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)

Merck Sharp & Dohme (MSD)

Status and phase: Active, not recruiting; Phase 3

Conditions: Metastatic Non-small Cell Lung Cancer

Treatments: Biological: Pembrolizumab; Drug: Nab-paclitaxel; Drug: Cisplatin; Drug: Pegylated filgrastim; Biological: Pembrolizumab coformulated with hyaluronidase; Drug: Filgrastim; Drug: Pemetrexed; Drug: Carboplatin; Drug: Paclitaxel

Study type: Interventional

Funder types: Industry

Identifiers

NCT05722015

MK-3475A-D77 (Other Identifier)

2022-501506-36-00 (Other Identifier)

jRCT2031230049 (Registry Identifier)

3475A-D77

Details and patient eligibility

About

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 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.

Enrollment: 377 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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377 participants in 2 patient groups

Arm 1 (MK-3475A + Platinum Doublet Chemotherapy)

Experimental group

Description:

Participants with treatment-naïve metastatic NSCLC will receive MK 3475A SC in combination with platinum doublet chemotherapy.

Treatment:

Drug: Paclitaxel

Drug: Carboplatin

Drug: Filgrastim

Drug: Pemetrexed

Biological: Pembrolizumab coformulated with hyaluronidase

Drug: Pegylated filgrastim

Drug: Cisplatin

Drug: Nab-paclitaxel

Arm 2 (Pembrolizumab + Platinum Doublet Chemotherapy)

Active Comparator group

Description:

Participants with treatment-naïve metastatic NSCLC will receive Pembrolizumab IV in combination with platinum doublet chemotherapy.

Treatment:

Drug: Paclitaxel

Drug: Carboplatin

Drug: Filgrastim

Drug: Pemetrexed

Drug: Pegylated filgrastim

Drug: Cisplatin

Biological: Pembrolizumab

Drug: Nab-paclitaxel