SEQUENTIAL CHEMOTHERAPY WITH CISPLATIN PLUS VINORELBINE FOLLOWED BY WEEKLY DOCETAXEL IN LOCALLY ADVANCED OR METASTATIC NON SMALL-CELL LUNG CANCER - ND

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2008-003250-15-IT

Enrollment

Registered

2008-07-08

Start date

2008-06-24

Completion date

Unknown

Last updated

2025-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

locally advanced or metastatic NSCLC MedDRA version: 9.1 Level: LLT Classification code 10061873 Term: Non-small cell lung cancer

Interventions

Product Name: Cisplatin Pharmaceutical Form: Powder for infusion* INN or Proposed INN: Cisplatin Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 100- Product Name:

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Age >= 18 yers Diagnosis of cytologically-histologically confirmed locally advanced or metastatic NSCLC karnofsky PS of >= 70 at study entry Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Symptomatic brain metastasis Previous chemoterapy for metastatic lung cancer Radiotherapy within 4 weeks prior to study entry Woman who are pregnant or breastfeeding

Design outcomes

Primary

Measure	Time frame
Main Objective: To determine time to disease progression of sequential chemotherapy with cisplatin plus vinorelbine followed by weekly docetaxel in patients with locally advanced or metastatic NSCLC not previously treated with chemoterapy;Secondary Objective: To detrmine the safety of the combination To determine the overall survival To determine the median response duration;Primary end point(s): To determine time to disease progression of sequential chemotherapy with cisplatin plus vinorelbine followed by weekly docetaxel in patients with locally advanced or metastatic NSCLC not previously treated with chemoterapy	—

Measure

Time frame

Main Objective: To determine time to disease progression of sequential chemotherapy with cisplatin plus vinorelbine followed by weekly docetaxel in patients with locally advanced or metastatic NSCLC not previously treated with chemoterapy;Secondary Objective: To detrmine the safety of the combination To determine the overall survival To determine the median response duration;Primary end point(s): To determine time to disease progression of sequential chemotherapy with cisplatin plus vinorelbine followed by weekly docetaxel in patients with locally advanced or metastatic NSCLC not previously treated with chemoterapy

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Countries

Italy

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026