Study of LY01610 in Patients With Recurrent Small Cell Lung Cancer
ConditionRelapsed Small Cell Lung Cancer
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorLuye Pharma Group Ltd.
About this trial
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)
Eligibility criteria
Qualifiers
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);
Disqualifiers
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;
Trial design
Treatments tested in this trial
- Irinotecan hydrochloride liposome Injection
- Topotecan
Treatment groups
686 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov