Non Small Cell Lung CancerPhase 2NCT07375316
A ctDNA-guided Phase II Trial of Osimertinib in Combination With Sacituzumab Tirumotecan in EGFR-mutated Advanced NSCLC Patients With Positive ctDNA After lead-in Osimertinib Monotherapy
A Phase 2 study testing Osimertinib + Sacituzumab Tirumotecan and Osimertinib in people with Non Small Cell Lung Cancer, run by Guangdong Association of Clinical Trials at 4 sites in China.
Trial summary
EGFR-mutated advanced NSCLC patients without ctDNA clearance after lead-in osimertinib monotherapy have inferior PFS compared with those with ctDNA clearance. Consequently, these patients might need an intensified therapeutic strategy, such as osimertinib combined with chemotherapy or ADC. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non Small Cell Lung Cancer
- What is being tested?
- Osimertinib + Sacituzumab Tirumotecan and Osimertinib
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 4 sitesChina
- Study dates
- 15 Dec 2025to 30 Dec 2028
- 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
- Age ≥18 years at the time of signing the Informed Consent Form (ICF), regardless of gender;
- Histologically or cytologically confirmed locally advanced (stage IIIB/IIIC) or metastatic (Stage IV) non-squamous NSCLC not amenable to radical surgery and/or radical radiotherapy (regardless of concurrent/sequential chemotherapy) (according to TNM staging of lung cancer published by the Union for International Cancer Control and American Joint Committee on Cancer (UICC/AJCC), 8th edition);
- Presence of sensitizing EGFR mutation (exon 19 deletion and/or L858R);
- Completion of 3~5-week first-line treatment with osimertinib monotherapy. Non-PD as assessed by investigator per RECIST v1.1, and willing to undergo ctDNA testing (patients with positive ctDNA test results will be enrolled in Cohort 1; patients with negative ctDNA test results will be enrolled in observational Cohort 2);
- ≥1 measurable target lesion per RECIST v1.1;
- ECOG Performance Status score of 0 or 1 within 7 days before enrollment;
Show all 13Show fewer
- Adequate organ and bone marrow function (no blood transfusion, recombinant human thrombopoietin, or colony stimulating factor therapy within 2 weeks prior to the first dose), defined as follows:
- Hematology: neutrophil count (NEUT) ≥ 1.5×109/L; platelet (PLT) ≥ 100×109/L; hemoglobin(Hb) ≥ 90g/L;
- Liver function: AST and ALT ≤ 2.5× ULN (if liver metastases are present, ≤5 × ULN); total bilirubin (TBIL) ≤ 1.5×ULN (if liver metastases are present, ≤3 × ULN); serum albumin ≥30g/L;
- Renal function: serum creatinine (Cr) ≤ 1.5 × ULN, or creatinine clearance ≥ 50 mL/min (calculated using the standard Cockcroft-Gault formula);
- Coagulation function: international normalized ratio (INR), activated partial thromboplastin time (APTT) and prothrombin time (PT) ≤ 1.5× ULN;
- Use of effective medical contraception during the study treatment period and for 6 months after the end of dosing for female subjects of childbearing potential and male subjects with partners of childbearing potential;
- Willingness to participate in the study, sign the ICF, and comply with the protocol-specified visits and relevant procedures.
Who cannot join
- For NSCLC, histologically or cytologically confirmed squamous cell carcinoma component or presence of coexisting small cell lung cancer, neuroendocrine carcinoma, or carcinosarcoma component;
- Known presence of meningeal metastases, brainstem metastases, spinal cord metastases and/or compression, and active brain metastases. Patients with asymptomatic, focal leptomeningeal metastases on contrast-enhanced MRI may be eligible if, in the investigator's opinion, no local therapy or dehydration/symptomatic treatment is required;
- Prior treatment with systemic anti-tumor therapy for locally advanced or metastatic NSCLC other than osimertinib;
- Prior treatment with any TROP2-targeted therapy or any therapy that targets topoisomerase I (including ADCs);
- Other malignancies (except cured local tumors, such as basal cell carcinoma of skin, squamous cell carcinoma of skin, carcinoma in situ of the cervix) within 3 years prior to enrollment;
- Presence of any of the following cardiovascular and cerebrovascular diseases or risk factors:
Show all 35Show fewer
- Myocardial infarction, unstable angina, acute or persistent myocardial ischemia, Class III or IV heart failure [according to New York Heart Association (NYHA) classification], symptomatic or poorly controlled serious arrhythmia, cerebrovascular accident, transient ischemic attack, and other serious cardiovascular and cerebrovascular diseases within 6 months prior to enrollment;
- Previous history of myocardial diseases such as myocarditis, primary cardiomyopathy and specific cardiomyopathy;
- Any peripheral arterial thromboembolic event, pulmonary embolism, deep vein thrombosis, or other serious thromboembolic event within 3 months prior to enrollment;
- Major vascular disease such as aortic aneurysm, aortic dissecting aneurysm that may be life-threatening or require surgery within 6 months prior to first dose;
- Mean corrected QT interval (QTcF) between ventricular depolarization to repolarization > 470 ms;
- Uncontrolled systemic disease as judged by the investigator:
- Poorly controlled diabetes mellitus (two consecutive fasting glucose ≥10 mmol/L);
- Poorly controlled hypertension (systolic blood pressure > 160 mmHg and/or diastolic blood pressure > 100 mmHg);
- Presence of clinically symptomatic pleural effusion, pericardial effusion, or ascites requiring repeated drainage (> 1 time/week);
- History of (noninfectious) pneumonitis/interstitial lung disease (ILD) that required steroids, or has current pneumonitis/ILD, or suspected pneumonitis/ILD that cannot be ruled out by imaging at screening;
- Documented severe dry eye syndrome, severe meibomian gland disease and/or blepharitis, or history of corneal disease that prevents/delays corneal healing;
- Clinically severe lung impairment caused by complications that may involve the lung, or prior pneumonectomy;
- Presence of active chronic inflammatory bowel disease, GI tract obstruction, severe ulcers, gastrointestinal perforation, abdominal abscess, or acute GI tract bleed;
- Active gastrointestinal disease or other conditions that significantly affect the absorption and metabolism of osimertinib (e.g., refractory nausea and vomiting, chronic gastrointestinal disease, inability to swallow drug, or previous major bowel resection);
- Tumor invasion or compression of surrounding important organs and blood vessels (e.g. heart, esophagus, superior vena cava, etc.) accompanied by related symptoms (e.g. superior vena cava syndrome), or presence of risk of developing esophagotracheal fistula or esophagopleural fistula;
- Toxicities treated by prior anti-tumor therapy having not recovered to ≤ Grade 1 (as per NCI CTCAE V5.0) or to the levels specified in the eligibility criteria;
- Serious infection within 4 weeks prior to enrollment or active infection requiring systemic anti-infective therapy within 2 weeks prior to enrollment;
- Known active tuberculosis;
- Presence of active hepatitis B (HBV-DNA test is required in case of hepatitis B surface antigen [HBsAg] positive; HBV-DNA ≥ 2000 IU/mL or above the lower limit of detection, whichever is higher) or hepatitis C (hepatitis C antibody positive, and HCV-RNA > the lower limit of detection);
- Positive result of human immunodeficiency virus (HIV) test or history of acquired immunodeficiency syndrome (AIDS); known active syphilis infection;
- Known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation;
- Major surgery within 4 weeks prior to enrollment or expected major surgery during the study;
- Known allergy to the study drug or any of its components, and a history of known severe hypersensitivity to other monoclonal antibodies;
- Medications or herbal supplements that are currently used (or cannot be discontinued prior to receiving the first dose of study treatment) and are known to be strong inducers or inhibitors of cytochrome P450 (CYP) 3A4 (washout for at least 3 weeks);
- Receipt of radiotherapy at a total dose of >30 Gy for lung lesions within 6 months prior to enrollment; receipt of non-thoracic or extensive radiotherapy at a total dose of >30 Gy within 4 weeks prior to enrollment; palliative radiotherapy for symptom control is allowed, but must be completed at least 2 weeks prior to enrollment;
- Live vaccines inoculated within 30 days prior to enrollment or planned to be inoculated during the study;
- Rapid deterioration of disease, such as significant changes in performance status during the screening process prior to the first dose;
- Pregnant or lactating women;
- Any condition that, in the opinion of the investigator, may interfere with the evaluation of the study drug or the interpretation of the subject's safety or study results, or any other circumstances that, in the opinion of the investigator, make the subject unsuitable for participation in this study
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Yi-Chen Zhang contact
China4 sites, 4 recruiting
- Recruiting
Guangdong Lung Cancer Institute, Guangdong Provincial People's Hospital, Guangdong Academy of Medical Sciences, Southern Medical University
Guangzhou, Guangdong, 510080
Qing Zhou, +51221 862083807812, gzzhouqing@126.com
- Recruiting
Meizhou People's Hospital (Huangtang Hospital), Meizhou Academy of Medical Sciences
Meizhou, Guangdong, 514031
Guowu Wu
- Recruiting
The First Affiliated Hospital of Shantou University Medical College
Shantou, Guangdong, 515041
- Recruiting
Peking University Shenzhen Hospital
Shenzhen, Guangdong, 518036
Fen Wang
About this study
Official title: A ctDNA-guided Phase II Trial of Osimertinib in Combination With Sacituzumab Tirumotecan in EGFR-mutated Advanced NSCLC Patients With Positvie ctDNA After lead-in Osimertinib Monotherapy
EGFR-mutated advanced NSCLC patients without ctDNA clearance after lead-in osimertinib monotherapy have inferior PFS compared with those with ctDNA clearance. Consequently, these patients might need an intensified therapeutic strategy, such as osimertinib combined with chemotherapy or ADC. This study aims to explore the efficacy and safety of osimertinib in combination with sacituzumab tirumotecan adaptively in EGFR-mutated advanced NSCLC patients with positive ctDNA after lead-in osimertinib monotherapy.
Read the detailed description
This is an investigator-initiated, multicenter, ctDNA-guided phase II study to evaluate the efficacy and safety of osimertinib in combination with sacituzumab tirumotecan adaptively in EGFR-mutated advanced NSCLC patients with positive ctDNA after lead-in osimertinib monotherapy (Cohort 1). Patients screened to be with negative ctDNA after lead-in osimertinib will be prospectively enrolled in a real-world cohort to observe PFS on continued osimertinib monotherapy (Cohort 2).
Approximately 120 eligible patients are planned to undergo tumor assessment and ctDNA testing upon completion of one cycle (3~5 weeks per cycle) treatment with osimertinib (obtained commercially at the standard dose of 80mg orally daily). Patients without disease progression assessed by imaging will be enrolled into different study cohorts based on ctDNA test results.
Only patients who test positive for ctDNA will be enrolled in Cohort 1 of the clinical study to receive the combinational treatment of intravenous sac-TMT at a fixed dose of 4mg/kg every 2 weeks plus oral osimertinib also at a fixed dose of 80mg daily until disease progression, death, unacceptable toxicity, or another treatment discontinuation criterion is met, whichever occurs first.
Patients who test negative for ctDNA will continue to receive osimertinib monotherapy and be prospectively enrolled in observational Cohort 2. In this observational cohort, treatments and treatment-related data collection are at the discretion of physicians.
- Conditions
- Non Small Cell Lung Cancer
- Being tested
- Osimertinib + Sacituzumab Tirumotecan, Osimertinib
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Osimertinib + Sacituzumab TirumotecanDrug
Osimertinib (80mg QD) + Sacituzumab Tirumotecan (4 mg/m2) on Day 1 and Day 8 of 28-day cycles (4 mg/m2 Q2W).
OsimertinibDrug
Osimertinib (80mg QD)
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1: （experimental cohort）Osimertinib + Sacituzumab Tirumotecan | Experimental | Drug: Osimertinib/Sacituzumab Tirumotecan. Osimertinib (80mg QD) + Sacituzumab Tirumotecan (4 mg/m2) on Day 1 and Day 8 of 28-day cycles (4 mg/m2 Q2W). Receives: Drug: Osimertinib + Sacituzumab Tirumotecan |
| Cohort 2: （observational cohort）Osimertinib monotherapy | Active comparator | Drug: Osimertinib •Osimertinib (80mg QD). Receives: Drug: Osimertinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free Survival (PFS) in Cohort 1, Assessed by Investigator
PFS is defined as time from the date of start of combinational treatment until the date of disease progression per RECIST 1.1, as assessed by investigator, or death due to any cause.
Measured: From date of start of combinational treatment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 months.
Secondary outcomes (5)
Overall Response Rate (ORR) in Cohort 1, Assessed by Investigator
ORR is defined as the percentage of subjects who have a best overall response of Complete Response (CR) or Partial Response (PR) per RECIST 1.1 as assessed by the Investigator.
Measured: Tumour assessments will be conducted according to the RECIST v1.1, with valuations performed every six weeks during the first year after first dose and every 12 weeks thereafter, up to 36 months.
Disease Control Rate (DCR) in Cohort 1, Assessed by Investigator
DCR is defined as the percentage of subjects who have a best overall response of Complete Response (CR) or Partial Response (PR) or Stable Disease (SD) per RECIST 1.1 as assessed by the Investigator.
Measured: Tumour assessments will be conducted according to the RECIST v1.1, with valuations performed every six weeks during the first year after first dose and every 12 weeks thereafter, up to 36 months.
Overall Survival (OS) in Cohort 1
OS is defined as the time from the date of start of combinational treatment until the date of death due to any cause.
Measured: From date of start of combinational treatment until the date of death from any cause, assessed up to 36 months
Adverse Events in Cohort 1
The number of patients with adverse events and the severity according to CTCAE v5.0.
Measured: From the start of study drug to 30 days after the last dose of study drug
Progression-free survival in Cohort 2, Assessed by Investigator
PFS is defined as time from the date of start of treatment until the date of disease progression per RECIST 1.1, as assessed by investigator, or death due to any cause.
Measured: From date of start of treatment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2026
- Study start15 Dec 2025
- Primary completion30 Jun 2028 (estimated)
- Study completion30 Dec 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 CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guangdong Association of Clinical Trials
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07375316
- Sponsor's protocol ID
- CTONG2509
- Status last verified
- Apr 2026
- First submitted
- 6 Jan 2026
- Last updated
- 26 May 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 26 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A ctDNA-guided Phase II Trial of Osimertinib in Combination With Sacituzumab Tirumotecan in EGFR-mutated Advanced NSCLC Patients With Positvie ctDNA After lead-in Osimertinib Monotherapy
- ClinicalTrials.gov ID
- NCT07375316
- Acronym / sponsor ID
- CTONG2509
- Conditions
- Non Small Cell Lung Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Guangdong Association of Clinical TrialsUniversity, hospital or other
- Study start
- 15 Dec 2025 (actual)
- Primary completion
- 30 Jun 2028 (estimated)
- Study completion
- 30 Dec 2028 (estimated)
- First posted
- 29 Jan 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.
EGFR-mutated advanced NSCLC patients without ctDNA clearance after lead-in osimertinib monotherapy have inferior PFS compared with those with ctDNA clearance. Consequently, these patients might need an intensified therapeutic strategy, such as osimertinib combined with chemotherapy or ADC. This study aims to explore the efficacy and safety of osimertinib in combination with sacituzumab tirumotecan adaptively in EGFR-mutated advanced NSCLC patients with positive ctDNA after lead-in osimertinib monotherapy.
Detailed description
This is an investigator-initiated, multicenter, ctDNA-guided phase II study to evaluate the efficacy and safety of osimertinib in combination with sacituzumab tirumotecan adaptively in EGFR-mutated advanced NSCLC patients with positive ctDNA after lead-in osimertinib monotherapy (Cohort 1). Patients screened to be with negative ctDNA after lead-in osimertinib will be prospectively enrolled in a real-world cohort to observe PFS on continued osimertinib monotherapy (Cohort 2).
Approximately 120 eligible patients are planned to undergo tumor assessment and ctDNA testing upon completion of one cycle (3~5 weeks per cycle) treatment with osimertinib (obtained commercially at the standard dose of 80mg orally daily). Patients without disease progression assessed by imaging will be enrolled into different study cohorts based on ctDNA test results.
Only patients who test positive for ctDNA will be enrolled in Cohort 1 of the clinical study to receive the combinational treatment of intravenous sac-TMT at a fixed dose of 4mg/kg every 2 weeks plus oral osimertinib also at a fixed dose of 80mg daily until disease progression, death, unacceptable toxicity, or another treatment discontinuation criterion is met, whichever occurs first.
Patients who test negative for ctDNA will continue to receive osimertinib monotherapy and be prospectively enrolled in observational Cohort 2. In this observational cohort, treatments and treatment-related data collection are at the discretion of physicians.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort 1: （experimental cohort）Osimertinib + Sacituzumab Tirumotecan | Experimental | Drug: Osimertinib + Sacituzumab TirumotecanDrug: Osimertinib/Sacituzumab Tirumotecan. Osimertinib (80mg QD) + Sacituzumab Tirumotecan (4 mg/m2) on Day 1 and Day 8 of 28-day cycles (4 mg/m2 Q2W). |
| Cohort 2: （observational cohort）Osimertinib monotherapy | Active comparator | Drug: OsimertinibDrug: Osimertinib •Osimertinib (80mg QD). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Age ≥18 years at the time of signing the Informed Consent Form (ICF), regardless of gender;
- Histologically or cytologically confirmed locally advanced (stage IIIB/IIIC) or metastatic (Stage IV) non-squamous NSCLC not amenable to radical surgery and/or radical radiotherapy (regardless of concurrent/sequential chemotherapy) (according to TNM staging of lung cancer published by the Union for International Cancer Control and American Joint Committee on Cancer (UICC/AJCC), 8th edition);
- Presence of sensitizing EGFR mutation (exon 19 deletion and/or L858R);
- Completion of 3~5-week first-line treatment with osimertinib monotherapy. Non-PD as assessed by investigator per RECIST v1.1, and willing to undergo ctDNA testing (patients with positive ctDNA test results will be enrolled in Cohort 1; patients with negative ctDNA test results will be enrolled in observational Cohort 2);
- ≥1 measurable target lesion per RECIST v1.1;
Key exclusion criteria (35 listed)
- For NSCLC, histologically or cytologically confirmed squamous cell carcinoma component or presence of coexisting small cell lung cancer, neuroendocrine carcinoma, or carcinosarcoma component;
- Known presence of meningeal metastases, brainstem metastases, spinal cord metastases and/or compression, and active brain metastases. Patients with asymptomatic, focal leptomeningeal metastases on contrast-enhanced MRI may be eligible if, in the investigator's opinion, no local therapy or dehydration/symptomatic treatment is required;
- Prior treatment with systemic anti-tumor therapy for locally advanced or metastatic NSCLC other than osimertinib;
- Prior treatment with any TROP2-targeted therapy or any therapy that targets topoisomerase I (including ADCs);
- Other malignancies (except cured local tumors, such as basal cell carcinoma of skin, squamous cell carcinoma of skin, carcinoma in situ of the cervix) within 3 years prior to enrollment;
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 |
|---|---|---|
| Osimertinib + Sacituzumab TirumotecanOsimertinib (80mg QD) + Sacituzumab Tirumotecan (4 mg/m2) on Day 1 and Day 8 of 28-day cycles (4 mg/m2 Q2W). | Drug | Cohort 1: （experimental cohort）Osimertinib + Sacituzumab Tirumotecan |
| OsimertinibOsimertinib (80mg QD) | Drug | Cohort 2: （observational cohort）Osimertinib monotherapy |
Primary outcome
Progression-free Survival (PFS) in Cohort 1, Assessed by Investigator
Time frame: From date of start of combinational treatment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 months.
PFS is defined as time from the date of start of combinational treatment until the date of disease progression per RECIST 1.1, as assessed by investigator, or death due to any cause.
5 secondary outcomes
Overall Response Rate (ORR) in Cohort 1, Assessed by Investigator
Time frame: Tumour assessments will be conducted according to the RECIST v1.1, with valuations performed every six weeks during the first year after first dose and every 12 weeks thereafter, up to 36 months.
Disease Control Rate (DCR) in Cohort 1, Assessed by Investigator
Time frame: Tumour assessments will be conducted according to the RECIST v1.1, with valuations performed every six weeks during the first year after first dose and every 12 weeks thereafter, up to 36 months.
Overall Survival (OS) in Cohort 1
Time frame: From date of start of combinational treatment until the date of death from any cause, assessed up to 36 months
Adverse Events in Cohort 1
Time frame: From the start of study drug to 30 days after the last dose of study drug
Progression-free survival in Cohort 2, Assessed by Investigator
Time frame: From date of start of treatment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 months
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 26 May 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.
Yi-Chen Zhang contact
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Osimertinib + Sacituzumab Tirumotecan and Osimertinib in people with Non Small Cell Lung Cancer, run by Guangdong Association of Clinical Trials at 4 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 13 inclusion and 35 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: looking for participants now, as of the sponsor's last update on 26 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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.
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?
Contact Qing Zhou (+51221 862083827812, gzzhouqing@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free Survival (PFS) in Cohort 1, Assessed by Investigator (time frame: From date of start of combinational treatment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 months.). 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 26 May 2026.