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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
PD-L1 expression status available at or after the time of diagnosis of advanced or metastatic NSCLC disease
Can provide existing biopsy taken within 2 years prior to entering trial or provide fresh biopsy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from randomization to death due to any cause, assessed up to 24 months.
Awards & highlights

Study Summary

This trial tests the optimal dose & efficacy of a drug to treat advanced lung cancer patients that didn't respond to initial treatments.

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.Check my eligibility
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.See study design
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 advanced lung cancer's PD-L1 status is known.
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I can provide a biopsy taken within the last 2 years or a new one.
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My cancer has returned or worsened after treatment with anti-PD-(L)1 therapy.
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My organs are working well.
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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.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Dose-finding to determine recommended Phase 2 dose
Therapeutic procedure
Progression-free survival [Efficacy]
Secondary outcome measures
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

Find a Location

Who is running the clinical trial?

iTeos Belgium SALead Sponsor
5 Previous Clinical Trials
746 Total Patients Enrolled

Media Library

Part 1, open label Clinical Trial Eligibility Overview. Trial Name: NCT05403385 — Phase 2
Non-Small Cell Lung Cancer Research Study Groups: Part 1, open label, Part 2, active treatment, Part 2, placebo
Non-Small Cell Lung Cancer Clinical Trial 2023: Part 1, open label Highlights & Side Effects. Trial Name: NCT05403385 — Phase 2
Part 1, open label 2023 Treatment Timeline for Medical Study. Trial Name: NCT05403385 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What security measures are present in Part 2, active treatment to ensure patient safety?

"The safety of the active treatment Part 2 was deemed a score of 2 due to its Phase 2 status; as such, there are some data points that back up its security but nothing yet validating efficacy."

Answered by AI

How extensive is the cohort for this medical experiment?

"Confirmed. According to clinicaltrials.gov, this medical investigation is open for enrolment and began recruiting on August 26th 2022. As of the last edit, made on November 14th 2022, a total of 192 patients need to be registered from 3 different study sites."

Answered by AI

What are the fundamental goals of this experiment?

"This medical trial's primary objective is to evaluate the safety and tolerability of the medication. The secondary objectives include evaluating efficacy, such as overall survival, duration of response, and disease control rate - each tracked over a period up to 24 months from enrolment."

Answered by AI

Is this research endeavor presently open for enrollment?

"Affirmative. According to the information published on clinicaltrials.gov, this medical trial is in full swing and accepting participants since August 26th 2022. The last update was made November 14th 2022 with 192 patients required from 3 different locations."

Answered by AI
~74 spots leftby Apr 2025