Study of Inupadenant (EOS100850) With Chemotherapy as Second Line Treatment for Nonsquamous Non-small Cell Lung Cancer

Running, not enrolling · Phase 2 · Has a placebo group

Conditions studied: Metastatic NSCLC - Non-Small Cell Lung Cancer, Locally Advanced NSCLC - Non-Small Cell Lung Cancer

In brief

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.

Key facts

Study ID

NCT05403385

Run by

iTeos Therapeutics

People needed

36

Starts

2022-08-26

Expected to finish

2025-10-01

Last updated by the study team

2025-08-03

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Highlands Oncology Group — Fayetteville, Arkansas, United States
• H. Lee Moffitt Cancer Center and Research Institute — Tampa, Florida, United States
• Algemeen Ziekenhuis Sint-Lucas — Ghent, Belgium
• Jessa Ziekenhuis — Hasselt, Belgium
• AZ Delta — Roeselare, Belgium
• William Osler Health System — Brampton, Ontario, Canada
• 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, Spain
• Complejo Hospitalario de Navarra (CHN) — Pamplona, Pamplona, Spain
• Hospital Universitari i Politecnic La Fe de Valencia — Valencia, Valencia, Spain
• 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

Full record on ClinicalTrials.gov

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