Description:
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).
Title
- Brief Title: Oral Navelbine and Cisplatin Followed by Metronomic Oral Navelbine in Non-Small Cell Lung Cancer
- 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
Clinical Trial IDs
- ORG STUDY ID:
CTONG 1512
- NCT ID:
NCT02985203
Conditions
Interventions
| Drug | Synonyms | Arms |
|---|
| Vinorelbine Oral | Navelbine | Vinorelbine oral |
Purpose
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).
Detailed Description
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.
Trial Arms
| Name | Type | Description | Interventions |
|---|
| Vinorelbine oral | Experimental | Oral Navelbine plus Cisplatin followed by metronomic oral vinorelbine. | |
| Physician's choice | No Intervention | Observation or maintenance therapy other than orla navelbine. | |
Eligibility Criteria
Inclusion Criteria:
- Men or women aged ≥ 18 years with life expectancy ≥ 6 months
- Histologically or cytologically confirmed advanced (Stage III B - IV) NSCLC which has
not received antineoplastic treatment and not suitable for radical treatment,
including those have been resected more than 1 year before signing informed consent
form (ICF) then metastasized or relapsed and currently requiring chemotherapy
- With no history of cancer other than in situ uterine cervix cancer or skin basal cell
carcinoma with no active disease within 5 years prior to signing the ICF
- With at least one measurable target lesion(s) according to RECIST 1.1
- Adequate hematopoietic function
- Adequate hepatic and renal function
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1
- Women of child-bearing potential must have a negative pregnancy test (urine or serum)
within 7 days of drug administration and agree to take an adequate contraceptive
measure
- Men who have sexual life and have a wife of child-bearing age must agree to take an
adequate contraceptive measure during and for 12 weeks after the last treatment with
Navelbine
- Signed written informed consent
- Able to comply with the protocol
Exclusion Criteria:
- Non-small Cell Lung Cancer with positive sensitizing epidermal growth factor receptor
(EGFR) mutation positive or anaplastic lymphoma kinase (ALK) fusion oncogene, or with
unknown EGFR/ALK status
- Resectable Non-Small Cell Lung Cancer or suitable for radical radiotherapy/
chemotherapy
- Patients with medical conditions that the only manifestation is hydrothorax, ascites,
bone lesions or other unmeasurable diseases
- Symptomatic CNS metastasis (CNS metastasis which has received radiotherapy or surgery
and symptom has been stable for more than 4 weeks could be enrolled)
- With invasive malignancies except lung cancer
- Inadequate hematopoietic function:
- Neutrophil <1.5*109/L;
- Hb < 100g/L;
- platelet count (PLT) <100*109/L
- Inadequate hepatic or renal function:
- aspartate aminotransferase (AST)/alanine aminotransferase (ALT)/alkaline
phosphatase (AKP)>2.5 upper limit of normal (ULN) in patients without liver or
bone metastasis
- AST and/or ALT >1.5 ULN with AKP>2.5 ULN
- AKP>5 ULN in patients with bone metastasis
- ALT/AST>5 ULN in patients with liver metastasis
- Total bilirubin > 1.5 ULN
- Serum creatinine >1.5 ULN
- Calculated creatinine clearance below 60ml/min (Cockcroft and Gault formula)
- Blood calcium>ULN
- Patient is pregnant or nursing
- Patients with psychiatric disorder or other disease leading to incompliance to the
therapy
- Known hypersensitivity to any ingredient of the regimen
- Treatment with any investigational drug within 30 days before the beginning of
treatment with study drug
- Malabsorption syndrome or any other disorder affecting gastrointestinal absorption
- Any other severe, acute, or chronic medical condition or laboratory abnormality that
may increase the risk associated with study participation or study drug administration
or may interfere with the interpretation of study results and, in the judgment of the
Investigator, would make the patient inappropriate for the study.
| Maximum Eligible Age: | N/A |
| Minimum Eligible Age: | 18 Years |
| Eligible Gender: | All |
| Healthy Volunteers: | No |
Primary Outcome Measures
| Measure: | Disease control rate during maintenance |
| Time Frame: | 12 weeks |
| Safety Issue: | |
| Description: | |
Secondary Outcome Measures
| Measure: | Response rate during maintenance |
| Time Frame: | 12 weeks |
| Safety Issue: | |
| Description: | |
| Measure: | Duration of response |
| Time Frame: | 8 months |
| Safety Issue: | |
| Description: | |
| Measure: | progression-free survival |
| Time Frame: | 8 months |
| Safety Issue: | |
| Description: | |
Details
| Phase: | Phase 2 |
| Primary Purpose: | Interventional |
| Overall Status: | Terminated |
| Lead Sponsor: | Guangdong Association of Clinical Trials |
Trial Keywords
- lung cancer
- vinorelbine
- metronomic chemotherapy
Last Updated
March 12, 2020
