Clinical trial · Interventional
Study of Inupadenant (EOS100850) With Chemotherapy as Second Line Treatment for Nonsquamous 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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Locally Advanced NSCLC - Non-Small Cell Lung Cancer | — | UNRESOLVED | — |
| Metastatic NSCLC - Non-Small Cell Lung Cancer | — | UNRESOLVED | — |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Carboplatin | Drug | Carboplatin | ALIAS |
| inupadenant | Drug | — | UNRESOLVED |
| Pemetrexed | Drug | Pemetrexed | ALIAS |
| Placebo | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Part 1, open label
- description
- Inupadenant will be given at one or more dose levels to determine the recommended Phase 2 dose (RP2D).
- interventionNames
- Drug: inupadenant
- Drug: Carboplatin
- Drug: Pemetrexed
- type
- EXPERIMENTAL
- label
- Part 2, active treatment
- description
- Treatment with inupadenant combined with carboplatin and pemetrexed
- interventionNames
- Drug: inupadenant
- Drug: Carboplatin
- Drug: Pemetrexed
- type
- PLACEBO_COMPARATOR
- label
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available