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Status unknownNCT00168883Updated Nov 1, 2006

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

A Phase 2 interventional study of Carboplatin and Paclitaxel in Carcinoma, Non-Small-Cell Lung, sponsored by Charite University, Berlin, Germany. Status unknown at 1 site in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2006-11-01.

Sponsored by Charite University, Berlin, Germany · Phase 2, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Sep 2006), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 2
Study type
Interventional
Enrollment
80
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

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

Read the 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).

02

Conditions studied

  • Carcinoma, Non-Small-Cell Lung

Keywords

  • NSCLC
  • curative non-treatable NSCLC UICC stage IIIB and IV
03

In context

Carcinoma, Non-Small-Cell Lung

6,488 studies on the registry are indexed under Carcinoma, Non-Small-Cell Lung; 1,632 are open to participants now.

This study's enrollment of 80 is above the median of 62 across 5,213 interventional studies indexed under Carcinoma, Non-Small-Cell Lung.

Browse Carcinoma, Non-Small-Cell Lung studies →

Lead sponsor

Charite University, Berlin, Germany is the lead sponsor of 836 studies on the registry; 129 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • New York Heart Association (NYHA) III or IV
  • Brain metastases
  • Neurotoxicity Grade 2 or greater
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
80 participants

Interventions

  • DrugCarboplatin
  • DrugPaclitaxel
  • DrugVinorelbine
06

What researchers measure

Primary outcomes

  1. Determination of response rate (stable disease [SD] or better)

  2. Determination of safety of the combination and life quality

Secondary outcomes

  1. Determination of remission rate

  2. Determination of time to progression

  3. Determination of 1-year survival rate

07

Study locations

1 of 1 sites recruiting
  • Hematology & Oncology Charité CBF Berlin
    Berlin, 12203, Germany
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 1, 2006, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00168883
Lead sponsor
Charite University, Berlin, Germany
Collaborators
Bristol-Myers Squibb, Pierre Fabre Pharma GmbH
First posted
Sep 15, 2005
Start date
Oct 2002
Completion
Dec 2006
Last update
Nov 1, 2006

Study contacts

Ulrich Keilholz, MD
Contact
ulrich.keilholz@charite.de
+49-30-8445-3596
Alexander Schmittel, MD
Contact
alexander.schmittel@charite.de
+49-30-8445-3090
Ulrich Keilholz, MD
principal investigator · Charite University, Berlin, Germany
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Sep 2006. You cannot join it, but the record below documents what was studied.

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