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

Launched by ITEOS THERAPEUTICS · May 31, 2022

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment option for patients with advanced non-small cell lung cancer (NSCLC) that has not responded to previous treatments. The researchers want to find the best dose of a drug called inupadenant when it is combined with two standard chemotherapy drugs, carboplatin and pemetrexed. They will then compare how well this combination works and how safe it is compared to the standard chemotherapy treatments alone.

To participate in this trial, patients need to have a confirmed diagnosis of metastatic (stage IV) or locally advanced (stage III) nonsquamous NSCLC. They should have measurable cancer and have previously been treated with an anti-PD(L)1 therapy for at least 12 weeks. Eligible participants can be of any age between 65 and 74, and both men and women can join. Once enrolled, participants will receive the new treatment and be closely monitored for any side effects and how well the treatment is working. It’s important to note that patients with certain health conditions or those who are pregnant or breastfeeding cannot participate in this trial.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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 Criteria:
• • 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