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

Sponsor
Guangdong Association of Clinical Trials
Study ID
NCT02985203
Phase
PHASE2
Status
Terminated

Conditions

  • Lung Neoplasm Malignant

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Vinorelbine Oral — DRUG
    Oral vinorelbine plus cisplatin Followed by Metronomic oral Vinorelbine

Study Details

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).

Key Dates

Start date
Nov 30, 2016
Status verified
Jun 2018
Primary completion
Apr 30, 2018
Completion
Apr 30, 2018

Study Design

Enrollment
45 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Vinorelbine oral
    Oral Navelbine plus Cisplatin followed by metronomic oral vinorelbine.
  • No Intervention: Physician's choice
    Observation or maintenance therapy other than orla navelbine.

Primary Outcome Measure

Disease control rate during maintenance [ Time Frame: 12 weeks ]

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