A Study of Subcutaneous (SC) Pembrolizumab Coformulated With Berahyaluronidase Alfa (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: Drug: Pegylated filgrastim; Drug: Cisplatin; Drug: Nab-paclitaxel; Drug: Paclitaxel; Drug: Pemetrexed; Biological: Pembrolizumab Formulated with Berahyaluronidase Alfa; Drug: Carboplatin; Drug: Filgrastim; Biological: Pembrolizumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT05722015

MK-3475A-D77 (Other Identifier)

U1111-1280-9384 (Registry 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 pembrolizumab formulated with berahyaluronidase alfa (MK-3475A) versus (vs) intravenous (IV) pembrolizumab (MK-3475), administered with chemotherapy in first line treatment of adult participants with metastatic non-small cell lung cancer. The primary hypotheses of this study are pembrolizumab formulated with berahyaluronidase alfa 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)

---

377 participants in 2 patient groups

Arm 1: Pembrolizumab Formulated With Berahyaluronidase Alfa + Platinum Doublet Chemotherapy

Experimental group

Description:

Participants with treatment-naïve metastatic NSCLC receive 790 mg of Pembrolizumab Formulated With Berahyaluronidase Alfa via subcutaneous (SC) injection on Day 1 of each 6-week cycle for 18 cycles (up to approximately 108 weeks) in combination with platinum doublet chemotherapy.

Treatment:

Drug: Filgrastim

Drug: Carboplatin

Biological: Pembrolizumab Formulated with Berahyaluronidase Alfa

Drug: Pemetrexed

Drug: Paclitaxel

Drug: Nab-paclitaxel

Drug: Cisplatin

Drug: Pegylated filgrastim

Arm 2: Pembrolizumab + Platinum Doublet Chemotherapy

Active Comparator group

Description:

Participants with treatment-naïve metastatic NSCLC receive 400 mg pembrolizumab intravenous (IV) infusion in combination with platinum doublet chemotherapy.

Treatment:

Biological: Pembrolizumab

Drug: Filgrastim

Drug: Carboplatin

Drug: Pemetrexed

Drug: Paclitaxel

Drug: Nab-paclitaxel

Drug: Cisplatin

Drug: Pegylated filgrastim