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

NCT02985203 | Terminated Phase 2 DMC

• 1 other identifier: CTONG 1512
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Lung Neoplasm Malignant

Keywords

lung cancer; vinorelbine; metronomic chemotherapy

Outcome Measures

Primary Outcomes (1)

• Disease control rate during maintenance

  12 weeks

Secondary Outcomes (3)

• Response rate during maintenance

  12 weeks

• Duration of response

  8 months

• progression-free survival

  8 months

Other Outcomes (1)

• Adverse events

  8 months

Study Arms (2)

Vinorelbine oral

EXPERIMENTAL

Oral Navelbine plus Cisplatin followed by metronomic oral vinorelbine.

Drug: Vinorelbine Oral

Physician's choice

NO INTERVENTION

Observation or maintenance therapy other than orla navelbine.

Interventions

Vinorelbine Oral DRUG

Oral vinorelbine plus cisplatin Followed by Metronomic oral Vinorelbine

Also known as: Navelbine

Vinorelbine oral

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Guangdong Association of Clinical Trials: lead

Study Sites (1)

Guangdong General Hospital

Guangzhou, Guangdong, 510080, China

Location

MeSH Terms

Conditions

Lung Neoplasms

Interventions

Vinorelbine

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Indolizidines; Indolizines

Study Officials

• Zhen Wang, PhD,MD

  Guangdong General Hospital&Guangdong Academy of Medical Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 29, 2016
• First Posted: December 7, 2016
• Study Start: November 1, 2016
• Primary Completion: April 1, 2018
• Study Completion: April 1, 2018
• Last Updated: March 12, 2020

Record last verified: 2018-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)