Study of Pembrolizumab and Chemotherapy With or Without Radiation in Small Cell Lung Cancer (SCLC)
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|ClinicalTrials.gov Identifier: NCT02934503|
Recruitment Status : Terminated (This study was terminated as the standard of care for small cell lung cancer changed in 2018 to include immunotherapy in the front line setting, making this study no longer clinically relevant.)
First Posted : October 17, 2016
Results First Posted : November 16, 2021
Last Update Posted : November 16, 2021
|Condition or disease||Intervention/treatment||Phase|
|Small Cell Lung Cancer (SCLC)||Biological: Pembrolizumab Drug: Cisplatin Drug: Carboplatin Drug: Etoposide Radiation: Radiation therapy||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||5 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Study of Pembrolizumab and Dynamic PD-L1 Expression in Extensive Stage Small Cell Lung Cancer (SCLC)|
|Actual Study Start Date :||January 23, 2017|
|Actual Primary Completion Date :||October 1, 2019|
|Actual Study Completion Date :||October 1, 2019|
Experimental: Cisplatin or carboplatin, Etoposide, Pembrolizumab & Radiation
Cohort A: cisplatin (75 mg/m^2) + carboplatin (AUC 6) + etoposide (100mg/m^2) for four to six, 3-week cycles + pembrolizumab (200 mg) followed by radiation. Pembrolizumab will be started with first cycle of chemotherapy and continued for up to 2 years.
Cohort B: Pembrolizumab (200 mg) will be added to standard therapy with cisplatin (75 mg/m2) or carboplatin (AUC 6) and etoposide (100 mg/m2) (and radiation, if appropriate), after one 3- week cycle of standard therapy and continued for up to 2 years.
Cohort C: 200 mg IV infusion of Pembrolizumab every 3 weeks over about 30 minutes after completion of standard chemotherapy with cisplatin (75 mg/ m2) and etoposide (100 mg/m2). Treatment with pembrolizumab will continue for up to 2 years.
Cohort D: Pembrolizumab 200 mg IV infusion every 3 weeks in vein after completion of standard chemotherapy and radiation. Pembrolizumab will start within 6 weeks of completing radiation therapy and continue for up to 2 years.
200 mg IV fixed dose every 3 weeks until progression or for up to 2 years of therapy.
Other Name: Keytruda
Other Name: Platinol
Other Name: Paraplatin
IV every 3 weeks for up to 6 cycles (minimum of 4 cycles, maximum of 6).
Other Name: Etopophos
Radiation: Radiation therapy
Thoracic radiotherapy will be given per institutional standards(dose and duration may vary for individual participants).
- Change in PD-L1 Expression Status as Determined by Immunohistochemistry in Pretreatment and Archival Samples [ Time Frame: up to 5 months ]
- Number of Participants With Progression-free Survival (PFS) [ Time Frame: up to 6 months ]Progression-Free Survival (PFS) is defined as the time from randomization (or registration) to the earlier of progression or death due to any cause
- Number of Participants With Overall Survival [ Time Frame: up to 9 months ]Overall Survival (OS) is defined as the time from randomization (or registration) to death due to any cause, or censored at date last known alive.
- Response Evaluation Using Response Evaluation Criteria In Solid Tumors (RECIST) [ Time Frame: at 6 weeks ]
- Response Evaluation Using Response Evaluation Criteria In Solid Tumors (RECIST) [ Time Frame: at 12 weeks ]
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): NCT02934503
|United States, New York|
|Laura and Isaac Perlmutter Cancer Center at NYU Langone|
|New York, New York, United States, 10016|
|Principal Investigator:||Joshua Sabari, MD,||NYU Perlmutter Cancer Center|