Clinical Trials in Italy / NCT07286149
Recruiting
Phase 1/2
A Clinical Study of MK-1084 With Other Treatments for Non-small Cell Lung Cancer (MK-3475-01F)
NCT07286149 · tracked via the Priya Life Science Italy tracker
Condition(s) studied
Lung Neoplasm Malignant
Investigational drug(s) / intervention(s)
MK-1084: Oral administration
Patritumab deruxtecan: IV infusion
Sacituzumab tirumotecan: IV Infusion
Cetuximab: IV Infusion
Rescue Medications: 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 summary
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
Inclusion Criteria:
The main inclusion criteria include but are not limited to the following:
* 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
* Has provided tumor tissue for biomarker analysis from an archival sample or a newly obtained core or excisional biopsy of a tumor lesion not previously irradiated
* Participants with human immunodeficiency virus (HIV) infection must have well-controlled HIV on antiretroviral therapy (ART) per protocol
Exclusion Criteria:
The main exclusion criteria include but are not limited to the following:
* 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
* Has evidence of any leptomeningeal disease
* Has uncontrolled or significant cardiovascular disorder or cerebrovascular disease prior to allocation/randomization
* Has one or more of the following ophthalmological conditions: a) Clinically significant corneal disease b) history of documented severe dry eye syndrome, severe Meibomian gland disease and/or blepharitis
* HIV-infected participants with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease
* 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 or any other form of immunosuppressive therapy within 7 days prior to the first dose of study intervention
* Has known additional malignancy that is progressing or has required active treatment within the past 3 years
* Has any history of interstitial lung disease (ILD)/pneumonitis irrespective of steroid use or current ILD, or suspected ILD
* Has an active infection requiring systemic therapy
* Has not adequately recovered from major surgery or has ongoing surgical complications
Primary outcome measure(s)
- Number of Participants Who Experience a Dose Limiting Toxicity (DLT) — Up to 42 days
DLT will be defined as any drug-related AE observed during the DLT evaluation period (up to 42 days) that results in a change to a given dose or a delay in initiating the next treatment. - Number of Participants Who Experience an Adverse Event (AE) — Up to approximately 63 months
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants that experience AEs will be reported. - Number of Participants Who Discontinue Study Treatment Due to an AE — Up to approximately 62 months
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants that discontinue study intervention due to an AE will be reported. - Objective Response Rate (ORR) — Up to approximately 63 months
ORR is defined as the percentage of participants with Complete Response (CR: disappearance of all target lesions) or Partial Response (PR: at least a 30% decrease in the sum of diameters of target lesions) per Response Evaluation Criteria In Solid Tumors Version 1.1 (RECIST 1.1). The percentage of participants who experience CR or PR as assessed by Blinded Independent Central Review (BICR) will be presented.
Trial sites (29)
| Facility | City | Region | Status |
|---|---|---|---|
| Clermont Oncology Center ( Site 0041) | Clermont | Florida | Recruiting |
| University of Illinois Hospital & Health Sciences System ( Site 0044) | Chicago | Illinois | Recruiting |
| Providence Portland Medical Center ( Site 0043) | Portland | Oregon | Recruiting |
| Providence Oncology and Hematology Care Clinic - Westside ( Site 0059) | Portland | Oregon | Recruiting |
| Hospital São Lucas da PUCRS ( Site 0283) | Porto Alegre | Rio Grande do Sul | Recruiting |
| Fundação Pio XII - Hospital de Câncer de Barretos ( Site 0282) | Barretos | São Paulo | Recruiting |
| Fundação Faculdade Regional de Medicina de São José do Rio Preto ( Site 0286) | São José do Rio Preto | São Paulo | Recruiting |
| Hospital Paulistano ( Site 0280) | São Paulo | São Paulo | Recruiting |
| Centro de Estudios Clínicos SAGA-CECSAGA ( Site 0162) | Santiago | Region M. de Santiago | Recruiting |
| Fundación Arturo López Pérez ( Site 0161) | Santiago | Region M. de Santiago | Recruiting |
| Bradfordhill ( Site 0160) | Santiago | Region M. de Santiago | Recruiting |
| Guangdong Provincial People s Hospital ( Site 0300) | Guangzhou | Guangdong | Recruiting |
| Yunnan Province Cancer Hospital ( Site 0302) | Kunming | Yunnan | Recruiting |
| UniversitaetsklInikum Tuebingen ( Site 0192) | Tübingen | Baden-Wurttemberg | Recruiting |
| THORACIC GENERAL HOSPITAL OF ATHENS "I SOTIRIA" ( Site 0204) | Athens | Attica | Recruiting |
| Alexandra General Hospital of Athens-ONCOLOGY DEPT. ( Site 0205) | Athens | Attica | Recruiting |
| Papageorgiou General Hospital of Thessaloniki ( Site 0206) | N.Efkarpia | Thessaloniki | Recruiting |
| Queen Mary Hospital ( Site 0230) | Hong Kong | Hong Kong | Recruiting |
| Hong Kong United Oncology Centre ( Site 0232) | Jordan | Hong Kong | Recruiting |
| Prince of Wales Hospital ( Site 0231) | Shatin | Hong Kong | Recruiting |
| Shaare Zedek Medical Center ( Site 0186) | Jerusalem | Israel | Recruiting |
| Meir Medical Center ( Site 0181) | Kfar Saba | Israel | Recruiting |
| Sheba Medical Center ( Site 0180) | Ramat Gan | Israel | Recruiting |
| IRCCS - Istituto Romagnolo per lo Studio dei Tumori (IRST) "Dino Amadori" ( Site 0176) | Meldola | Forli-Cesena | Recruiting |
| Severance Hospital, Yonsei University Health System ( Site 0080) | Seoul | South Korea | Recruiting |
| Institut Català d'Oncologia - L'Hospitalet ( Site 0090) | Hospitalet | Barcelona | Recruiting |
| HOSPITAL UNIVERSITARIO QUIRONSALUD MADRID ( Site 0091) | Pozuelo de Alarcón | Madrid | Recruiting |
| Hospital Clinic de Barcelona ( Site 0092) | Barcelona | Spain | Recruiting |
| Hospital Universitario Virgen Macarena ( Site 0093) | Seville | Spain | Recruiting |
More Merck Sharp & Dohme LLC trials in Italy
Other trials for the same condition
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07286149 on ClinicalTrials.gov ↗ ← All trials in Italy