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

This study has been withdrawn prior to enrollment.
(Trial never initiated)
Information provided by (Responsible Party):
Genmab Identifier:
First received: September 29, 2011
Last updated: October 7, 2011
Last verified: October 2011
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 Intervention Phase
Non-small Cell Lung Cancer
Drug: zalutumumab
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 NLM:

Further study details as provided by Genmab:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 0
Arms Assigned Interventions
Experimental: zalutumumab Drug: zalutumumab
IV infusion, 16mg/kg on weekly basis until DP


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01449357

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

Responsible Party: Genmab Identifier: NCT01449357     History of Changes
Other Study ID Numbers: GEN210 
Study First Received: September 29, 2011
Last Updated: October 7, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Genmab:

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Bronchial Neoplasms
Carcinoma, Bronchogenic
Lung Diseases
Neoplasms by Site
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs processed this record on May 25, 2016