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Combining Inupadenant with Chemotherapy for Non-Small Cell Lung Cancer

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

Phase 2 Interventional iTeos Therapeutics · NCT05403385

This study is testing the best dose of a new drug called inupadenant when used with standard chemotherapy to see if it helps people with advanced non-small cell lung cancer who haven't responded to previous treatments.

Quick facts

PhasePhase 2
Study typeInterventional
Enrollment186 (estimated)
Ages18 Years and up
SexAll
SponsoriTeos Therapeutics Industry-sponsored
Drugs / interventionschemotherapy
Locations67 sites (Fayetteville, Arkansas and 66 other locations)
Trial IDNCT05403385 on ClinicalTrials.gov

What this trial studies

This study aims to determine the optimal dose of inupadenant when combined with carboplatin and pemetrexed for patients with metastatic or locally advanced non-squamous non-small cell lung cancer (NSCLC) who have progressed after first-line anti-PD(L)1 treatment. The trial consists of two parts: an open-label, dose-finding phase followed by a comparison of the efficacy and safety of the optimal dose of inupadenant against a placebo, both in conjunction with standard chemotherapy. Participants will undergo imaging, safety assessments, and pharmacokinetic analyses throughout the treatment and follow-up phases.

Who should consider this trial

Good fit: Ideal candidates include individuals with metastatic or locally advanced unresectable non-squamous NSCLC who have previously received anti-PD(L)1 therapy.

Not a fit: Patients with symptomatic CNS metastases, specific genetic mutations (EGFR, ALK, ROS1), or those with autoimmune diseases requiring systemic treatment may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new effective option for patients with advanced non-squamous NSCLC who have limited treatment options after first-line therapy.

How similar studies have performed: Other studies have shown promise in combining immunotherapy with chemotherapy for NSCLC, suggesting potential for success with this approach.

Eligibility criteria

Show full inclusion / exclusion criteria 
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

Where this trial is running

Fayetteville, Arkansas and 66 other locations

+17 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Metastatic NSCLC - Non-Small Cell Lung CancerLocally Advanced NSCLC - Non-Small Cell Lung Cancernon-squamous NSCLCsecond line2Ladenosineimmunotherapy
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.