Trial Outcomes & Findings for Pembrolizumab and Paclitaxel in Refractory Small Cell Lung Cancer (NCT NCT02551432)

NCT ID: NCT02551432

Last Updated: 2020-02-10

Results Overview

Tumor response will be assessed based on modified RECIST 1.1

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 26 participants
• Primary outcome timeframe: 3 months
• Results posted on: 2020-02-10

Participant Flow

Participant milestones

Measure	Paclitaxel Pembrolizumab * PD-L1 Induction phase : Paclitaxel 175 mg/m2, Day 1 q 3weeks, intravenous, * Post Induction treatment phase: Paclitaxel 175 mg/m2, Day 1 q 3weeks (maximum up to total 6 cycles) + pembrolizumab 200 mg D1 q 3 weeks, intravenous, * Maintenance phase: pembrolizumab 200 mg D1 q 3 weeks, intravenous till PD or unacceptable toxicity pembrolizumab, paclitaxel: pembrolizumab, paclitaxel
Overall Study STARTED	26
Overall Study COMPLETED	26
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Pembrolizumab and Paclitaxel in Refractory Small Cell Lung Cancer

Baseline characteristics by cohort

Measure	Paclitaxel Pembrolizumab n=26 Participants * PD-L1 Induction phase : Paclitaxel 175 mg/m2, Day 1 q 3weeks, intravenous, * Post Induction treatment phase: Paclitaxel 175 mg/m2, Day 1 q 3weeks (maximum up to total 6 cycles) + pembrolizumab 200 mg D1 q 3 weeks, intravenous, * Maintenance phase: pembrolizumab 200 mg D1 q 3 weeks, intravenous till PD or unacceptable toxicity pembrolizumab, paclitaxel: pembrolizumab, paclitaxel
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	9 Participants n=5 Participants
Age, Categorical >=65 years	17 Participants n=5 Participants
Age, Continuous	68.5 years n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants
Sex: Female, Male Male	23 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	26 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	0 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 South Korea	26 participants n=5 Participants

PRIMARY outcome

Timeframe: 3 months

Tumor response will be assessed based on modified RECIST 1.1

Outcome measures

Measure

Paclitaxel Pembrolizumab n=26 Participants * PD-L1 Induction phase : Paclitaxel 175 mg/m2, Day 1 q 3weeks, intravenous, * Post Induction treatment phase: Paclitaxel 175 mg/m2, Day 1 q 3weeks (maximum up to total 6 cycles) + pembrolizumab 200 mg D1 q 3 weeks, intravenous, * Maintenance phase: pembrolizumab 200 mg D1 q 3 weeks, intravenous till PD or unacceptable toxicity pembrolizumab, paclitaxel: pembrolizumab, paclitaxel

Objective Response Rate

6 Participants

SECONDARY outcome

Timeframe: from first dose to disease progression or death due to any cause, whichever came first, up to 24months

Tumor response will be assessed based on modified RECIST 1.1

Outcome measures

Measure

Paclitaxel Pembrolizumab n=26 Participants * PD-L1 Induction phase : Paclitaxel 175 mg/m2, Day 1 q 3weeks, intravenous, * Post Induction treatment phase: Paclitaxel 175 mg/m2, Day 1 q 3weeks (maximum up to total 6 cycles) + pembrolizumab 200 mg D1 q 3 weeks, intravenous, * Maintenance phase: pembrolizumab 200 mg D1 q 3 weeks, intravenous till PD or unacceptable toxicity pembrolizumab, paclitaxel: pembrolizumab, paclitaxel

Progression-free Survival

5.0 months Interval 2.7 to 6.7

SECONDARY outcome

Timeframe: from first dose to death due to any cause, whichever came first, assessed up to 24 months

Tumor response will be assessed based on modified RECIST 1.1

Outcome measures

Measure

Paclitaxel Pembrolizumab n=26 Participants * PD-L1 Induction phase : Paclitaxel 175 mg/m2, Day 1 q 3weeks, intravenous, * Post Induction treatment phase: Paclitaxel 175 mg/m2, Day 1 q 3weeks (maximum up to total 6 cycles) + pembrolizumab 200 mg D1 q 3 weeks, intravenous, * Maintenance phase: pembrolizumab 200 mg D1 q 3 weeks, intravenous till PD or unacceptable toxicity pembrolizumab, paclitaxel: pembrolizumab, paclitaxel

Overall Response (OS)

9.1 months Interval 6.5 to 15.0

SECONDARY outcome

Timeframe: 3 months

Safety will be assessed for all subjects and documented according to the CTCAE v4.0

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 3 months

find out predictive biomarker for pembrolizumab. Factors potentially associated with pembrolizumab response will b analyzed for providing the rationale for future patient selection.

Outcome measures

Outcome data not reported

Adverse Events

Paclitaxel Pembrolizumab

Serious events: 9 serious events

Other events: 26 other events

Deaths: 0 deaths

Serious adverse events

Measure	Paclitaxel Pembrolizumab n=26 participants at risk * PD-L1 Induction phase : Paclitaxel 175 mg/m2, Day 1 q 3weeks, intravenous, * Post Induction treatment phase: Paclitaxel 175 mg/m2, Day 1 q 3weeks (maximum up to total 6 cycles) + pembrolizumab 200 mg D1 q 3 weeks, intravenous, * Maintenance phase: pembrolizumab 200 mg D1 q 3 weeks, intravenous till PD or unacceptable toxicity pembrolizumab, paclitaxel: pembrolizumab, paclitaxel
Blood and lymphatic system disorders neutropenia	7.7% 2/26 • From the first dose to 30 days after the last dose(till PD or unacceptable toxicity), an average of 1 year
Infections and infestations Pneumonia	7.7% 2/26 • From the first dose to 30 days after the last dose(till PD or unacceptable toxicity), an average of 1 year
Endocrine disorders type 1 Diabetes Mellitus	3.8% 1/26 • From the first dose to 30 days after the last dose(till PD or unacceptable toxicity), an average of 1 year
Blood and lymphatic system disorders febrile neutropenia	7.7% 2/26 • From the first dose to 30 days after the last dose(till PD or unacceptable toxicity), an average of 1 year
Musculoskeletal and connective tissue disorders Asthenia	7.7% 2/26 • From the first dose to 30 days after the last dose(till PD or unacceptable toxicity), an average of 1 year

Other adverse events

Measure	Paclitaxel Pembrolizumab n=26 participants at risk * PD-L1 Induction phase : Paclitaxel 175 mg/m2, Day 1 q 3weeks, intravenous, * Post Induction treatment phase: Paclitaxel 175 mg/m2, Day 1 q 3weeks (maximum up to total 6 cycles) + pembrolizumab 200 mg D1 q 3 weeks, intravenous, * Maintenance phase: pembrolizumab 200 mg D1 q 3 weeks, intravenous till PD or unacceptable toxicity pembrolizumab, paclitaxel: pembrolizumab, paclitaxel
Blood and lymphatic system disorders anemia	23.1% 6/26 • From the first dose to 30 days after the last dose(till PD or unacceptable toxicity), an average of 1 year
Musculoskeletal and connective tissue disorders Myalgia	34.6% 9/26 • From the first dose to 30 days after the last dose(till PD or unacceptable toxicity), an average of 1 year
Gastrointestinal disorders Anorexia	19.2% 5/26 • From the first dose to 30 days after the last dose(till PD or unacceptable toxicity), an average of 1 year
Metabolism and nutrition disorders Nausea	15.4% 4/26 • From the first dose to 30 days after the last dose(till PD or unacceptable toxicity), an average of 1 year
Metabolism and nutrition disorders Vomiting	7.7% 2/26 • From the first dose to 30 days after the last dose(till PD or unacceptable toxicity), an average of 1 year
Gastrointestinal disorders Constipation	15.4% 4/26 • From the first dose to 30 days after the last dose(till PD or unacceptable toxicity), an average of 1 year
Gastrointestinal disorders Diarrhea	23.1% 6/26 • From the first dose to 30 days after the last dose(till PD or unacceptable toxicity), an average of 1 year
Nervous system disorders Dizziness	15.4% 4/26 • From the first dose to 30 days after the last dose(till PD or unacceptable toxicity), an average of 1 year
Nervous system disorders Headache	7.7% 2/26 • From the first dose to 30 days after the last dose(till PD or unacceptable toxicity), an average of 1 year
Skin and subcutaneous tissue disorders Pruritus	19.2% 5/26 • From the first dose to 30 days after the last dose(till PD or unacceptable toxicity), an average of 1 year
Nervous system disorders Peripheral sensory neuropathy	57.7% 15/26 • From the first dose to 30 days after the last dose(till PD or unacceptable toxicity), an average of 1 year
Blood and lymphatic system disorders Hyponatremia	7.7% 2/26 • From the first dose to 30 days after the last dose(till PD or unacceptable toxicity), an average of 1 year

Additional Information

Bhumsuk Keam

Seoul National University Hospital

Phone: 82+10-3231-2208

Email: bhumsuk@snu.ac.kr

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place