NCT05403385

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

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

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: iTeos Therapeutics · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The study is composed of two parts. Part 1 follows an open-label, dose-finding design where individual cohorts are treated with various dose levels of inupadenant combined with standard of care dosing of carboplatin and pemetrexed. The recommended phase 2 dose is determined prior to initiation of Part 2 which then compares inupadenant to placebo with both arms treated in combination with standard of care carboplatin and pemetrexed. Participants in both parts are enrolled from two populations of patients with nonsquamous NSCLC that have progressed after first line treatment as follows: non-resectable patients treated with chemoradiotherapy followed by anti-PD-(L)1 or metastatic patients treated with anti-PD-(L)1 therapy without chemotherapy. Imaging, safety and PRO assessments are performed during the treatment and follow-up phase as well as pharmacokinetic and other exploratory analyses.

Conditions

• Metastatic NSCLC - Non-Small Cell Lung Cancer
• Locally Advanced NSCLC - Non-Small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	inupadenant	Adenosine 2a receptor antagonist
DRUG	Placebo	matched placebo capsule to inupadenant
DRUG	Carboplatin	standard of care chemotherapeutic, alkylating agent
DRUG	Pemetrexed	standard of care chemotherapeutic, anti-metabolite

Timeline

• Start date: 2022-08-26
• Primary completion: 2025-06-13
• Completion: 2025-10-01
• First posted: 2022-06-03
• Last updated: 2025-08-03

Locations

21 sites across 8 countries: United States, Belgium, Canada, Czechia, France, Italy, Spain, Switzerland

Regulatory

• FDA-regulated drug study