Oral Navelbine and Cisplatin Followed by Metronomic Oral Navelbine in Non-Small Cell Lung Cancer
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|ClinicalTrials.gov Identifier: NCT02985203|
Recruitment Status : Terminated (No participants were enrolled as schedule.)
First Posted : December 7, 2016
Last Update Posted : March 12, 2020
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).
|Condition or disease||Intervention/treatment||Phase|
|Lung Neoplasm Malignant||Drug: Vinorelbine Oral||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||45 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||November 2016|
|Actual Primary Completion Date :||April 2018|
|Actual Study Completion Date :||April 2018|
Experimental: Vinorelbine oral
Oral Navelbine plus Cisplatin followed by metronomic oral vinorelbine.
Drug: Vinorelbine Oral
Oral vinorelbine plus cisplatin Followed by Metronomic oral Vinorelbine
Other Name: Navelbine
No Intervention: Physician's choice
Observation or maintenance therapy other than orla navelbine.
- Disease control rate during maintenance [ Time Frame: 12 weeks ]
- Response rate during maintenance [ Time Frame: 12 weeks ]
- Duration of response [ Time Frame: 8 months ]
- progression-free survival [ Time Frame: 8 months ]
- Adverse events [ Time Frame: 8 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02985203
|Guangdong General Hospital|
|Guangzhou, Guangdong, China, 510080|
|Principal Investigator:||Zhen Wang, PhD,MD||Guangdong General Hospital&Guangdong Academy of Medical Sciences|