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

Description

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.

Conditions

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

Talk to us

Study Overview

On this page

Study Details

Study overview

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.

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

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

Condition
Metastatic NSCLC - Non-Small Cell Lung Cancer
Intervention / Treatment

-

Contacts and Locations

Fayetteville

Highlands Oncology Group, Fayetteville, Arkansas, United States, 72703

Whittier

Innovative Clinical Research Institute (ICRI), Whittier, California, United States, 90603

Orange City

Mid-Florida Hematology & Oncology Centers, PA, Orange City, Florida, United States, 32763

Tampa

H. Lee Moffitt Cancer Center and Research Institute, Tampa, Florida, United States, 33612

Omaha

Oncology Hematology West P.C. dba Nebraska Cancer Specialists, Omaha, Nebraska, United States, 68310

Florham Park

Summit Medical Group PA, Florham Park, New Jersey, United States, 07932

Fayetteville

Carolina Institute for Clinical Research (Cumberland County Hospital System), Fayetteville, North Carolina, United States, 28303

Canton

Gabrail Cancer & Research Center, Canton, Ohio, United States, 44718

Gettysburg

Gettysburg Cancer Center, Gettysburg, Pennsylvania, United States, 17325

Tyler

UT Health East Texas HOPE Cancer Center, Tyler, Texas, United States, 75701

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • * 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

iTeos Therapeutics,

Iteos Clinical Trials, STUDY_DIRECTOR, iTeos Belgium SA

Study Record Dates

2025-05