Trial Title:
A Study of Subcutaneous (SC) Pembrolizumab Coformulated With Hyaluronidase (MK-3475A) vs Intravenous Pembrolizumab in Adult Participants With Metastatic Non-small Cell Lung Cancer (NSCLC) (MK-3475A-D77)-Japan Extension
NCT ID:
NCT06212752
Condition:
Metastatic Non-small Cell Lung Cancer
Conditions: Official terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Paclitaxel
Albumin-Bound Paclitaxel
Carboplatin
Pembrolizumab
Pemetrexed
Lenograstim
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Active, not recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Biological
Intervention name:
Pembrolizumab coformulated with hyaluronidase
Description:
MK3475A SC will be administered for squamous and nonsquamous NSCLC as per the schedule
specified in arm; participants may be eligible for second course.
Arm group label:
Arm 1 (MK-3475A + Platinum Doublet Chemotherapy)
Other name:
MK-3475A
Intervention type:
Drug
Intervention name:
Pemetrexed
Description:
Pemetrexed 500 mg/m² by IV Infusion will be administered for nonsquamous NSCLC as per the
schedule specified in arm.
Arm group label:
Arm 1 (MK-3475A + Platinum Doublet Chemotherapy)
Arm group label:
Arm 2 (Pembrolizumab + Platinum Doublet Chemotherapy)
Other name:
Alimta
Intervention type:
Drug
Intervention name:
Cisplatin
Description:
Cisplatin 75 mg/m² by IV Infusion will be administered for nonsquamous and squamous NSCLC
as per the schedule specified in arm.
Arm group label:
Arm 1 (MK-3475A + Platinum Doublet Chemotherapy)
Arm group label:
Arm 2 (Pembrolizumab + Platinum Doublet Chemotherapy)
Other name:
Platinol-AQ
Intervention type:
Drug
Intervention name:
Carboplatin
Description:
Carboplatin AUC 5 mg/mL/min in nonsquamous and AUC 6 mg/mL/min in squamous NSCLC will be
administered as per the schedule specified in arm.
Arm group label:
Arm 1 (MK-3475A + Platinum Doublet Chemotherapy)
Arm group label:
Arm 2 (Pembrolizumab + Platinum Doublet Chemotherapy)
Intervention type:
Drug
Intervention name:
Paclitaxel
Description:
Paclitaxel 200 mg/m² by IV Infusion will be administered for squamous NSCLC as per the
schedule specified in arm.
Arm group label:
Arm 1 (MK-3475A + Platinum Doublet Chemotherapy)
Arm group label:
Arm 2 (Pembrolizumab + Platinum Doublet Chemotherapy)
Other name:
Taxol
Intervention type:
Drug
Intervention name:
Nab-paclitaxel
Description:
Nab-paclitaxel 100 mg/m² by IV Infusion will be administered for squamous NSCLC as per
the schedule specified in arm.
Arm group label:
Arm 1 (MK-3475A + Platinum Doublet Chemotherapy)
Arm group label:
Arm 2 (Pembrolizumab + Platinum Doublet Chemotherapy)
Other name:
Albumin-bound paclitaxel
Intervention type:
Biological
Intervention name:
Pembrolizumab
Description:
Pembrolizumab by IV Infusion will be administered for squamous and nonsquamous NSCLC as
per the schedule specified in arm; participants may be eligible for second course.
Arm group label:
Arm 2 (Pembrolizumab + Platinum Doublet Chemotherapy)
Other name:
MK-3475, KEYTRUDA
Intervention type:
Drug
Intervention name:
Filgrastim
Description:
Filgrastim will be administered as per the schedule specified for the arm.
Arm group label:
Arm 1 (MK-3475A + Platinum Doublet Chemotherapy)
Arm group label:
Arm 2 (Pembrolizumab + Platinum Doublet Chemotherapy)
Intervention type:
Drug
Intervention name:
Pegylated filgrastim
Description:
Pegylated filgrastim will be administered as per the schedule specified for the arm.
Arm group label:
Arm 1 (MK-3475A + Platinum Doublet Chemotherapy)
Arm group label:
Arm 2 (Pembrolizumab + Platinum Doublet Chemotherapy)
Summary:
This study is to assess the pharmacokinetics (PK) and safety of SC MK-3475A vs
intravenous (IV) pembrolizumab, administered with chemotherapy in first line treatment of
adult Japanese participants with metastatic non-small cell lung cancer. The primary
hypotheses of this study are MK-3475A subcutaneous (SC) is noninferior to pembrolizumab
IV with respect to PK parameters.
Detailed description:
Japan extension study will require approximately six years which includes one additional
year (beyond the global study's last participant last study related contact) from the
time the first participant (or their legally acceptable representative) provides informed
consent until the last participant's last study related contact to complete.
The Japan extension study will include participants previously enrolled in Japan in the
global study for MK-3475A-D77 (NCT05722015) plus the study will continue to enroll
participants in Japan until the sample size for participants in Japan reaches
approximately 39.
Criteria for eligibility:
Criteria:
The key inclusion and exclusion criteria include but are not limited to the following:
Inclusion Criteria:
- Has histologically or cytologically confirmed diagnosis of squamous or non-squamous
Non-small Cell Lung Cancer (NSCLC).
- Must provide archival tumor tissue sample or newly obtained core, incisional, or
excisional biopsy of a tumor lesion not previously irradiated.
- Has a life expectancy of at least 3 months.
Exclusion Criteria:
- Has a diagnosis of small cell lung cancer or, for mixed tumors, presence of small
cell elements.
- Has received prior systemic anticancer therapy for metastatic NSCLC.
- Has received prior systemic anticancer therapy including investigational agents
within 4 weeks before randomization.
- Has received prior radiotherapy within 2 weeks of start of study intervention or has
radiation-related toxicity requiring corticosteroids.
- Has received radiation therapy to the lung (>30 Gray) within 6 months of start of
study intervention.
- Has received a live or live-attenuated vaccine within 30 days before the first dose
of study intervention.
- Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid
therapy.
- Has a known additional malignancy that is progressing or has required active
treatment within the past 3 years.
- Has an active autoimmune disease that has required systemic treatment in past 2
years.
- Has an active infection requiring systemic therapy.
- Has a history of human immunodeficiency virus (HIV) infection.
- Has a history of Hepatitis B or C.
- Has not adequately recovered from major surgery or has ongoing surgical
complications.
- Has a history of allogenic tissue/solid organ transplant.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Fujita Health University ( Site 4406)
Address:
City:
Toyoake
Zip:
470-1192
Country:
Japan
Facility:
Name:
Kurume University Hospital ( Site 4412)
Address:
City:
Kurume
Zip:
830-0011
Country:
Japan
Facility:
Name:
Gunma Prefectural Cancer Center ( Site 4416)
Address:
City:
Otashi
Zip:
373-8550
Country:
Japan
Facility:
Name:
National Hospital Organization Hokkaido Cancer Center ( Site 4415)
Address:
City:
Sapporo
Zip:
003-0804
Country:
Japan
Facility:
Name:
Kanagawa Cardiovascular and Respiratory Center ( Site 4404)
Address:
City:
Yokohama
Zip:
236-0051
Country:
Japan
Facility:
Name:
Miyagi Cancer Center ( Site 4401)
Address:
City:
Natori
Zip:
981-1293
Country:
Japan
Facility:
Name:
Sendai Kousei Hospital ( Site 4400)
Address:
City:
Sendai
Zip:
9800873
Country:
Japan
Facility:
Name:
Kurashiki Central Hospital ( Site 4409)
Address:
City:
Kurashiki
Zip:
710-8602
Country:
Japan
Facility:
Name:
Kansai Medical University Hospital ( Site 4408)
Address:
City:
Hirakata
Zip:
573-1191
Country:
Japan
Facility:
Name:
Osaka Medical and Pharmaceutical University Hospital ( Site 4414)
Address:
City:
Takatsuki
Zip:
569-8686
Country:
Japan
Facility:
Name:
Saitama Prefectural Cancer Center ( Site 4402)
Address:
City:
Ina-machi
Zip:
362-0806
Country:
Japan
Facility:
Name:
Shizuoka Cancer Center ( Site 4405)
Address:
City:
Nagaizumi-cho,Sunto-gun
Zip:
411-8777
Country:
Japan
Facility:
Name:
Tochigi Cancer Center ( Site 4417)
Address:
City:
Utsunomiya
Zip:
320-0834
Country:
Japan
Facility:
Name:
Juntendo University Hospital ( Site 4413)
Address:
City:
Bunkyo-ku
Zip:
1138431
Country:
Japan
Facility:
Name:
National Hospital Organization Kyushu Medical Center ( Site 4411)
Address:
City:
Fukuoka
Zip:
810-8563
Country:
Japan
Facility:
Name:
National Hospital Organization Kyushu Cancer Center ( Site 4410)
Address:
City:
Fukuoka
Zip:
811-1395
Country:
Japan
Facility:
Name:
Osaka International Cancer Institute ( Site 4407)
Address:
City:
Osaka
Zip:
541-8567
Country:
Japan
Facility:
Name:
Nippon Medical School Hospital ( Site 4403)
Address:
City:
Tokyo
Zip:
113-8603
Country:
Japan
Start date:
June 13, 2023
Completion date:
May 22, 2028
Lead sponsor:
Agency:
Merck Sharp & Dohme LLC
Agency class:
Industry
Source:
Merck Sharp & Dohme LLC
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06212752
https://www.merckclinicaltrials.com/
https://trialstransparency.merckclinicaltrials.com/Study.aspx?id=3475A-D77&&kw=3475A-D77
