NSCLC Harboring EGFR MutationsNCT07714304
JS212 in Combination With JS111 as First-Line Treatment in EGFR-Mutant Advanced NSCLC
A study testing JS212 for Injection and JS111 capsules (AP-L1898) in people with NSCLC Harboring EGFR Mutations, run by Huan Zhou at 2 sites in China.
Trial summary
This is a single-arm clinical study evaluating the safety, tolerability, and preliminary efficacy of JS212 in combination with JS111 as first-line treatment in participants with epidermal growth factor receptor (EGFR)-mutant locally advanced or metastatic non-small cell lung cancer (NSCLC) who have not received prior… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- NSCLC Harboring EGFR Mutations
- What is being tested?
- JS212 for Injection and JS111 capsules (AP-L1898)
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 2 sitesChina
- Study dates
- 13 Jul 2026to 23 Jul 2029
- Phase
- Interventional
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants must meet all of the following criteria to be eligible for enrollment in this study:
- Male or female participants aged 18 to 75 years, inclusive, at the time of signing the informed consent form.
- Histologically or cytologically confirmed recurrent or metastatic solid tumor that is unresectable and not amenable to curative radiotherapy or chemoradiotherapy.
- Confirmed EGFR-sensitizing mutation, defined as an exon 19 deletion or L858R mutation, either occurring alone or together with other EGFR mutations, including concomitant T790M mutation. Local laboratory test reports are acceptable, provided that testing is performed using a well-validated assay, an assay that has passed external quality assessment, a laboratory qualified for molecular pathology diagnosis or genetic testing, or an assay approved by the National Medical Products Administration (NMPA). Participants must not have received prior systemic antitumor therapy for locally advanced or metastatic nonsquamous NSCLC. Participants with recurrent NSCLC who previously received adjuvant or neoadjuvant therapy, including chemotherapy, radiotherapy, or other treatment, or definitive radiotherapy or chemoradiotherapy, may be enrolled if the interval between the last treatment and disease recurrence is more than 6 months.
- At least 1 measurable lesion according to Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST v1.1).
- Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 or 1.
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- Life expectancy of at least 12 weeks.
- Adequate major organ function.
- Women of childbearing potential (WOCBP) who are sexually active with a nonsterilized male partner must have a negative serum pregnancy test within 7 days before the first dose and must agree to have no plans for pregnancy and to use highly effective contraception from the time of signing the informed consent form until 7 months after the last dose of JS212 or 2 months after the last dose of JS111, whichever contraception period is longer.
- Nonsterilized male participants who are sexually active with a female partner of childbearing potential must agree to use effective contraception, as described in Appendix 2, from the time of signing the informed consent form until 4 months after the last dose of JS212 or JS111. Sperm donation is prohibited during this period.
- The participant voluntarily agrees to participate in the study and signs the informed consent form.
Who cannot join
- Participants meeting any of the following criteria will be excluded from the study:
- 1. Any of the following disease-related conditions:
- Histologically or cytologically confirmed tumor containing a small-cell lung cancer component, large-cell neuroendocrine carcinoma, sarcomatoid features, or a squamous cell carcinoma component greater than 10%;
- Known leptomeningeal metastases;
- Symptomatic brain parenchymal metastases. Participants with asymptomatic brain metastases may be enrolled if considered stable by the investigator.
- Uncontrolled pleural effusion or pericardial effusion, or ascites requiring repeated drainage once per month or more frequently;
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- Spinal cord compression not treated with surgery and/or radiotherapy, or previously diagnosed spinal cord compression without clinical evidence of disease stability for at least 4 weeks before enrollment following treatment.
- 2. Receipt of any of the following treatments:
- Chemotherapy or other systemic antitumor therapy within 3 weeks or 5 half-lives before the first dose, whichever is shorter; small-molecule targeted therapy within 2 weeks before the first dose; or limited-field local radiotherapy, such as palliative radiotherapy for bone metastases, within 2 weeks before the first dose;
- Use of a strong CYP3A inhibitor or inducer within 14 days before the first dose of study treatment, or anticipated need for continued treatment with such medications during the study;
- Current treatment with medications known to prolong the QT interval or potentially cause torsades de pointes, or anticipated need for continued treatment with such medications during the study;
- Receipt of any investigational drug within 4 weeks or 5 half-lives before the first dose of study treatment, whichever is shorter;
- Concurrent enrollment in another clinical study, unless it is an observational, noninterventional study or the participant is in the follow-up phase of an interventional clinical study;
- Major surgery, such as craniotomy, thoracotomy, or laparotomy, within 4 weeks before the first dose of study treatment;
- Prior treatment with any EGFR tyrosine kinase inhibitor, any antibody-drug conjugate with a topoisomerase I inhibitor payload, or any antibody and/or antibody-drug conjugate targeting EGFR and/or HER3;
- 3. Toxicities from prior antitumor therapy that have not recovered to Grade 1 or lower according to CTCAE.
- 4. Known allergy or hypersensitivity to any study treatment or any of its excipients.
- 5. Any of the following cardiac findings:
- 1. Fridericia-corrected QT interval (QTcF) at rest of ≥450 milliseconds in male participants or ≥470 milliseconds in female participants, based on the mean of 3 QTcF measurements obtained during screening; 2. Clinically significant arrhythmia, including but not limited to complete left bundle branch block, third-degree atrioventricular block, second-degree atrioventricular block, or PR interval >250 milliseconds; 3. Risk factors for torsades de pointes, such as clinically significant hypokalemia as judged by the investigator, a family history of long QT syndrome, or a family history of arrhythmia, such as pre-excitation syndrome; 4. Left ventricular ejection fraction (LVEF) <50%. 6. Any condition that may affect the absorption, distribution, metabolism, or elimination of oral medication, including inability to swallow medication, frequent vomiting, persistent uncontrolled diarrhea, extensive gastrointestinal resection, Crohn's disease, or ulcerative colitis.
- 7. Confirmed or suspected interstitial lung disease, drug-induced pneumonitis, a history of idiopathic pneumonitis or idiopathic pulmonary fibrosis, or another moderate or severe pulmonary disease that substantially impairs lung function, except for Grade 1 or lower radiation pneumonitis.
- 8. Any severe or uncontrolled ocular disorder, particularly severe dry eye syndrome, keratoconjunctivitis sicca, severe exposure keratitis, or another condition that may increase the risk of epithelial injury, as judged by the physician; or an ocular abnormality requiring surgery or expected to require surgery during the study, except for cataracts not requiring urgent surgery.
- 9. Severe infection of CTCAE Grade 3 or higher within 4 weeks before the first dose of study treatmen.
- 10. A history of immunodeficiency, including a positive human immunodeficiency virus test, another acquired or congenital immunodeficiency disorder, a history of organ transplantation or allogeneic bone marrow transplantation, or autologous hematopoietic stem cell transplantation.
- 11. Active tuberculosis infection identified by medical history or computed tomography, a history of active tuberculosis infection within 1 year before enrollment, or a history of active tuberculosis infection more than 1 year before enrollment without adequate standard treatment.
- 12. Active hepatitis B, defined as hepatitis B surface antigen (HBsAg) positivity with hepatitis B e antibody (HBeAb) or hepatitis B core antibody (HBcAb) positivity and HBV DNA ≥1000 copies/mL or ≥200 IU/mL; or active hepatitis C, defined as hepatitis C virus antibody positivity with HCV RNA above the lower limit of detection of the assay.
- 13. Any other malignancy diagnosed within 5 years before the first dose that required treatment, except for malignancies with a low risk of metastasis and a 5-year survival rate greater than 90%, such as adequately treated basal cell or squamous cell carcinoma of the skin, carcinoma in situ of the cervix or breast, adequately treated localized prostate cancer, or adequately treated papillary thyroid carcinoma.
- 14. Female participants who are pregnant, breastfeeding, or planning to become pregnant during the study.
- 15. Uncontrolled concomitant disease, including but not limited to symptomatic congestive heart failure within 6 months before the first dose of study treatment, uncontrolled hypertension, unstable angina pectoris, uncontrolled arrhythmia.
- 16. Any other factor that, in the investigator's judgment, may cause the participant to discontinue the study prematurely, including a current or prior medical condition, including psychiatric illness, requiring concomitant treatment; a clinically significant laboratory abnormality; or family or social circumstances that may affect participant safety or the collection of study data.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites
The First Affiliated Hospital of Anhui Medical University
Hefei, Anhui, 230088
Huan Zhou, Ph.D, 086 13665527160, zhouhuanbest@vip.163.com
Hospital
Shanghai Chest Hospital
Shanghai, Shanghai Municipality, 200030
Zhiren Yang, Ph.D., 086 13965082087, 503091240@qq.com
University
About this study
Official title: A Phase II, Open-Label, Single-Arm Study of JS212 in Combination With JS111 as First-Line Treatment in Patients With Epidermal Growth Factor Receptor (EGFR)-Mutant Advanced Non-Small Cell Lung Cancer (NSCLC)
This is a single-arm clinical study evaluating the safety, tolerability, and preliminary efficacy of JS212 in combination with JS111 as first-line treatment in participants with epidermal growth factor receptor (EGFR)-mutant locally advanced or metastatic non-small cell lung cancer (NSCLC) who have not received prior systemic therapy for advanced disease.
The study consists of a safety lead-in stage followed by a clinical expansion stage. Approximately 20 participants are planned to be enrolled across the two stages. Participants will receive JS212 by intravenous infusion on Day 1 of each 21-day cycle and JS111 at 160 mg orally once daily until treatment discontinuation criteria are met.
During the safety lead-in stage, up to 10 participants will be enrolled and monitored for significant toxicities during the first 21 days after initial administration. The Safety Monitoring Committee (SMC) will review available safety, tolerability, and efficacy data and determine the JS212 dose to be further evaluated, whether an additional higher or lower dose should be explored, and whether the study may proceed to the clinical expansion stage.
Read the detailed description
This is a single-arm clinical study designed to evaluate the safety, tolerability, and preliminary antitumor activity of JS212 in combination with JS111 as first-line treatment in participants with EGFR-mutant locally advanced or metastatic NSCLC who have not previously received systemic therapy for EGFR-mutant advanced disease.
Participants will receive JS212 by intravenous infusion on Day 1 once every 3 weeks (Q3W), in combination with JS111 at 160 mg administered orally once daily (QD). Each treatment cycle is 21 days. Study treatment will continue until disease progression, unacceptable toxicity, withdrawal of consent, or another protocol-defined treatment discontinuation criterion is met.
The study includes two sequential stages: a safety lead-in stage and a clinical expansion stage. Approximately 20 participants are planned to be enrolled in total, although the final sample size may be adjusted by the Safety Monitoring Committee based on accumulating safety, tolerability, and efficacy data.
Safety Lead-in Stage
Up to 10 participants will be enrolled in the safety lead-in stage. The first 21 days following the initial administration of JS212 and JS111 will constitute the significant toxicity observation period.
The SMC will review the accumulated data and determine the JS212 dose to be used in combination with JS111 during the clinical expansion stage.
Before study initiation or during study conduct, the SMC may also consider emerging safety, tolerability, pharmacologic, and efficacy data from other ongoing studies of JS212 administered as monotherapy or in combination with other agents. Based on these data, the SMC may recommend modification of the JS212 dose, evaluation of another dose level, or omission of the safety lead-in stage and direct initiation of the clinical expansion stage, as specified in the SMC Charter.
Clinical Expansion Stage
After review of the safety lead-in data, participants enrolled in the clinical expansion stage will receive the SMC-selected dose of JS212 in combination with JS111 at 160 mg QD. The clinical expansion stage will further characterize the safety, tolerability, and preliminary antitumor activity of the combination.
Treatment will be administered in 21-day cycles and will continue until disease progression, unacceptable toxicity, withdrawal of consent, or another protocol-defined treatment discontinuation criterion is met. The study is expected to enroll approximately 20 participants in total across the safety lead-in and clinical expansion stages. The SMC may adjust the number of participants based on emerging study data.
Study Objectives
The primary objective is to evaluate the safety and tolerability of JS212 in combination with JS111 and to determine the JS212 dose to be further evaluated in combination with JS111.
The secondary or exploratory objective is to evaluate the preliminary antitumor activity of JS212 in combination with JS111 as first-line treatment in participants with EGFR-mutant locally advanced or metastatic NSCLC.
- Conditions
- NSCLC Harboring EGFR Mutations
- Being tested
- JS212 for Injection, JS111 capsules (AP-L1898)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JS212 for InjectionDrug
Administered by intravenous infusion on Day 1 of each 21-day cycle.
JS111 capsules (AP-L1898)Drug
160 mg once daily (QD)
| Study group | Role | What they receive |
|---|---|---|
| JS212 for Injection + JS111 capsules (AP-L1898) | Experimental | JS212：JS212 will be administered by intravenous infusion on Day 1 of each 21-day cycle.
JS111：160 mg once daily (QD) Receives: Drug: JS212 for Injection; Drug: JS111 capsules (AP-L1898) |
What is being measured
The primary outcome is the main question the study is designed to answer.
ORR
Objective response rate (ORR), assessed per RECIST v1.1
Measured: up to 3 years
Safety (AE)
Incidence and severity of adverse events (AEs), and abnormal laboratory or clinical findings.
Measured: up to 6 years
Secondary outcomes (4)
PFS
Progression-free survival (PFS), assessed by investigators (RECIST v1.1)
Measured: up to 6 years
DoR
Duration of response (DoR), assessed by BICR and investigators
Measured: up to 6 years
DCR
Disease control rate (DCR), assessed by BICR and investigators
Measured: up to 6 years
OS
overall survival (OS)
Measured: up to 6 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2026
- Study start13 Jul 2026 (estimated)
- Primary completion13 Nov 2026 (estimated)
- Study completion23 Jul 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NSCLC Harboring EGFR MutationsStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Huan Zhou
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Huan Zhou, Shanghai Junshi Bioscience Co., Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07714304
- Sponsor's protocol ID
- NSCLC-IIT-JS212-F01
- Status last verified
- Jul 2026
- First submitted
- 15 Jul 2026
- Last updated
- 20 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II, Open-Label, Single-Arm Study of JS212 in Combination With JS111 as First-Line Treatment in Patients With Epidermal Growth Factor Receptor (EGFR)-Mutant Advanced Non-Small Cell Lung Cancer (NSCLC)
- ClinicalTrials.gov ID
- NCT07714304
- Acronym / sponsor ID
- NSCLC-IIT-JS212-F01
- Conditions
- NSCLC Harboring EGFR Mutations
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Huan ZhouUniversity, hospital or other
- Study start
- 13 Jul 2026 (estimated)
- Primary completion
- 13 Nov 2026 (estimated)
- Study completion
- 23 Jul 2029 (estimated)
- First posted
- 20 Jul 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 is a single-arm clinical study evaluating the safety, tolerability, and preliminary efficacy of JS212 in combination with JS111 as first-line treatment in participants with epidermal growth factor receptor (EGFR)-mutant locally advanced or metastatic non-small cell lung cancer (NSCLC) who have not received prior systemic therapy for advanced disease.
The study consists of a safety lead-in stage followed by a clinical expansion stage. Approximately 20 participants are planned to be enrolled across the two stages. Participants will receive JS212 by intravenous infusion on Day 1 of each 21-day cycle and JS111 at 160 mg orally once daily until treatment discontinuation criteria are met.
During the safety lead-in stage, up to 10 participants will be enrolled and monitored for significant toxicities during the first 21 days after initial administration. The Safety Monitoring Committee (SMC) will review available safety, tolerability, and efficacy data and determine the JS212 dose to be further evaluated, whether an additional higher or lower dose should be explored, and whether the study may proceed to the clinical expansion stage.
Detailed description
This is a single-arm clinical study designed to evaluate the safety, tolerability, and preliminary antitumor activity of JS212 in combination with JS111 as first-line treatment in participants with EGFR-mutant locally advanced or metastatic NSCLC who have not previously received systemic therapy for EGFR-mutant advanced disease.
Participants will receive JS212 by intravenous infusion on Day 1 once every 3 weeks (Q3W), in combination with JS111 at 160 mg administered orally once daily (QD). Each treatment cycle is 21 days. Study treatment will continue until disease progression, unacceptable toxicity, withdrawal of consent, or another protocol-defined treatment discontinuation criterion is met.
The study includes two sequential stages: a safety lead-in stage and a clinical expansion stage. Approximately 20 participants are planned to be enrolled in total, although the final sample size may be adjusted by the Safety Monitoring Committee based on accumulating safety, tolerability, and efficacy data.
Safety Lead-in Stage
Up to 10 participants will be enrolled in the safety lead-in stage. The first 21 days following the initial administration of JS212 and JS111 will constitute the significant toxicity observation period.
The SMC will review the accumulated data and determine the JS212 dose to be used in combination with JS111 during the clinical expansion stage.
Before study initiation or during study conduct, the SMC may also consider emerging safety, tolerability, pharmacologic, and efficacy data from other ongoing studies of JS212 administered as monotherapy or in combination with other agents. Based on these data, the SMC may recommend modification of the JS212 dose, evaluation of another dose level, or omission of the safety lead-in stage and direct initiation of the clinical expansion stage, as specified in the SMC Charter.
Clinical Expansion Stage
After review of the safety lead-in data, participants enrolled in the clinical expansion stage will receive the SMC-selected dose of JS212 in combination with JS111 at 160 mg QD. The clinical expansion stage will further characterize the safety, tolerability, and preliminary antitumor activity of the combination.
Treatment will be administered in 21-day cycles and will continue until disease progression, unacceptable toxicity, withdrawal of consent, or another protocol-defined treatment discontinuation criterion is met. The study is expected to enroll approximately 20 participants in total across the safety lead-in and clinical expansion stages. The SMC may adjust the number of participants based on emerging study data.
Study Objectives
The primary objective is to evaluate the safety and tolerability of JS212 in combination with JS111 and to determine the JS212 dose to be further evaluated in combination with JS111.
The secondary or exploratory objective is to evaluate the preliminary antitumor activity of JS212 in combination with JS111 as first-line treatment in participants with EGFR-mutant locally advanced or metastatic NSCLC.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| JS212 for Injection + JS111 capsules (AP-L1898) | Experimental | Drug: JS212 for Injection, Drug: JS111 capsules (AP-L1898)JS212：JS212 will be administered by intravenous infusion on Day 1 of each 21-day cycle. JS111：160 mg once daily (QD) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Participants must meet all of the following criteria to be eligible for enrollment in this study:
Key exclusion criteria (29 listed)
- Participants meeting any of the following criteria will be excluded from the study:
- 3. Toxicities from prior antitumor therapy that have not recovered to Grade 1 or lower according to CTCAE.
- 4. Known allergy or hypersensitivity to any study treatment or any of its excipients.
- 1. Fridericia-corrected QT interval (QTcF) at rest of ≥450 milliseconds in male participants or ≥470 milliseconds in female participants, based on the mean of 3 QTcF measurements obtained during screening; 2. Clinically significant arrhythmia, including but not limited to complete left bundle branch block, third-degree atrioventricular block, second-degree atrioventricular block, or PR interval >250 milliseconds; 3. Risk factors for torsades de pointes, such as clinically significant hypokalemia as judged by the investigator, a family history of long QT syndrome, or a family history of arrhythmia, such as pre-excitation syndrome; 4. Left ventricular ejection fraction (LVEF) <50%. 6. Any condition that may affect the absorption, distribution, metabolism, or elimination of oral medication, including inability to swallow medication, frequent vomiting, persistent uncontrolled diarrhea, extensive gastrointestinal resection, Crohn's disease, or ulcerative colitis.
- 7. Confirmed or suspected interstitial lung disease, drug-induced pneumonitis, a history of idiopathic pneumonitis or idiopathic pulmonary fibrosis, or another moderate or severe pulmonary disease that substantially impairs lung function, except for Grade 1 or lower radiation pneumonitis.
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 |
|---|---|---|
| JS212 for InjectionAdministered by intravenous infusion on Day 1 of each 21-day cycle. | Drug | JS212 for Injection + JS111 capsules (AP-L1898) |
| JS111 capsules (AP-L1898)160 mg once daily (QD) | Drug | JS212 for Injection + JS111 capsules (AP-L1898) |
Primary outcome
ORR
Time frame: up to 3 years
Objective response rate (ORR), assessed per RECIST v1.1
Safety (AE)
Time frame: up to 6 years
Incidence and severity of adverse events (AEs), and abnormal laboratory or clinical findings.
4 secondary outcomes
PFS
Time frame: up to 6 years
DoR
Time frame: up to 6 years
DCR
Time frame: up to 6 years
OS
Time frame: up to 6 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 20 Jul 2026.
- Individual participant dataSharing planned: No
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing JS212 for Injection and JS111 capsules (AP-L1898) in people with NSCLC Harboring EGFR Mutations, run by Huan Zhou at 2 sites in China.
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 29 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 20 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 2 sites in China. 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.
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?
Contact kui Zhang (+8618168028925, kui_zhang@junshipharma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ORR (time frame: up to 3 years). The study lists 2 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 20 Jul 2026.