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

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

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00970580
Enrollment
18
Registered
2009-09-02
Start date
2009-10-31
Completion date
2011-09-30
Last updated
2013-09-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non-Small Cell Lung Cancer

Keywords

BIIB022, Stage IV, Taxol, Stage IIIB, Carboplatin, Paclitaxel, Non Small Cell Lung Cancer, Treatment Naive, Anti IGF1R, NSCLC, Open Label, IGF1R, Paraplatin, Cytotoxic, Mitotic Inhibitor, Taxane, Alkylating agent

Brief summary

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.

Interventions

DRUGBIIB022 With Paclitaxel and Carboplatin

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

Sponsors

Biogen
Lead SponsorINDUSTRY

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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

Design outcomes

Primary

MeasureTime frame
To evaluate the safety and tolerability of BIIB022 in combination with paclitaxel and carboplatin6 months

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026