Study of Inupadenant (EOS100850) with Chemotherapy As Second Line Treatment for Nonsquamous Non-small Cell Lung Cancer
Locally Advanced NSCLC - Non-Small Cell Lung Cancer | Metastatic NSCLC - Non-Small Cell Lung CancerThe 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.
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Conditions de participation
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Sexe:
ALL -
Âges admissibles:
18 and up
Critères de participation
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.
Exclusion Criteria:
* 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
Lieu de l'étude
William Osler Health System
William Osler Health SystemBrampton, Ontario
Canada
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Clinical Trial Center
University of Alberta - Cross Cancer Institute (CCI)
University of Alberta - Cross Cancer Institute (CCI)Edmonton, Alberta
Canada
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Clinical Trial Center
- Étude parrainée par
- iTeos Therapeutics
- Participants recherchés
- Plus d'informations
- ID de l'étude:
NCT05403385