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Purpose

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

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Single Group Assignment Part 1 sequential dose escalation. Part 2 randomized double-blind.
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description
Quadruple masking : The dose-finding part (Part 1) of this study is open-label whereas the randomized part (Part 2) is double-blinded. Therefore, for Part 2, the subject, the Investigator and Sponsor personnel or delegate(s) who are involved in the treatment administration or clinical evaluation of the subjects will be unaware of the group assignments. The chemotherapy agents administered during Part 2 will be open label.

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Part 1, open label 		Inupadenant will be given at one or more dose levels to determine the recommended Phase 2 dose (RP2D).
  • Drug: inupadenant
    Adenosine 2a receptor antagonist
    Other names:
    • EOS100850
  • Drug: Carboplatin
    standard of care chemotherapeutic, alkylating agent
  • Drug: Pemetrexed
    standard of care chemotherapeutic, anti-metabolite
    Other names:
    • Alimta
Experimental
Part 2, active treatment 		Treatment with inupadenant combined with carboplatin and pemetrexed
  • Drug: inupadenant
    Adenosine 2a receptor antagonist
    Other names:
    • EOS100850
  • Drug: Carboplatin
    standard of care chemotherapeutic, alkylating agent
  • Drug: Pemetrexed
    standard of care chemotherapeutic, anti-metabolite
    Other names:
    • Alimta
Placebo Comparator
Part 2, placebo 		Treatment with matched placebo combined with carboplatin and pemetrexed
  • Drug: Placebo
    matched placebo capsule to inupadenant
  • Drug: Carboplatin
    standard of care chemotherapeutic, alkylating agent
  • Drug: Pemetrexed
    standard of care chemotherapeutic, anti-metabolite
    Other names:
    • Alimta

Recruiting Locations

UT Health East Texas HOPE Cancer Center
Tyler, Texas 75701
Contact:
Clinical Trial Center

More Details

Status
Recruiting
Sponsor
iTeos Therapeutics

Study Contact

iTeos Belgium SA
+32 71 91 99 33
clinical_info@iteostherapeutics.com

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 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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.