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Trial Title:
A Study of XZP-3621 in Chinese Patients With ALK Positive NSCLC
NCT ID:
NCT05482087
Condition:
ALK-positive NSCLC
Conditions: Keywords:
XZP-3621
ALK-positive NSCLC
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Not yet recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
XZP-3621
Description:
ALK inhibitor-treated ALK-positive NSCLC treatment
Arm group label:
XZP-3621
Summary:
This was a single-arm, open-label, multicenter, phase II study to evaluate the efficacy
and safety of the ALK inhibitor XZP-3621 when used as single agent in patients with
ALK-rearranged stage IIIB, IIIC or IV NSCLC previously treated with other ALK inhibitors
or non-previously treated.
Detailed description:
This is a Phase 2, China only, multi center, open label, three cohorts study, in ALK
positive locally advanced or metastatic NSCLC patients will be enrolled to receive
XZP-3621 monotherapy.
(in Cohort 1) Treatment-Naive with any ALK inhibitor. (in Cohort 2) Disease progression
after crizotinib as the only ALK inhibitor. (in Cohort 3) Disease progression after other
ALK inhibitors,including or not including crizotinib previously treated.
The patients will receive XZP-3621 at 500 mg orally once daily (QD), taken with
food.Patients will be treated until disease progression, unacceptable toxicity,
withdrawal of consent, or death, whichever occurred first. 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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Patients must be 18-75 years-of-age;
2. 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
Ventana immunohistochemistry (IHC) test or FISH or PCR or NGS,Sufficient tumor
tissue available to perform ALK status is required if not determined.
3. Subject should have:
(in Cohort 1) Treatment-Naive with any ALK inhibitor. (in Cohort 2) Disease
progression after crizotinib as the only ALK inhibitor. (in Cohort 3) Disease
progression after other ALK inhibitors,including or not including crizotinib
previously treated.
4. Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) score of 0 to 2;
5. All Subjects must have at least 1 measurable extracranial target lesion according to
RECIST v1.1 that has not been previously irradiated.
6. CNS metastases are allowed if:
1. Asymptomatic: either untreated and not currently requiring corticosteroid
treatment, or
2. Previously diagnosed and treatment has been completed with full recovery from
the acute effects of radiation therapy or surgery prior to enrollment, and if
corticosteroid treatment for these metastases has been withdrawn for at least 4
weeks with neurological stability.
3. Such cases are not be allowed,such as leptomeningeal disease (LMD) or
carcinomatous meningitis (CM) if visualized on magnetic resonance imaging
(MRI), or if baseline CSF positive cytology is available .
7. Have recovered from toxicities related to prior anticancer therapy to national
cancer institute common terminology criteria for adverse events (NCI CTCAE) v5.0
grade less than or equal to (<=)2. (Note: treatment-related alopecia and AEs that in
the investigator's judgment do not constitute a safety risk for the subject are
allowed.)
8. Prior chemotherapy and radiotherapy (other than palliative) must be completed at
least 4 weeks prior to initial administration; Palliative radiotherapy must be
completed 1 week prior to initial administration.
9. Patients treated with any ALK inhibitor must be discontinued for ≥5 half-life or 14
days, whichever is longer, before XZP-3621 tablets are first administered;
10. Life expectancy of at least 12 weeks;
11. Adequate organ system function, defined as follows:
1. Absolute neutrophil count (ANC) ≥1.5 x 109/L; Platelets ≥100 x 109/L;Hemoglobin
≥9 g/dL (≥90 g/L)
2. 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.
3. 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.
12. Serum pregnancy test (for females of childbearing potential) negative at screening.
13. Ability to understand the nature of this trial and give written informed consent.
Exclusion Criteria:
- Patients who meet any of the following criteria will be excluded from study entry:
1. Combined with small cell lung cancer;
2. Uncontrolled malignant pleural/peritoneal effusion and/or pericardial effusion
(uncontrolled means that the effusion increases significantly within one week
after extraction and has obvious symptoms requiring further puncture or other
intervention) ;
3. Patients with a previous malignancy within the past 5 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.);
4. Previous treatment history of organ transplantation, hematopoietic stem cell or
bone marrow transplantation;
5. Patient has had major surgery within 4 weeks prior (2 weeks for resection of
brain metastases) to the first dose of study drug or has not recovered from
side effects of such procedure;
6. 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);
7. Known human immunodeficiency virus (HIV);
8. Clinically active infections affecting the safety of subjects, including active
tuberculosis;
9. Uncontrolled hyperglycemia;
10. Subject with predisposing characteristics for acute pancreatitis according to
investigator judgment, including but not limited to current gallstone
disease,history of pancreatitis or history of increased amylase or lipase that
was due to pancreatic disease within 28 days of initial administration;
11. Subject with uncontrolled electrolyte disturbances (e.g., low calcium, low
magnesium, or hypokalemia) that are identified by investigator;
12. Unable to swallow;
13. 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;
14. 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:
1. Arterial disease such as cerebral vascular accident/stroke (including
Transient Ischemic Attack -TIA), myocardial infarction, unstable angina;
2. Venous diseases such as cerebral venous thrombosis, symptomatic pulmonary
embolism;
3. 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;
15. Uncontrolled hypertension defined by a Systolic Blood Pressure (SBP) ≥ 150 mm
Hg and/or Diastolic Blood Pressure (DBP) ≥ 95 mm Hg;
16. Patient has impairment of GI function or GI disease that may significantly
alter the absorption of XZP-3621 (e.g., ulcerative diseases, uncontrolled
nausea, vomiting, diarrhea, or malabsorption syndrome);
17. Patient receiving treatment with medications that meet one of the following
criteria and that cannot be discontinued at least 14 days prior to the start of
treatment with XZP-3621 and for the duration of the study;
- Strong inhibitors or strong inducers of CYP3A4.
- Medications with a known risk of prolonging the QT interval or inducing
Torsades de Pointes.
18. Participation in other studies involving investigational drug(s) within 28 days
prior to study entry and/or during study participation;
19. Pregnant female patients; breastfeeding female patients;
20. History of hypersensitivity to any of the additives in the XZP-3621 or
crizotinib drug formulation;
21. Other severe acute or chronic medical or psychiatric condition, including
recent (within the past year) or active suicidal ideation or behavior;
22. laboratory abnormality that may increase the risk associated with study
participation or investigational product administration or may interfere with
the interpretation of study results and, in the judgment of the investigator
and/or the sponsor, would make the subject inappropriate for entry into this
study.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Jilin Province Cancer Hospital
Address:
City:
Jilin
Zip:
130000
Country:
China
Contact:
Last name:
Ying Cheng, MD
Phone:
86431-80596315
Email:
1165095416@qq.com
Start date:
September 2022
Completion date:
July 1, 2025
Lead sponsor:
Agency:
Xuanzhu Biopharmaceutical Co., Ltd.
Agency class:
Industry
Source:
Xuanzhu Biopharmaceutical Co., Ltd.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05482087