Locally Recurrent Lung Non-Small Cell CarcinomaPhase 2NCT07835789
Testing Repeat Radiation Therapy for Recurrent Non-small Cell Lung Cancer
A Phase 2 study testing Biospecimen Collection, Computed Tomography and Immunotherapy in people with Locally Recurrent Lung Non-Small Cell Carcinoma and Stage II Lung Cancer AJCC v8, run by NRG Oncology.
Trial summary
This phase II trial compares repeat radiation therapy (RT) to standard drug treatment alone in treating patients with stage II-III non-small cell lung cancer (NSCLC) that has come back after initial radiation at or adjacent to the site of the original tumor (locally recurrent). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Locally Recurrent Lung Non-Small Cell Carcinoma, Stage II Lung Cancer AJCC v8, Stage III Lung Cancer AJCC v8
- What is being tested?
- Biospecimen Collection, Computed Tomography and Immunotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 138 participants
- Where
- No sites listed yet
- Study dates
- 18 Dec 2026to 30 Sep 2034
- 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
- History of stage II-III NSCLC treated with fractionated (≤ 4 Gy per fraction) curative-intent (total dose ≥ 45 Gy) thoracic radiotherapy, completed ≥ 12 months before study entry
- Participants must have recurrent/progressive disease in the lung and/or regional lymph nodes that is not suitable for treatment with stereotactic body radiation therapy (SBRT) and for which palliative thoracic radiotherapy is not required at the time of study entry
- Biopsy to confirm recurrent/progressive disease at some point after the previous course of thoracic radiotherapy and before entering this study is required
- A portion of the disease that would be treated with radiotherapy on Arm 2 of this protocol must fall within the 50% isodose cloud of the radiotherapy plan
- New systemic lung cancer therapy initiated within 12 weeks prior to study entry that is still ongoing is not permitted
- Participants must not have definitive clinical or radiographic evidence of distant metastatic NSCLC at present or in the past
Show all 17Show fewer
- Age ≥ 18
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-2
- Not Pregnant and Not Nursing
- Negative urine or serum pregnancy test (in persons of childbearing potential) within 14 days prior to registration. Childbearing potential is defined as any person who has experienced menarche and who has not undergone surgical sterilization (hysterectomy or bilateral oophorectomy) or who is not postmenopausal
- Prior thoracic radiotherapy for NSCLC must have been delivered as definitive treatment, as opposed to in the preoperative or postoperative setting. One prior radiotherapy course must meet the specifications, and the radiotherapy plan from that course must be available in Digital Imaging and Communications in Medicine (DICOM) format
- Patients who have received additional prior radiotherapy (i.e., more than one prior radiotherapy course) may be enrolled, provided that only one prior radiotherapy course is deemed to affect the risks associated with treatment with radiotherapy on this study. As examples, prior radiotherapy for an extrathoracic malignancy would likely not affect the risks associated with reirradiation on this study. Prior radiotherapy for breast cancer may be permissible, depending on the extent of lung irradiation. Similarly, prior SBRT for a peripheral lung tumor may be permissible
- No prior SBRT for a central lung tumor, hilar lymph node, or mediastinal lymph node
- Prior lobar and sublobar lung resections are allowed, but prior pneumonectomy is not allowed
- Prior chemotherapy, targeted therapy, and/or immunotherapy for lung cancer is allowed
- No history of CTCAE version (v.) 5.0 grade 2-4 RT pneumonitis or ongoing CTCAE v. 5.0 grade 2-4 pneumonitis from any cause
- No clinically significant interstitial lung disease
Who cannot join
None listed.
About this study
Official title: A Phase II Randomized Study of Reirradiation for Locally Recurrent Non-Small Cell Lung Cancer
This phase II trial compares repeat radiation therapy (RT) to standard drug treatment alone in treating patients with stage II-III non-small cell lung cancer (NSCLC) that has come back after initial radiation at or adjacent to the site of the original tumor (locally recurrent). Radiation therapy uses high energy x-rays, particles, or radioactive seeds to kill cancer cells and shrink tumors. Chemotherapy drugs used in standard drug treatment work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Immunotherapy drugs used in standard drug treatment may induce changes in body's immune system and may interfere with the ability of tumor cells to grow and spread. Targeted therapy drugs used in standard treatment identify and attack specific tumor cells. This trial may help doctors determine whether repeat RT delays the cancer from growing or spreading by 6 months or more after initial radiation compared to standard drug treatment alone in patients with stage II-III locally recurrent NSCLC.
Read the detailed description
PRIMARY OBJECTIVE:
- In patients with NSCLC who develop locoregional disease recurrence after thoracic radiotherapy, to compare progression-free survival outcomes following curative-intent reirradiation versus systemic therapy alone.
SECONDARY OBJECTIVES:
- To compare overall survival outcomes across study arms. II. To compare clinician-scored adverse events, scored using Common Terminology Criteria for Adverse Events (CTCAE), across study arms.
III. To compare patient-reported adverse events, scored using Patient-Reported Outcomes (PRO)-CTCAE, across study arms.
IV. To compare patterns of disease progression across study arms.
EXPLORATORY OBJECTIVES:
- To evaluate clinical and dosimetric predictors of high-grade treatment-related toxicity within the experimental study arm.
II. To compare the toxicity and efficacy of proton beam radiotherapy versus photon radiotherapy within the experimental study arm.
III. To calculate regional lung ventilation using four-dimensional (4D) computed tomography (CT) planning scans and evaluate associated predictors of pulmonary toxicity.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM 1: Patients receive standard of care (SOC) systemic therapy, which may include chemotherapy, immunotherapy, and/or targeted therapy on study. Patients also undergo positron emission tomography/computed tomography (PET/CT) and magnetic resonance imaging (MRI) during screening, as well as chest CT and optional blood sample collection throughout the study.
ARM 2: Patients undergo radiation therapy (RT) for 20 treatment fractions over approximately 5 weeks or RT for 30 treatment fractions over approximately 6 weeks in the absence of disease progression or unacceptable toxicity. Patients receiving 6-week RT may also receive chemotherapy during RT per decision of patient and doctor decision. Patients also undergo PET/CT and MRI during screening, as well as chest CT and optional blood sample collection throughout the study.
After completion of study treatment, patients are followed up periodically until 5 years.
- Conditions
- Locally Recurrent Lung Non-Small Cell Carcinoma, Stage II Lung Cancer AJCC v8, Stage III Lung Cancer AJCC v8
- Being tested
- Biospecimen Collection, Computed Tomography, Immunotherapy, Magnetic Resonance Imaging, Positron Emission Tomography
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biospecimen CollectionProcedure or surgery
Also called Biological Sample Collection, Biospecimen Collected, Sample Collection, Specimen Collection
Undergo blood sample collection
Computed TomographyProcedure or surgery
Also called CAT, CAT Scan, Computed Axial Tomography, Computerized Axial Tomography
Undergo PET/CT and/or chest CT
ImmunotherapyOther
Also called Immunological, Immunological Therapy, Immunologically Directed Therapy
Given SOC immunotherapy
Magnetic Resonance ImagingProcedure or surgery
Also called Magnetic Resonance, Magnetic Resonance Imaging (MRI), Magnetic resonance imaging (procedure), Magnetic Resonance Imaging Scan
Undergo MRI
Positron Emission TomographyProcedure or surgery
Also called Medical Imaging, Positron Emission Tomography, PET, PET Scan, Positron emission tomography (procedure)
Undergo PET/CT
Radiation TherapyRadiation
Also called Cancer Radiotherapy, Energy Type, ENERGY_TYPE, Irradiate
Undergo repeat RT
Systemic ChemotherapyDrug
Given SOC chemotherapy
Targeted TherapyOther
Also called Target/Mechanism, Targeted, Targeting Therapy
Given SOC targeted therapy
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 (SOC systemic therapy) | Active comparator | Patients receive SOC systemic therapy, which may include chemotherapy, immunotherapy, and/or targeted therapy on study. Patients also undergo PET/CT and MRI during screening, as well as chest CT and optional blood sample collection throughout the study. Receives: Procedure: Biospecimen Collection; Procedure: Computed Tomography; Other: Immunotherapy; Procedure: Magnetic Resonance Imaging; Drug: Systemic Chemotherapy; Other: Targeted Therapy |
| Arm 2 (repeat RT, chemotherapy) | Experimental | Patients undergo RT for 20 treatment fractions over approximately 5 weeks or RT for 30 treatment fractions over approximately 6 weeks in the absence of disease progression or unacceptable toxicity. Patients receiving 6-week RT may also receive chemotherapy during RT per decision of patient and doctor decision. Patients also undergo PET/CT and MRI during screening, as well as chest CT and optional blood sample collection throughout the study. Receives: Procedure: Biospecimen Collection; Procedure: Computed Tomography; Procedure: Magnetic Resonance Imaging; Procedure: Positron Emission Tomography; Radiation: Radiation Therapy; Drug: Systemic Chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival (PFS)
The primary analysis of PFS will be conducted in the intent-to-treat population, defined as all randomized patients. The distributions of PFS will be estimated by the Kaplan-Meier method. The primary comparison between arms will use a one-sided stratified log-rank test with the randomization stratification factors. A stratified Cox proportional hazards model will be used to estimate the hazard ratio and corresponding confidence interval. An unstratified log-rank test and unstratified Cox proportional hazards model will also be provided as sensitivity analyses. No post hoc modification or collapsing of stratification categories based on observed event counts will be performed. If the stratified Cox model is not estimable because of sparse data, the unstratified Cox model will be used to summarize the treatment hazard ratio and confidence interval, with the reason documented.
Measured: From randomization to the first occurrence of disease progression or death from any cause, whichever occurs first, assessed up to 5 years
Secondary outcomes (4)
Overall survival
Will be summarized using Kaplan-Meier methods. Comparisons between arms will be summarized descriptively using hazard ratio estimates and corresponding confidence intervals.
Measured: From randomization to death from any cause, assessed up to 5 years
Incidence of clinician-scored treatment-related adverse events
Clinician-scored adverse events will be summarized by study arm using the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE). For each patient, the maximum severity reported for each adverse event will be used in the summaries. Adverse events will be summarized regardless of relationship to protocol treatment as assessed by the investigator. All adverse events, adverse events leading to withdrawal, interruption or modification of protocol treatment, Grade ≥ 3 adverse events, and serious adverse events will be summarized. Deaths and cause of death will be summarized. Event summaries will be presented by type, grade, and attribution and will be performed at the time of the primary endpoint analysis.
Measured: Up to 5 years
Incidence of patient-reported adverse events
A composite grading algorithm (Basch 2021) will be utilized to derive a single numerical grade for each adverse event scored at each timepoint using Patient-Reported Outcomes (PRO)-CTCAE. Patient-reported adverse events measured using PRO-CTCAE will also be summarized descriptively by arm and time point, together with compliance and missing-data patterns.
Measured: Up to 5 years
Site of first disease progression
Patterns of first failure will be summarized descriptively by arm using the categories specified in the protocol, including locoregional/intrathoracic progression, distant progression, or both. Formal hypothesis testing for these secondary endpoints is not planned unless otherwise specified in a future statistical analysis plan.
Measured: Up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2026
- Study start18 Dec 2026 (estimated)
- Primary completion30 Sep 2029 (estimated)
- Study completion30 Sep 2034 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Locally Recurrent Lung Non-Small Cell CarcinomaStudies of the same condition, open and under way.
- More trials run by NRG OncologyThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 138 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NRG Oncology
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nitin Ohri, Principal investigator, NRG Oncology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07835789
- Sponsor's protocol ID
- NRG-LU011
- Other IDs
- NCI-2026-06282, NRG-LU011, NRG-LU011, U10CA180868
- Status last verified
- Sep 2026
- First submitted
- 17 Sep 2026
- Last updated
- 23 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Randomized Study of Reirradiation for Locally Recurrent Non-Small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT07835789
- Acronym / sponsor ID
- NRG-LU011
- Conditions
- Locally Recurrent Lung Non-Small Cell Carcinoma, Stage II Lung Cancer AJCC v8, Stage III Lung Cancer AJCC v8
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 138 participants (estimated)
- Lead sponsor
- NRG OncologyUniversity, hospital or other
- Study start
- 18 Dec 2026 (estimated)
- Primary completion
- 30 Sep 2029 (estimated)
- Study completion
- 30 Sep 2034 (estimated)
- First posted
- 23 Sep 2026 (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 phase II trial compares repeat radiation therapy (RT) to standard drug treatment alone in treating patients with stage II-III non-small cell lung cancer (NSCLC) that has come back after initial radiation at or adjacent to the site of the original tumor (locally recurrent). Radiation therapy uses high energy x-rays, particles, or radioactive seeds to kill cancer cells and shrink tumors. Chemotherapy drugs used in standard drug treatment work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Immunotherapy drugs used in standard drug treatment may induce changes in body's immune system and may interfere with the ability of tumor cells to grow and spread. Targeted therapy drugs used in standard treatment identify and attack specific tumor cells. This trial may help doctors determine whether repeat RT delays the cancer from growing or spreading by 6 months or more after initial radiation compared to standard drug treatment alone in patients with stage II-III locally recurrent NSCLC.
Detailed description
PRIMARY OBJECTIVE:
- In patients with NSCLC who develop locoregional disease recurrence after thoracic radiotherapy, to compare progression-free survival outcomes following curative-intent reirradiation versus systemic therapy alone.
SECONDARY OBJECTIVES:
- To compare overall survival outcomes across study arms. II. To compare clinician-scored adverse events, scored using Common Terminology Criteria for Adverse Events (CTCAE), across study arms.
III. To compare patient-reported adverse events, scored using Patient-Reported Outcomes (PRO)-CTCAE, across study arms.
IV. To compare patterns of disease progression across study arms.
EXPLORATORY OBJECTIVES:
- To evaluate clinical and dosimetric predictors of high-grade treatment-related toxicity within the experimental study arm.
II. To compare the toxicity and efficacy of proton beam radiotherapy versus photon radiotherapy within the experimental study arm.
III. To calculate regional lung ventilation using four-dimensional (4D) computed tomography (CT) planning scans and evaluate associated predictors of pulmonary toxicity.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM 1: Patients receive standard of care (SOC) systemic therapy, which may include chemotherapy, immunotherapy, and/or targeted therapy on study. Patients also undergo positron emission tomography/computed tomography (PET/CT) and magnetic resonance imaging (MRI) during screening, as well as chest CT and optional blood sample collection throughout the study.
ARM 2: Patients undergo radiation therapy (RT) for 20 treatment fractions over approximately 5 weeks or RT for 30 treatment fractions over approximately 6 weeks in the absence of disease progression or unacceptable toxicity. Patients receiving 6-week RT may also receive chemotherapy during RT per decision of patient and doctor decision. Patients also undergo PET/CT and MRI during screening, as well as chest CT and optional blood sample collection throughout the study.
After completion of study treatment, patients are followed up periodically until 5 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1 (SOC systemic therapy) | Active comparator | Procedure: Biospecimen Collection, Procedure: Computed Tomography, Other: Immunotherapy, Procedure: Magnetic Resonance Imaging, Drug: Systemic Chemotherapy, Other: Targeted TherapyPatients receive SOC systemic therapy, which may include chemotherapy, immunotherapy, and/or targeted therapy on study. Patients also undergo PET/CT and MRI during screening, as well as chest CT and optional blood sample collection throughout the study. |
| Arm 2 (repeat RT, chemotherapy) | Experimental | Procedure: Biospecimen Collection, Procedure: Computed Tomography, Procedure: Magnetic Resonance Imaging, Procedure: Positron Emission Tomography, Radiation: Radiation Therapy, Drug: Systemic ChemotherapyPatients undergo RT for 20 treatment fractions over approximately 5 weeks or RT for 30 treatment fractions over approximately 6 weeks in the absence of disease progression or unacceptable toxicity. Patients receiving 6-week RT may also receive chemotherapy during RT per decision of patient and doctor decision. Patients also undergo PET/CT and MRI during screening, as well as chest CT and optional blood sample collection throughout the study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- History of stage II-III NSCLC treated with fractionated (≤ 4 Gy per fraction) curative-intent (total dose ≥ 45 Gy) thoracic radiotherapy, completed ≥ 12 months before study entry
- Participants must have recurrent/progressive disease in the lung and/or regional lymph nodes that is not suitable for treatment with stereotactic body radiation therapy (SBRT) and for which palliative thoracic radiotherapy is not required at the time of study entry
- Biopsy to confirm recurrent/progressive disease at some point after the previous course of thoracic radiotherapy and before entering this study is required
- A portion of the disease that would be treated with radiotherapy on Arm 2 of this protocol must fall within the 50% isodose cloud of the radiotherapy plan
- New systemic lung cancer therapy initiated within 12 weeks prior to study entry that is still ongoing is not permitted
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Biospecimen CollectionAlso: Biological Sample Collection, Biospecimen Collected, Sample Collection, Specimen CollectionUndergo blood sample collection | Procedure or surgery | Arm 1 (SOC systemic therapy), Arm 2 (repeat RT, chemotherapy) |
| Computed TomographyAlso: CAT, CAT Scan, Computed Axial Tomography, Computerized Axial TomographyUndergo PET/CT and/or chest CT | Procedure or surgery | Arm 1 (SOC systemic therapy), Arm 2 (repeat RT, chemotherapy) |
| ImmunotherapyAlso: Immunological, Immunological Therapy, Immunologically Directed TherapyGiven SOC immunotherapy | Other | Arm 1 (SOC systemic therapy) |
| Magnetic Resonance ImagingAlso: Magnetic Resonance, Magnetic Resonance Imaging (MRI), Magnetic resonance imaging (procedure), Magnetic Resonance Imaging ScanUndergo MRI | Procedure or surgery | Arm 1 (SOC systemic therapy), Arm 2 (repeat RT, chemotherapy) |
| Positron Emission TomographyAlso: Medical Imaging, Positron Emission Tomography, PET, PET Scan, Positron emission tomography (procedure)Undergo PET/CT | Procedure or surgery | Arm 2 (repeat RT, chemotherapy) |
| Radiation TherapyAlso: Cancer Radiotherapy, Energy Type, ENERGY_TYPE, IrradiateUndergo repeat RT | Radiation | Arm 2 (repeat RT, chemotherapy) |
| Systemic ChemotherapyGiven SOC chemotherapy | Drug | Arm 1 (SOC systemic therapy), Arm 2 (repeat RT, chemotherapy) |
| Targeted TherapyAlso: Target/Mechanism, Targeted, Targeting TherapyGiven SOC targeted therapy | Other | Arm 1 (SOC systemic therapy) |
Primary outcome
Progression-free survival (PFS)
Time frame: From randomization to the first occurrence of disease progression or death from any cause, whichever occurs first, assessed up to 5 years
The primary analysis of PFS will be conducted in the intent-to-treat population, defined as all randomized patients. The distributions of PFS will be estimated by the Kaplan-Meier method. The primary comparison between arms will use a one-sided stratified log-rank test with the randomization stratification factors. A stratified Cox proportional hazards model will be used to estimate the hazard ratio and corresponding confidence interval. An unstratified log-rank test and unstratified Cox proportional hazards model will also be provided as sensitivity analyses. No post hoc modification or collapsing of stratification categories based on observed event counts will be performed. If the stratified Cox model is not estimable because of sparse data, the unstratified Cox model will be used to summarize the treatment hazard ratio and confidence interval, with the reason documented.
4 secondary outcomes
Overall survival
Time frame: From randomization to death from any cause, assessed up to 5 years
Incidence of clinician-scored treatment-related adverse events
Time frame: Up to 5 years
Incidence of patient-reported adverse events
Time frame: Up to 5 years
Site of first disease progression
Time frame: Up to 5 years
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 23 Sep 2026.
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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.
Nitin Ohri principal investigator
NRG Oncology
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Biospecimen Collection, Computed Tomography and Immunotherapy in people with Locally Recurrent Lung Non-Small Cell Carcinoma and Stage II Lung Cancer AJCC v8, run by NRG Oncology.
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 17 inclusion and 0 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: opening soon, as of the sponsor's last update on 23 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
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 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?
Progression-free survival (PFS) (time frame: From randomization to the first occurrence of disease progression or death from any cause, whichever occurs first, assessed up to 5 years). 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 23 Sep 2026.