A Multi-centre, Open Label, Single Arm, Ph IV, Interventional Study to Evaluate the Efficacy of Erlotinib Following 4 Cycles of Platinum-based Chemotherapy in Pts With Locally Advanced or Metastatic NSCLC Who Have Not Experienced Disease Progression or Unacceptable Toxicity During Chemotherapy.
Phase 4
18 Years
N/A
18 Years
N/A
Open (Enrolling)
Both
Non-Small Cell Lung Cancer
Both
Non-Small Cell Lung Cancer
Trial Information
A Multi-centre, Open Label, Single Arm, Ph IV, Interventional Study to Evaluate the Efficacy of Erlotinib Following 4 Cycles of Platinum-based Chemotherapy in Pts With Locally Advanced or Metastatic NSCLC Who Have Not Experienced Disease Progression or Unacceptable Toxicity During Chemotherapy.
Inclusion Criteria:
- Adult patients; >/= 18 years of age
- Histologically documented non-small cell lung cancer (NSCLC)
- Locally advanced or recurrent (Stage IIIB) or metastatic (Stage IV) disease
- Completion of 4 cycles of an acceptable, standard, platinum-based chemotherapy
doublet without progression
- ECOG performance status 0-1
- Patients of reproductive potential must agree to use effective contraception
Exclusion Criteria:
- Prior exposure to agents directed at the HER axis (e.g. gefitinib, cetuximab,
trastuzumab)
- Prior treatment with any monoclonal antibody therapy
- Any other malignancies within the previous 5 years, except for adequately treated
carcinoma in situ of the cervix or squamous cell skin cancer
- Clinically significant cardiovascular, hepatic, renal or metabolic disease or active
infection
- Pre-existing interstitial lung disease
- HIV, HBV or HCV infection
- Pregnant or lactating women
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Progression-free survival rate (tumour assessment by magnetic resonance imaging (MRI) according to RECIST criteria)
Outcome Time Frame:
Week 52
Safety Issue:
No
Principal Investigator
Clinical Trials
Investigator Role:
Study Director
Investigator Affiliation:
Hoffmann-La Roche
Authority:
India: Drug Controller General
Study ID:
ML25478
NCT ID:
NCT01230710
Start Date:
March 2011
Completion Date:
September 2013
Related Keywords:
- Non-Small Cell Lung Cancer
- Carcinoma, Non-Small-Cell Lung
- Lung Neoplasms
- Disease Progression
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