Non-Squamous Non-Small Cell Lung Cancer (NSCLC)Phase 1/2PULMO-01NCT06879717
A Study of Roginolisib (IOA-244) in Combination With Dostarlimab With or Without Docetaxel in Metastatic Non Small-cell Lung Cancer (NSCLC) Patients
A Phase 1/2 study testing roginolisib, Dostarlimab and Docetaxel in people with Non-Squamous Non-Small Cell Lung Cancer (NSCLC) and Advanced Non Squamous NSCLC, run by iOnctura at 7 sites in 3 countries.
Trial summary
The goal of this clinical trial is to learn how roginolisib works in combination with dostarlimab with or without docetaxel in adult patients with advanced non small-cell lung cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-Squamous Non-Small Cell Lung Cancer (NSCLC), Advanced Non Squamous NSCLC
- What is being tested?
- roginolisib, Dostarlimab and Docetaxel
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 7 sitesin 3 countries
- Study dates
- 22 Apr 2025to Jan 2028
- Phase
- Phase 1/2
- 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
- Male or female ≥18 years of age inclusive, at the time of signing the informed consent.
- Capable of giving signed informed consent, which includes compliance with the requirements of this protocol.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.
- Histologically or cytologically confirmed stage IIIb/IV or recurrent non-squamous NSCLC.
- Have measurable disease per RECIST v1.1 as determined by the investigator. Tumour lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions.
- Documented radiographic disease progression on or after prior anti-PD(L)1 therapy and platinum chemotherapy or after standard immunotherapy without chemotherapy in accordance with standard of care.
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- Male or female patients of child-bearing potential must be willing to use highly effective forms of contraception (refer to APPENDIX 3 for details on highly effective methods of contraception and definitions of women of childbearing potential [WOCBP]and of fertile men):
- Women of childbearing potential (WOCBP) must have a negative serum test as per local guidelines during screening and EOT and agree to have regular urine pregnancy testing throughout the study. WOCBP must agree to use a highly effective method of contraception and refrain from donating eggs throughout the study and until 4 months after last dose of IMP;
- Male patients must agree to use barrier method of contraception [condom plus spermicide] from screening through Safety Follow-up visit, at least 1 month after the last dose of IMP. Men should refrain from donating sperm from the day of first dose of IMP, throughout the study and until 3 months after last dose of IMP. Men with partners of child-bearing potential must also be willing to ensure that their partner uses a highly effective method of contraception for the same duration. Men with pregnant or lactating partners should be advised to use barrier method contraception (e.g., condom plus spermicidal gel) to prevent exposure to the foetus or neonate.
Who cannot join
- Inability to swallow food or any condition of the upper gastrointestinal tract that precludes administration of oral medications.
- Histologically or cytologically confirmed squamous NSCLC.
- Previously treated with dostarlimab or docetaxel.
- Have prior significant medical history and AEs:
- History of a prior Grade 3 or 4 immune-related AE (irAE) or any grade ocular irAE from prior immunotherapy which did not respond to corticosteroid therapy or resolved with treatment interruptions and returned to at least Grade 1; immunemediated severe neurologic events of any grade (e.g., myasthenic syndrome/myasthenia gravis, encephalitis, Guillain-Barré Syndrome, or transverse myelitis), exfoliative dermatitis of any grade (SJS, TENS, or DRESS syndrome), or myocarditis of any grade.
- Have not recovered from toxic effect(s) of prior therapy to ≤ Grade 1, other than alopecia or fatigue or neuropathy which must be ≤ Grade 2.
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- Active autoimmune process (e.g., rheumatoid arthritis, moderate or severe psoriasis, multiple sclerosis, inflammatory bowel disease, immune colitis) that has required systemic treatment in the past 2 years. Replacement therapy (e.g.thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment.
- Known active CNS metastases and/or carcinomatous meningitis.
- Note: Patients with previously treated brain metastases may participate provided they are stable (without evidence of progression by imaging for at least 4 weeks before the first dose of study treatment and any neurologic symptoms have returned to baseline), have no evidence of new or enlarging brain metastases, and have not required steroids for at least 7 days before study treatment. e. History of long QT syndrome or history or presence of an abnormal ECG that, in the Investigator's opinion, is clinically meaningful. Screening QTc interval > 450 milliseconds is excluded (corrected by Fridericia). In the event that a single QTc is > 450 milliseconds, the patient may enrol if the average QTc for the 3 ECGs is < 450 milliseconds. For patients with an intraventricular conduction delay (QRS interval > 120 msec), the JTc interval may be used in place of the QTc with Sponsor approval. The JTc must be < 340 milliseconds if JTc is used in place of the QTc. Patients with left bundle branch block are excluded.
- History of or current risk factor for torsade de pointes (e.g., heart failure, hypokalaemia, or a family history of long QT syndrome). g. Clinically significant (i.e., active) cardiovascular disease: cerebral vascular accident/stroke (< 6 months prior to enrolment), myocardial infarction (< 6 months prior to enrolment), unstable angina, congestive heart failure (≥ New York Heart Association Classification Class II), or any of the following (<6 months prior to enrolment): acute coronary syndromes, coronary angioplasty or bypass grafting, serious cardiac arrhythmia requiring medication including second degree (Type 2) or third degree AV block, cardiomyopathy, pericarditis or myocarditis.
- Any history of interstitial lung disease or pneumonitis. i. History of allogenic stem cell transplantation or organ transplantation. j. Cirrhosis or current unstable liver or biliary disease per investigator assessment defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, oesophageal/ gastric varices, persistent jaundice k. Women who are pregnant or breastfeeding l. Active infection requiring systemic therapy. m. Patients with active malignancy requiring concurrent intervention or previous malignancies (except non-melanoma skin cancers, and the following in situ cancers: bladder, gastric, colon, endometrial, cervical/dysplasia, melanoma or breast) unless a complete remission was achieved at least 2 years prior to study entry and no additional therapy is required during the study period.
- Any serious or uncontrolled medical disorder or active infection that, in the opinion of the Investigator, may increase the risk associated with study participation, study drug administration, or would impair the ability of the patient to receive protocol therapy.
- Treatment with anticancer medications, investigational drugs, surgery and/or radiation within the following interval before the first administration of study drug:
- <90 days for prior taxane.
- <14 days for chemotherapy, targeted small-molecule therapy, surgical resection of lesions or radiation therapy (prior palliative radiotherapy must have been completed at least 14 days prior to study drug administration). Patients must also not require corticosteroids and must have recovered from pneumonitis as a result of treatment and show no evidence of pneumonitis for at least 1 month. A 1-week washout is permitted for palliative radiation to non-CNS disease with Sponsor approval. Note: The use of denosumab is permitted.
- < 14 days for a prior PD1 pathway-targeted agent.
- < 28 days for prior monoclonal antibody used for anticancer therapy with the exception of PD1 pathway-targeted agents.
- < 28 days or 5 half-lives (whichever is longer) before the first dose for all other investigational study drugs or devices. For investigational agents with long halflives (e.g., > 5 days), enrolment before the fifth half-life requires Medical Monitor approval.
- Radiotherapy -At least 6 weeks from prior radioisotope therapy. Note: Investigational agents that are not designed as antineoplastic treatment but used in combination with standard therapies are allowed.
- Receiving an immune-suppressive based treatment for any reason (including chronic use of systemic corticosteroid at doses > 10 mg/day prednisone equivalent) within 14 days prior to the first dose of study treatment. Use of inhaled or topical steroids (including but not limited to creams or intra-articular injection) or brief corticosteroid use for radiographic procedures or systemic corticosteroids ≤ 10 mg is permitted.
- Have received a live vaccine within 30 days of planned start of study therapy while on trial. With regards to other type of vaccines, including SARS-Co2 vaccines, are allowed.
- Known allergy or reaction to any component of either study drugs or formulation components.
- Known alcohol or other substance abuse.
- Laboratory and medical history parameters not within Protocol-defined range. Cycle 1 Day 1 laboratory assessments for the determination of eligibility do not need to be performed if the screening laboratory assessments were performed within 7 days of Cycle 1 Day 1. If the screening laboratory assessments were performed more than 7 days before Cycle 1 Day 1, then the haematology and serum chemistry laboratory results must be confirmed up to 3 days before treatment initiation on Cycle 1 Day 1.
- Absolute neutrophil count < 1.5 × 109/L.
- Platelet count < 100 × 109/L.
- Haemoglobin < 9 g/dL (transfusion is acceptable to meet this criterion).
- Serum creatinine ≥ 1.5 × institutional upper limit of normal (ULN) or measured or calculated creatinine clearance (CrCl) (glomerular filtration rate can also be used in place of creatinine or CrCl) < 50 mL/min for patients with creatinine levels > 1.5 × institutional ULN.
- Aspartate aminotransferase (AST) or ALT ≥ 2.5 × ULN in the absence of hepatic metastases or ≥ 5 × ULN with hepatic metastases at screening.
- Total bilirubin ≥ 1.2 × ULN are excluded unless direct bilirubin is ≤ ULN. If there is no institutional ULN, then direct bilirubin must be < 40% of total bilirubin to be eligible (except patients with Gilbert syndrome, who must have total bilirubin < 51.3 μmol/L).
- International normalized ratio or prothrombin time (PT) > 1.5 × ULN.
- Activated partial thromboplastin time (aPTT) > 1.5 × ULN.
- Evidence of acute infection of hepatitis B virus (HBV), (for example: positive for HBsAg, anti-HBc, IgM anti-HBc and negative for anti-HBs), hepatitis C virus (HCV) (for example: HCV antibody reactive; HCV RNA detected) and Human Immunodeficiency Virus (HIV). Patients who are on stable antiviral therapy for their viral infection of hepatitis (e.g., HBV, HCV) or HIV (i.e., for at least 12 months) and willing to remain on these during and for 6 months after end of study treatment, and/or asymptomatic are eligible for the study.
Trial locations and contacts
7 sites in 3 countries.
7 sites in 3 countries
Spain3 sites
Institut Català d'Oncologia Hospitalet
Barcelona, 08908
Hospital Universitari Son Espases
Palma, 07120
Hospital Universitario y Politécnico La Fe
Valencia, 46026
Belgium2 sites
Antwerp University Hospital
Antwerp, 2650
AZ Delta VZW
Roeselare, 8800
Italy2 sites
Istituto Romagnolo per lo studio dei Tumori "Dino Amadori"
Meldola, Forlì-Cesena, 47014
Humanitas University, Department of Medical Oncology
Rozzano, Milan, 20072
About this study
Official title: A Phase I/IIa Study of Roginolisib in Combination With Dostarlimab With or Without Docetaxel in Patients With Advanced Non-squamous NSCLC Who Have Progressed on Standard of Care Immune Checkpoint Therapy and Platinum Doublet Chemotherapy or Standard Immunotherapy Without Chemotherapy (PULMO-1)
The goal of this clinical trial is to learn how roginolisib works in combination with dostarlimab with or without docetaxel in adult patients with advanced non small-cell lung cancer. The main questions it aims to answer are:
To compare across the treatment arms the proportion of patients with a reduction in Treg cells To evaluate the safety and tolerability of roginolisib plus dostarlimab, with or without docetaxel
Read the detailed description
A Phase I/IIa open-label, randomised study of oral roginolisib (IOA-244 [roginolisib hemi-fumarate]) in combination with dostarlimab with or without docetaxel in Advanced Non small-cell lung cancer (NSCLC) patients.
This study will enrol approximately 45 male and female patients aged over 18 years with advanced NSLCL who have process on standard of care immune checkpoint therapy and platinum doublet chemotherapy or standard immunotherapy without chemotherapy. The disease must be measurable (i.e., at least 1 measurable lesion) as per RECIST v1.1 by Computerised Tomography (CT) scan or Magnetic Resonance Imaging (MRI).
- Being tested
- roginolisib, Dostarlimab, Docetaxel
- Keywords
- Advanced non-squamous Non Small Cell Lung Cancer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
roginolisibDrug
tablet, 40mg tablet strength
DostarlimabDrug
500 mg administered as IV infusion
DocetaxelDrug
75 mg/m2 administered over 1 hour as IV infusion
| Study group | Role | What they receive |
|---|---|---|
| Arm 1: Roginolisib + dostarlimab + docetaxel | Experimental | IOA-244 80 mg (corresponding to 72 mg roginolisib) once daily oral dosing on a 21-day cycle. Dostarlimab: 500 mg administered as IV infusion over 30 minutes on Day 1 of every 21-day cycle to a maximum of 35 cycles. Docetaxel: 75 mg/m2 administered over 1 hour as IV infusion on Day 1 of every 21-day cycle. Receives: Drug: roginolisib; Drug: Dostarlimab; Drug: Docetaxel |
| Arm 2: Roginolisib + dostarlimab | Experimental | IOA-244 80 mg (corresponding to 72 mg roginolisib) once daily oral dosing on a 21-day cycle. Dostarlimab: 500 mg administered as IV infusion over 30 minutes on Day 1 of every 21-day cycle to a maximum of 35 cycles. Receives: Drug: roginolisib; Drug: Dostarlimab |
| Arm 3: Dostarlimab + docetaxel | Active comparator | Dostarlimab: 500 mg administered as IV infusion over 30 minutes on Day 1 of every 21-day cycle to a maximum of 35 cycles. Docetaxel: 75 mg/m2 administered over 1 hour as IV infusion on Day 1 of every 21-day cycle. Receives: Drug: Dostarlimab; Drug: Docetaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE V5
Safety measured by AEs
Measured: On Day 1 and Day 15 of Cycle 1; Day 1 of Cycle 2 onwards. Each cycle is 21 days
To compare across treatment arms the proportion of patients with a reduction in peripheral blood Tregs (for example as defined by CD4+CD25+CD127- expression)
Change from baseline of at least 50% by Day 42 as assessed by mass cytometry (cytometry by time of flight, CyTOF)
Measured: On Day 1 of each Cycle. Cycle length is 21 days
Number of Participants With changes in laboratory parameters
Measures by chemistry and haematology laboratory parameters
Measured: On Day 1and Day 15 of Cycle 1; Day 1 of Cycle 2 onwards. Each cycle is 21 days
Number of Participants with Changes in ECG from baseline
Measured by 12 Lead ECG
Measured: On Day 1 and Day 15 of Cycle 1; Day 1 of Cycle 2 onwards. Each cycle is 21 days
Number of Participants With Change on Physical Examination from Baseline
Measured by physical examination
Measured: On Day 1and Day 15 of Cycle 1; Day 1 of Cycle 2 onwards. Each cycle is 21 days
Secondary outcomes (8)
To further evaluate immune cell subsets in peripheral blood following treatment with roginolisib when given in combination with dostarlimab, and with/without docetaxel
Change from baseline in immune related signatures as assessed by mass cytometry (expanded analyses using the same sample used for the primary endpoint)
Measured: On Day 1 of each cycle up to 36 weeks. Each cycle is 21 days
To evaluate preliminary signs of clinical efficacy of roginolisib when given in combination with dostarlimab, and with/without docetaxel
Objective Response Rate (ORR) per RECIST v1.1 as assessed by the investigator
Measured: Every 6 weeks whilst on treatment anticipated to be 36 weeks
To evaluate preliminary signs of clinical efficacy of roginolisib when given in combination with dostarlimab, and with/without docetaxel
Duration of response (DOR) per RECIST v1.1 as assessed by the investigator
Measured: Every 6 weeks whilst on treatment anticipated to be 36 weeks
To evaluate preliminary signs of clinical efficacy of roginolisib when given in combination with dostarlimab, and with/without docetaxel
Disease Control Rate (DCR) per RECIST v1.1 as assessed by the investigator
Measured: Every 6 weeks whilst on treatment anticipated to be 36 weeks
To evaluate preliminary signs of clinical efficacy of roginolisib when given in combination with dostarlimab, and with/without docetaxel
Clinical Benefit Rate (CBR) per RECIST v1.1 as assessed by the investigator
Measured: Every 6 weeks whilst on treatment anticipated to be 36 weeks
To evaluate preliminary signs of clinical efficacy of roginolisib when given in combination with dostarlimab, and with/without docetaxel
Progression free survival (PFS) per RECIST v1.1 as assessed by the investigator
Measured: Every 6 weeks whilst on treatment anticipated to be 36 weeks
To evaluate preliminary signs of clinical efficacy of roginolisib when given in combination with dostarlimab, and with/without docetaxel
Overall survival (OS)
Measured: Every 12 weeks after safety follow-up until their death or end of study
Pharmacokinetic (PK) concentration of roginolisib when given in combination with dostarlimab, and with/without docetaxel
Plasma concentrations of roginolisib
Measured: Day 1 of each whilst on treatment anticipated to be 36 weeks. Cycle length is 21 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2025
- Study start22 Apr 2025
- Primary completionJan 2027 (estimated)
- Study completionJan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Squamous Non-Small Cell Lung Cancer (NSCLC)Studies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomised, parallel-arm, comparator controlled, open-label
- Masking
- None (open label)
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- iOnctura
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Michael Lahn, MD, Study director, iOnctura
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06879717
- Sponsor's protocol ID
- IOA-244-202
- Other IDs
- 2024-517741-14
- Acronym
- PULMO-01
- Status last verified
- Jan 2026
- First submitted
- 5 Mar 2025
- Last updated
- 16 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/IIa Study of Roginolisib in Combination With Dostarlimab With or Without Docetaxel in Patients With Advanced Non-squamous NSCLC Who Have Progressed on Standard of Care Immune Checkpoint Therapy and Platinum Doublet Chemotherapy or Standard Immunotherapy Without Chemotherapy (PULMO-1)
- ClinicalTrials.gov ID
- NCT06879717
- Acronym / sponsor ID
- PULMO-01 / IOA-244-202
- Keywords
- Advanced non-squamous Non Small Cell Lung Cancer
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- iOncturaIndustry (pharma, biotech, devices)
- Study start
- 22 Apr 2025 (actual)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Jan 2028 (estimated)
- First posted
- 17 Mar 2025 (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 goal of this clinical trial is to learn how roginolisib works in combination with dostarlimab with or without docetaxel in adult patients with advanced non small-cell lung cancer. The main questions it aims to answer are:
To compare across the treatment arms the proportion of patients with a reduction in Treg cells To evaluate the safety and tolerability of roginolisib plus dostarlimab, with or without docetaxel
Detailed description
A Phase I/IIa open-label, randomised study of oral roginolisib (IOA-244 [roginolisib hemi-fumarate]) in combination with dostarlimab with or without docetaxel in Advanced Non small-cell lung cancer (NSCLC) patients.
This study will enrol approximately 45 male and female patients aged over 18 years with advanced NSLCL who have process on standard of care immune checkpoint therapy and platinum doublet chemotherapy or standard immunotherapy without chemotherapy. The disease must be measurable (i.e., at least 1 measurable lesion) as per RECIST v1.1 by Computerised Tomography (CT) scan or Magnetic Resonance Imaging (MRI).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Randomised, parallel-arm, comparator controlled, open-label
| Arm | Type | Receives |
|---|---|---|
| Arm 1: Roginolisib + dostarlimab + docetaxel | Experimental | Drug: roginolisib, Drug: Dostarlimab, Drug: DocetaxelIOA-244 80 mg (corresponding to 72 mg roginolisib) once daily oral dosing on a 21-day cycle. Dostarlimab: 500 mg administered as IV infusion over 30 minutes on Day 1 of every 21-day cycle to a maximum of 35 cycles. Docetaxel: 75 mg/m2 administered over 1 hour as IV infusion on Day 1 of every 21-day cycle. |
| Arm 2: Roginolisib + dostarlimab | Experimental | Drug: roginolisib, Drug: DostarlimabIOA-244 80 mg (corresponding to 72 mg roginolisib) once daily oral dosing on a 21-day cycle. Dostarlimab: 500 mg administered as IV infusion over 30 minutes on Day 1 of every 21-day cycle to a maximum of 35 cycles. |
| Arm 3: Dostarlimab + docetaxel | Active comparator | Drug: Dostarlimab, Drug: DocetaxelDostarlimab: 500 mg administered as IV infusion over 30 minutes on Day 1 of every 21-day cycle to a maximum of 35 cycles. Docetaxel: 75 mg/m2 administered over 1 hour as IV infusion on Day 1 of every 21-day cycle. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Male or female ≥18 years of age inclusive, at the time of signing the informed consent.
- Capable of giving signed informed consent, which includes compliance with the requirements of this protocol.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.
- Histologically or cytologically confirmed stage IIIb/IV or recurrent non-squamous NSCLC.
- Have measurable disease per RECIST v1.1 as determined by the investigator. Tumour lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions.
Key exclusion criteria (33 listed)
- Inability to swallow food or any condition of the upper gastrointestinal tract that precludes administration of oral medications.
- Histologically or cytologically confirmed squamous NSCLC.
- Previously treated with dostarlimab or docetaxel.
- Have prior significant medical history and AEs:
- Treatment with anticancer medications, investigational drugs, surgery and/or radiation within the following interval before the first administration of study drug:
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 |
|---|---|---|
| roginolisibtablet, 40mg tablet strength | Drug | Arm 1: Roginolisib + dostarlimab + docetaxel, Arm 2: Roginolisib + dostarlimab |
| Dostarlimab500 mg administered as IV infusion | Drug | Arm 1: Roginolisib + dostarlimab + docetaxel, Arm 2: Roginolisib + dostarlimab, Arm 3: Dostarlimab + docetaxel |
| Docetaxel75 mg/m2 administered over 1 hour as IV infusion | Drug | Arm 1: Roginolisib + dostarlimab + docetaxel, Arm 3: Dostarlimab + docetaxel |
Primary outcome
Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE V5
Time frame: On Day 1 and Day 15 of Cycle 1; Day 1 of Cycle 2 onwards. Each cycle is 21 days
Safety measured by AEs
To compare across treatment arms the proportion of patients with a reduction in peripheral blood Tregs (for example as defined by CD4+CD25+CD127- expression)
Time frame: On Day 1 of each Cycle. Cycle length is 21 days
Change from baseline of at least 50% by Day 42 as assessed by mass cytometry (cytometry by time of flight, CyTOF)
Number of Participants With changes in laboratory parameters
Time frame: On Day 1and Day 15 of Cycle 1; Day 1 of Cycle 2 onwards. Each cycle is 21 days
Measures by chemistry and haematology laboratory parameters
Number of Participants with Changes in ECG from baseline
Time frame: On Day 1 and Day 15 of Cycle 1; Day 1 of Cycle 2 onwards. Each cycle is 21 days
Measured by 12 Lead ECG
Number of Participants With Change on Physical Examination from Baseline
Time frame: On Day 1and Day 15 of Cycle 1; Day 1 of Cycle 2 onwards. Each cycle is 21 days
Measured by physical examination
8 secondary outcomes
To further evaluate immune cell subsets in peripheral blood following treatment with roginolisib when given in combination with dostarlimab, and with/without docetaxel
Time frame: On Day 1 of each cycle up to 36 weeks. Each cycle is 21 days
To evaluate preliminary signs of clinical efficacy of roginolisib when given in combination with dostarlimab, and with/without docetaxel
Time frame: Every 6 weeks whilst on treatment anticipated to be 36 weeks
To evaluate preliminary signs of clinical efficacy of roginolisib when given in combination with dostarlimab, and with/without docetaxel
Time frame: Every 6 weeks whilst on treatment anticipated to be 36 weeks
To evaluate preliminary signs of clinical efficacy of roginolisib when given in combination with dostarlimab, and with/without docetaxel
Time frame: Every 6 weeks whilst on treatment anticipated to be 36 weeks
To evaluate preliminary signs of clinical efficacy of roginolisib when given in combination with dostarlimab, and with/without docetaxel
Time frame: Every 6 weeks whilst on treatment anticipated to be 36 weeks
To evaluate preliminary signs of clinical efficacy of roginolisib when given in combination with dostarlimab, and with/without docetaxel
Time frame: Every 6 weeks whilst on treatment anticipated to be 36 weeks
To evaluate preliminary signs of clinical efficacy of roginolisib when given in combination with dostarlimab, and with/without docetaxel
Time frame: Every 12 weeks after safety follow-up until their death or end of study
Pharmacokinetic (PK) concentration of roginolisib when given in combination with dostarlimab, and with/without docetaxel
Time frame: Day 1 of each whilst on treatment anticipated to be 36 weeks. Cycle length is 21 days
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 16 Jan 2026.
- Individual participant dataSharing planned: Undecided
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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.
Michael Lahn, MD study director
iOnctura
7 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing roginolisib, Dostarlimab and Docetaxel in people with Non-Squamous Non-Small Cell Lung Cancer (NSCLC) and Advanced Non Squamous NSCLC, run by iOnctura at 7 sites in 3 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 9 inclusion and 33 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 16 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Spain, Belgium, Italy. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE V5 (time frame: On Day 1 and Day 15 of Cycle 1; Day 1 of Cycle 2 onwards. Each cycle is 21 days). The study lists 5 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 16 Jan 2026.