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.
Additional locations may be listed on ClinicalTrials.gov for NCT05403385.
See trial information on ClinicalTrials.gov for a list of participating sites.
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.
Lead OrganizationiTeos Therapeutics
