The purpose of this study is to determine the effect of MGd in non-small-cell lung cancer (NSCLC) when given alone, and to evaluate the difference between two dosing regimens.
Outline: Two-arm, open-label, randomized, 2-stage Phase II trial. Patients will be randomized on the first stage to 1 of 2 treatment arms: Arm A - 10 mg/kg MGd once per week Arm B - 15 mg/kg MGd once every 3 weeks Patients will be treated on 3 week cycles, up to a maximum of 8 cycles (24 weeks). Patients with either objective response or stable disease after 2 cycles will receive up to 8 cycles of therapy. Patients with progressive disease will be terminated from the study. At the end of Stage I, both treatment arms will be evaluated, and only the arm(s) that demonstrate at least one response (Complete Response or Partial Response) will proceed to Stage II. If both arms demonstrate a response, then both will proceed to Stage II.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
108
Unnamed facility
Fountain Valley, California, United States
Unnamed facility
Los Angeles, California, United States
Unnamed facility
Palm Springs, California, United States
To estimate the response rates of two different MGd dosing regimens for the treatment of NSCLC
To select the most effective regimen based on tumor response
To estimate the time to progression
To estimate survival
To evaluate the safety and tolerability of 2 dosing regimens of MGd in NSCLC patients
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Unnamed facility
Columbia, Missouri, United States
Unnamed facility
St Louis, Missouri, United States
Unnamed facility
Omaha, Nebraska, United States
Unnamed facility
Albuquerque, New Mexico, United States
Unnamed facility
Rochester, New York, United States
Unnamed facility
Akron, Ohio, United States
Unnamed facility
Knoxville, Tennessee, United States
...and 6 more locations