Trial Outcomes & Findings for Study of Pembrolizumab and Chemotherapy With or Without Radiation in Small Cell Lung Cancer (SCLC) (NCT NCT02934503)

NCT ID: NCT02934503

Last Updated: 2021-11-16

Results Overview

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

5 participants

Primary outcome timeframe

up to 5 months

Results posted on

2021-11-16

Participant Flow

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. Due to this change in standard of care practice, the study was closed. It only accrued 5 participants - randomization/proper crossover assignment was not performed; therefore, data is not presented "per arm".

Participant milestones

Participant milestones
Measure	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. 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).
Overall Study STARTED	5
Overall Study COMPLETED	1
Overall Study NOT COMPLETED	4

Reasons for withdrawal

Reasons for withdrawal
Measure	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. 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).
Overall Study progression of disease	3
Overall Study Withdrawal by Subject	1

Baseline Characteristics

Study of Pembrolizumab and Chemotherapy With or Without Radiation in Small Cell Lung Cancer (SCLC)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Cisplatin or Carboplatin, Etoposide, Pembrolizumab & Radiation n=5 Participants 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).
Age, Continuous	68 years n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants
Sex: Female, Male Male	3 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	5 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	5 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	5 participants n=5 Participants

PRIMARY outcome

Timeframe: up to 5 months

Population: 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. Due to this change in standard of care practice, the study was closed. It accrued 5 patients and therefore there is insufficient data to report on any of the outcomes/endpoints.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 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

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: at 6 weeks

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: at 12 weeks

Outcome measures

Outcome data not reported

Adverse Events

Cisplatin or Carboplatin, Etoposide, Pembrolizumab & Radiation

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Joshua Sabari

NYU Langone

Phone: 212-731-6363

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place