| TITRE |
(EN) 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 |
| CLINICAL TRIAL.gov ID |
NCT05061550 |
| TYPE(S) DE CANCER |
Poumon non à petites cellules |
| PHASE |
Phase II |
| TYPE D'ÉTUDE |
Clinique |
| INSTITUTION |
CENTRE UNIVERSITAIRE DE SANTE MCGILL
1001 boul. Décarie
|
| VILLE |
Montréal
|
| INVESTIGATEUR(RICE) PRINCIPAL(E) |
Jonathan Spicer
|
| COORDONATEUR(RICE) |
Nicola Raby
nicola.raby@muhc.mcgill.ca
514-934-1934 poste 34095
|
| STATUT |
Actif en recrutement
|
| DATE D'ACTIVATION |
2022-09-19 |
| CRITÈRES D'ÉLIGIBILITÉ |
(EN)
- 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.
|
| CRITÈRES D'EXCLUSION |
(EN)
- 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.
|
