Clinical Trials in Italy / NCT05403385
Active, not recruiting
Phase 2
Study of Inupadenant (EOS100850) With Chemotherapy as Second Line Treatment for Nonsquamous Non-small Cell Lung Cancer
NCT05403385 · tracked via the Priya Life Science Italy tracker
Condition(s) studied
Metastatic NSCLC - Non-Small Cell Lung CancerLocally Advanced NSCLC - Non-Small Cell Lung Cancer
Investigational drug(s) / intervention(s)
inupadenant: Adenosine 2a receptor antagonist
Placebo: matched placebo capsule to inupadenant
Carboplatin: standard of care chemotherapeutic, alkylating agent
Pemetrexed: standard of care chemotherapeutic, anti-metabolite
Study summary
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.
Eligibility
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
Primary outcome measure(s)
- Dose-finding to determine recommended Phase 2 dose — At the end of Cycle 1 (each cycle is 21 days)
Incidence of dose-limiting toxicities - Incidence of treatment-emergent adverse events [Safety and Tolerability] — Duration of intervention (up to 24 months) plus 30 days follow-up or up to database lock
Incidence of adverse events (AEs), serious adverse events, AEs leading to discontinuation, deaths, and clinically significant laboratory abnormalities. - Progression-free survival [Efficacy] — From randomization to first-documented radiological progression or date of death from any cause, whichever comes first, assessed up to 24 months.
Time from first dose to the date of first documented radiologic progression per RECIST v1.1 or time of death, whichever comes first
Trial sites (21)
| Facility | City | Region | Status |
|---|---|---|---|
| Highlands Oncology Group | Fayetteville | Arkansas | |
| H. Lee Moffitt Cancer Center and Research Institute | Tampa | Florida | |
| Algemeen Ziekenhuis Sint-Lucas | Ghent | Belgium | |
| Jessa Ziekenhuis | Hasselt | Belgium | |
| AZ Delta | Roeselare | Belgium | |
| William Osler Health System | Brampton | Ontario | |
| Vseobecna Fakultni Nemocnice | Prague | Czechia | |
| CHU de Caen | Caen | France | |
| Hopital de la Timone Centre d'Essais Précoces en Cancérologie de Marseille (CEPCM) | Marseille | France | |
| CHU Nantes | Nantes | France | |
| Istituto Nazionale dei Tumori | Milan | Italy | |
| Gruppo Humanitas - Istituto Clinico Humanitas | Rozzano | Italy | |
| Hospital Universitari Son Espases | Palma de Mallorca | Balearic Islands | |
| Complejo Hospitalario de Navarra (CHN) | Pamplona | Pamplona | |
| Hospital Universitari i Politecnic La Fe de Valencia | Valencia | Valencia | |
| Centro Oncologico de Galicia | A Coruña | Spain | |
| Hospital Infanta Cristina (Hospital Universitario de Badajoz) | Badajoz | Spain | |
| Hospital Universitario Vall d'Hebron | Barcelona | Spain | |
| Althaia Hospital | Manresa | Spain | |
| Complejo Hospitalario Universitario de Ourense | Ourense | Spain | |
| Centre Hospitalier Universitaire Vaudois | Lausanne | Switzerland |
Other trials for the same condition
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT05403385 on ClinicalTrials.gov ↗ ← All trials in Italy