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

NCT05403385 Phase 2 ACTIVE_NOT_RECRUITING

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.

Details

Lead sponsor	iTeos Therapeutics
Phase	Phase 2
Status	ACTIVE_NOT_RECRUITING
Enrolment	36
Start date	2022-08-26
Completion	2025-10

Conditions

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

Interventions

• inupadenant
• Placebo
• Carboplatin
• Pemetrexed

Primary outcomes

• 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

Countries

United States, Belgium, Canada, Czechia, France, Italy, Spain, Switzerland