Switch Maintenance Pembrolizumab in Patients With NSCLC After First Line Platinum Doublet Chemotherapy (SWIPE)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02705820|
Recruitment Status : Active, not recruiting
First Posted : March 11, 2016
Last Update Posted : January 27, 2021
|Condition or disease||Intervention/treatment||Phase|
|Metastatic Non Small Cell Lung Cancer||Drug: Pembrolizumab||Phase 2|
There are currently no data on maintenance therapy with PD1/PDL1 inhibitors in NSCLC. After an initial response / stable disease to first line chemotherapy, non progressors / candidates for maintenance treatment, represent an ideal setting / patient group to test the efficacy of Pembrolizumab given that chemotherapy results in antigen release, hence it has the potential to augment immune checkpoint blockade, and following disease cytoreduction, this represents a lower disease burden setting, that may suit checkpoint inhibition better given the recent studies in Prostate cancer with Ipilimumab and Melanoma with Pembrolizumab(suggesting better outcomes for patients with less extensive disease).
Primary endpoint: percentage of patients that have not progressed at 1 year using immune related radiological criteria.
All patients to be treated with fixed dose 200mg iv Pembrolizumab until unacceptable toxicity, disease progression or completion of 2 years therapy.
Statistical Analysis Plan Summary The study employs a one stage phase II Fleming's design using irPFS at 1 year as primary endpoint. Using response hypotheses of H0 < 12 % and Ha> 25% i.e. that the irPFS at 1 year for the maintenance Pembrolizumab arm is 25%, compared to 12% in the normal chemotherapy maintenance arm, with a significance level (i.e., the probability of rejecting H0 when it is true) α=0.05 and the power (i.e. the probability of deciding the regimen is active) is 0.8 when true response rate is 25%, 48 patients are required to be entered into this study.
Entry Criteria Diagnosis/Condition for Entry into the Trial In order to be eligible for trial entry, patients must have a diagnosis of metastatic Non Small Cell Lung Cancer, and should not have progressed after first line palliative chemotherapy with a platinum doublet. They should have received no more than six (6) cycles of a platinum doublet chemotherapy, and should be able to receive treatment within three (3) to six (6) weeks from the last chemotherapy administration.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||48 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Study of Switch Maintenance Pembrolizumab in Patients With Non Small Cell Lung Cancer (NSCLC) Who do Not Progress After First Line Platinum Doublet Chemotherapy. (SWIPE)|
|Actual Study Start Date :||April 25, 2016|
|Estimated Primary Completion Date :||July 31, 2021|
|Estimated Study Completion Date :||July 31, 2021|
Experimental: single arm study
experimental treatment with maintenance pembrolizumab
Switch maintenance pembrolizumab treatment
Other Name: MK-3475
- Immune Related Progression Free Survival (irPFS) at 1 year [ Time Frame: 1 years ]
- Response rates using RECIST [ Time Frame: 2 years ]
- Response Rates with immune related Response Criteria (irRC) [ Time Frame: 2 years ]
- Radiological Progression Free Survival (PFS) using RECIST criteria [ Time Frame: 3 years ]
- Immune-related PFS using irRC [ Time Frame: 3 years ]
- Overall survival [ Time Frame: 3 years ]
- Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 [ Time Frame: 3 years ]
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): NCT02705820
|Bank of Cyprus Oncology Centre|
|Nicosia, Strovolos, Cyprus, 2006|
|Principal Investigator:||Dr Haris Charalambous, BM MRCP FRCR||Consultant Oncologist, BOC Oncology Centre|