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

October 7, 2011 updated by: Genmab

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

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
within 6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
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
within 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Genmab

Investigators

  • Study Chair: Not applicable, Study cancelled, H. Lee Moffitt Cancer Center, Tampa, Florida, USA

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

September 29, 2011

First Submitted That Met QC Criteria

October 7, 2011

First Posted (Estimate)

October 10, 2011

Study Record Updates

Last Update Posted (Estimate)

October 10, 2011

Last Update Submitted That Met QC Criteria

October 7, 2011

Last Verified

October 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GEN210

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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