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

Charité University Medicine Berlin logo

Charité University Medicine Berlin

Status and phase

Unknown
Phase 2

Conditions

Carcinoma, Non-Small-Cell Lung

Treatments

Drug: Carboplatin
Drug: Vinorelbine
Drug: Paclitaxel

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT00168883
Haema CBF NSCLC UK/AS 03

Details and patient eligibility

About

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

Full 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).

Sex

All

Ages

18+ years old

Volunteers

No 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

Trial contacts and locations

1

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Central trial contact

Ulrich Keilholz, MD; Alexander Schmittel, MD

Data sourced from clinicaltrials.gov

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