Status:
ACTIVE_NOT_RECRUITING
Study of Inupadenant (EOS100850) With Chemotherapy as Second Line Treatment for Nonsquamous Non-small Cell Lung Cancer
Lead Sponsor:
iTeos Therapeutics
Collaborating Sponsors:
iTeos Belgium SA
Conditions:
Metastatic NSCLC - Non-Small Cell Lung Cancer
Locally Advanced NSCLC - Non-Small Cell Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 f...
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...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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
Key Trial Info
Start Date :
August 26 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2025
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT05403385
Start Date
August 26 2022
End Date
October 1 2025
Last Update
August 3 2025
Active Locations (21)
Enter a location and click search to find clinical trials sorted by distance.
1
Highlands Oncology Group
Fayetteville, Arkansas, United States, 72703
2
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, United States, 33612
3
Algemeen Ziekenhuis Sint-Lucas
Ghent, Belgium, 9000
4
Jessa Ziekenhuis
Hasselt, Belgium, 3500