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

NCT ID: NCT01449357

Last Updated: 2011-10-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE2

Study Classification

INTERVENTIONAL

Brief Summary

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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

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Conditions

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Non-small Cell Lung Cancer

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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zalutumumab

Group Type EXPERIMENTAL

zalutumumab

Intervention Type DRUG

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

Interventions

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zalutumumab

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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Genmab

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Not applicable, Study cancelled

Role: STUDY_CHAIR

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

Other Identifiers

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GEN210

Identifier Type: -

Identifier Source: org_study_id