Non-Small-Cell Lung CarcinomaPhase 1/2ARTEMIDE-01NCT04995523
A Study of AZD2936 Anti-TIGIT/Anti-PD-1 Bispecific Antibody in Participants With Advanced or Metastatic NSCLC
A Phase 1/2 study testing AZD2936 in people with Non-Small-Cell Lung Carcinoma, run by AstraZeneca at 40 sites in 16 countries.
Trial summary
This is a Phase I/II study designed to evaluate if experimental anti-TIGIT/anti-PD-1 bispecific antibody rilvegostomig (AZD2936) is safe, tolerable and efficacious in participants with Advanced or Metastatic Non-small Cell Lung Cancer. Read more about this study
- Who is it for?
- Ages 18 to 130 years
- Conditions the study is for
- Non-Small-Cell Lung Carcinoma
- What is being tested?
- AZD2936
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 212 participants
- Where
- 40 sitesin 16 countries
- Study dates
- 14 Sep 2021to 1 Jun 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 to 130 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Written informed consent
- Aged 18 or above
- Part A and Part B: Unresectable stage III or stage IV squamous or non-squamous NSCLC not amenable to curative surgery or radiation. Part C and Part D: Stage IV squamous or non-squamous NSCLC not amenable to curative surgery or radiation. Part E: Stage IV squamous NSCLC not amenable to curative surgery or radiation.
- Documented PD-L1 expression by PD-L1 IHC per local report.
- Part A and Part B: Confirmed progression during treatment with a CPI-including regimen.
- Part C and Part D: No prior I/O treatment for metastatic NSCLC.
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- Part E: No prior treatment for metastatic NSCLC.
- ECOG performance status of 0 or 1 at enrolment.
- Life expectancy of ≥ 12 weeks at enrolment.
- Have at least 1 measurable lesion per RECIST v1.1.
- Adequate bone marrow, liver and kidney function
Who cannot join
- Sensitizing epidermal growth factor receptor (EGFR) mutations or anaplastic lymphoma kinase (ALK) fusion
- Documented test result for any other known genomic alteration for which a targeted therapy is approved in first line per local standard of care (e.g. ROS1, NTRK fusions, BRAF, V600E mutation)
- Previous treatment with an anti-TIGIT therapy
- Any concurrent chemotherapy, radiotherapy, investigational, biologic, or hormonal therapy for cancer treatment.
- Part A and Part B: Primary or secondary resistance after treatment with 2 or more regiments including a CPI.
- Part C and Part D: Any prior systemic treatment with an immune oncology agent (prior administration of immune-oncology agent for curative intent to treat other invasive malignancy is permitted).
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- Treatment with one previous systemic chemotherapy will be allowed.
- Part E: Any prior systemic treatment for metastatic NSCLC, including but not limited to chemotherapy, anti-PD-1, anti-PD-L1, anti-CTLA-4.
- Symptomatic central nervous system (CNS) metastasis.
- Thromboembolic event within 3 months prior to enrolment.
- Other invasive malignancy within 2 years prior to screening.
Trial locations and contacts
40 sites in 16 countries.
40 sites in 16 countries
Brazil5 sites
Research Site
Florianópolis, 88034-000
Research Site
Natal, 59075-740
Research Site
Porto Alegre, 90035903
Research Site
Rio de Janeiro, 20231-050
Research Site
São Paulo, 01246-000
Japan4 sites
Research Site
Kashiwa, 227-8577
Research Site
Niigata, 951-8566
Research Site
Sendai, 981-0914
Research Site
Tokyo, 104-0045
Taiwan4 sites
Research Site
Taichung, 40201
Research Site
Taichung, 40705
Research Site
Tainan, 70403
Research Site
Taipei, 110
United States3 sites
Research Site
Chicago, Illinois, 60637
Research Site
Fairfax, Virginia, 22031
Research Site
Rochester, Minnesota, 55905
Netherlands3 sites
Research Site
Groningen, 9713 GZ
Research Site
Leiden, 2333 ZA
Research Site
Utrecht, 3584 CX
South Korea3 sites
Research Site
Seoul, 03082
Research Site
Seoul, 03722
Research Site
Seoul, 05505
Spain3 sites
Research Site
Barcelona, 08035
Research Site
Madrid, 28027
Research Site
Madrid, 28041
Thailand3 sites
Research Site
Bangkok, 10700
Research Site
Chanthaburi, 22000
Research Site
Muang, 50200
Malaysia2 sites
Research Site
Kuala Lumpur, 59100
Research Site
Kuching, 93586
About this study
Official title: Phase I/II, Open-label, Dose Escalation and Dose Expansion Study to Evaluate Safety, Pharmacokinetics, Pharmacodynamics and Efficacy of AZD2936 Anti-TIGIT/Anti-PD-1 Bispecific Antibody in Participants With Advanced or Metastatic NSCLC
This is a Phase I/II study designed to evaluate if experimental anti-TIGIT/anti-PD-1 bispecific antibody rilvegostomig (AZD2936) is safe, tolerable and efficacious in participants with Advanced or Metastatic Non-small Cell Lung Cancer.
Read the detailed description
This is a first-time-in-human (FTIH), open-label, multicenter, multi-part, dose-escalation and dose-expansion study to evaluate the safety, pharmacokinetics (PK), pharmacodynamics, and efficacy of rilvegostomig (AZD2936) in adult participants with stage III unresectable or stage IV NSCLC. The study includes 4 parts: Part A (dose escalation) and Parts B-E (dose expansion).
- Conditions
- Non-Small-Cell Lung Carcinoma
- Being tested
- AZD2936
- Keywords
- TIGIT, Anti-TIGIT, PD-1, Anti-PD-1, NSCLC, Non-small Cell Lung Cancer, Advanced, Metastatic, Solid Tumor, Solid Tumour, Stage 3 NSCLC, Stage III NSCLC, Stage 4 NSCLC, Stage IV NSCLC, PD L1+ tumors
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Parkinson Disease 4, Autosomal Dominant Lewy Body, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AZD2936Drug
Also called Rilvegostomig
Anti-TIGIT/Anti-PD-1 Bispecific Antibody
| Study group | Role | What they receive |
|---|---|---|
| Dose Escalation Part A: Checkpoint inhibitor (CPI) experienced Non-small Cell Lung Cancer (NSCLC) | Experimental | Rilvegostomig Intravenous (IV) monotherapy Receives: Drug: AZD2936 |
| Dose Expansion Part B: CPI experienced NSCLC | Experimental | Rilvegostomig IV monotherapy Receives: Drug: AZD2936 |
| Dose Expansion Part C: CPI Naive NSCLC | Experimental | Rilvegostomig IV monotherapy Receives: Drug: AZD2936 |
| Dose Expansion Part D: CPI Naive NSCLC | Experimental | Rilvegostomig IV monotherapy Receives: Drug: AZD2936 |
| Dose Expansion Part E: treatment Naive Squamous NSCLC | Experimental | Rilvegostomig IV monotherapy Receives: Drug: AZD2936 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of participants with adverse events (AEs) and immune mediated AEs (imAEs), serious AEs (SAEs), dose limiting toxicities (DLTs), vital signs, and abnormal laboratory parameters
A DLT is a toxicity defined by the study protocol that occurs from the first dose of study intervention up to the end of the DLT evaluation period that is assessed as clearly unrelated to the primary disease or intercurrent illness.
Measured: Part A, B, C, D and E: From the time of informed consent until 90 days after the last dose of rilvegostomig
Rate of rilvegostomig discontinuation due to toxicity
Percentage of participants with AEs leading to discontinuation of rilvegostomig
Measured: Part A, B, C, D and E: From first dose to the last dose of rilvegostomig (an average of 6 months)
Objective Response Rate (ORR)
Percentage of participants with a confirmed Complete Response (CR) or Partial Response (PR) according to RECIST v1.1
Measured: Part B, C, D and E: From first dose of rilvegostomig to progressive disease (PD) or death in the absence of disease progression (approximately 2 years)
Secondary outcomes (11)
ORR
Percentage of participants with a confirmed CR or PR according to RECIST v1.1
Measured: Part A: From first dose of rilvegostomig to PD or death in the absence of disease progression (approximately 2 years).
Disease control rate (DCR)
Percentage of participants who have a best objective response of confirmed CR or PR or who have SD lasting for at least a certain time of period after start of treatment
Measured: Part A, B, C, E: From first dose of rilvegostomig to PD or death in the absence of disease progression (approximately 2 years). Part D: From randomization to PD or death in the absence of disease progression (approximately 2 years).
Duration of response (DoR)
The time from first response according to RECIST v1.1 until progression or death in the absence of disease progression
Measured: Part A, B, C, D and E: From first dose of rilvegostomig to PD or death in the absence of disease progression (approximately 2 years).
Durable response rate (DRR)
The percentage of participants according to RECIST v1.1 with a confirmed CR or PR lasting 6 months or more
Measured: Part A, B, C, D and E: From first dose of rilvegostomig to PD or death in the absence of disease progression (approximately 2 years).
Progression-free survival (PFS)
The time from first dose of study intervention until the date of objective disease progression or death in the absence of disease progression
Measured: Part B, C, E: From first dose of rilvegostomig to PD or death in the absence of disease progression (approximately 2 years). Part D: From randomization to PD or death in the absence of disease progression (approximately 2 years).
Measure the receptor occupancy (RO) of TIGIT and PD-1 on peripheral blood
Evaluation of the target engagement of rilvegostomig in peripheral blood
Measured: Part A, B: From first dose of study intervention, at predefined intervals throughout the administration of rilvegostomig (approximately 2 years). The predefined intervals for Part A will be different from Part B.
PK of rilvegostomig: Maximum plasma concentration of the study drug (Cmax)
Maximum observed plasma concentration of rilvegostomig
Measured: From first dose of study intervention, at predefined intervals throughout the administration of rilvegostomig (approximately 2 years). The predefined intervals for Part A will be different from Part B, C, D and E.
PK of rilvegostomig: Area under the concentration-time curve (AUC)
Area under the plasma concentration-time curve
Measured: From first dose of study intervention, at predefined intervals throughout the administration of rilvegostomig (approximately 2 years). The predefined intervals for Part A will be different from Part B, C, D and E.
PK of rilvegostomig: Clearance
A pharmacokinetic measurement of the volume of plasma from which the study intervention is completely removed per unit time.
Measured: From first dose of study intervention, at predefined intervals throughout the administration of rilvegostomig (approximately 2 years). The predefined intervals for Part A will be different from Part B, C, D and E.
PK of rilvegostomig: Terminal elimination half-life (t 1/2)
Terminal elimination half life
Measured: From first dose of study intervention, at predefined intervals throughout the administration of rilvegostomig (approximately 2 years). The predefined intervals for Part A will be different from Part B, C, D and E.
Incidence of anti-drug antibodies (ADA) against rilvegostomig in serum
Immunogenicity of rilvegostomig
Measured: From first dose of study intervention, at predefined intervals throughout the administration of rilvegostomig (approximately 2 years). The predefined intervals for Part A will be different from Part B, C, D and E.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2021
- Study start14 Sep 2021
- Primary completion28 Aug 2026 (estimated)
- Study completion1 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Small-Cell Lung CarcinomaStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- 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
- Non-randomised
- Intervention model
- Sequential
- Model description
- The study includes 5 parts: Part A: Dose escalation; B \& C \& E: Dose expansion non-randomized; D: Randomized RP2D \& alternative dose.
- Masking
- None (open label)
- Enrolment
- 212 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04995523
- Sponsor's protocol ID
- D7020C00001
- Other IDs
- 2023-508262-15-00, 2021-000857-23, 2023
- Acronym
- ARTEMIDE-01
- Status last verified
- Jul 2026
- First submitted
- 16 Jul 2021
- Last updated
- 14 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I/II, Open-label, Dose Escalation and Dose Expansion Study to Evaluate Safety, Pharmacokinetics, Pharmacodynamics and Efficacy of AZD2936 Anti-TIGIT/Anti-PD-1 Bispecific Antibody in Participants With Advanced or Metastatic NSCLC
- ClinicalTrials.gov ID
- NCT04995523
- Acronym / sponsor ID
- ARTEMIDE-01 / D7020C00001
- Conditions
- Non-Small-Cell Lung Carcinoma
- Keywords
- TIGIT, Anti-TIGIT, PD-1, Anti-PD-1, NSCLC, Non-small Cell Lung Cancer, Advanced, Metastatic, Solid Tumor, Solid Tumour, Stage 3 NSCLC, Stage III NSCLC, Stage 4 NSCLC, Stage IV NSCLC, PD L1+ tumors
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 212 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 14 Sep 2021 (actual)
- Primary completion
- 28 Aug 2026 (estimated)
- Study completion
- 1 Jun 2028 (estimated)
- First posted
- 9 Aug 2021 (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.
This is a Phase I/II study designed to evaluate if experimental anti-TIGIT/anti-PD-1 bispecific antibody rilvegostomig (AZD2936) is safe, tolerable and efficacious in participants with Advanced or Metastatic Non-small Cell Lung Cancer.
Detailed description
This is a first-time-in-human (FTIH), open-label, multicenter, multi-part, dose-escalation and dose-expansion study to evaluate the safety, pharmacokinetics (PK), pharmacodynamics, and efficacy of rilvegostomig (AZD2936) in adult participants with stage III unresectable or stage IV NSCLC. The study includes 4 parts: Part A (dose escalation) and Parts B-E (dose expansion).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 5
- Model description
- The study includes 5 parts: Part A: Dose escalation; B \& C \& E: Dose expansion non-randomized; D: Randomized RP2D \& alternative dose.
| Arm | Type | Receives |
|---|---|---|
| Dose Escalation Part A: Checkpoint inhibitor (CPI) experienced Non-small Cell Lung Cancer (NSCLC) | Experimental | Drug: AZD2936Rilvegostomig Intravenous (IV) monotherapy |
| Dose Expansion Part B: CPI experienced NSCLC | Experimental | Drug: AZD2936Rilvegostomig IV monotherapy |
| Dose Expansion Part C: CPI Naive NSCLC | Experimental | Drug: AZD2936Rilvegostomig IV monotherapy |
| Dose Expansion Part D: CPI Naive NSCLC | Experimental | Drug: AZD2936Rilvegostomig IV monotherapy |
| Dose Expansion Part E: treatment Naive Squamous NSCLC | Experimental | Drug: AZD2936Rilvegostomig IV monotherapy |
Who may qualify
- Ages
- 18 to 130 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Written informed consent
- Aged 18 or above
- Part A and Part B: Unresectable stage III or stage IV squamous or non-squamous NSCLC not amenable to curative surgery or radiation. Part C and Part D: Stage IV squamous or non-squamous NSCLC not amenable to curative surgery or radiation. Part E: Stage IV squamous NSCLC not amenable to curative surgery or radiation.
- Documented PD-L1 expression by PD-L1 IHC per local report.
- Part A and Part B: Confirmed progression during treatment with a CPI-including regimen.
Key exclusion criteria (11 listed)
- Sensitizing epidermal growth factor receptor (EGFR) mutations or anaplastic lymphoma kinase (ALK) fusion
- Documented test result for any other known genomic alteration for which a targeted therapy is approved in first line per local standard of care (e.g. ROS1, NTRK fusions, BRAF, V600E mutation)
- Previous treatment with an anti-TIGIT therapy
- Any concurrent chemotherapy, radiotherapy, investigational, biologic, or hormonal therapy for cancer treatment.
- Part A and Part B: Primary or secondary resistance after treatment with 2 or more regiments including a CPI.
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 |
|---|---|---|
| AZD2936Also: RilvegostomigAnti-TIGIT/Anti-PD-1 Bispecific Antibody | Drug | Dose Escalation Part A: Checkpoint inhibitor (CPI) experienced Non-small Cell Lung Cancer (NSCLC), Dose Expansion Part B: CPI experienced NSCLC, Dose Expansion Part C: CPI Naive NSCLC, Dose Expansion Part D: CPI Naive NSCLC, Dose Expansion Part E: treatment Naive Squamous NSCLC |
Primary outcome
Percentage of participants with adverse events (AEs) and immune mediated AEs (imAEs), serious AEs (SAEs), dose limiting toxicities (DLTs), vital signs, and abnormal laboratory parameters
Time frame: Part A, B, C, D and E: From the time of informed consent until 90 days after the last dose of rilvegostomig
A DLT is a toxicity defined by the study protocol that occurs from the first dose of study intervention up to the end of the DLT evaluation period that is assessed as clearly unrelated to the primary disease or intercurrent illness.
Rate of rilvegostomig discontinuation due to toxicity
Time frame: Part A, B, C, D and E: From first dose to the last dose of rilvegostomig (an average of 6 months)
Percentage of participants with AEs leading to discontinuation of rilvegostomig
Objective Response Rate (ORR)
Time frame: Part B, C, D and E: From first dose of rilvegostomig to progressive disease (PD) or death in the absence of disease progression (approximately 2 years)
Percentage of participants with a confirmed Complete Response (CR) or Partial Response (PR) according to RECIST v1.1
11 secondary outcomes
ORR
Time frame: Part A: From first dose of rilvegostomig to PD or death in the absence of disease progression (approximately 2 years).
Disease control rate (DCR)
Time frame: Part A, B, C, E: From first dose of rilvegostomig to PD or death in the absence of disease progression (approximately 2 years). Part D: From randomization to PD or death in the absence of disease progression (approximately 2 years).
Duration of response (DoR)
Time frame: Part A, B, C, D and E: From first dose of rilvegostomig to PD or death in the absence of disease progression (approximately 2 years).
Durable response rate (DRR)
Time frame: Part A, B, C, D and E: From first dose of rilvegostomig to PD or death in the absence of disease progression (approximately 2 years).
Progression-free survival (PFS)
Time frame: Part B, C, E: From first dose of rilvegostomig to PD or death in the absence of disease progression (approximately 2 years). Part D: From randomization to PD or death in the absence of disease progression (approximately 2 years).
Measure the receptor occupancy (RO) of TIGIT and PD-1 on peripheral blood
Time frame: Part A, B: From first dose of study intervention, at predefined intervals throughout the administration of rilvegostomig (approximately 2 years). The predefined intervals for Part A will be different from Part B.
PK of rilvegostomig: Maximum plasma concentration of the study drug (Cmax)
Time frame: From first dose of study intervention, at predefined intervals throughout the administration of rilvegostomig (approximately 2 years). The predefined intervals for Part A will be different from Part B, C, D and E.
PK of rilvegostomig: Area under the concentration-time curve (AUC)
Time frame: From first dose of study intervention, at predefined intervals throughout the administration of rilvegostomig (approximately 2 years). The predefined intervals for Part A will be different from Part B, C, D and E.
PK of rilvegostomig: Clearance
Time frame: From first dose of study intervention, at predefined intervals throughout the administration of rilvegostomig (approximately 2 years). The predefined intervals for Part A will be different from Part B, C, D and E.
PK of rilvegostomig: Terminal elimination half-life (t 1/2)
Time frame: From first dose of study intervention, at predefined intervals throughout the administration of rilvegostomig (approximately 2 years). The predefined intervals for Part A will be different from Part B, C, D and E.
Incidence of anti-drug antibodies (ADA) against rilvegostomig in serum
Time frame: From first dose of study intervention, at predefined intervals throughout the administration of rilvegostomig (approximately 2 years). The predefined intervals for Part A will be different from Part B, C, D and E.
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 14 Jul 2026.
- Individual participant dataSharing planned: Yes. Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
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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.
The record lists no contact. Use the official record to reach the sponsor.
40 sites in 16 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing AZD2936 in people with Non-Small-Cell Lung Carcinoma, run by AstraZeneca at 40 sites in 16 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 11 inclusion and 11 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 14 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 40 sites in Brazil, Japan, Taiwan, United States, Netherlands and 11 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. 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?
Percentage of participants with adverse events (AEs) and immune mediated AEs (imAEs), serious AEs (SAEs), dose limiting toxicities (DLTs), vital signs, and abnormal laboratory parameters (time frame: Part A, B, C, D and E: From the time of informed consent until 90 days after the last dose of rilvegostomig). 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 14 Jul 2026.