Non-small Cell Lung CancerPhase 3NCT05204628
A Study to Evaluate and Compare the Efficacy and Safety of XZP-3621 Versus Crizotinib
A Phase 3 study testing XZP-3621 and Crizotinib in people with Non-small Cell Lung Cancer, run by Xuanzhu Biopharmaceutical Co., Ltd. at 1 site in China.
Trial summary
This randomized, multicenter, Phase III, open-label study will evaluate the efficacy and safety of XZP-3621 versus crizotinib and to evaluate the pharmacokinetics of XZP-3621 in Chinese participants with treatment-naive ALK-positive advanced NSCLC. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Non-small Cell Lung Cancer
- What is being tested?
- XZP-3621 and Crizotinib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 238 participants
- Where
- 1 siteChina
- Study dates
- 7 Feb 2022to 1 Jul 2025
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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
- Patients must be 18-75 years-of-age;
- Patients with Histologically or cytologically confirmed diagnosis of advanced or recurrent (Stage IIIB and IIIC not amenable for multimodality treatment) or metastatic (Stage IV) NSCLC that is ALK-positive where ALK status is determined by the NMPA-approved (for use in China) Ventana (D5F3) immunohistochemistry (IHC) test or FISH or PCR or NGS, Sufficient tumor tissue available to perform ALK status is required if not determined.
- Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) score of 0 to 2;
- Life expectancy of at least 12 weeks;
- Ability to swallow and retain oral medication;
- Adequate organ system function, defined as follows:
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- Absolute neutrophil count (ANC) ≥1.5 x 109/L; Platelets ≥100 x 109/L; Hemoglobin ≥9 g/dL (≥90 g/L)
- Total bilirubin ≤1.5 times the upper limit of normal (ULN); Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5 *ULN if no liver involvement or ≤5 * ULN with liver involvement.
- Creatinine < 1.5 *ULN. If >1.5 * ULN, patient may still be eligible if calculated creatinine clearance >50 mL/min (0.83mL/s) as calculated by the Cockcroft-Gault method.
- No prior systemic treatment for advanced or recurrent NSCLC (Stage IIIB and IIIC not amenable for multimodality treatment) or metastatic (Stage IV) NSCLC
- Tumor Requirements: At least 1 extracranial measurable target lesion per RECIST v. 1.1 that has not been previously irradiated.
- Serum pregnancy test (for females of childbearing potential) negative at screening.
- Ability to understand the nature of this trial and give written informed consent.
Who cannot join
- Patients who meet any of the following criteria will be excluded from study entry:
- Patients with a previous malignancy within the past 3 years are excluded (other than curatively treated basal cell carcinoma of the skin, early gastrointestinal (GI) cancer by endoscopic resection, in situ carcinoma of the cervix, or any cured cancer that is considered to have no impact in PFS and OS for the current NSCLC).
- Any GI disorder that may affect absorption of oral medications, such as mal-absorption syndrome or status post-major bowel resection ;
- Active and clinically significant bacterial, fungal, or viral infection including hepatitis B virus (HBV) or hepatitis C virus (HCV) (eg, in case of known HBsAg or HCV antibody positivity), known human immunodeficiency virus (HIV), or acquired immunodeficiency syndrome (AIDS)-related illness;
- Clinically significant vascular (both arterial and venous) and non-vascular cardiac conditions, (active or within 3 months prior to enrollment), which may include, but are not limited to:
- Arterial disease such as cerebral vascular accident/stroke (including Transient Ischemic Attack -TIA), myocardial infarction, unstable angina;
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- Venous diseases such as cerebral venous thrombosis, symptomatic pulmonary embolism;
- Non-vascular cardiac disease such as congestive heart failure (New York Heart Association Classification Class ≥ II), second-degree or third-degree AV block (unless paced) or any AV block with PR >220 msec; or ongoing cardiac dysrhythmias of NCI CTCAE Grade ≥2, uncontrolled atrial fibrillation of any grade, bradycardia defined as <50 bpm (unless patient is otherwise healthy such as long-distance runners, etc.), machine-read Electrocardiogram (ECG) with QTc >470 msec, or congenital long QT syndrome;
- Patients with predisposing characteristics for acute pancreatitis according to investigator judgment (eg, uncontrolled hyperglycemia, current gallstone disease) in the last month prior to randomization;
- History of extensive, disseminated, bilateral or presence of Grade 3 or 4 interstitial fibrosis or interstitial lung disease including a history of pneumonitis, hypersensitivity pneumonitis, interstitial pneumonia, interstitial lung disease, obliterative bronchiolitis, and pulmonary fibrosis;
- Concurrent use of known strong CYP3A4 inhibitors and inducers (consult the sponsor if in doubt whether a food or a drug falls into any of the above categories) within 7 days prior to the first dose of XZP-3621 or crizotinib.
- Participation in other studies involving investigational drug(s) within 2 weeks prior to study entry and/or during study participation;
- Pregnant female patients; breastfeeding female patients;
- History of organ transplant;
- Co-administration of anti-cancer therapies other than those administered in this study;
- Baseline QTc>470ms ;
- History of hypersensitivity to any of the additives in the XZP-3621 or crizotinib drug formulation;
- Any psychological condition that potentially hampers compliance with the study protocol requirements or follow-up procedures; this condition should be discussed with the participant before study entry.
Trial locations and contacts
1 site in 1 country.
China1 site
Jilin Province Cancer Hospital
Changchun, Jilin, 132000
Ying Cheng, MD, +860431-80596315, 1165095416@qq.com
About this study
Official title: Randomized Multicenter Phase III Open-Label Study to Evaluate and Compare the Efficacy and Safety of XZP-3621 Versus Crizotinib in Chinese Patients With Treatment-Naive Anaplastic Lymphoma Kinase-Positive Advanced Non-Small Cell Lung Cancer
This randomized, multicenter, Phase III, open-label study will evaluate the efficacy and safety of XZP-3621 versus crizotinib and to evaluate the pharmacokinetics of XZP-3621 in Chinese participants with treatment-naive ALK-positive advanced NSCLC. Participants will be randomized 1:1 into one of the two treatment groups to receive either XZP-3621 (500 milligrams [mg] once daily [QD]) or crizotinib (250 mg BID) orally, respectively.
Read the detailed description
This is a randomized, active controlled, multicenter Phase III open-label study in patients with treatment-naive ALK-positive advanced NSCLC. Patients will be randomized 1:1 into one of the two treatment arms to receive either XZP-3621 or crizotinib. The primary endpoint of the study is investigator-assessed PFS.
Central randomization will be performed via a web-based response system using the following stratification factors: chemotherapy (yes vs. no) and CNS metastases at baseline (yes vs. no).
The experimental arm will receive XZP-3621 at 500 mg orally once daily (QD), taken with food. The control arm will receive crizotinib at 250 mg orally BID, taken with or without food.
Patients will be treated until disease progression, unacceptable toxicity, withdrawal of consent, or death. After disease progression (as per RECIST v1.1), patients should discontinue the study medication. After disease progression, patients will be treated at the discretion of the investigator according to local practice. Information regarding the nature and the duration of subsequent therapies will be collected.
- Conditions
- Non-small Cell Lung Cancer
- Being tested
- XZP-3621, Crizotinib
- Keywords
- XZP-3621, Crizotinib
- 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.
XZP-3621Drug
XZP-3621 tablets will be administered orally at a dose of 500 mg QD until disease progression, unacceptable toxicity withdrawal of consent, or death, whichever occurred first.
CrizotinibDrug
Crizotinib capsules will be administered orally at a dose of 250 mg BID until disease progression, unacceptable toxicity withdrawal of consent, or death, whichever occurred first.
| Study group | Role | What they receive |
|---|---|---|
| XZP-3621 | Experimental | Participants will receive XZP-3621 tablets orally at a dose of 500 mg QD with food until disease progression, unacceptable toxicity withdrawal of consent, or death, whichever occurred first. Receives: Drug: XZP-3621 |
| Crizotinib | Active comparator | Participants will receive crizotinib capsules orally at a dose of 250 mg BID with or without food until disease progression, unacceptable toxicity withdrawal of consent, or death, whichever occurred first. Receives: Drug: Crizotinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-Free Survival (PFS)
PFS was defined as the time (in months) from randomization to the first documentation of disease progression, as determined by investigators using Response Evaluation Criteria in Solid Tumor (RECIST) v1.1 or to death from any cause, whichever occurred first.
Measured: From the date of randomization to the date of the first documented disease progression or death, whichever occurred first (up to overall period of approximately 30 months)
Secondary outcomes (12)
Progression-Free Survival (PFS)
PFS was defined as the time (in months) from randomization to the first documentation of disease progression, as Determined by Blind Independent Central Review(BICR)Using RECISTv1.1., or to death from any cause, whichever occurred first.
Measured: From the date of randomization to the date of the first documented disease progression or death, whichever occurred first (up to overall period of approximately 30 months).
Overall Survival (OS)
OS defined as time from date of randomization to date of death due to any cause, as Determined by the investigator and Blind Independent Central Review (BICR) Using RECISTv1.1
Measured: From randomization until death (up to approximately 30 months).
Overall Response Rate (ORR)
ORR defined as the proportion of patients with a best overall response defined as Complete Response (CR) or Partial Response (PR) as evaluated by Blinded Independent Central Review (BICR) and by investigator assessment per RECIST 1.1
Measured: From randomization until death (up to approximately 30 months)
Duration of Response (DOR)
DOR defined as the time from date of first documented CR or PR to date of first documented disease progression or death due to any cause
Measured: From randomization until death (up to approximately 30 months)
Disease Control Rate (DCR)
DCR defined as the proportion of patients with best overall response of CR, PR, or Stable Disease (SD)
Measured: Baseline, Week 8, thereafter every 8 weeks until disease progression, death or withdrawal from the study (up to overall period of approximately 30 months)
Intracranial Objective Response Rate (IC-ORR)
IC-ORR as Determined by BICR and investigator Using Response Assessment in Neuro-Oncology Brain Metastases (RANO-BM)
Measured: Baseline, Week 8, thereafter every 8 weeks until disease progression, death or withdrawal from the study (up to overall period of approximately 30 months)
Intracranial Duration of Response (IC-DoR)
IC-ORR as Determined by BICR and investigator Using Response Assessment in Neuro-Oncology Brain Metastases (RANO-BM)
Measured: Baseline, Week 8, thereafter every 8 weeks until disease progression, death or withdrawal from the study (up to overall period of approximately 30 months)
Area Under the Plasma Concentration-time Curve (AUC) of XZP-3621 and Its Metabolite
AUC was collected for both XZP-3621 and its major metabolite, and was based on their concentrations in plasma over time.
Measured: Pre-dose (within 1 hour before XZP-3621), 4 hours post-dose at first dosing day and Week 4; Pre-dose (within 1 hour) at Week 8,12,16 (up to 4 months)
Maximum Plasma Concentration Observed (Cmax) of XZP-3621 and Its Metabolite
Cmax was collected for both XZP-3621 and its major metabolite, and was based on their concentrations in plasma over time.
Measured: Pre-dose (within 1 hour before XZP-3621), 4 hours post-dose at first dosing day and Week 4; Pre-dose (within 1 hour) at Week 8,12,16 (up to 4 months)
Time to Deterioration by EORTC Quality of Life Questionnaire Lung Cancer Module 13 (LC13)
The EORTC QLQ-LC13 module generated one multiple-item scale score assessing dyspnea and a series of single item scores assessing chest pain, arm/shoulder pain, pain in other parts, coughing, sore mouth, dysphagia, peripheral neuropathy, alopecia, and hemoptysis. All the scales and single-item scores were linearly transformed so that each score ranged from 0 to 100. A higher score on the global health and functioning subscales is indicative of better functioning. Confirmed clinically meaningful deterioration in lung cancer symptoms is defined as a >or=10-point increase from baseline in a symptom score that must be held for at least two consecutive assessments or an initial >or=10-point increase above baseline followed by death within 5 weeks from the last assessment.
Measured: Baseline, Week 4, thereafter every 4 weeks until disease progression, death or withdrawal from the study and 2 weeks after permanent discontinuation (up to overall period of approximately 30 months)
Change From Baseline in Global Health Status/Quality of Life as Assessed by EORTC QLQ-C30
HRQoL: perceived quality of participant's life, includes self-reported multidimensional measures of physical and mental health. Patient-reported symptoms (PROs) and HRQoL will be collected by administering the european organisation for research and treatment of cancer (EORTC) quality of life (QLQ)-C30 questionnaire. EORTC-QLQ-C30 contains 30 items across 5 functional scales (physical, role, cognitive, emotional, and social), 9 symptom scales (fatigue, nausea and vomiting, pain, dyspnea, sleep disturbance, appetite loss, constipation, diarrhea, and financial difficulties) and a global health status/QOL scale. The 30 items have 4 response levels (not at all, a little, quite a bit, and very much), with 2 questions relying on a 7-point numeric rating scale. Raw scores are converted into overall score ranging from 0 to 100, where lower scores indicate better QOL. A negative change from Baseline indicates improvement.
Measured: Baseline, Week 4, thereafter every 4 weeks until disease progression, death or withdrawal from the study and 4 weeks after permanent discontinuation (up to overall period of approximately 30 months)
Percentage of Participants with Non-serious Adverse Events and Serious Adverse Events
Percentage of Participants with Non-serious, Adverse Events and Serious Adverse Events. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product
Measured: Up to overall period of approximately 30 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2022
- Study start7 Feb 2022 (estimated)
- Primary completion7 May 2025 (estimated)
- Study completion1 Jul 2025 (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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 238 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xuanzhu Biopharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ying Cheng, MD, Principal investigator, Jilin Province Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05204628
- Sponsor's protocol ID
- XZP-3621-3001
- Status last verified
- Nov 2021
- First submitted
- 20 Dec 2021
- Last updated
- 24 Jan 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Multicenter Phase III Open-Label Study to Evaluate and Compare the Efficacy and Safety of XZP-3621 Versus Crizotinib in Chinese Patients With Treatment-Naive Anaplastic Lymphoma Kinase-Positive Advanced Non-Small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT05204628
- Acronym / sponsor ID
- XZP-3621-3001
- Conditions
- Non-small Cell Lung Cancer
- Keywords
- XZP-3621, Crizotinib
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 238 participants (estimated)
- Lead sponsor
- Xuanzhu Biopharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 7 Feb 2022 (estimated)
- Primary completion
- 7 May 2025 (estimated)
- Study completion
- 1 Jul 2025 (estimated)
- First posted
- 24 Jan 2022 (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 randomized, multicenter, Phase III, open-label study will evaluate the efficacy and safety of XZP-3621 versus crizotinib and to evaluate the pharmacokinetics of XZP-3621 in Chinese participants with treatment-naive ALK-positive advanced NSCLC. Participants will be randomized 1:1 into one of the two treatment groups to receive either XZP-3621 (500 milligrams [mg] once daily [QD]) or crizotinib (250 mg BID) orally, respectively.
Detailed description
This is a randomized, active controlled, multicenter Phase III open-label study in patients with treatment-naive ALK-positive advanced NSCLC. Patients will be randomized 1:1 into one of the two treatment arms to receive either XZP-3621 or crizotinib. The primary endpoint of the study is investigator-assessed PFS.
Central randomization will be performed via a web-based response system using the following stratification factors: chemotherapy (yes vs. no) and CNS metastases at baseline (yes vs. no).
The experimental arm will receive XZP-3621 at 500 mg orally once daily (QD), taken with food. The control arm will receive crizotinib at 250 mg orally BID, taken with or without food.
Patients will be treated until disease progression, unacceptable toxicity, withdrawal of consent, or death. After disease progression (as per RECIST v1.1), patients should discontinue the study medication. After disease progression, patients will be treated at the discretion of the investigator according to local practice. Information regarding the nature and the duration of subsequent therapies will be collected.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| XZP-3621 | Experimental | Drug: XZP-3621Participants will receive XZP-3621 tablets orally at a dose of 500 mg QD with food until disease progression, unacceptable toxicity withdrawal of consent, or death, whichever occurred first. |
| Crizotinib | Active comparator | Drug: CrizotinibParticipants will receive crizotinib capsules orally at a dose of 250 mg BID with or without food until disease progression, unacceptable toxicity withdrawal of consent, or death, whichever occurred first. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Patients must be 18-75 years-of-age;
- Patients with Histologically or cytologically confirmed diagnosis of advanced or recurrent (Stage IIIB and IIIC not amenable for multimodality treatment) or metastatic (Stage IV) NSCLC that is ALK-positive where ALK status is determined by the NMPA-approved (for use in China) Ventana (D5F3) immunohistochemistry (IHC) test or FISH or PCR or NGS, Sufficient tumor tissue available to perform ALK status is required if not determined.
- Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) score of 0 to 2;
- Life expectancy of at least 12 weeks;
- Ability to swallow and retain oral medication;
Key exclusion criteria (18 listed)
- Patients with a previous malignancy within the past 3 years are excluded (other than curatively treated basal cell carcinoma of the skin, early gastrointestinal (GI) cancer by endoscopic resection, in situ carcinoma of the cervix, or any cured cancer that is considered to have no impact in PFS and OS for the current NSCLC).
- Any GI disorder that may affect absorption of oral medications, such as mal-absorption syndrome or status post-major bowel resection ;
- Active and clinically significant bacterial, fungal, or viral infection including hepatitis B virus (HBV) or hepatitis C virus (HCV) (eg, in case of known HBsAg or HCV antibody positivity), known human immunodeficiency virus (HIV), or acquired immunodeficiency syndrome (AIDS)-related illness;
- Clinically significant vascular (both arterial and venous) and non-vascular cardiac conditions, (active or within 3 months prior to enrollment), which may include, but are not limited to:
- Patients with predisposing characteristics for acute pancreatitis according to investigator judgment (eg, uncontrolled hyperglycemia, current gallstone disease) in the last month prior to randomization;
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 |
|---|---|---|
| XZP-3621XZP-3621 tablets will be administered orally at a dose of 500 mg QD until disease progression, unacceptable toxicity withdrawal of consent, or death, whichever occurred first. | Drug | XZP-3621 |
| CrizotinibCrizotinib capsules will be administered orally at a dose of 250 mg BID until disease progression, unacceptable toxicity withdrawal of consent, or death, whichever occurred first. | Drug | Crizotinib |
Primary outcome
Progression-Free Survival (PFS)
Time frame: From the date of randomization to the date of the first documented disease progression or death, whichever occurred first (up to overall period of approximately 30 months)
PFS was defined as the time (in months) from randomization to the first documentation of disease progression, as determined by investigators using Response Evaluation Criteria in Solid Tumor (RECIST) v1.1 or to death from any cause, whichever occurred first.
12 secondary outcomes
Progression-Free Survival (PFS)
Time frame: From the date of randomization to the date of the first documented disease progression or death, whichever occurred first (up to overall period of approximately 30 months).
Overall Survival (OS)
Time frame: From randomization until death (up to approximately 30 months).
Overall Response Rate (ORR)
Time frame: From randomization until death (up to approximately 30 months)
Duration of Response (DOR)
Time frame: From randomization until death (up to approximately 30 months)
Disease Control Rate (DCR)
Time frame: Baseline, Week 8, thereafter every 8 weeks until disease progression, death or withdrawal from the study (up to overall period of approximately 30 months)
Intracranial Objective Response Rate (IC-ORR)
Time frame: Baseline, Week 8, thereafter every 8 weeks until disease progression, death or withdrawal from the study (up to overall period of approximately 30 months)
Intracranial Duration of Response (IC-DoR)
Time frame: Baseline, Week 8, thereafter every 8 weeks until disease progression, death or withdrawal from the study (up to overall period of approximately 30 months)
Area Under the Plasma Concentration-time Curve (AUC) of XZP-3621 and Its Metabolite
Time frame: Pre-dose (within 1 hour before XZP-3621), 4 hours post-dose at first dosing day and Week 4; Pre-dose (within 1 hour) at Week 8,12,16 (up to 4 months)
Maximum Plasma Concentration Observed (Cmax) of XZP-3621 and Its Metabolite
Time frame: Pre-dose (within 1 hour before XZP-3621), 4 hours post-dose at first dosing day and Week 4; Pre-dose (within 1 hour) at Week 8,12,16 (up to 4 months)
Time to Deterioration by EORTC Quality of Life Questionnaire Lung Cancer Module 13 (LC13)
Time frame: Baseline, Week 4, thereafter every 4 weeks until disease progression, death or withdrawal from the study and 2 weeks after permanent discontinuation (up to overall period of approximately 30 months)
Change From Baseline in Global Health Status/Quality of Life as Assessed by EORTC QLQ-C30
Time frame: Baseline, Week 4, thereafter every 4 weeks until disease progression, death or withdrawal from the study and 4 weeks after permanent discontinuation (up to overall period of approximately 30 months)
Percentage of Participants with Non-serious Adverse Events and Serious Adverse Events
Time frame: Up to overall period of approximately 30 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2022.
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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.
Ying Cheng, MD principal investigator
Jilin Province Cancer Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing XZP-3621 and Crizotinib in people with Non-small Cell Lung Cancer, run by Xuanzhu Biopharmaceutical Co., Ltd. at 1 site 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 18 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: status not confirmed, as of the sponsor's last update on 24 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Chao Li (+86-18566662772, lichao@xuanzhubio.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) (time frame: From the date of randomization to the date of the first documented disease progression or death, whichever occurred first (up to overall period of approximately 30 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 24 Jan 2022.