NCT01449357

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.

Trial Health

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 29, 2011

Completed
11 days until next milestone

First Posted

Study publicly available on registry

October 10, 2011

Completed
Last Updated

October 10, 2011

Status Verified

October 1, 2011

First QC Date

September 29, 2011

Last Update Submit

October 7, 2011

Conditions

Non-small Cell Lung Cancer

Keywords

NSCLCZalutumumabEfficacySafety

Outcome Measures

Primary Outcomes (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.

    within 6 months

Secondary Outcomes (1)

  • 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

Study Arms (1)

zalutumumab

EXPERIMENTAL
Drug: zalutumumab

Interventions

zalutumumabDRUG

IV infusion, 16mg/kg on weekly basis until DP

zalutumumab

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients must have documented disease progression after TKI treatment (verified by CT scan and/or MRI according to RECIST).

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

zalutumumab

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Not applicable, Study cancelled

    H. Lee Moffitt Cancer Center, Tampa, Florida, USA

    STUDY CHAIR
0

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 29, 2011

First Posted

October 10, 2011

Last Updated

October 10, 2011

Record last verified: 2011-10