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Completed

NCT Number: NCT00312975

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

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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Key information

Conditions

Carcinoma, Non-Small-Cell Lung Bronchial Neoplasms Carcinoma, Bronchogenic Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Research Site, Calgary, Alberta, Canada

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Exclusion criteria

  • No other systemic therapy except 1st-line platinum based treatment
  • Symptomatic or uncontrolled brain mets or uncontrolled pleural effusions.

Treatment and study plan

CP-675,206

Drug

Given intravenously every 3 months

Best supportive care

Drug

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

Primary outcomes

  1. The length of time until there is evidence of disease progression in patients treated with CP-675,206 and in patients receiving best supportive care.

    Time frame: 3 months to 2 years from randomization

Secondary outcomes

  1. Survival

    Time frame: 2 years

  2. Levels of study drug in blood samples taken at specified time points.

    Time frame: up to 2 years

  3. Whether polymorphisms of certain genes influence safety.

    Time frame: up to 2 years

  4. Health-related quality of life outcomes.

    Time frame: up to 2 years

  5. Tumor response

    Time frame: up to 2 years

  6. Number of patients with adverse events as a measure of safety of CP-675,206 when administered to patients with NSCLC

    Time frame: up to 2 years

  7. Blood levels of any human anti-human antibody response

    Time frame: up to 2 years

  8. Immune response.

    Time frame: up to 2 years

  9. Efficacy

    Time frame: up to 2 years

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

Phase 2 Randomized, Non-Comparative Study Of CP-675,206 Or Best Supportive Care Immediately Following First-Line, Platinum-Based Therapy In Patients With Stage IIIB (With Effusion) Or Stage IV Non-Small Cell Lung Cancer That Has Responded Or Remained Stable

Important dates

Study start
2006
Primary completion
2008
Study completion
2010
First posted
Apr 11, 2006
Registry last updated
Jun 7, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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