COPERNICUS - A Phase 2b, Open-Label, Two-cohort Study of Subcutaneous Amivantamab in Combination With Lazertinib as First-Line Treatment, or Subcutaneous Amivantamab in Combination With Platinum-Based Chemotherapy as Second-line Treatment, for Common EGFR-Mutated Locally Advanced or Metastatic Non-Small Cell Lung Cancer (61186372NSC2012).

Studio Clinico

Patologia: Neoplasie del polmone

Osservazionale-Sperimentale: Sperimentale

Monocentrico-Multicentrico: Multicentrico

Randomizzato: No

Fase di studio: II

Linee di trattamento: Prima linea

Criteri di inclusione: 

- Have histologically or cytologically confirmed advanced or metastatic non-small cell lung cancer (NSCLC) that is not amenable to curative intent therapy
- Epidermal growth factor resistance-mutation (EGFRm) must be an Ex19del or Ex21 L858R substitution, as detected by food and drug administration (FDA)-approved or other validated test in a clinical laboratory improvement amendments (CLIA)-certified laboratory (sites in the US), or an accredited local laboratory (sites outside of the US) in accordance with site standard of care. In the European union (EU), the local test must be Conformité Européenne (CE)-marked or an in-house laboratory-developed test from health institutions in the EU in accordance with Article 5(5) of the in vitro diagnostic regulations (IVDR ) 2071/746, as amended
- Have at least 1 measurable lesion, according to RECIST version (v)1.1, that has not been previously irradiated
- Any toxicities from prior systemic anticancer therapy must have resolved to national cancer institute common terminology criteria for adverse events (NCI-CTCAE) version 5.0 grade 1 or baseline level (except for alopecia [any grade], grade <=2 peripheral neuropathy, or grade <=2 hypothyroidism stable on hormone replacement)
- Have an eastern cooperative oncology group (ECOG) performance status of 0 to 1.

Criteri di esclusione: 

- Medical history of active interstitial lung disease (ILD), including drug-induced ILD or radiation pneumonitis. Participants with medical history of radiation pneumonitis, including radiation pneumonitis which required steroid treatment, should consult with the medical monitor and eligibility be assessed on a case-by-case basis
- Had major surgery excluding placement of vascular access or tumor biopsy or had significant traumatic injury within 4 weeks before the first dose of anticancer treatments or will not have fully recovered from surgery, or has surgery planned during the time the participant is expected to participate in the study
- Participant has uncontrolled tumor-related pain (symptomatic lesions amenable to palliative radiotherapy should be treated prior to first dosing)
- Received an investigational treatment that has not been cleared (based on at least 5 half lives of any pharmaceutical treatment) before the planned first dose of study treatment or is currently enrolled in an investigational study
- Has a prior or concurrent second malignancy (other than the disease under study) which natural history or treatment could likely interfere with any study endpoints of safety or the efficacy of the study treatment(s).

Numero di pazienti previsti: 

15

Schema di trattamento: 

Coorte 1 (unica attiva in Italia)

I partecipanti nella Coorte 1 riceveranno amivantamab SC Q4S e si autosomministreranno lazertinib orale 240 mg giornalmente (daily, QD).
Amivantamab SC:
• 1.600 mg (2.240 mg se il peso corporeo è ≥80 kg) i Giorni 1, 8, 15 e 22 del Ciclo 1.
• 3.520 mg (4.640 mg se il peso corporeo è ≥80 kg) il Giorno 1 di ciascun ciclo successivo, a partire dal Ciclo 2
Tutti i partecipanti allo studio nella Coorte 1 riceveranno una terapia anticoagulante a dose profilattica secondo le linee guida NCCN Versione 1.2025 - Raccomandazioni per la malattia tromboembolica venosa associata a un tumore, le linee guida ESMO (2023) o le linee guida locali per una durata minima di 4 mesi di trattamento (Giorno 1-120) dall’inizio della terapia antitumorale.

Trattamento sperimentale: 

Amivantamab SC + Lazertinib

Trattamento di controllo: 

-

Obiettivi primari dello studio: 

L’obiettivo primario di questo studio è valutare l’attività antitumorale di amivantamab e lazertinib (Coorte 1).

Obiettivi secondari dello studio: 

La sicurezza e la tollerabilità complessive saranno valutate come obiettivo secondario.

Centri partecipanti

Nord Italia

Centro Italia

Informazioni Generali

Protocollo

Numero di iscrizione a registro: 2025-520730-28

Data di inserimento: 08.05.2026

Promotore

Janssen Research & Development, LLC

Principal Investigator ITALIA

Riferimento: Dr. - -

Telefono: 00000

Email: na@na.it

Localita: -