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Phase II Study to Investigate the Efficacy and Safety of ZK 219477 as Second Line Therapy in Patients With Stage IIIB or Stage IV Non Small Cell Lung Cancer (NSCLC)


Phase 2
18 Years
N/A
Not Enrolling
Both
Carcinoma, Non Small Cell Lung

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Trial Information

Phase II Study to Investigate the Efficacy and Safety of ZK 219477 as Second Line Therapy in Patients With Stage IIIB or Stage IV Non Small Cell Lung Cancer (NSCLC)


The study has previously been posted by Schering AG, Germany. Schering AG, Germany has been
renamed to Bayer Schering Pharma AG, Germany.Bayer Schering Pharma AG, Germany is the
sponsor of the trial.


Inclusion Criteria:



- Non-small-cell lung cancer

- Only one previous chemotherapy with a platinum-containing drug

- Use of highly effective birth control methods in females of child-bearing potential

Exclusion Criteria:

- No more than 1 previous chemotherapy for advanced disease

- Previous participation in another trial within the last 4 weeks

- Breast feeding

- Active infections

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

The primary efficacy variable is defined as Proportion of patients with either CR or PR as 'best overall response'. Tumor assessment is performed according to RECIST criteria.

Outcome Time Frame:

Tumor evaluation (MRI or scan) every 2 cycles until disease progression.

Safety Issue:

No

Principal Investigator

Bayer Study Director

Investigator Role:

Study Director

Investigator Affiliation:

Bayer

Authority:

Germany: Federal Institute for Drugs and Medical Devices

Study ID:

91374

NCT ID:

NCT00160069

Start Date:

August 2005

Completion Date:

April 2009

Related Keywords:

  • Carcinoma, Non Small Cell Lung
  • Stage IIIB or stage IV non-small-cell lung cancer.
  • Carcinoma
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

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