A Study Of SY-3505 Versus Crizotinib In First Line Treatment Of Patients With ALK-Positive NSCLC

NCT06254599 | Not Yet Recruiting Phase 3

• 1 other identifier: CT-3505-III-01
• Study Type: interventional
• Target: 255
• Locations: 1 country
• Sites: 1

Brief Summary

A phase 3 study to evaluate the efficacy and safety of SY-3505 vs. crizotinib in patients with ALK-positive non-small cell lung cancer who had not received prior systemic therapy.

Conditions

Non-small Cell Lung Cancer

Keywords

SY-3505; Anaplastic lymphoma kinase; Non-small Cell Lung Cancer; Third-generation ALK tyrosine kinase inhibitor

Outcome Measures

Primary Outcomes (1)

• Progression-free survival (PFS) assessed by independent radiology review (IRC) based on Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 (v1.1) criteria.

  PFS was defined as the time from randomization to the date of the first documentation of progressive disease as assessed by the independent radiologist or death due to any cause, whichever occurred first.

  Up to 2 years

Secondary Outcomes (8)

• Progression-free survival (PFS) assessed by investigator based on RECIST v1.1 criteria.

  Up to 2 years

• Objective Response Rate (ORR) assessed by IRC and investigator

  Up to 2 years

• Disease Control Rate (DCR) assessed by IRC and investigator

  Up to 2 years

• Duration of Response (DoR) assessed by IRC and investigator

  Up to 2 years

• Intracranial Objective Response Rate (IC-ORR) assessed by IRC and investigator

  Up to 2 years

Study Arms (2)

SY-3505

EXPERIMENTAL

SY-3505, single agent, 600 mg oral capsules, QD, continuously

Drug: SY-3505 Capsules

Crizotinib

ACTIVE COMPARATOR

Crizotinib, single agent, 250 mg oral capsules, BID, continuously

Drug: Crizotinib Capsules

Interventions

SY-3505 Capsules DRUG

A third-generation ALK tyrosine kinase inhibitor

Also known as: CT-3505; Ficonalkib

SY-3505

Crizotinib Capsules DRUG

An oral ALK tyrosine kinase inhibitor

Also known as: Xalkori

Crizotinib

Eligibility Criteria

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

You may qualify if:

• At the time of signing the informed consent form (ICF), age is ≥ 18 years.
• Histologically or cytologically diagnosed with stage IV or stage IIIB and IIIC NSCLC that cannot be cured by surgery or radiotherapy (as per the 8th edition of the International Association for the Study of Lung Cancer \[IASLC\] Lung Cancer Staging).
• No prior systemic anti-tumor therapy for NSCLC, including but not limited to systemic chemotherapy, ALK-TKI, immunotherapy, and biologic therapy, etc. \[1. Patients assessed by the investigator as not having received "adequate" systemic anti-tumor therapy (such as having received up to 1 prior chemotherapy regimen, etc.), and 2. Patients who have received neoadjuvant or adjuvant therapy, with the last treatment at least 6 months before randomization, are allowed to be included\].
• The tumor tissue or blood sample of the patient meets one of the following two criteria: a. Previously confirmed by a local laboratory as ALK fusion-positive (patients included based on previously confirmed ALK fusion-positive test results should provide tumor tissue \[available archived samples or fresh biopsy samples\] that meets the requirements as much as possible after signing the ICF and before the first dose for central laboratory ALK fusion positive reconfirmation based on study progression needs). b. In the absence of a previous ALK fusion positive test report, a tumor tissue (available archived samples or fresh biopsy samples) or blood sample meeting the requirements must be provided, and the sample is confirmed as ALK fusion positive in the designated center laboratory by the sponsor.
• At least one extra-cranial target lesion that meets the RECIST v 1.1 criteria definition; for lesions previously treated with radiotherapy, only when the lesion shows clear progression after radiotherapy can it be considered a target lesion.
• Eastern Cooperative Oncology Group performance status (ECOG PS) of 0-2.
• Expected survival time of ≥ 3 months.
• Before the first dose, the adverse events (AEs) related to previous anti-tumor therapy have recovered to Grade ≤ 1 as defined by NCI-CTCAE v 5.0 (excluding toxicities judged by the investigator to have no safety risks, such as alopecia, Grade 2 peripheral neuropathy related to previous platinum-based treatment, etc.).
• Organ function levels must meet the following requirements (supportive treatment that affects the following results has not been received within 7 days before the test):
• Bone marrow function: Absolute neutrophil count (ANC) ≥ 1.0×10\^9/L, platelets (PLT) ≥ 75×10\^9/L, hemoglobin (Hb) ≥ 90g/L;
• Liver function: In the absence of liver metastasis, serum aspartate aminotransferase (AST) and alanine aminotransferase (ALT) both ≤ 2.5× the upper limit of normal (ULN), and serum total bilirubin (TBIL) ≤ 1.5× ULN; with liver metastasis, AST and ALT both ≤ 5.0× ULN, and TBIL ≤ 3× ULN;
• Renal function: Creatinine clearance rate (Ccr) ≥ 50 mL/min (according to the Cockcroft and Gault formula);
• Coagulation function: International normalized ratio (INR) and prothrombin time (PT) ≤ 1.5× ULN (except for patients receiving anticoagulant therapy).
• Able to swallow pills and able to comply with the visits and related procedures as specified in the protocol.
• Fertile subjects agree to use effective contraceptive measures during the entire study period and for at least 3 months after the last dose

You may not qualify if:

• Patients who meet any of the following criteria are not eligible to participate in this study:
• Carrying known major driver gene mutations other than ALK, such as EGFR, MET, RET, ROS1, NTRK, etc. (patients with co-mutations can discuss with the investigator whether they can be included).
• History of allergy to any component or excipient of SY-3505 capsules or crizotinib capsules.
• Concurrent primary malignancies, with the following exceptions: cured and not relapsed malignant tumors within 2 years before screening, and cured basal cell carcinoma or squamous cell carcinoma of the skin, carcinoma in situ of the cervix, or carcinoma in situ of the breast.
• Presence of symptomatic primary central nervous system (CNS) tumors, symptomatic CNS metastases, leptomeningeal carcinomatosis, or untreated spinal cord compression. Exception: Patients with stable CNS conditions (no evidence of progression on imaging examinations for at least 4 weeks before the first dose and all neurological symptoms have returned to baseline), no evidence of new or enlarged brain metastases, no CNS surgery or radiotherapy within 4 weeks before the first dose, no stereotactic radiosurgery (SRS) within 2 weeks, and discontinuation or stable dose of steroids within 2 weeks (this exception does not include carcinomatous meningitis, which should be excluded regardless of its clinical status).
• Concomitant symptoms or diseases before the first dose that are poorly controlled even after optimal treatment (chronic diseases do not require screening):
• Uncontrolled active systemic bacterial, viral, or fungal infections;
• Pleural effusion, ascites, or pericardial effusion poorly controlled after intervention (poorly controlled indicates significant increase in effusion within 2 weeks after drainage, with significant symptoms requiring re-puncture or other interventions);
• Poorly controlled diabetes (fasting blood glucose ≥ 11.1mmol/L and/or HbA1c ≥ 8%);
• Symptomatic hyperthyroidism or hypothyroidism that is not controlled according to the investigator's assessment;
• Clinically significant electrolyte disturbances evaluated by the investigator (such as hypocalcemia, hypomagnesemia, or hypokalemia);
• Clinically significant active gastrointestinal diseases, including active ulcerative colitis, Crohn's disease, gastrointestinal ulcers, or previous surgical procedures that may significantly affect drug absorption.
• Presence of severe cardiovascular diseases/abnormalities, meeting any of the following:
• Fridericia-corrected QT interval (QTcF) \> 470 msec (females) or 450 msec (males) during screening (if QTcF prolongation suspected to be drug-induced is assessed as safe and controllable by the investigator, the patient can be included after correction with medication);
• Left ventricular ejection fraction (LVEF) \< 50%;

Sponsors & Collaborators

• Shouyao Holdings (Beijing) Co. LTD: lead

Study Sites (1)

Cancer Hospital, Chinese Academy of Medical Sciences

Beijing, 100021, China

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Crizotinib

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Aminopyridines; Pyridines

Study Officials

• Yinghui Sun

  Shouyao Holdings (Beijing) Co. LTD

  STUDY DIRECTOR

Central Study Contacts

Yinghui Sun

CONTACT

86-10-88858616; yhsun@centaurusbio.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 1, 2024
• First Posted: February 12, 2024
• Study Start: May 1, 2024
• Primary Completion: May 1, 2026
• Study Completion (Estimated): May 1, 2027
• Last Updated: February 12, 2024

Record last verified: 2024-02

Locations

CN (1)