informed consent to participate in the trial.

Conditions

• NSCLC

Interventions

Type	Name	Description
DRUG	Anlotinib	Anlotinib which has shown an affirmatory efficacy in ALTER0303 controlled trial as a 3rd-line treatment on advanced NSCLC is a tyrosine kinase inhibitor with a favorable safety profile in phase I trial which mainly targets VEGFR1/2/3, FGFR, PDGFR and c-kit.
DRUG	Docetaxel	a chemotherapy medication used to treat a number of types of cancer.This includes breast cancer, head and neck cancer, stomach cancer, prostate cancer and non-small-cell lung cancer.It may be used by itself or along with other chemotherapy medication.It is given by slow injection into a vein.
DRUG	Carboplatin	Carboplatin is used to treat a number of forms of cancer. This includes ovarian cancer, lung cancer, head and neck cancer, brain cancer, and neuroblastoma. It may be used for some types of testicular cancer but cisplatin is generally more effective.

Timeline

• Start date: 2019-03-01
• Primary completion: 2019-12-01
• Completion: 2020-12-01
• First posted: 2019-01-10
• Last updated: 2019-01-10

Locations

1 site across 1 country: China