Informations générales (source: ClinicalTrials.gov)
A Phase II, Open-label, Multicentre, Randomised Study of Neoadjuvant and Adjuvant Treatment in Patients With Resectable, Early-stage (II to IIIB) Non-small Cell Lung Cancer (NeoCOAST-2) (NeoCOAST-2)
Interventional
Phase 2
AstraZeneca (Voir sur ClinicalTrials)
avril 2022
mai 2030
10 avril 2025
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 (CTX); or Volrustomig or Rilvegostomig in combination with CTX; or
Datopotamab deruxtecan (Dato-DXd) in combination with Durvalumab or Rilvegostomig and
single agent platinum chemotherapy in participants with resectable, early-stage non-small
cell lung cancer.
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| HOPITAL FOCH | Jaafar BENNOUNA | 05/05/2025 07:12:10 | Contacter | ||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| Research Site - 33076 - Bordeaux - France | Contact (sur clinicalTrials) | ||||
| Research Site - 35000 - Rennes Cedex - France | Contact (sur clinicalTrials) | ||||
| Research Site - 76031 - Rouen - France | Contact (sur clinicalTrials) | ||||
| Research Site - 83000 - Limoges - France | Contact (sur clinicalTrials) | ||||
| Research Site - 83000 - Toulon - France | Contact (sur clinicalTrials) | ||||
| Research Site - 84902 - Avignon Cedex - France | Contact (sur clinicalTrials) | ||||
| Research Site - 92150 - Suresnes - France | Contact (sur clinicalTrials) | ||||
| Research Site - 93009 - Bobigny - France | Contact (sur clinicalTrials) | ||||
Critères
Tous
Inclusion Criteria:
- 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.
- 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.
- Participants with sensitising EGFR mutations or ALK translocations.
- Participants with baseline PD-L1 expression status <1% (Arms 6 and 7 only).
- 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 interstitial lung disease (ILD) 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-TIGIT (T cell immunoreceptor with Ig and
ITIM domains), 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.