A Multicenter, Randomized, Open-label, Parallel-design Phase 3 Study to Evaluate the Efficacy and Safety of LY01610 (Irinotecan Hydrochloride Liposome Injection) Versus Topotecan in Patients With Recurrent Small Cell Lung Cancer (SCLC)

Luye Pharma Group Ltd.1 site in 1 country686 target enrollmentMarch 3, 2024

ConditionsRelapsed Small Cell Lung Cancer

InterventionsIrinotecan hydrochloride liposome Injection Topotecan

DrugsIrinotecan hydrochloride liposome Injection Topotecan

Overview

Phase: Phase 3
Intervention: Irinotecan hydrochloride liposome Injection
Conditions: Relapsed Small Cell Lung Cancer
Sponsor: Luye Pharma Group Ltd.
Enrollment: 686
Locations: 1
Primary Endpoint: Overall survival (OS)
Status: Recruiting
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

This is a multicenter，randomized, open label, active-controlled, parallel-group study comparing efficacy and safety of LY01610(Irinotecan hydrochloride liposome Injection) and Topotecan in Patients with Recurrent Small Cell Lung Cancer (SCLC)

Detailed Description

A multicenter, randomized, open-label, parallel study was designed to evaluate the efficacy and safety of LY01610 versus topotecan in the second-line treatment of patients with recurrent SCLC who were diagnosed by histopathology and/or cytology and had disease progression after first-line platinum-based chemotherapy, to conduct a population pharmacokinetics (PopPk) study, and to explore the effect of genetic polymorphisms on the pharmacokinetics properties, efficacy and safety of this product.

Registry

clinicaltrials.gov

Start Date

March 3, 2024

End Date

October 2028

Last Updated

2 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Luye Pharma Group Ltd.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Age ≥ 18 years, male or female;
•Patients with histologically and/or cytologically confirmed small cell lung cancer;
•Disease progression (CTFI ≥ 30 days and ≤ 6 months) occurred after at least 4 cycles of first-line etoposide + platinum two-drug chemotherapy-based treatment, regardless of whether the primary tumor was treated with radiotherapy; the stage of patients with limited stage SCLC should meet more than T1-2, N0, or not suitable for surgery;
•At least one evaluable lesion (according to RECIST 1.1 criteria);
•Expected survival time ≥ 3 months;
•Eastern Cooperative Oncology Group (ECOG) score \< 2;
•Patients who received no liver metastasis; or the number of liver metastases was ≤ 3 and the longest diameter of a single lesion was ≤ 1.5 cm; or although the longest diameter of a single lesion was \> 1.5 cm, the imaging was stable for at least 3 weeks after local treatment control;
•Patients with brain metastasis at baseline should meet all the following conditions: lesions not involving the brainstem, the number of brain metastases ≤ 2 (but patients with only intracranial target lesions should be excluded), imaging stability for at least 3 weeks after local treatment control, and no application of dehydration drugs and hormones before screening,Without any symptoms of brain metastasis;
•Organ function meeting the following criteria at screening: a.Blood routine: neutrophil (ANC) ≥ 1.5 × 109/L, platelet (PLT) ≥ 100 × 109/L, hemoglobin (Hb) ≥ 90 g/L; b.Liver function: total bilirubin (TBIL) ≤ 1.0 × upper limit of normal (ULN); aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.0 × ULN; if liver metastases, AST and ALT ≤ 3 × ULN; serum albumin ≥ 30 g/L; c.Renal function: serum creatinine ≤ 1.5 × ULN or creatinine clearance ≥ 40 mL/min; d.Coagulation function: Prothrombin time - international normalized ratio (PT-INR) \< 1.5;
•Has fully understood and voluntarily signed a written informed consent form for this study and is able to comply with the requirements and restrictions listed in the informed consent form;

Exclusion Criteria

•Pathological diagnosis of compound small cell lung cancer;
•Patients with meningeal metastasis, spinal cord tumor invasion, spinal cord compression syndrome;
•Superior vena cava syndrome with symptoms or significantly aggravated imaging, which may require radiotherapy/surgery/endoscopic therapy/intervention and other non-medical treatment; the presence of large amount of pleural effusion, ascites and/or pericardial effusion with local treatment and unstable control;
•Active infection (including tuberculosis infection) requiring systemic anti-bacterial, antifungal, antiviral and other treatments during screening;
•Recurrent symptomatic poorly controlled chronic obstructive pulmonary disease, extensive interstitial lung disease (including interstitial pneumonia, pulmonary interstitial fibrosis, etc.) at screening,
•Extensive radiation pneumonitis, pulmonary embolism or active massive hemoptysis; Patients with severe gastrointestinal diseases or gastrointestinal disorders (such as gastrointestinal bleeding, gastrointestinal obstruction, unhealed peptic ulcer, immune enteritis, ulcerative colitis, Crohn's disease, ischemic necrotizing enteritis, diarrhea \> grade 1, other gastrointestinal diseases that may affect the tolerance of chemotherapy) at screening;
•Patients with the following cardiovascular and cerebrovascular diseases or history:
•patients with unstable hypertension (systolic blood pressure ≥ 160 mmHg and/or diastolic blood pressure ≥ 100 mmHg) or a history of hypertensive crisis or hypertensive encephalopathy;
•patients with unstable severe arrhythmia;
•patients with the following cardiovascular and cerebrovascular diseases within 6 months: myocardial infarction, unstable angina, coronary revascularization/angioplasty, coronary artery bypass grafting, coronary artery stenting, New York Heart Association (NYHA) class ≥ 2 cardiac insufficiency, severe unstable arrhythmia, deep vein thrombosis, pulmonary embolism history, active cerebral infarction, active cerebral hemorrhage;

Arms & Interventions

LY01610

Patients will consecutively receive LY01610 on Day 1 q2wk (every two weeks = one treatment cycle)

Intervention: Irinotecan hydrochloride liposome Injection

Topotecan

Patients will consecutively receive Topotecan on Days 1-5 q3wk(every three weeks = one treatment cycle)

Intervention: Topotecan

Outcomes

Primary Outcomes

Overall survival (OS)

Time Frame: From the date of randomization to the date of death or last contact, whichever occurs first, assessed up to 52 month

Overall survival is defined as the time from randomization to date of death.

Secondary Outcomes

Progression-free survival (PFS)(From the date of randomization to the date of progressive disease, death or last tumor assessment or further anticancer treatment, whichever occurs first, assessed up to 52 months)
Overall response rate(At baseline and every six weeks (± one week) through study completion, an average of 1 year)
Overall survival rate at 1 year(At 12 months)
Duration of response(From the date of first documentation of complete or partial response to the date of documented progression disease, death or last contact, whichever occurs first, assessed up to 52 months)
Patient-reported outcomes(At baseline and every six weeks (± one week) through study completion, an average of 1 year)
Maximum plasma concentration(From Pre-dose of Cycle 1 and up to Pre-dose of Cycle 2（each Cycle is 14 days）)
Time to maximum plasma concentration(From Pre-dose of Cycle 1 and up to Pre-dose of Cycle 2（each Cycle is 14 days）)
Area under the plasma concentration-time curve(From Pre-dose of Cycle 1 and up to Pre-dose of Cycle 2（each Cycle is 14 days）)
Elimination half-life(From Pre-dose of Cycle 1 and up to Pre-dose of Cycle 2（each Cycle is 14 days）)
Plasma concentrations for Population PK Analyses(From Pre-dose of Cycle 1 and up to Pre-dose of Cycle 2（each Cycle is 14 days）)
Incidence of treatment-emergent adverse events, serious adverse events and laboratory abnormalities(From the date of randomization through study completion, an average of 1 year)