What side effects are associated with this type of intervention?

Common treatments for NSCLC, such as carboplatin and pemetrexed, often result in side effects like neutropenia, febrile neutropenia, nausea, fatigue, and increased liver function tests. Immunotherapy agents like pembrolizumab and atezolizumab, when combined with chemotherapy, can cause additional side effects including rash, stomatitis, hypertension, and hemoptysis. Severe adverse events such as pneumonia and pneumonitis have also been reported, particularly with the use of durvalumab. These treatments generally have a manageable side effect profile, but close monitoring is essential.

What prior FDA approvals exist?

Several FDA-approved treatments for Non-Small Cell Lung Cancer (NSCLC) involve combinations of chemotherapy and immunotherapy. For instance, the combination of pembrolizumab (an anti-PD-1 therapy) with chemotherapy (carboplatin and pemetrexed) has been approved for first-line treatment of metastatic nonsquamous NSCLC. Additionally, the combination of atezolizumab (an anti-PD-L1 therapy) with bevacizumab, carboplatin, and paclitaxel (ABCP regimen) has also received FDA approval for advanced nonsquamous NSCLC. These treatments aim to enhance the immune response against cancer cells while utilizing chemotherapy to target rapidly dividing cells.

What other types of research exist?

Promising novel alternatives to Inupadenant for NSCLC patients include Furmonertinib, which has shown efficacy in EGFR mutation-positive NSCLC, and the combination of Atezolizumab with platinum-based chemotherapy, which has demonstrated positive outcomes in advanced NSCLC. Additionally, therapies like Pembrolizumab combined with Bevacizumab and Cabozantinib combined with Atezolizumab are also emerging as effective treatments for advanced NSCLC.

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Inupadenant + Chemotherapy for Non-Small Cell Lung Cancer

Phase 2

Recruiting

Research Sponsored by iTeos Belgium SA

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Have relapsed or progressed after prior anti-PD-(L)1 therapy as specified

ECOG performance status of 0 to 1

Must not have

Uncontrolled or significant cardiovascular disease

Treatment with a live or live attenuated vaccine

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from randomization to death due to any cause, assessed up to 24 months.

Awards & highlights

Summary

This trial tests a new drug, inupadenant, combined with standard chemotherapy drugs in lung cancer patients who did not respond to their first treatment. The goal is to see if this combination works better than the standard treatment alone.

Who is the study for?

This trial is for adults with advanced non-squamous Non-Small Cell Lung Cancer (NSCLC) that's worsened after first-line treatments. They must have a performance status indicating they can care for themselves, measurable disease progression, and no major organ dysfunction. Excluded are those with untreated brain metastases, active lung or autoimmune diseases, certain other cancers or infections, recent surgeries, significant heart issues, or women who are pregnant/breastfeeding.

What is being tested?

The study has two parts: the first part finds the best dose of Inupadenant combined with chemotherapy drugs Carboplatin and Pemetrexed. The second part tests how well Inupadenant works compared to a placebo when both are added to the same chemo regimen in patients whose cancer progressed after initial treatment.

What are the potential side effects?

Possible side effects include reactions related to immune system activation such as inflammation in various organs including lungs (pneumonitis), infusion-related reactions from drug administration, fatigue due to treatment burden on the body's resources, digestive disturbances from chemotherapy impact on gut lining and blood cell production issues affecting immunity.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My cancer has returned or worsened after treatment with anti-PD-(L)1 therapy.

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I can carry out all my daily activities without help.

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My lung cancer is advanced and cannot be removed by surgery.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have serious heart problems that are not under control.

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I have received a live vaccine recently.

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I am not on medications that strongly affect drug metabolism enzymes.

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I have an autoimmune disease treated in the last 6 months or had a severe reaction to immune therapy.

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I have brain metastases or leptomeningeal disease that is either causing symptoms or has not been treated.

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I have not been on systemic therapy for an infection in the last 7 days.

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I have another active cancer besides the one being treated.

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I have an immune system disorder or I'm taking medication that weakens my immune system.

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I had a severe reaction to previous immune therapy that made me stop it permanently.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from randomization to death due to any cause, assessed up to 24 months.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from randomization to death due to any cause, assessed up to 24 months.

This trial's timeline: 3 weeks for screening, Varies for treatment, and from randomization to death due to any cause, assessed up to 24 months. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Dose-finding to determine recommended Phase 2 dose

Therapeutic procedure

Progression-free survival [Efficacy]

Secondary study objectives

Area under the concentration-time curve (AUCinf)

Disease Control Rate [Efficacy]

Duration of Response [Efficacy]

+7 more

Trial Design

3Treatment groups

Experimental Treatment

Placebo Group

Group I: Part 2, active treatmentExperimental Treatment3 Interventions

Treatment with inupadenant combined with carboplatin and pemetrexed

Group II: Part 1, open labelExperimental Treatment3 Interventions

Inupadenant will be given at one or more dose levels to determine the recommended Phase 2 dose (RP2D).

Group III: Part 2, placeboPlacebo Group3 Interventions

Treatment with matched placebo combined with carboplatin and pemetrexed

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Carboplatin

FDA approved

Pemetrexed

FDA approved

0 / 12Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Non-Small Cell Lung Cancer (NSCLC) include targeted therapies and immunotherapies. Targeted therapies, such as EGFR inhibitors (e.g., osimertinib) and ALK inhibitors (e.g., crizotinib), work by blocking specific molecules involved in cancer cell growth and survival. Immunotherapies, like PD-1/PD-L1 inhibitors (e.g., pembrolizumab), enhance the immune system's ability to recognize and destroy cancer cells. These treatments are crucial for NSCLC patients as they offer more personalized and effective options, often with fewer side effects compared to traditional chemotherapy. Inupadenant, an Adenosine A2A Receptor Antagonist, represents a novel approach by potentially modulating the tumor microenvironment to improve immune response against cancer cells.

Non-Radiation Based Early Pain Relief Treatment Options for Patients With Non-Small Cell Lung Cancer and Cancer Induced Bone Pain: A Systematic Review.A tabulated summary of targeted and biologic therapies for non-small-cell lung cancer.