| Titre |
A Randomized, Double-blind, Multi-center, Phase III Study of AK112 or Placebo Combined With Pemetrexed and Carboplatin in Patients With EGFR-mutant Locally Advanced or Metastatic Non-squamous NSCLC Who Have Failed to EGFR-TKI Treatment |
| Protocole ID |
HARMONi |
| ClinicalTrials.gov ID |
NCT05184712 |
| Type(s) de cancer |
Poumon non à petites cellules |
| Phase |
Phase III |
| Stade |
Maladie avancée ou métastatique |
| Type étude |
Clinique |
| Médicament |
AK112 ou placebo combiné avec pemetrexed et carboplatine |
| Institution |
INSTITUT UNIVERSITAIRE DE CARDIOLOGIE ET DE PNEUMOLOGIE DE QUEBEC - UL
|
| Ville |
Québec |
| Investigateur(trice) principal(e) |
Dre Catherine Labbé
|
| Coordonnateur(trice) |
Brigitte Fortin
418-656-8711 poste 2639
|
| Statut |
 Actif en recrutement |
| Date d'activation |
31-07-2023 |
| Critètes d'éligibilité |
- Ability to understand and voluntarily sign a written informed consent form (ICF), which must be signed before the specified study procedures required for the study are performed.
- Males or females aged ≥ 18 years at the time of signing informed consent.
- Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0 or 1.
- Life expectancy ≥3 months?
- Locally advanced (stage IIIB/IIIC) or metastatic (stage IV) non-squamous NSCLC confirmed by histology or cytology, inoperable and unable to receive radiotherapy and chemotherapy;
- The tumor histology, cytology or hematology confirmed the presence of EGFR activating mutations before enrollment
- Have previously received 3rd generation EGFR-TKI treatment and have progressed on or following
- Subjects have at least one measurable non-brain tumor lesion per RECIST v1.1
- Major organ function prior to treatment meets the following criteria
- Patients of childbearing potential must agree to use effective contraceptive measures
|
| Critètes d'exclusion |
- Histological or cytological pathology confirmed the presence of small cell carcinoma components, or the main component is squamous cell carcinoma
- There are reports confirming the existence of other driver gene mutations with known drug treatments
- Subjects who received any prior treatments targeting the mechanism of tumor immunity
- The subject has received systemic anti-tumor therapy other than EGFR-TKI
- Currently enrolled in any other clinical study
- Received EGFR-TKI treatment, palliative local treatment, non-specific immunomodulatory treatment within 2 weeks prior to the first dose.
- Tumor surrounds important blood vessels or has obvious necrosis, cavitation, or invades surrounding important organs and blood vessels.
- Symptomatic central nervous system metastases
- Active malignancies within the past 3 years, with the exception of tumors in this study and cured local tumors
- Active autoimmune disease requiring systemic treatment within 2 years prior to the start of study treatment
- There is a history of major diseases 1 year prior to the first dose.
- .Medical history of gastrointestinal perforation or gastrointestinal fistula within 6 months prior to the first dose
- Received chest radiation therapy prior to the first dose
- Presence of clinically symptomatic pleural effusion, pericardial effusion, or ascites requiring frequent drainage.
- Active or previously documented inflammatory bowel disease (e.g., Crohn's disease or ulcerative colitis).
|
Groupe d'étude en oncologie du Québec