| 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.
|
Groupe d'étude en oncologie du Québec