Event Group
Event Groups are part of the Adverse Events Module within the Results Section. They provide a way to organize and summarize adverse event data by grouping related events together.
Each Event Group typically represents a category or class of adverse events and includes statistical information such as the number of participants affected and at risk for different event types: deaths, serious events, and other events.
Event Group path is as follows:
Study -> Results Section -> Adverse Events Module -> Event Group
Event Group
Ignite Creation Date:
2025-12-24 @ 7:40 PM
Ignite Modification Date:
2025-12-25 @ 5:20 PM
NCT ID:
NCT02934503
Group ID:
EG000
Title:
Cisplatin or Carboplatin, Etoposide, Pembrolizumab & Radiation
Description:
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.
Pembrolizumab: 200 mg IV fixed dose every 3 weeks until progression or for up to 2 years of therapy.
Cisplatin: 75 mg/m2
Carboplatin: AUC 6
Etoposide: IV every 3 weeks for up to 6 cycles (minimum of 4 cycles, maximum of 6).
Radiation therapy: Thoracic radiotherapy will be given per institutional standards(dose and duration may vary for individual participants).
Deaths Number Affected:
0
Deaths Number At Risk:
None
Serious Number Affected:
0
Serious Number At Risk:
5
Other Number Affected:
0
Other Number At Risk:
5
Study:
NCT02934503
Results Section:
NCT02934503
Adverse Events Module:
NCT02934503