Pembrolizumab and Paclitaxel in Refractory Small Cell Lung Cancer (MISP-MK3475)

• ClinicalTrials.gov Identifier: NCT02551432
• Recruitment Status: Completed
• First Posted: September 16, 2015
• Results First Posted: February 10, 2020
• Last Update Posted: February 10, 2020
• Sponsor: Seoul National University Hospital
• Information provided by (Responsible Party): Bhumsuk Keam, Seoul National University Hospital

• Study Type: Interventional
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Small Cell Lung Cancer
• Intervention: Drug: pembrolizumab, paclitaxel
• Enrollment: 26

Participant Flow

Recruitment Details
Pre-assignment Details

Arm/Group Title	Paclitaxel Pembrolizumab
Arm/Group Description	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
Period Title: Overall Study
Started	26
Completed	26
Not Completed	0

Baseline Characteristics

Arm/Group Title		Paclitaxel Pembrolizumab
Arm/Group Description		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 Number of Baseline Participants		26
Baseline Analysis Population Description		[Not Specified]
Age, Categorical; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	26 participants
	<=18 years	0 0.0%
	Between 18 and 65 years	9 34.6%
	>=65 years	17 65.4%
Age, Continuous; Median (Full Range); Unit of measure: Years
	Number Analyzed	26 participants
		68.5; (54 to 78)
Sex: Female, Male; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	26 participants
	Female	3 11.5%
	Male	23 88.5%
Race (NIH/OMB); Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	26 participants
	American Indian or Alaska Native	0 0.0%
	Asian	26 100.0%
	Native Hawaiian or Other Pacific Islander	0 0.0%
	Black or African American	0 0.0%
	White	0 0.0%
	More than one race	0 0.0%
	Unknown or Not Reported	0 0.0%
Region of Enrollment; Measure Type: Number; Unit of measure: Participants
South Korea	Number Analyzed	26 participants
		26

Outcome Measures

1. Primary Outcome

Title	Objective Response Rate
Description	Tumor response will be assessed based on modified RECIST 1.1
Time Frame	3 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Paclitaxel Pembrolizumab
Arm/Group Description:	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 Number of Participants Analyzed	26
Measure Type: Count of Participants; Unit of Measure: Participants
	6 23.1%

2. Secondary Outcome

Title	Progression-free Survival
Description	Tumor response will be assessed based on modified RECIST 1.1
Time Frame	from first dose to disease progression or death due to any cause, whichever came first, up to 24months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Paclitaxel Pembrolizumab
Arm/Group Description:	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 Number of Participants Analyzed	26
Median (95% Confidence Interval); Unit of Measure: months
	5.0; (2.7 to 6.7)

3. Secondary Outcome

Title	Overall Response (OS)
Description	Tumor response will be assessed based on modified RECIST 1.1
Time Frame	from first dose to death due to any cause, whichever came first, assessed up to 24 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Paclitaxel Pembrolizumab
Arm/Group Description:	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 Number of Participants Analyzed	26
Median (95% Confidence Interval); Unit of Measure: months
	9.1; (6.5 to 15.0)

4. Secondary Outcome

Title	Safety(Toxicity)
Description	Safety will be assessed for all subjects and documented according to the CTCAE v4.0
Time Frame	3 months

Outcome Measure Data Not Reported

5. Other Pre-specified Outcome

Title	Number of Participants With Adverse Events as a Measure of Safety and Tolerability
Description	find out predictive biomarker for pembrolizumab. Factors potentially associated with pembrolizumab response will b analyzed for providing the rationale for future patient selection.
Time Frame	3 months

Outcome Measure Data Not Reported

Adverse Events

Time Frame	From the first dose to 30 days after the last dose(till PD or unacceptable toxicity), an average of 1 year
Adverse Event Reporting Description	[Not Specified]
Arm/Group Title	Paclitaxel Pembrolizumab
Arm/Group Description	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
All-Cause Mortality
	Paclitaxel Pembrolizumab
	Affected / at Risk (%)
Total	0/26 (0.00%)
Serious Adverse Events
	Paclitaxel Pembrolizumab
	Affected / at Risk (%)
Total	9/26 (34.62%)
Blood and lymphatic system disorders
neutropenia †	2/26 (7.69%)
febrile neutropenia †	2/26 (7.69%)
Endocrine disorders
type 1 Diabetes Mellitus †	1/26 (3.85%)
Infections and infestations
Pneumonia †	2/26 (7.69%)
Musculoskeletal and connective tissue disorders
Asthenia †	2/26 (7.69%)
† Indicates events were collected by systematic assessment
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	5%
	Paclitaxel Pembrolizumab
	Affected / at Risk (%)
Total	26/26 (100.00%)
Blood and lymphatic system disorders
anemia †	6/26 (23.08%)
Hyponatremia †	2/26 (7.69%)
Gastrointestinal disorders
Anorexia †	5/26 (19.23%)
Constipation †	4/26 (15.38%)
Diarrhea †	6/26 (23.08%)
Metabolism and nutrition disorders
Nausea †	4/26 (15.38%)
Vomiting †	2/26 (7.69%)
Musculoskeletal and connective tissue disorders
Myalgia †	9/26 (34.62%)
Nervous system disorders
Dizziness †	4/26 (15.38%)
Headache †	2/26 (7.69%)
Peripheral sensory neuropathy †	15/26 (57.69%)
Skin and subcutaneous tissue disorders
Pruritus †	5/26 (19.23%)
† Indicates events were collected by systematic assessment

Limitations and Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact

• Name/Title: Bhumsuk Keam
• Organization: Seoul National University Hospital
• Phone: 82+10-3231-2208
• EMail: bhumsuk@snu.ac.kr

• Responsible Party: Bhumsuk Keam, Seoul National University Hospital
• ClinicalTrials.gov Identifier: NCT02551432
• Other Study ID Numbers: MISP MK3475
• First Submitted: July 7, 2015
• First Posted: September 16, 2015
• Results First Submitted: November 25, 2019
• Results First Posted: February 10, 2020
• Last Update Posted: February 10, 2020