| TITRE |
(EN) A Phase Ib/II Dose Finding Study Assessing Safety and Efficacy of [177Lu]Lu-DOTA-TATE in Newly Diagnosed Extensive Stage Small Cell Lung Cancer (ES-SCLC) in Combination With Carboplatin, Etoposide, and Atezolizumab in Induction and With Atezolizumab in Maintenance Phase |
| PROTOCOLE ID |
CAAA601A42101 |
| CLINICAL TRIAL.gov ID |
NCT05142696 |
| TYPE(S) DE CANCER |
Poumon à petites cellules |
| PHASE |
Phase I-II |
| TYPE D'ÉTUDE |
Clinique |
| INSTITUTION |
HOPITAL GENERAL JUIF SIR MORTIMER B.DAVIS
3755 rue de la Côte Ste. Catherine
(514) 340-8222
|
| VILLE |
Montréal
|
| INVESTIGATEUR(RICE) PRINCIPAL(E) |
Jennifer Friedmann
|
| COORDONATEUR(RICE) |
Martha Elbebawy
martha.elbebawy@ladydavis.ca
514-340-8222 poste 28224
|
| STATUT |
Actif en recrutement
|
| CRITÈRES D'ÉLIGIBILITÉ |
(EN)
- Participant is >= 18 years on the day of signing informed consent form
- Histologically or cytologically confirmed ES-SCLC
- Presence of measurable disease (at least one target lesion) according to RECIST v1.1 demonstrating moderate or higher uptake of [68Ga]Ga-DOTA-TATE on PET imaging; in case of liver involvement, at least one liver lesion > = 1 cm
- No prior systemic treatment for ES-SCLC (except the first cycle of chemotherapy with or without atezolizumab of the induction period
- ECOG status =< 1
- Provision of tumor tissue to support exploratory biomarker analysis
- Life expectancy of >= 6 months
|
| CRITÈRES D'EXCLUSION |
(EN)
- Participant has received prior therapy with an antibody or drug against immune checkpoint pathways
- Active autoimmune diseases or history of autoimmune diseases that may relapse
- Severe chronic or active infections (including active tuberculosis, HBV, or HCV infection) requiring systemic antibacterial, antifungal or antiviral therapy within 2 weeks before Cycle 1 Day 1
- Any major surgical procedure requiring general anesthesia =< 28 days before Cycle 1 Day 1
- History or current diagnosis of electrocardiogram (ECG) abnormalities indicating significant risk of safety for participants participating in the study
- Known hypersensitivity to the active substances or any of the excipients of the study drugs
- Concurrent participation in another therapeutic clinical study
- Prior administration of therapeutic radiopharmaceuticals
|
