Pembrolizumab Every 12 Weeks Versus Every 3 Weeks in Treating Patients With Non-small Cell Lung Cancer
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|ClinicalTrials.gov Identifier: NCT04032418|
Recruitment Status : Recruiting
First Posted : July 25, 2019
Last Update Posted : February 21, 2021
|Condition or disease||Intervention/treatment||Phase|
|Lung Non-Small Cell Carcinoma||Biological: Pembrolizumab||Phase 2|
I. To evaluate the 1-year progression-free survival rate with 200mg pembrolizumab administered every 3 weeks compared to 200mg pembrolizumab administered every 12 weeks.
I. To assess overall survival between the two treatment groups. II. To assess the serious adverse event profiles between the two treatment groups.
I. To evaluate circulating biomarkers of treatment response and resistance. II. To characterize fecal microbiotic profile and to correlate those results with tumor characteristics and antitumor immune responses.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients receive pembrolizumab intravenously (IV) over 30 minutes every 3 weeks for up to 24 months in the absence of disease progression or unacceptable toxicity.
ARM II: Patients receive pembrolizumab IV over 30 minutes every 12 weeks for up to 24 months in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up at 30 days, and then every 12 weeks for at least 12 months.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||152 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Randomized Phase II Study of Pembrolizumab 200mg every12 Weeks Versus Every 3 Weeks in NSCLC With Clinical Benefit to Pembrolizumab Monotherapy: Multicenter International Study|
|Actual Study Start Date :||February 13, 2020|
|Estimated Primary Completion Date :||September 3, 2022|
|Estimated Study Completion Date :||September 3, 2023|
Active Comparator: Arm I (200mg pembrolizumab 3 weeks)
Patients receive 200mg pembrolizumab IV over 30 minutes every 3 weeks for up to 24 months in the absence of disease progression or unacceptable toxicity.
Experimental: Arm II (200mg pembrolizumab 12 weeks)
Patients receive 200mg pembrolizumab IV over 30 minutes every 12 weeks for up to 24 months in the absence of disease progression or unacceptable toxicity.
- 1-year progression-free survival (PFS) [ Time Frame: Baseline to 12 months ]Measured using Response Evaluation Criteria in Solid Tumors (RECIST) 1.1.
- Overall survival [ Time Frame: Up to 12 months after treatment completion ]Defined as the number of months between Loading Phase enrollment and death from any cause. Analysis of overall survival between the two treatment groups will be carried forth using a log-rank test accounting for the stratification factors, including other known variables such as PD-L1 tumor proportion score, line of therapy, histology, mutation profile.
- Incidence of adverse events [ Time Frame: Up to 12 months ]Assessed by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. Will be assessed through the evaluation of grade 3 or higher toxicities deemed possibly related to treatment. Both efficacy and toxicity rates will be estimated using simple relative frequencies. The corresponding 95% confidence intervals for the estimated probabilities will be computed.
- Cox regression models in terms of treatment resistance [ Time Frame: Up to 12 months ]Circulating biomarkers of treatment response and resistance
- Length of time on treatment [ Time Frame: Up to 12 months ]Length of time on treatment as a time varying covariate will be carried out using Cox regression models.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04032418
|United States, New York|
|Roswell Park Cancer Institute||Recruiting|
|Buffalo, New York, United States, 14263|
|Contact: Grace K. Dy 716-845-3099 Grace.Dy@roswellpark.org|
|Principal Investigator: Grace K. Dy|
|Principal Investigator:||Grace K Dy||Roswell Park Cancer Institute|