Study of Pembrolizumab (MK-3475) Subcutaneous (SC) Versus Pembrolizumab Intravenous (IV) Administered With Platinum Doublet Chemotherapy in Participants With Metastatic Squamous or Nonsquamous Non-Small Cell Lung Cancer (NSCLC) (MK-3475-A86)
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ClinicalTrials.gov Identifier: NCT04956692 |
Recruitment Status :
Active, not recruiting
First Posted : July 9, 2021
Results First Posted : May 20, 2024
Last Update Posted : May 20, 2024
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Sponsor:
Merck Sharp & Dohme LLC
Information provided by (Responsible Party):
Merck Sharp & Dohme LLC
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Study Type | Interventional |
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Study Design | Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment |
Condition |
Non-Small Cell Lung Cancer |
Interventions |
Biological: Pembrolizumab SC Biological: Pembrolizumab IV Drug: Paclitaxel Drug: Nab-Paclitaxel Drug: Carboplatin Drug: Cisplatin Drug: Pemetrexed |
Enrollment | 531 |
Participant Flow
Recruitment Details | |
Pre-assignment Details |
Arm/Group Title | Arm A: Pembrolizumab SC + Platinum Doublet Chemotherapy | Arm B: Pembrolizumab IV + Platinum Doublet Chemotherapy |
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Arm/Group Description | Participants receive pembrolizumab subcutaneous (SC) administration on Day 1 of each cycle (cycle length = 3 weeks) for up to 35 cycles (up to ~2 years) PLUS paclitaxel IV (on Day 1 of each cycle) OR nab-paclitaxel IV (on Days 1, 8, and 15 of each cycle) and carboplatin IV (on Day 1 of each cycle) for 4 cycles for squamous non-small cell lung cancer (NSCLC); PLUS carboplatin IV (on Day 1 of each cycle) Or cisplatin IV (on Day 1 of each cycle) for 4 cycles and pemetrexed IV (on Day 1 of each cycle) until progression, intolerable adverse events, or participant/physician decision for non-squamous NSCLC. | Participants receive pembrolizumab intravenous (IV) administration on Day 1 of each cycle (cycle length = 3 weeks) for up to 35 cycles (up to ~2 years) PLUS paclitaxel IV (on Day 1 of each cycle) OR nab-paclitaxel IV (on Days 1, 8, and 15 of each cycle) and carboplatin IV (on Day 1 of each cycle) for 4 cycles for squamous non-small cell lung cancer (NSCLC); PLUS carboplatin IV (on Day 1 of each cycle) Or cisplatin IV (on Day 1 of each cycle) for 4 cycles and pemetrexed IV (on Day 1 of each cycle) until progression, intolerable adverse events, or participant/physician decision for non-squamous NSCLC. |
Period Title: Overall Study | ||
Started | 358 | 173 |
Treated | 356 | 172 |
Completed | 0 | 0 |
Not Completed | 358 | 173 |
Reason Not Completed | ||
Death | 115 | 47 |
Lost to Follow-up | 0 | 1 |
Withdrawal by Parent/Guardian | 2 | 0 |
Withdrawal by Subject | 5 | 2 |
Ongoing in Study | 236 | 123 |
Baseline Characteristics
Arm/Group Title | Arm A: Pembrolizumab SC + Platinum Doublet Chemotherapy | Arm B: Pembrolizumab IV + Platinum Doublet Chemotherapy | Total | |
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Arm/Group Description | Participants receive pembrolizumab subcutaneous (SC) administration on Day 1 of each cycle (cycle length = 3 weeks) for up to 35 cycles (up to ~2 years) PLUS paclitaxel IV (on Day 1 of each cycle) OR nab-paclitaxel IV (on Days 1, 8, and 15 of each cycle) and carboplatin IV (on Day 1 of each cycle) for 4 cycles for squamous non-small cell lung cancer (NSCLC); PLUS carboplatin IV (on Day 1 of each cycle) Or cisplatin IV (on Day 1 of each cycle) for 4 cycles and pemetrexed IV (on Day 1 of each cycle) until progression, intolerable adverse events, or participant/physician decision for non-squamous NSCLC. | Participants receive pembrolizumab intravenous (IV) administration on Day 1 of each cycle (cycle length = 3 weeks) for up to 35 cycles (up to ~2 years) PLUS paclitaxel IV (on Day 1 of each cycle) OR nab-paclitaxel IV (on Days 1, 8, and 15 of each cycle) and carboplatin IV (on Day 1 of each cycle) for 4 cycles for squamous non-small cell lung cancer (NSCLC); PLUS carboplatin IV (on Day 1 of each cycle) Or cisplatin IV (on Day 1 of each cycle) for 4 cycles and pemetrexed IV (on Day 1 of each cycle) until progression, intolerable adverse events, or participant/physician decision for non-squamous NSCLC. | Total of all reporting groups | |
Overall Number of Baseline Participants | 358 | 173 | 531 | |
Baseline Analysis Population Description |
[Not Specified]
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
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Number Analyzed | 358 participants | 173 participants | 531 participants | |
64.1 (8.6) | 65.6 (9.2) | 64.6 (8.8) | ||
Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 358 participants | 173 participants | 531 participants | |
Female |
101 28.2%
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47 27.2%
|
148 27.9%
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Male |
257 71.8%
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126 72.8%
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383 72.1%
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Ethnicity (NIH/OMB)
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 358 participants | 173 participants | 531 participants | |
Hispanic or Latino |
50 14.0%
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27 15.6%
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77 14.5%
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Not Hispanic or Latino |
307 85.8%
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146 84.4%
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453 85.3%
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Unknown or Not Reported |
1 0.3%
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0 0.0%
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1 0.2%
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Race (NIH/OMB)
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 358 participants | 173 participants | 531 participants | |
American Indian or Alaska Native |
6 1.7%
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3 1.7%
|
9 1.7%
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Asian |
72 20.1%
|
32 18.5%
|
104 19.6%
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|
Native Hawaiian or Other Pacific Islander |
0 0.0%
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0 0.0%
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0 0.0%
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|
Black or African American |
8 2.2%
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3 1.7%
|
11 2.1%
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White |
232 64.8%
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113 65.3%
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345 65.0%
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More than one race |
24 6.7%
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14 8.1%
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38 7.2%
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Unknown or Not Reported |
16 4.5%
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8 4.6%
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24 4.5%
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Outcome Measures
Adverse Events
Limitations and Caveats
[Not Specified]
More Information
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS 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.
If publication activity is not directed by the Sponsor, the investigator agrees to submit all manuscripts or abstracts to the Sponsor before submission. This allows the Sponsor to protect proprietary information and to provide comments.
Results Point of Contact
Name/Title: | Senior Vice President, Global Clinical Development |
Organization: | Merck Sharp & Dohme LLC |
Phone: | 1-800-672-6372 |
EMail: | ClinicalTrialsDisclosure@merck.com |
Responsible Party: | Merck Sharp & Dohme LLC |
ClinicalTrials.gov Identifier: | NCT04956692 |
Other Study ID Numbers: |
3475-A86 MK-3475-A86 ( Other Identifier: Merck ) jRCT2021210032 ( Registry Identifier: jRCT (Japan Registry of Clinical Trials) ) 2020-002729-27 ( EudraCT Number ) |
First Submitted: | July 6, 2021 |
First Posted: | July 9, 2021 |
Results First Submitted: | March 27, 2024 |
Results First Posted: | May 20, 2024 |
Last Update Posted: | May 20, 2024 |