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Randomized Phase 2 Study of 3 Therapeutic Modalities in PS 2/3 Patients With NSCLC Stage IIIB/IV


Phase 2
18 Years
80 Years
Not Enrolling
Both
Carcinoma, Non-Small-Cell Lung

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Trial Information

Randomized Phase 2 Study of 3 Therapeutic Modalities in PS 2/3 Patients With NSCLC Stage IIIB/IV


Arm A Iressa 250 mg daily PROG/TOX --> Taxotere 75 mg/m² d1 (d1=d22)

Arm B Gemzar 1250 mg/m² d1 & d8 (d1=d22) PROG/TOX --> Iressa 250 mg daily

Arm C Taxotere 75 mg/m² d1 (d1=d22) PROG/TOX --> Iressa 250 mg daily


Inclusion Criteria:



- Stage IIIB/IV NSCLC

- patients with performance status 2 or 3.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Progression-free Survival (PFS)

Outcome Time Frame:

week

Safety Issue:

Yes

Principal Investigator

Jean-Francois Morere, Pr

Investigator Role:

Principal Investigator

Investigator Affiliation:

IFCT

Authority:

France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Study ID:

IFCT-0301

NCT ID:

NCT00198393

Start Date:

November 2004

Completion Date:

December 2008

Related Keywords:

  • Carcinoma, Non-Small-Cell Lung
  • stage IIIB/IV NSCLC
  • patients with performance status 2 or 3.
  • Carcinoma
  • Carcinoma, Non-Small-Cell Lung

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