Study for Patients With Non Small Cell Lung Cancer (NSCLC)

Randomized Phase II Study to Determine the Efficacy of a Three Weekly vs. Weekly Therapy With Paclitaxel Plus Carboplatin vs. Paclitaxel Plus Vinorelbine for Patients With Non Small Cell Lung Cancer According to UICC Stage IIIB and IV

Status

UNKNOWN

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00168883

Enrollment

Registered

2005-09-15

Start date

2002-10-31

Completion date

2006-12-31

Last updated

2006-11-01

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

Conditions

Carcinoma, Non-Small-Cell Lung

Keywords

NSCLC, curative non-treatable NSCLC UICC stage IIIB and IV

Brief summary

This is a randomized study to assess the efficacy and safety of chemotherapy with platin compared to chemotherapy without platin.

Detailed description

Randomized Phase II design, multicenter study, to assess the efficacy and safety of combined chemotherapy with Paclitaxel and Carboplatin versus a platinum free chemotherapy with Paclitaxel and Vinorelbine, within the combination therapies there are two different dosing intervals, which will be assessed as well (4 Arm study).

Interventions

DRUGCarboplatin

DRUGPaclitaxel

DRUGVinorelbine

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Chemotherapy naive patients with histologically confirmed NSCLC stage III and IV

Exclusion criteria

* New York Heart Association (NYHA) III or IV * Brain metastases * Neurotoxicity Grade 2 or greater

Design outcomes

Primary

Measure	Time frame
Determination of response rate (stable disease [SD] or better)	—
Determination of safety of the combination and life quality	—

Secondary

Measure	Time frame
Determination of remission rate	—
Determination of time to progression	—
Determination of 1-year survival rate	—

Countries

Germany

Contacts

Primary ContactUlrich Keilholz, MD

ulrich.keilholz@charite.de+49-30-8445-3596

Backup ContactAlexander Schmittel, MD

alexander.schmittel@charite.de+49-30-8445-3090

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026