Study on Inupadenant with Chemotherapy as Second Line Treatment for Nonsquamous Non-small Cell Lung Cancer

Sponsor: iTeos Therapeutics

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05403385

Provider View

This clinical trial is testing a new drug, inupadenant, combined with chemotherapy drugs carboplatin and pemetrexed, for patients with nonsquamous non-small cell lung cancer (NSCLC) that has worsened after initial treatment. The study aims to find the best dose and compare its effectiveness and safety to standard chemotherapy alone.

Patient Parameters

Program Overview

The study aims to find the best dose of a new drug, inupadenant, when used with chemotherapy drugs carboplatin and pemetrexed for patients with advanced or metastatic nonsquamous non-small cell lung cancer (NSCLC) that has progressed after initial treatment with anti-PD(L)1 therapy. The study will then compare the effectiveness and safety of this combination to the standard chemotherapy treatment alone.

Description

This study is divided into two parts. In the first part, researchers will test different doses of inupadenant combined with standard doses of carboplatin and pemetrexed to find the best dose for further testing. In the second part, they will compare the effects of inupadenant to a placebo, with both groups receiving the standard chemotherapy treatment.

Participants will include patients with nonsquamous NSCLC that has worsened after initial treatment. This includes patients whose cancer cannot be removed by surgery and who have been treated with chemoradiotherapy followed by anti-PD-(L)1 therapy, as well as those with metastatic cancer treated with anti-PD-(L)1 therapy without chemotherapy.

Throughout the study, participants will undergo imaging tests, safety assessments, and other evaluations to monitor their health and the treatment's effects. Researchers will also conduct various analyses to understand how the drug is processed in the body and its potential benefits.

Eligibility Criteria

Inclusion Criteria

  • Have a confirmed diagnosis of advanced or metastatic nonsquamous non-small cell lung cancer (NSCLC).
  • Have measurable cancer that can be tracked using standard criteria.
  • Have information on PD-L1 expression levels from diagnosis, with all levels eligible.
  • Have a biopsy sample taken within the last 4 years or be willing to provide a new sample if safe.
  • Have received at least 12 weeks of treatment with one anti-PD-(L)1 drug, either alone or with other immunotherapy, in the metastatic setting, or after chemoradiotherapy in the advanced setting.
  • Be in good overall health with an ECOG performance status of 0 or 1, meaning fully active or restricted in physically strenuous activity but ambulatory.

Exclusion Criteria

  • Have cancer that has spread to the brain or spinal cord and is causing symptoms.
  • Have specific genetic mutations (EGFR, ALK, or ROS1) in the cancer.
  • Have an autoimmune disease requiring treatment or an immune deficiency needing ongoing immunosuppressive drugs or steroids.
  • Have untreated hepatitis B or C, or HIV unless well-controlled with treatment.
  • Have had severe side effects from previous immune therapy.
  • Have uncontrolled or serious heart disease.
  • Be pregnant or breastfeeding.
  • Not agree to use effective birth control during treatment and for 6 months after the last chemotherapy dose.

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