A Single-arm Phase II Trial Investigating the Efficacy and Safety of Zalutumumab in Patients With Non-Small Cell Lung Cancer Who Have Progressive Disease After Treatment With Tyrosine Kinase Inhibitors
Phase 2
18 Years
N/A
18 Years
N/A
Not Enrolling
Both
Non-small Cell Lung Cancer
Both
Non-small Cell Lung Cancer
Trial Information
A Single-arm Phase II Trial Investigating the Efficacy and Safety of Zalutumumab in Patients With Non-Small Cell Lung Cancer Who Have Progressive Disease After Treatment With Tyrosine Kinase Inhibitors
Inclusion Criteria:
- Patients must have documented disease progression after TKI treatment (verified by CT
scan and/or MRI according to RECIST).
Exclusion Criteria:
- Estimated life expectancy of less than 3 months.
- Received the following treatments within 2 weeks prior to Visit 2:
- Cytotoxic or cytostatic anti-cancer chemotherapy
- Total resection or irradiation of the target lesion
- Any investigational agent
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:
Objective Response (OR) defined as complete response (CR) or partial response (PR) according to the RECIST criteria (revised version 1.1) within 6 months.
Outcome Time Frame:
within 6 months
Safety Issue:
No
Principal Investigator
Not applicable, Study cancelled
Investigator Role:
Study Chair
Investigator Affiliation:
H. Lee Moffitt Cancer Center, Tampa, Florida, USA
Authority:
United States: Food and Drug Administration
Study ID:
GEN210
NCT ID:
NCT01449357
Start Date:
Completion Date:
Related Keywords:
- Non-Small Cell Lung Cancer
- NSCLC
- Zalutumumab
- Efficacy
- Safety
- Carcinoma, Non-Small-Cell Lung
- Lung Neoplasms
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