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

This study has been completed.
Information provided by:
Biogen Identifier:
First received: September 1, 2009
Last updated: September 12, 2013
Last verified: November 2011
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.

Condition Intervention Phase
Non-Small Cell Lung Cancer
Drug: BIIB022 With Paclitaxel and Carboplatin
Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official 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

Resource links provided by NLM:

Further study details as provided by Biogen:

Primary Outcome Measures:
  • To evaluate the safety and tolerability of BIIB022 in combination with paclitaxel and carboplatin [ Time Frame: 6 months ]

Enrollment: 18
Study Start Date: October 2009
Study Completion Date: September 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: BIIB022 in Combination with Paclitaxel and Carboplatin
BIIB022 in Combination with Paclitaxel and Carboplatin
Drug: BIIB022 With Paclitaxel and Carboplatin
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


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00970580

United States, California
Resesarch Site
Los Angeles, California, United States
Resesarch Site
San Diego, California, United States
United States, Colorado
Resesarch Site
Denver, Colorado, United States
Sponsors and Collaborators
  More Information

Responsible Party: Therese Senta-McMillian, Clinical Team Manager, PRA International Identifier: NCT00970580     History of Changes
Other Study ID Numbers: 212-LC-101
Study First Received: September 1, 2009
Last Updated: September 12, 2013

Keywords provided by Biogen:
Stage IV
Stage IIIB
Non Small Cell Lung Cancer
Treatment Naive
Anti IGF1R
Open Label
Mitotic Inhibitor
Alkylating agent

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Antimitotic Agents
Albumin-Bound Paclitaxel
Antibodies, Monoclonal
Alkylating Agents
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Physiological Effects of Drugs processed this record on May 25, 2017