ACTIVE_NOT_RECRUITING

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

Conditions

Metastatic NSCLC - Non-Small Cell Lung Cancer Locally Advanced NSCLC - Non-Small Cell Lung Cancer non-squamous NSCLC second line 2L adenosine immunotherapy

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood 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.

Official Title

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

Quick Facts

Study Start:2022-08-26

Study Completion:2025-10

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:ACTIVE_NOT_RECRUITING

Study ID

NCT05403385

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.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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

Inclusion Criteria

Exclusion 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

Contacts and Locations

Principal Investigator

Iteos Clinical Trials

STUDY_DIRECTOR

iTeos Belgium SA

Study Locations (Sites)

Highlands Oncology Group

Fayetteville, Arkansas, 72703

United States

H. Lee Moffitt Cancer Center and Research Institute

Tampa, Florida, 33612

United States

Collaborators and Investigators

Sponsor: iTeos Therapeutics

Iteos Clinical Trials, STUDY_DIRECTOR, iTeos Belgium SA

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-08-26

Study Completion Date2025-10

Study Record Updates

Study Start Date2022-08-26

Study Completion Date2025-10

Terms related to this study

Keywords Provided by Researchers

non-squamous NSCLC
second line
2L
adenosine
immunotherapy

Additional Relevant MeSH Terms

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