A Clinical Study of MK-1084 With Other Treatments for Non-small Cell Lung Cancer (MK-3475-01F)

Conditions

• Lung Neoplasm Malignant

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• MK-1084 — DRUG
  Oral administration
• Patritumab deruxtecan — BIOLOGICAL
  IV infusion
• Sacituzumab tirumotecan — BIOLOGICAL
  IV Infusion
• Cetuximab — BIOLOGICAL
  IV Infusion
• Rescue Medications — DRUG
  Participants receive rescue medication at the investigator's discretion for prevention of nausea and vomiting, per approved product label. Recommended rescue medications are histamine-1 (H1) receptor antagonist, histamine-2 (H2) receptor antagonist, acetaminophen or equivalent, dexamethasone or equivalent infusion, or steroid mouthwash (dexamethasone or equivalent), 5-hydroxytryptamine type 3 (5-HT3) receptor antagonist, neurokinin 1 (NK-1) receptor antagonist and corticosteroid.

Study Details

Researchers want to learn if MK-1084, the study medicine, can treat advanced or metastatic non-squamous NSCLC. MK-1084 is a targeted therapy, which is a treatment that works to control how specific types of cancer cells grow and spread. The goals of this study are to learn: * About the safety of MK-1084 and if people tolerate it when taken with other treatments * How many people have the cancer respond (get smaller or go away) to the treatments

Key Dates

First listed

Dec 16, 2025

Start date

Apr 30, 2026

Status verified

Aug 2026

Primary completion

Aug 17, 2029

Completion

Apr 13, 2032

Study Design

Enrollment

140 participants (estimated)

Allocation

RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Arms

• Experimental: MK-1084 + Patritumab deruxtecan (HER3-DXd)
  Participants will receive MK-1084 and HER3-DXd until discontinuation due to toxicity, adverse event (AE) or at the discretion of an investigator.
• Experimental: MK-1084 + Sacituzumab tirumotecan (Sac-TMT)
  Participants will receive MK-1084 and sac-TMT until discontinuation due to toxicity, AE or at the discretion of an investigator.
• Experimental: MK-1084 + Cetuximab
  Participants will receive MK-1084 and cetuximab until discontinuation due to toxicity, AE or at the discretion of an investigator. Per amendment 3, the MK-1084 + Cetuximab arm was discontinued.

Primary Outcome Measure

Number of Participants Who Experience a Dose Limiting Toxicity (DLT) [ Time Frame: Up to 42 days ]

Central Contacts

• Toll Free Number
  1-888-577-8839
  [email protected]

Locations (4)

Find similar trials in Clermont, FL

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