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A Study of Investigational Agents in Participants With Previously Treated Stage IV Nonsquamous Non-small Cell Lung Cancer (NSCLC) (MK-3475-01H/KEYMAKER-U01)

NCT06780085 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 96

Last updated 2026-05-18

No results posted yet for this study

Summary

Researchers are looking for new ways to treat metastatic nonsquamous non-small cell lung cancer (NSCLC) that has been treated before. Metastatic means the cancer has spread to other parts of the body. Nonsquamous means the cancer did not start in squamous cells, which are flat cells that line the inside of the lungs.

Standard treatment (usual treatment) for NSCLC is surgery, then immunotherapy with or without chemotherapy after surgery. Immunotherapy is a treatment that helps the immune system fight cancer. Chemotherapy is a medicine that works to destroy cancer cells or stop them from growing.

However, standard treatment may not work or may stop working for some people. Researchers want to know if 2 antibody drug conjugates (ADCs) can help treat metastatic nonsquamous NSCLC that did not respond (get smaller or go away) to treatment. An ADC attaches to specific targets on cancers cells and delivers treatment to destroy those cells.

Researchers will compare 2 different ADCs (the study treatments) to chemotherapy in this study. The goals of this study are to learn:

* About the safety of the study treatments and if people tolerate them
* How many people have the cancer respond to the study treatments

Conditions

  • Carcinoma, Non-Small-Cell Lung

Interventions

BIOLOGICAL

Raludotatug Deruxtecan

IV Infusion

BIOLOGICAL

Ifinatamab Deruxtecan

IV Infusion

DRUG

Docetetaxel

IV Infusion

DRUG

5-hydroxytryptamine subtype 3 receptor antagonist

Administered as a rescue medication per approved product label before R-DXd or I-DXd infusion

DRUG

Neurokinin-1 receptor antagonist

Administered as a rescue medication per approved product label before R-DXd or I-DXd infusion

DRUG

Corticosteroid

Administered as a rescue medication per approved product label before R-DXd or I-DXd infusion, and for 3 days starting 1 day prior to docetaxel administration

Sponsors & Collaborators

Principal Investigators

  • Medical Director · Merck Sharp & Dohme LLC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-05-13
Primary Completion
2032-03-12
Completion
2032-03-12
FDA Drug
Yes

Countries

  • United States
  • Chile
  • Germany
  • Greece
  • Hungary
  • Israel
  • Italy
  • Poland
  • Spain
  • Turkey (Türkiye)

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06780085 on ClinicalTrials.gov