Lung Neoplasm Malignant Clinical Trial
Official title:
A Clinical Study to Investigate 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
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).
In the 1st stage (Week 1-12), all patients will receive combination chemotherapy, i.e.
Platinum and Navelbine, for 4 cycles. The regimen is:
Navelbine oral 60mg/m2 d1,8 the first cycle; oral 80mg/m2 day1,8 in sequential cycles q3w
plus cisplatin: 75mg/m2 d1 q3w.
In the 2nd stage (Week 13-25), patients who complete the combination chemotherapy with
acceptable tolerance and have no 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). The allocation will be done in sequence at each site, i.e., the first
subject who complete the combination chemotherapy with acceptable tolerance and have no PD
will be allocated to Arm A, and the second will be allocated to Arm B, and so on. Arm A will
continue with oral Navelbine 3 times weekly as maintenance therapy, up to 12 weeks, or till
progression, unacceptable toxicity or death occurred. As contrast, Arm B will receive other
therapy as per the physician's choice.
Arm A: Navelbine oral 50mg three times per week (Day 1, 3, 5 of each week ) Arm B:
Physician's choice (other than Navelbine oral) computed tomography (CT) or magnetic resonance
imaging (MRI) will be done at the screening visit, Week 7, Week 13 (before the initiation of
maintenance therapy), Week 19 (after 6 weeks of maintenance therapy), and Week 25 (after 12
weeks of maintenance therapy), to evaluate the tumor response. The Disease Control Rate
(proportion of patients in complete response (CR), partial response (PR) or stable disease
(SD)) after 6 weeks and 12 weeks of maintenance therapy will be evaluated separately for the
2 arms. And Arm B is for observational study only, and will provide rationale for control
group selecting in future study.
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