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Zalutumumab in Non-Small Cell Lung Cancer (NSCLC) Patients Refractory to Tyrosine Kinase Inhibitors

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ClinicalTrials.gov Identifier: NCT01449357
Recruitment Status : Withdrawn (Trial never initiated)
First Posted : October 10, 2011
Last Update Posted : October 10, 2011
Sponsor:
Information provided by (Responsible Party):
Genmab

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Non-small Cell Lung Cancer Drug: zalutumumab Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer
U.S. FDA Resources

Arm Intervention/treatment
Experimental: zalutumumab Drug: zalutumumab
IV infusion, 16mg/kg on weekly basis until DP



Primary Outcome Measures :
  1. Objective Response (OR) defined as complete response (CR) or partial response (PR) according to the RECIST criteria (revised version 1.1) within 6 months. [ Time Frame: within 6 months ]

Secondary Outcome Measures :
  1. Disease Control defined as CR, PR or Stable Disease (SD) according to the RECIST criteria (revised version 1.1) within 6 months. [ Time Frame: within 6 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01449357


Sponsors and Collaborators
Genmab
Investigators
Study Chair: Not applicable, Study cancelled H. Lee Moffitt Cancer Center, Tampa, Florida, USA

Responsible Party: Genmab
ClinicalTrials.gov Identifier: NCT01449357     History of Changes
Other Study ID Numbers: GEN210
First Posted: October 10, 2011    Key Record Dates
Last Update Posted: October 10, 2011
Last Verified: October 2011

Keywords provided by Genmab:
NSCLC
Zalutumumab
Efficacy
Safety

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs