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

Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorMerck Sharp & Dohme LLC

About this trial

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

Eligibility criteria

Qualifiers

Has histologically or cytologically confirmed diagnosis of advanced or metastatic non-squamous non-small cell lung cancer (NSCLC)

Has tumor tissue or circulating tumor deoxyribonucleic acid (ctDNA) that demonstrates the presence of Kirsten rat sarcoma viral oncogene (KRAS) mutation of glycine to cysteine at codon 12 (G12C) mutations

Has documented disease progression after receiving 1-2 prior lines of programmed cell death protein 1 (PD-1)/programmed death-ligand 1 (PD-L1) therapy and platinum-based chemotherapy

Provides archival tumor tissue sample of a tumor lesion not previously irradiated

Disqualifiers

Has a diagnosis of small cell lung cancer or, for mixed tumors, presence of small cell elements

Has clinically severe pulmonary compromise resulting from intercurrent pulmonary illnesses

Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis

Has active inflammatory bowel disease requiring immunosuppressive medication or previous history of inflammatory bowel disease

Trial design

Treatments tested in this trial

  • MK-1084
  • Patritumab deruxtecan
  • Sacituzumab tirumotecan
  • Cetuximab
  • Rescue Medications

Treatment groups

190 Participants
are divided into 3 treatment groups

Locations

24
Brazil
Hospital São Lucas da PUCRS ( Site 0283)90610-000, Porto AlegreRio Grande do Sul, Brazil
Fundação Pio XII - Hospital de Câncer de Barretos ( Site 0282)14784-400, BarretosSão Paulo, Brazil
Fundação Faculdade Regional de Medicina de São José do Rio Preto ( Site 0286)15090-000, São José do Rio PretoSão Paulo, Brazil
Hospital Paulistano ( Site 0280)01321001, São PauloSão Paulo, Brazil

Sponsors and collaborators

Merck Sharp & Dohme LLC

Lead sponsor

Daiichi Sankyo

Collaborator