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

Condition(s) studied

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

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)

Other trials for the same condition