Carcinoma, Non-small-cell Lung
Conditions
Brief summary
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.
Interventions
DRUGCP-675,206
Given intravenously every 3 months
DRUGbest supportive care
As per investigator discretion. Excludes chemotherapy or other anti-cancer therapy
Sponsors
AstraZeneca
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | 3 months to 2 years from randomization |
Secondary
| Measure | Time frame |
|---|---|
| Levels of study drug in blood samples taken at specified time points. | up to 2 years |
| Whether polymorphisms of certain genes influence safety. | up to 2 years |
| Health-related quality of life outcomes. | up to 2 years |
| Tumor response | up to 2 years |
| Survival | 2 years |
| Blood levels of any human anti-human antibody response | up to 2 years |
| Immune response. | up to 2 years |
| Efficacy | up to 2 years |
| Number of patients with adverse events as a measure of safety of CP-675,206 when administered to patients with NSCLC | up to 2 years |
Countries
Canada, Czechia, South Korea, United Kingdom, United States
Outcome results
None listed