drugset / Trial / NCT02985203

Oral Navelbine and Cisplatin Followed by Metronomic Oral Navelbine in Non-Small Cell Lung Cancer

NCT02985203 ↗

Phase 2 Terminated 45 enrolled Guangdong Association of Clinical Trials
Non-randomizedParallel-groupOpen-labelTreatment

Summary

This is an open-label, multi-center clinical trial, aims to evaluate the efficacy and safety of combination of oral Navelbine and Cisplatin followed by metronomic oral Navelbine in Patients with advanced Non-Small Cell Lung Cancer. The study comprises two stages. In the 1st stage (Week 1-12), all patients will receive combination chemotherapy. In the 2nd stage (Week 13-25), patients who complete the combination chemotherapy with acceptable tolerance and have no progressive disease (PD) will be allocated into 2 arms, to evaluate the efficacy and safety of maintenance chemotherapy with metronomic oral Navelbine (Arm A) or other regimen (Arm B).

Timeline

Start
2016-11
Primary completion
2018-04
Completion
2018-04

Outcome

Outcome not reported

Stopped (Enrollment): “No participants were enrolled as schedule.”

Drugs

EvaluationDrugModalityDoseRoute
Subject Vinorelbine Small molecule 50 mg Oral
Subject Vinorelbine Small molecule 60 mg/m2 Oral
Subject Vinorelbine Small molecule 80 mg/m2 Oral

Indications