Informations générales (source: ClinicalTrials.gov)
A Randomized, Double-blind, Placebo-controlled, Phase 2 Study Evaluating Efficacy and Safety of Inupadenant in Combination with Carboplatin and Pemetrexed in Adults with Nonsquamous Non-small Cell Lung Cancer Who Have Progressed on Immunotherapy
Interventional
Phase 2
iTeos Therapeutics (Voir sur ClinicalTrials)
août 2022
mai 2025
21 septembre 2024
The study will first determine the optimal dose of inupadenant to be given in combination
with carboplatin and pemetrexed to patients that progressed after receiving first line
anti-PD(L)1 treatment for locally advanced or metastatic non-small cell lung cancer. The
efficacy and safety of the combination is then compared to standard of care carboplatin
and pemetrexed in the same populations.
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CHI DE CRETEIL | Gaelle ROUSSEAU | 29/03/2024 01:30:52 | 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 | |||||
| Centre Georges François Leclerc - 21079 - Dijon - France | Clinical Trial Center | Contact (sur clinicalTrials) | |||
| Centre Leon Berard - 69008 - Lyon - France | Clinical Trial Center | Contact (sur clinicalTrials) | |||
| CHU de Caen - 14003 - Caen - France | Clinical Trial Center | Contact (sur clinicalTrials) | |||
| CHU Nantes - 44093 - Nantes - France | Clinical Trial Center | Contact (sur clinicalTrials) | |||
| Hopital de la Timone Centre d'Essais Précoces en Cancérologie de Marseille (CEPCM) - 13005 - Marseille - France | Clinical Trial Center | Contact (sur clinicalTrials) | |||
| Hôpital d'Instruction des Armées Bégin (HIA Bégin) - 94160 - Saint-Mandé - France | Clinical Trial Center | Contact (sur clinicalTrials) | |||
| Hopital Saint André - CHU de Bordeaux - 33075 - Bordeaux - France | Clinical Trial Center | Contact (sur clinicalTrials) | |||
| Institut Bergonie - Centre Regional de Lutte Contre Le Cancer de Bordeaux et Sud Ouest - 33076 - Bordeaux - France | Clinical Trial Center | Contact (sur clinicalTrials) | |||
Critères
Tous
Inclusion Criteria:
- Confirmed diagnosis of metastatic (Stage IV) or locally advanced, unresectable
(Stage III) NSCLC of nonsquamous pathology
- Measurable disease as defined by RECIST v1.1
- PD-L1 expression status available at or after the time of diagnosis. All levels of
expression are eligible.
- Existing biopsy taken within 4 years prior to entering trial or provide fresh biopsy
where safe and feasible
- At least 12 weeks of treatment with only 1 anti-PD-(L)1 agent (mono or with IO
combo) in the metastatic setting, OR at least 12 weeks of anti-PD-(L)1 agent (mono
or with IO combo) following CRT in the unresectable, Stage III setting
- ECOG performance status of 0 to 1.
- Confirmed diagnosis of metastatic (Stage IV) or locally advanced, unresectable
(Stage III) NSCLC of nonsquamous pathology
- Measurable disease as defined by RECIST v1.1
- PD-L1 expression status available at or after the time of diagnosis. All levels of
expression are eligible.
- Existing biopsy taken within 4 years prior to entering trial or provide fresh biopsy
where safe and feasible
- At least 12 weeks of treatment with only 1 anti-PD-(L)1 agent (mono or with IO
combo) in the metastatic setting, OR at least 12 weeks of anti-PD-(L)1 agent (mono
or with IO combo) following CRT in the unresectable, Stage III setting
- ECOG performance status of 0 to 1.
- Symptomatic central nervous system (CNS) metastases or leptomeningeal disease.
- EGFR, ALK, or ROS1 mutation.
- Autoimmune disease requiring systemic treatment or immunodeficiency requiring
concurrent use of systemic immunosuppressants or corticosteroids
- Hepatitis B or C infection unless adequately treated with no detectable viral load;
Human immunodeficiency virus (HIV) unless well-controlled disease on therapy.
- History of life-threatening toxicity related to prior immune therapy
- Uncontrolled or significant cardiovascular disease
- Pregnant or breast-feeding
- Lack of agreement to use highly effective method of contraception during treatment
and for 6 months after the last administration of chemotherapy