Titre A Phase II Open-label, Multicentre, Randomised Study of Neoadjuvant and Adjuvant Treatment in Patients With Resectable, Early-stage (II to IIIA) Non-small Cell Lung Cancer
Protocole ID NeoCOAST-2
ClinicalTrials.gov ID NCT05061550
Type(s) de cancer Poumon non à petites cellules
Phase Phase II
Type étude Clinique
Médicament Durvalumab + chimiothérapie + oleclumab avant la chirurgie suivi de durvalumab + oleclumab post-chirurgie (Bras 1) OU Durvalumab + chimiothérapie + monalizumab avant la chirurgie suivi de durvalumab + monalizumab post-chirurgie (Bras 2)
Institution CENTRE HOSPITALIER DE L'UNIVERSITE DE MONTREAL  
Ville Montréal
Investigateur(trice) principal(e) Dr Moishe Liberman
Coordonnateur(trice) Adeline Jouquan
 514-890-8000 poste 26214
Statut Actif en recrutement
Date d'activation 31-05-2023
Critètes d'éligibilité
  • Newly diagnosed NSCLC patients with resectable disease (Stage IIA to Stage IIIA).
  • WHO or Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
  • Adequate organ and 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.
  • Participants will be suitable for inclusion if the planned surgery to be performed will be lobectomy, sleeve resection, or bilobectomy.
  • A pre- or post-bronchodilator forced expiratory volume in 1 (FEV1) of 1.0 L and diffusing capacity of the lungs for carbon monoxide (DLCO) > 40% postoperative predicted value.
Critètes d'exclusion
  • 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 ILD, 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.
  • 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, 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 drugs.
  • Prior exposure to immune-mediated therapy. Participants who received agents targeting the adenosine pathway and anti-NKG2A agents are also excluded.
  • Current or prior use of immunosuppressive medication within 14 days before the first dose of study drugs.