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

Non-small Cell Lung Cancer Clinical Trial

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01449357
• Other study ID #: GEN210
• Status: Withdrawn
• Phase: Phase 2
• First received: September 29, 2011
• Last updated: October 7, 2011

Study information

• Verified date: October 2011
• Source: Genmab
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non-small Cell Lung Cancer

Intervention

Drug:
• zalutumumab
IV infusion, 16mg/kg on weekly basis until DP

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Genmab

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No