Metastatic NSCLC - Non-Small Cell Lung CancerPhase 2NCT05403385
Study of Inupadenant (EOS100850) With Chemotherapy as Second Line Treatment for Nonsquamous Non-small Cell Lung Cancer
A Phase 2 study testing inupadenant, Carboplatin and Pemetrexed in people with Metastatic NSCLC - Non-Small Cell Lung Cancer and Locally Advanced NSCLC - Non-Small Cell Lung Cancer, run by iTeos Therapeutics at 21 sites in 8 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic NSCLC - Non-Small Cell Lung Cancer, Locally Advanced NSCLC - Non-Small Cell Lung Cancer
- What is being tested?
- inupadenant, Carboplatin and Pemetrexed
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 21 sitesin 8 countries
- Study dates
- 26 Aug 2022to Oct 2025
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
21 sites in 8 countries.
21 sites in 8 countries
Spain8 sites
Centro Oncologico de Galicia
A Coruña, 15009
Hospital Infanta Cristina (Hospital Universitario de Badajoz)
Badajoz, 06080
Hospital Universitario Vall d'Hebron
Barcelona, 08035
Althaia Hospital
Manresa, 08243
Complejo Hospitalario Universitario de Ourense
Ourense, 10090
Hospital Universitari Son Espases
Palma de Mallorca, Balearic Islands, 07120
Complejo Hospitalario de Navarra (CHN)
Pamplona, Pamplona, 37008
Hospital Universitari i Politecnic La Fe de Valencia
Valencia, Valencia, 46026
Belgium3 sites
Algemeen Ziekenhuis Sint-Lucas
Ghent, 9000
Jessa Ziekenhuis
Hasselt, 3500
AZ Delta
Roeselare, 8800
France3 sites
CHU de Caen
Caen, 14003
Hopital de la Timone Centre d'Essais Précoces en Cancérologie de Marseille (CEPCM)
Marseille, 13005
CHU Nantes
Nantes, 44093
United States2 sites
Highlands Oncology Group
Fayetteville, Arkansas, 72703
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, 33612
Italy2 sites
Istituto Nazionale dei Tumori
Milan, 20133
Gruppo Humanitas - Istituto Clinico Humanitas
Rozzano, 20089
About this study
Official title: 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
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.
Read the detailed description
The study is composed of two parts. Part 1 follows an open-label, dose-finding design where individual cohorts are treated with various dose levels of inupadenant combined with standard of care dosing of carboplatin and pemetrexed. The recommended phase 2 dose is determined prior to initiation of Part 2 which then compares inupadenant to placebo with both arms treated in combination with standard of care carboplatin and pemetrexed.
Participants in both parts are enrolled from two populations of patients with nonsquamous NSCLC that have progressed after first line treatment as follows: non-resectable patients treated with chemoradiotherapy followed by anti-PD-(L)1 or metastatic patients treated with anti-PD-(L)1 therapy without chemotherapy.
Imaging, safety and PRO assessments are performed during the treatment and follow-up phase as well as pharmacokinetic and other exploratory analyses.
- Conditions
- Metastatic NSCLC - Non-Small Cell Lung Cancer, Locally Advanced NSCLC - Non-Small Cell Lung Cancer
- Being tested
- inupadenant, Placebo, Carboplatin, Pemetrexed
- Keywords
- non-squamous NSCLC, second line, 2L, adenosine, immunotherapy
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
inupadenantDrug
Also called EOS100850
Adenosine 2a receptor antagonist
PlaceboDrug
matched placebo capsule to inupadenant
CarboplatinDrug
standard of care chemotherapeutic, alkylating agent
PemetrexedDrug
Also called Alimta
standard of care chemotherapeutic, anti-metabolite
| Study group | Role | What they receive |
|---|---|---|
| Part 1, open label | Experimental | Inupadenant will be given at one or more dose levels to determine the recommended Phase 2 dose (RP2D). Receives: Drug: inupadenant; Drug: Carboplatin; Drug: Pemetrexed |
| Part 2, active treatment | Experimental | Treatment with inupadenant combined with carboplatin and pemetrexed Receives: Drug: inupadenant; Drug: Carboplatin; Drug: Pemetrexed |
| Part 2, placebo | Placebo comparator | Treatment with matched placebo combined with carboplatin and pemetrexed Receives: Drug: Placebo; Drug: Carboplatin; Drug: Pemetrexed |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose-finding to determine recommended Phase 2 dose
Incidence of dose-limiting toxicities
Measured: At the end of Cycle 1 (each cycle is 21 days)
Incidence of treatment-emergent adverse events [Safety and Tolerability]
Incidence of adverse events (AEs), serious adverse events, AEs leading to discontinuation, deaths, and clinically significant laboratory abnormalities.
Measured: Duration of intervention (up to 24 months) plus 30 days follow-up or up to database lock
Progression-free survival [Efficacy]
Time from first dose to the date of first documented radiologic progression per RECIST v1.1 or time of death, whichever comes first
Measured: From randomization to first-documented radiological progression or date of death from any cause, whichever comes first, assessed up to 24 months.
Secondary outcomes (5)
Overall Response Rate [Efficacy]
Proportion of participants with a best overall response of complete (CR) or partial (PR) response as assessed by RECIST v1.1
Measured: From randomization to first-documented radiological improvement, if applicable, assessed up to 24 months or up to database lock.
Duration of Response [Efficacy]
Time from first CR or PR to first documented progression or death from any cause, per RECIST v1.1
Measured: From first-documented CR or PR to first radiological progression or date of death, whichever comes first, assessed up to 24 months or up to database lock.
Percent Change in Tumor Size [Efficacy]
Change in sum of size of target tumors from baseline, per RECIST v1.1
Measured: From randomization to the documented radiological assessment with the smallest tumor size sum, assessed up to 24 months or up to database lock.
Disease Control Rate [Efficacy]
Proportion of participants with CR, PR, or stable disease (SD) sustained over at least 2 consecutive tumor assessments, per RECIST v1.1
Measured: From randomization to second-documented radiological CR, PR or SD, if applicable, assessed up to 24 months or up to database lock.
Overall Survival [Efficacy]
Time from randomization to date of death due to any cause.
Measured: From randomization to death due to any cause, assessed up to 24 months or up to database lock.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2022
- Study start26 Aug 2022
- Primary completion13 Jun 2025
- Study completionOct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic NSCLC - Non-Small Cell Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Single Group Assignment Part 1 sequential dose escalation. Part 2 randomized double-blind.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- iTeos Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- iTeos Belgium SA
- Responsible party
- Sponsor
- Investigators
- Iteos Clinical Trials, Study director, iTeos Belgium SA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05403385
- Sponsor's protocol ID
- A2A-005
- Other IDs
- 2024-515393-27-00
- Status last verified
- Jul 2025
- First submitted
- 18 May 2022
- Last updated
- 3 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05403385
- Acronym / sponsor ID
- A2A-005
- Conditions
- Metastatic NSCLC - Non-Small Cell Lung Cancer, Locally Advanced NSCLC - Non-Small Cell Lung Cancer
- Keywords
- non-squamous NSCLC, second line, 2L, adenosine, immunotherapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 36 participants (actual)
- Lead sponsor
- iTeos TherapeuticsIndustry (pharma, biotech, devices)
- Collaborators
- iTeos Belgium SA
- Study start
- 26 Aug 2022 (actual)
- Primary completion
- 13 Jun 2025 (actual)
- Study completion
- Oct 2025 (estimated)
- First posted
- 3 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The study is composed of two parts. Part 1 follows an open-label, dose-finding design where individual cohorts are treated with various dose levels of inupadenant combined with standard of care dosing of carboplatin and pemetrexed. The recommended phase 2 dose is determined prior to initiation of Part 2 which then compares inupadenant to placebo with both arms treated in combination with standard of care carboplatin and pemetrexed.
Participants in both parts are enrolled from two populations of patients with nonsquamous NSCLC that have progressed after first line treatment as follows: non-resectable patients treated with chemoradiotherapy followed by anti-PD-(L)1 or metastatic patients treated with anti-PD-(L)1 therapy without chemotherapy.
Imaging, safety and PRO assessments are performed during the treatment and follow-up phase as well as pharmacokinetic and other exploratory analyses.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Single Group Assignment Part 1 sequential dose escalation. Part 2 randomized double-blind.
| Arm | Type | Receives |
|---|---|---|
| Part 1, open label | Experimental | Drug: inupadenant, Drug: Carboplatin, Drug: PemetrexedInupadenant will be given at one or more dose levels to determine the recommended Phase 2 dose (RP2D). |
| Part 2, active treatment | Experimental | Drug: inupadenant, Drug: Carboplatin, Drug: PemetrexedTreatment with inupadenant combined with carboplatin and pemetrexed |
| Part 2, placebo | Placebo comparator | Drug: Placebo, Drug: Carboplatin, Drug: PemetrexedTreatment with matched placebo combined with carboplatin and pemetrexed |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| inupadenantAlso: EOS100850Adenosine 2a receptor antagonist | Drug | Part 1, open label, Part 2, active treatment |
| Placebomatched placebo capsule to inupadenant | Drug | Part 2, placebo |
| Carboplatinstandard of care chemotherapeutic, alkylating agent | Drug | Part 1, open label, Part 2, active treatment, Part 2, placebo |
| PemetrexedAlso: Alimtastandard of care chemotherapeutic, anti-metabolite | Drug | Part 1, open label, Part 2, active treatment, Part 2, placebo |
Primary outcome
Dose-finding to determine recommended Phase 2 dose
Time frame: At the end of Cycle 1 (each cycle is 21 days)
Incidence of dose-limiting toxicities
Incidence of treatment-emergent adverse events [Safety and Tolerability]
Time frame: Duration of intervention (up to 24 months) plus 30 days follow-up or up to database lock
Incidence of adverse events (AEs), serious adverse events, AEs leading to discontinuation, deaths, and clinically significant laboratory abnormalities.
Progression-free survival [Efficacy]
Time frame: From randomization to first-documented radiological progression or date of death from any cause, whichever comes first, assessed up to 24 months.
Time from first dose to the date of first documented radiologic progression per RECIST v1.1 or time of death, whichever comes first
5 secondary outcomes
Overall Response Rate [Efficacy]
Time frame: From randomization to first-documented radiological improvement, if applicable, assessed up to 24 months or up to database lock.
Duration of Response [Efficacy]
Time frame: From first-documented CR or PR to first radiological progression or date of death, whichever comes first, assessed up to 24 months or up to database lock.
Percent Change in Tumor Size [Efficacy]
Time frame: From randomization to the documented radiological assessment with the smallest tumor size sum, assessed up to 24 months or up to database lock.
Disease Control Rate [Efficacy]
Time frame: From randomization to second-documented radiological CR, PR or SD, if applicable, assessed up to 24 months or up to database lock.
Overall Survival [Efficacy]
Time frame: From randomization to death due to any cause, assessed up to 24 months or up to database lock.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2025.
- Individual participant dataSharing planned: No
Related trials for Metastatic NSCLC - Non-Small Cell Lung Cancer
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingObservational study
A Prospective ,Multicenter ,Non-interventional ,Real-world Study Observing Changes in Molecular Markers Osimertinib Targeted Therapy in EGFRm NSCLC
Non Small Cell Lung Cancer
Active, not recruitingPhase 2
Datopotamab Deruxtecan (Dato-DXd, DS-1062a) in Advanced and/or Unresectable Non-Small Cell Lung Cancer
Metastatic Lung Cancer, Advanced Non Small Cell Lung Cancer
Not yet recruitingPhase 1/2
STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
NSCLC, Non-Small Cell Lung Cancer
RecruitingPhase 3
Study of Daraxonrasib (RMC-6236) in Patients With RAS Mutated NSCLC (RASolve 301)
NSCLC (Non-small Cell Lung Cancer), Non-Small Cell Lung Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Iteos Clinical Trials study director
iTeos Belgium SA
21 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing inupadenant, Carboplatin and Pemetrexed in people with Metastatic NSCLC - Non-Small Cell Lung Cancer and Locally Advanced NSCLC - Non-Small Cell Lung Cancer, run by iTeos Therapeutics at 21 sites in 8 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 3 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 21 sites in Spain, Belgium, France, United States, Italy and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose-finding to determine recommended Phase 2 dose (time frame: At the end of Cycle 1 (each cycle is 21 days)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2025.