Study of LY01610 in Patients With Recurrent Small Cell Lung Cancer

NCT06128837 | Recruiting Phase 3 DMC

• 1 other identifier: LY01610/CT-CHN-304
• Study Type: interventional
• Target: 686
• Locations: 1 country
• Sites: 1

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)

Conditions

Relapsed Small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

• Overall survival (OS)

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

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

Secondary Outcomes (11)

• 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

Study Arms (2)

LY01610

EXPERIMENTAL

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

Drug: Irinotecan hydrochloride liposome Injection

Topotecan

ACTIVE COMPARATOR

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

Drug: Topotecan

Interventions

Irinotecan hydrochloride liposome Injection DRUG

Irinotecan hydrochloride liposome Injection 80 mg/m² intravenously Days 1 q2wk

LY01610

Topotecan DRUG

Topotecan 1.2 mg/m² intravenously Days 1-5 q3w

Topotecan

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;
• Female subjects of childbearing potential and male subjects with partners of childbearing potential agree to use reliable contraceptive measures during the study and within 6 months after the infusion of study drug.

You may not qualify if:

• 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;
• Patients with any of the following conditions:
• positive hepatitis B virus surface antigen (HBsAg) test,And peripheral blood hepatitis B virus deoxyribonucleic acid (HBV-DNA) detection ≥ 1000 IU/mL;
• hepatitis C virus antibody (HCV-Ab) positive, and hepatitis C virus ribonucleic acid (HCV-RNA) detection ≥ 100 IU/mL;
• human immunodeficiency virus antibody (HIV-Ab) detection positive;
• Other malignancies within 5 years before screening (except cured stage IB or lower cervical cancer, non-invasive basal cell, scale-cell skin cancer or resectable carcinoma in situ);

Sponsors & Collaborators

• Luye Pharma Group Ltd.: lead

Study Sites (1)

Cancer Hospital, Chinese Academy of Medical Sciences

Beijing, China

RECRUITING

MeSH Terms

Conditions

Small Cell Lung Carcinoma

Interventions

Topotecan

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)

Camptothecin; Alkaloids; Heterocyclic Compounds

Study Officials

• yuankai shi, doctor

  Cancer Institute and Hospital, Chinese Academy of Medical Sciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

yuankai shi, doctor

CONTACT

8610-87788293; syuankaipumc@126.com

Study Design

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

Study Record Dates

• First Submitted: October 18, 2023
• First Posted: November 13, 2023
• Study Start: March 3, 2024
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): October 1, 2028
• Last Updated: March 15, 2024

Record last verified: 2024-03

Locations

CN (1)