A Study of XZP-3621 in Chinese Patients With ALK Positive NSCLC

NCT05482087 | Unknown Phase 2

• 1 other identifier: XZP-3621-2001
• Study Type: interventional
• Target: 190
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

ALK-positive NSCLC

Keywords

XZP-3621; ALK-positive NSCLC

Outcome Measures

Primary Outcomes (1)

• Overall Response Rate(ORR)

  ORR was defined as the proportion of patients with a best overall response defined as Complete Response (CR) or Partial Response (PR) as evaluated by investigator assessment per RECIST 1.1.CR was defined as the disappearance of all target lesions. PR was defined as a \>=30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions.

  From Cycle 1 Day 1 to documented progression of disease by Investigator (up to 20 months)[Note:Each cycle is 28 days]..

Secondary Outcomes (8)

• Progression-Free Survival(PFS)

  From Cycle1 Day1 to the date of the first documented disease progression(up to overall period of approximately 20 months)[Note:Each cycle is 28 days]..

• Overall Survival (OS)

  From Cycle 1 Day 1 until death (up to approximately 20 months)[Note:Each cycle is 28 days]..

• Duration of Response (DoR)

  From first documentation of CR or PR to documented progression of disease by Investigator( up to approximately 20 months)

• Disease Control Rate (DCR)

  Baseline, Week 8, thereafter every 8 weeks until disease progression, death or withdrawal from the study (up to overall period of approximately 20 months)

• Intracranial Objective Response Rate(IC-ORR)

  From Cycle 1 Day 1 to documented progression of disease by Investigator (up to 20 months).

Study Arms (1)

XZP-3621

EXPERIMENTAL

XZP-3621 single agent,500 mg oral tables，QD，continuously

Drug: XZP-3621

Interventions

XZP-3621 DRUG

ALK inhibitor-treated ALK-positive NSCLC treatment

XZP-3621

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 Ventana immunohistochemistry (IHC) test or FISH or PCR or NGS,Sufficient tumor tissue available to perform ALK status is required if not determined.
• 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.
• Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) score of 0 to 2;
• All Subjects must have at least 1 measurable extracranial target lesion according to RECIST v1.1 that has not been previously irradiated.
• CNS metastases are allowed if:
• Asymptomatic: either untreated and not currently requiring corticosteroid treatment, or
• 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.
• 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 .
• 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.)
• 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.
• 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;
• Life expectancy of at least 12 weeks;
• Adequate organ system function, defined as follows:

You may not qualify if:

• Patients who meet any of the following criteria will be excluded from study entry:
• Combined with small cell lung cancer;
• 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) ;
• 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.);
• Previous treatment history of organ transplantation, hematopoietic stem cell or bone marrow transplantation;
• 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;
• 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);
• Clinically active infections affecting the safety of subjects, including active tuberculosis;
• Uncontrolled hyperglycemia;
• 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;
• Subject with uncontrolled electrolyte disturbances (e.g., low calcium, low magnesium, or hypokalemia) that are identified by investigator;
• Unable to swallow;
• 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;
• 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:

Sponsors & Collaborators

• Xuanzhu Biopharmaceutical Co., Ltd.: lead

Study Sites (1)

Jilin Province Cancer Hospital

Jilin, Chang Chun, 130000, China

Location

Study Officials

• Ying Cheng, MD

  Jilin Province Cancer Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yaping Luo

CONTACT

15367827140; luoyaping@xuanzhubio.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 21, 2022
• First Posted: August 1, 2022
• Study Start: September 1, 2022
• Primary Completion: May 7, 2025
• Study Completion: July 1, 2025
• Last Updated: August 1, 2022

Record last verified: 2022-07

Locations

CN (1)