Actively Recruiting
Study of LY01610 in Patients With Recurrent Small Cell Lung Cancer
Led by Luye Pharma Group Ltd. · Updated on 2024-03-15
686
Participants Needed
1
Research Sites
239 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Study of LY01610 in Patients With Recurrent Small Cell Lung Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older, male or female
- Histologically and/or cytologically confirmed small cell lung cancer
- Disease progression between 30 days and 6 months after at least 4 cycles of first-line etoposide plus platinum chemotherapy
- Limited stage SCLC patients must have stage beyond T1-2, N0, or be unsuitable for surgery
- At least one measurable lesion based on RECIST 1.1 criteria
- Expected survival time of at least 3 months
- Eastern Cooperative Oncology Group (ECOG) performance status less than 2
- No liver metastasis or up to 3 liver metastases with a longest lesion diameter of 1.5 cm or less, or stable larger lesions after local treatment for at least 3 weeks
- Brain metastases allowed if 2 or fewer lesions not involving brainstem, stable for at least 3 weeks after local treatment, no symptoms, and no dehydration drugs or hormones before screening
- Adequate organ function including blood counts, liver, kidney, and coagulation parameters
- Able to understand and sign informed consent and comply with study requirements
- Agree to use reliable contraception during the study and for 6 months after treatment if of childbearing potential
You will not qualify if you...
- Diagnosis of compound small cell lung cancer
- Presence of meningeal metastasis, spinal cord tumor invasion, or spinal cord compression syndrome
- Superior vena cava syndrome with symptoms or worsening requiring interventions
- Large amounts of pleural, pericardial, or abdominal effusions with unstable control
- Active infections requiring systemic treatment including tuberculosis
- Poorly controlled chronic obstructive pulmonary disease or extensive interstitial lung disease
- Extensive radiation pneumonitis, pulmonary embolism, or active massive hemoptysis
- Severe gastrointestinal diseases affecting chemotherapy tolerance
- Unstable hypertension or history of hypertensive crisis
- Severe or unstable arrhythmias
- Recent serious cardiovascular or cerebrovascular events within 6 months
- Positive hepatitis B or C infection with high viral load, or HIV positive
- Other cancers within 5 years except certain cured or non-invasive skin and cervical cancers
- Severe diseases of major organs or other conditions deemed unsuitable by investigators
- Previous treatment with irinotecan, topotecan, or other topoisomerase I inhibitors
- Known hypersensitivity to study drugs or related compounds
- Recent live vaccinations
- Systemic antitumor therapy within 4 weeks before randomization
- Use of other clinical trial drugs or devices before randomization
- Use of strong CYP3A4 or UGT1A1 enzyme modifiers before randomization
- Unrecovered adverse reactions from prior antitumor treatments except alopecia and peripheral neuropathy
- History of drug abuse or alcoholism
- Pregnant or breastfeeding women
- Other unstable nervous system or mental disorders making participation unsuitable
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Cancer Hospital, Chinese Academy of Medical Sciences
Beijing, China
Actively Recruiting
Research Team
Y
yuankai shi, doctor
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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