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A Study of IMC-A12 (Cixutumumab) With and Without Other Standard Chemotherapies in Participants With Lung Cancer Who Have Not Received Chemotherapy Before

NCT00870870 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 64

Last updated 2018-06-01

Study results available
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Summary

The purpose of this study is to determine the number of participants whose cancer shrinks or disappears after treatment on the study.

Conditions

Interventions

DRUG

Gemcitabine

1000 milligrams per square meter (mg/m\^2) on Days 1 and 8 of each cycle \[First 6 cycles (18 weeks)\]

DRUG

Cisplatin

75 mg/m\^2 on Day 1 of each cycle \[First 6 cycles (18 weeks)\]

BIOLOGICAL

IMC-A12 (cixutumumab)

6 milligrams per kilogram (mg/kg) intravenous (IV) infusion, administered once per week (on Days 1, 8, and 15 of each cycle) \[First 6 cycles (18 weeks)\]

BIOLOGICAL

Cetuximab

400 mg/m\^2 IV infusion, administered on Day 1 of Cycle 1, 250 mg/m\^2 once per week thereafter \[First 6 cycles (18 weeks)\]

BIOLOGICAL

IMC-A12 (cixutumumab)

10 mg/kg IV infusion, administered once every 2 weeks (Maintenance therapy)

BIOLOGICAL

Cetuximab

500 mg/m\^2 IV infusion, administered once every 2 weeks (Maintenance therapy)

DRUG

Carboplatin

Area under the curve (AUC) = 5, Day 1 of each cycle \[First 6 cycles (18 weeks)\] \*Carboplatin will be replaced by Cisplatin

Sponsors & Collaborators

Principal Investigators

  • E-mail: ClinicalTrials@ ImClone.com · Eli Lilly and Company

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-03-31
Primary Completion
2012-04-30
Completion
2012-05-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00870870 on ClinicalTrials.gov