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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

This trial accepts healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • Irinotecan hydrochloride liposome Injection

    Drug

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

  • Topotecan

    Drug

    Topotecan 1.2 mg/m² intravenously Days 1-5 q3w

Treatment groups

686 Participants
are divided into 2 treatment groups
Group A: LY01610Experimental treatment 1 intervention
Group B: TopotecanActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Overall survival (OS)

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

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

Secondary outcomes

1

Progression-free survival (PFS)

Progression-free survival is the time from randomization to the first documented objective disease progression (PD) using RECIST v1.1 or death due to any cause, whichever occurs first

Time frame
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
2

Overall response rate

Overall response rate (ORR) will be the best response obtained in any evaluation according to RECIST v.1.1

Time frame
At baseline and every six weeks (± one week) through study completion, an average of 1 year
3

Overall survival rate at 1 year

Overall survival rate at 1 year is defined as the percentage of people who are still alive at 12 months after randomization.

Time frame
At 12 months
4

Duration of response

Duration of response (DoR) will be calculated from the date of first documentation of response per RECIST v.1.1 (complete or partial response, whichever occurs first) to the date of documented PD or death

Time frame
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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Luye Pharma Group Ltd.

Lead sponsor

Source ClinicalTrials.gov
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