MK-3475-01H - A Phase 2, Randomized, Umbrella Study With Rolling Arms of Investigational Agents in Participants With Previously Treated Stage IV Nonsquamous Non-small Cell Lung Cancer (NSCLC) - KEYMAKER-U01 Substudy 01H.

Studio Clinico

Patologia: Neoplasie del polmone

Osservazionale-Sperimentale: Sperimentale

Monocentrico-Multicentrico: Multicentrico

Randomizzato: Sì

Fase di studio: II Randomizzato

Richiesta mandatoria di tessuto: Sì

Linee di trattamento: Seconda linea

Criteri di inclusione: 

The main inclusion criteria include but are not limited to the following:

- Histologically or cytologically confirmed diagnosis of Stage IV nonsquamous non-small cell lung cancer (NSCLC)
- Documented disease progression per RECIST 1.1 after receiving an anti-programmed cell death 1 protein (PD-1)/programmed cell death ligand 1 (PD-L1) treatment and platinum-based chemotherapy
- Confirmation per local test report that epidermal growth factor receptor negative (EGFR-), anaplastic lymphoma kinase negative (ALK-), or c ros oncogene 1 negative (ROS1-) directed therapy is not indicated as primary therapy
- Measurable disease per RECIST 1.1 as assessed by investigator and verified by BICR
- Life expectancy of at least 3 months
- An Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 assessed within 7 days before randomization
- Is an individual of any sex/gender who is at least 18 years of age at the time of providing the informed consent
- Has adequate organ function
- If capable of producing sperm refrains from donating sperm plus either abstains from penile-vaginal intercourse or uses a penile/external condom, with contraceptive use consistent with local regulations
- Participant/participants of childbearing potential (POCBP) is not pregnant and has a negative highly sensitive pregnancy test; and is not breastfeeding and uses a highly effective contraceptive method
- Archival tumor tissue sample of a tumor lesion not previously irradiated has been provided
- Has provided tissue prior to treatment randomization from a newly obtained formalin-fixed sample from a new biopsy
- Human Immunodeficiency Virus (HIV)-infected participants must have well controlled HIV on antiretroviral therapy (ART)
- Participants who are hepatitis B surface antigen (HBsAg) positive have received hepatitis B virus (HBV) antiviral therapy for at least 4 weeks and have undetectable HBV viral load prior to randomization
- Participants with history of hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable at screening.

Criteri di esclusione: 

 The main exclusion criteria include but are not limited to the following:

- Diagnosis of small cell lung cancer or, for mixed tumors, presence of small cell elements
- Received radiation therapy to the lung
- Has uncontrolled or significant cardiovascular disorder prior to randomization
- Has clinically severe pulmonary compromise resulting from intercurrent pulmonary illnesses
- Participants who have adverse events (AEs) (other than alopecia) due to previous anticancer therapies must have recovered to ≤Grade 1 or baseline
- Has known severe hypersensitivity (≥Grade 3) to study intervention and/or any of its excipients
- Has evidence of ongoing uncontrolled systemic bacterial, fungal, or viral infection (including HIV infection)
- Has clinically significant corneal disease
- Has received prior radiotherapy within 2 weeks of start of study intervention, or radiation related toxicities, requiring corticosteroids
- Has inadequate washout period prior to randomization
- Has received a live or live-attenuated vaccine within 30 days before the first dose of study intervention
- Has diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy
- Has received an investigational agent or has used an investigational device within 4 weeks prior to study intervention administration
- Has known additional malignancy that is progressing or has required active treatment within the past 3 years
- Has known untreated central nervous system (CNS) metastases and/or carcinomatous meningitis
- Has evidence of any leptomeningeal disease
- Has history of (noninfectious) pneumonitis/ interstitial lung disease (ILD) that required steroids or has current pneumonitis/ILD, and/or suspected ILD/pneumonitis
- Has active autoimmune disease that has required systemic treatment in the past 2 years
- Has active infection requiring systemic therapy
- HIV-infected participants with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease
- Has active inflammatory bowel disease requiring immunosuppressive medication or previous clear history of inflammatory bowel disease
- Has known history of, or active, neurologic paraneoplastic syndrome
- Has history of allogeneic tissue/solid organ transplant
- Have not adequately recovered from major surgery or have ongoing surgical complications.

Trattamento sperimentale: 

Raludotatug Deruxtecan
Ifinatamab Deruxtecan

Trattamento di controllo: 

Docetetaxel

Centri partecipanti

Nord Italia

Centro Italia

Informazioni Generali

Protocollo

Numero di iscrizione a registro: 2024-518761-10-00 - NCT06780085

Data di inserimento: 16.12.2025

Promotore

Merck Sharp & Dohme LLC

Principal Investigator ITALIA

Riferimento: Dr. - -

Telefono: 00000

Email: na@na.it

Localita: -