Study of Taxane/Carboplatin +/- Cetuximab as First-Line Treatment for Patients With Advanced/Metastatic Non-Small Cell Lung Cancer

Lilly

Status and phase: Completed; Phase 3

Conditions: Non-Small-Cell Lung Carcinoma

Treatments: Drug: Cetuximab; Drug: Paclitaxel (Taxane); Drug: Carboplatin; Drug: Docetaxel (Taxane)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00112294

CA225-099

Details and patient eligibility

About

The primary purpose of this clinical research study is to learn if patients treated with the combination of Taxane/Carboplatin plus Cetuximab (C/T/C) have a longer progression-free survival than patients treated with Taxane/Carboplatin (T/C) alone. The safety of this treatment will also be studied.

Enrollment: 755 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Must have advanced or metastatic non-small cell lung cancer that has not been previously treated with any chemotherapy.
• Tumor/disease lesions that can be measured bidimensionally.
• Must be able to carry-out work of light or sedentary nature (e.g. light house work, office work).
• Adequate recovery from recent surgery or radiation therapy.
• Must be at least 4 weeks from last major surgery or prior treatment with an investigational agent. At least 12 weeks from any radiation therapy to chest.
• Accessible for treatment, follow-up and required visits at a participating center(s).

Exclusion criteria

• Prior chemotherapy or adjuvant chemotherapy for the treatment of lung cancer.
• Prior treatment with cetuximab or other epidermal growth factor (EGFR)-targeted therapy.
• Prior severe infusion reaction to antibody therapy.
• Concurrent malignancy (previous malignancy without evidence of disease for 5 years will be allowed to enter trial).
• Concurrent chemotherapy or therapy with another investigational agent not indicated in the protocol.
• Serious uncontrolled medical disorders that would impair the ability to receive therapy.
• History of myocardial infarction within prior 3 months, uncontrolled angina, uncontrolled arrhythmia, or uncontrolled congestive heart failure.
• Symptomatic or uncontrolled metastases in the central nervous system. Subjects receiving a glucocorticoid for central nervous system (CNS) metastases are not eligible, but those receiving an anticonvulsant are eligible.
• Peripheral neuropathy >= grade 2 (Common Toxicity Criteria Adverse Event [CTCAE] Version 3.0).
• Inadequate hematologic and/or liver and/or kidney function.
• Sexually active and fertile individuals or partners of these individuals who are unwilling or unable to use an acceptable method of birth control for entire trial and up to 4 weeks after the study.
• Women who are pregnant or breastfeeding.
• Women with a positive pregnancy test on enrollment prior to study drug administration.
• Altered mental status or psychiatric condition that prohibits understanding or rendering of consent.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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755 participants in 2 patient groups

Cetuximab+Taxane+Carboplatin (C/T/C)

Active Comparator group

Description:

Cetuximab was administered at an initial dose (Week 1) of 400 mg/m\^2 intravenous (IV) infusion (infused over 120 minutes) and a weekly maintenance dose of 250 mg/m\^2 IV infusion (infused over 60 minutes). A cycle of therapy was defined as 3 weeks. Taxane was paclitaxel 225 mg/m\^2 infused over 180 minutes on Day 1 and subsequently every 3 weeks or docetaxel 75 mg/m\^2 infused over 60 minutes on Day 1 and subsequently every 3 weeks. Carboplatin was infused over 30 minutes on Day 1 and subsequently every 3 weeks.

Treatment:

Drug: Cetuximab

Drug: Carboplatin

Drug: Paclitaxel (Taxane)

Drug: Docetaxel (Taxane)

Taxane+Carboplatin (T/C)

Active Comparator group

Description:

A cycle of therapy was defined as 3 weeks. Taxane was paclitaxel 225 mg/m\^2 infused over 180 minutes on Day 1 and subsequently every 3 weeks or docetaxel 75 mg/m\^2 infused over 60 minutes on Day 1 and subsequently every 3 weeks. Carboplatin was infused over 30 minutes on Day 1 and subsequently every 3 weeks.

Treatment:

Drug: Carboplatin

Drug: Paclitaxel (Taxane)

Drug: Docetaxel (Taxane)