A Study of BIIB022 in Combination With Paclitaxel and Carboplatin in Subjects With Non-Small Cell Lung Cancer

The purpose of this study is to determine whether BIIB022, Paclitaxel and Carboplatin are effective in the treatment of Treatment-Naive, Stage IIIB/IV Non-Small Cell Lung Cancer.

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Key information

Conditions

Non-small Cell Lung Cancer Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Resesarch Site, Los Angeles, California, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Age >/= 18 years old
Treatment-naive Stage IIIB/IV Non-Small Cell Lung Cancer
ECOG Performance Status 0 or 1

Exclusion criteria

History of another primary cancer within 3 years
Any prior or concurrent investigational or standard therapy for treatment of NSCLC
Prior anti-IGF-1R therapy
Unstable diabetes

Treatment and study plan

BIIB022 With Paclitaxel and Carboplatin

Drug

Escalating doses of BIIB022 with fixed dose and schedule of paclitaxel and carboplatin

Other names: Taxol, Paraplatin, BIIB022, Taxane, Anti-IGF-1R, Cytotoxic, Mitotic Inhibitor, IGF-1R, Alkylating agent

Primary outcomes

To evaluate the safety and tolerability of BIIB022 in combination with paclitaxel and carboplatin

Time frame: 6 months

Sponsors and collaborators

Lead sponsor

Biogen

Industry

Registry information

Official study title

A Phase 1b, Open-Label, Dose-Escalation Study of BIIB022 in Combination With Paclitaxel and Carboplatin in Subjects With Treatment-Naive, Stage IIIB/IV Non-Small Cell Lung Cancer

Important dates

Study start: 2009
Primary completion: 2011
Study completion: 2011
First posted: Sep 2, 2009
Registry last updated: Sep 16, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed