Patologia: Neoplasie del polmone
Osservazionale-Sperimentale: Sperimentale
Monocentrico-Multicentrico: Multicentrico
Randomizzato: Sì
Fase di studio: II
Richiesta mandatoria di tessuto: Sì
Linee di trattamento: Adiuvante/neoadiuvante
Criteri di inclusione:
- Newly diagnosed NSCLC patients with resectable disease (Stage IIA to Stage IIIB).
- WHO or Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Adequate organ and bone marrow function.
- Provision of tumour samples (newly acquired or archival tumour tissue [≤ 6 months old]) to confirm Programmed death-ligand 1 (PD-L1) status, epidermal growth factor receptor (EGFR), or anaplastic lymphoma kinase (ALK) status.
- Adequate pulmonary function.
Criteri di esclusione:
- Participants with sensitising EGFR mutations or ALK translocations.
- History of allogeneic organ transplantation.
- Active or prior documented autoimmune or inflammatory disorders.
- Uncontrolled intercurrent illness, uncontrolled hypertension, unstable angina pectoris, uncontrolled cardiac arrhythmia, active bleeding diseases, serious chronic gastrointestinal conditions associated with diarrhoea, or psychiatric illness/social situations that would limit compliance with study requirement.
- History of another primary malignancy.
- Participants with small-cell lung cancer or mixed small-cell lung cancer.
- History of active primary immunodeficiency.
- History of non-infectious ILD/pneumonitis that required steroids, has current ILD/pneumonitis, or has suspected ILD/pneumonitis that cannot be ruled out by imaging at screening.
- Participants who have preoperative radiotherapy treatment as part of their care plan.
- Participants who require or may require pneumonectomy, segmentectomies, or wedge resections, as assessed by their surgeon at baseline, to obtain potentially curative resection of primary tumour.
- QTcF (QT interval corrected by Fridericia's formula) interval ≥ 470 ms.
- Any medical contraindication to treatment with chemotherapy as listed in the local labelling.
- Participants with moderate or severe cardiovascular disease.
- Any concurrent chemotherapy, investigational product, biologic, or hormonal therapy for cancer treatment.
- Receipt of live attenuated vaccine within 30 days prior to the first dose of study interventions.
- Prior exposure to approved or investigational immune-mediated therapy including, but not limited to, other anti-CTLA-4, anti-PD-1, anti-PD-L1, and anti-PD-L2 antibodies. Participants who received agents targeting the adenosine pathway, anti-NKG2A, anti-HLA-E agents, and anti-LIF agents are also excluded. Participants who have received previous treatment with a TROP2 targeting ADC or with another ADC containing a chemotherapy agent that inhibits TOP1 activity are also excluded.
- Current or prior use of immunosuppressive medication within 14 days before the first dose of study interventions.
- Active or uncontrolled infections including HBA, HBV, HCV, and HIV.
Trattamento sperimentale:
- Oleclumab + Durvalumab + Platinum doublet chemotherapy
- Monalizumab + Durvalumab + Platinum doublet chemotherapy
- MEDI5752 + Platinum doublet chemotherapy
- Dato-DXd + durvalumab + single agent platinum
- AZD0171 + durvalumab + platinum doublet chemotherapy.
Trattamento di controllo:
-
Obiettivi primari dello studio:
The study is intended to assess the safety and efficacy of perioperative treatment with Durvalumab in combination with Oleclumab, Monalizumab or AZD0171 and platinum doublet chemotherapy; or MEDI5752 in combination with platinum doublet chemotherapy or datopotamab deruxtecan (Dato-DXd) in combination with durvalumab and single agent platinum chemotherapy in participants with resectable, early-stage non-small cell lung cancer.
Note generali:
NB: Oltre che nei Centri sotto elencati, lo studio è previsto anche nella seguente città:
- Genova (16100)
ASST Spedali Civili di Brescia
Piazzale Spedali Civili 1 - 25123 Brescia - BS
IRCCS - IRST Meldola Dino Amadori
Via P. Maroncelli 40 - 47014 Meldola - FC
Grande Ospedale Metropolitano Niguarda
Piazza Ospedale Maggiore 3 - 20162 Milano - MI
Istituto Clinico Humanitas Rozzano
Via Manzoni 56 - 20089 Rozzano - MI
A.O. San Gerardo
Via Pergolesi 33 - 20900 Monza - MB
Riferimento: Prof. Diego Luigi Cortinovis
Email: diegoluigi.cortinovis@irccs-sangerardo.it
Istituto Oncologico Veneto IRCCS
Via Gattamelata 64 - 35128 Padova - PD
Centro di Riferimento Oncologico
Via Franco Gallini 2 - 33081 Aviano - PN
Azienda Ospedaliera di Perugia
Via Dottori 1 - 06132 Perugia - PG
Ospedale Santa Maria della Misericordia
AOU Pisana - Cisanello
Via Paradisa 2 - 56124 Pisa - PI
Istituto Nazionale Tumori “Regina Elena”
Via Elio Chianesi 53 - 00144 Roma - RM
Numero di iscrizione a registro: 2021-003369-37 - NCT05061550
Data di inserimento: 18.12.2023
Data di aggiornamento: 24.05.2024
AstraZeneca
Riferimento: Dr. Info non disponibile
Telefono: 00000
Email: nd@nd.it
Localita: nd