Randomized Study Of CP-675,206 or Best Supportive Care Immediately After Platinum-Based Therapy For Non-Small Cell Lung Cancer (NSCLC)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-05-31

Study Completion Date

2010-02-28

Brief Summary

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The purpose of this trial is to study how long patients can remain progression free when they receive CP-675,206, compared to how long patients can remain progression free when they receive best supportive care. If you choose to take part, you will be randomized to receive either CP-675,206 as maintenance therapy or best supportive care. Best supportive care means you will not receive any study drug or other treatment for your cancer. Best supportive care could include treatment with antibiotics, analgesic drugs (medicine for pain), blood transfusions or psychosocial and nutritional support, depending on your needs. You have a 50% chance of being randomized to receive CP-675,206.

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Detailed Description

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Conditions

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Carcinoma, Non-small-cell Lung

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Arm A

Group Type EXPERIMENTAL

CP-675,206

Intervention Type DRUG

Given intravenously every 3 months

Arm B

Group Type ACTIVE_COMPARATOR

best supportive care

Intervention Type DRUG

As per investigator discretion. Excludes chemotherapy or other anti-cancer therapy

Interventions

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CP-675,206

Given intravenously every 3 months

Intervention Type DRUG

best supportive care

As per investigator discretion. Excludes chemotherapy or other anti-cancer therapy

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Stage IIIb (with effusion) or stage IV disease that has responded or remained stable after 6 cycles of a platinum containing 1st-line regimen
* Patients must be able to be randomized between 3 and no more than 6 weeks after the last dose of first-line therapy.