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

Phase 2

Withdrawn

• Conditions: Non-small Cell Lung Cancer
• Interventions: Drug: zalutumumab

• Registration Number: NCT01449357
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-09-29
• Status Verified: 2011-10
• Study First Submitted QC: 2011-10-07
• Last Update Submitted: 2011-10-07
• Study First Posted: 2011-10-10
• Last Update Posted: 2011-10-10

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
zalutumumab	zalutumumab	-

Primary Outcome Measures

Name	Time	Method
Objective Response (OR) defined as complete response (CR) or partial response (PR) according to the RECIST criteria (revised version 1.1) within 6 months.	within 6 months

Secondary Outcome Measures

Name	Time	Method
Disease Control defined as CR, PR or Stable Disease (SD) according to the RECIST criteria (revised version 1.1) within 6 months.	within 6 months