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Irinotecan Liposome(II) Combined With Ivonescimab as Second-line Treatment for Small Cell Lung Cancer : A Prospective, Single-arm, Multicenter Clinical Study

ConditionSCLC
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorThe Second Affiliated Hospital of Dalian Medical University

About this trial

This study will evaluate the efficacy and safety of irinotecan liposome(II) in combination with Ivonescimab as second line treatment for SCLC.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥18 years;

Histologically or cytologically confirmed SCLC;

Advanced SCLC who failed first-line platinum-based chemotherapy with or without checkpoint inhibitors;

The Eastern Cancer Cooperative Group (ECOG) performance score of 0 or 1;

Disqualifiers

Known allergy to irinotecan hydrochloride liposome injection (II) and eboxizumab or drug excipients

History of severe active autoimmune disease

Participated in other drug studies within 4 weeks before enrollment

Imaging during the screening period showed that the tumor surrounded important blood vessels or had significant necrosis and voids, and the investigators determined that entering the study would cause bleeding risk

Trial design

Design model

Single group

Treatments tested in this trial

  • irinotecan liposome(II) plus Ivonescimab via intravenously (IV) Q3W for 4-6 cycles, followed by Ivonescimab until disease progression or intolerable toxicity

    Drug

    Drug: ivonescimab 20mg/kg, IV, D1, Q3W Other Names: AK112 Drug: irinotecan liposome(II) 70mg/m\^2, IV, D1, Q3W

Treatment groups

40 Participants
are divided into 1 treatment group
Group A: Experimental: Irinotecan liposome (II) combined with ivonescimabExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Progression free survival (PFS)

PFS is defined as the time from the start of treatment until the first documentation of disease progression or death due to any cause, whichever occurs first (based on RECIST v1.1).

Time frame
Up to approximately 2 years

Secondary outcomes

1

Objective response rate（ORR）

Objective response rate (ORR) is the proportion of subjects with complete response (CR) or partial response (PR), based on RECIST v1.1.

Time frame
Up to approximately 2 years
2

Disease control rate (DCR)

DCR is defined as the proportion of subjects with CR, PR, or SD (subjects achieving SD will be included in the DCR if they maintain SD for ≥8 weeks), based on RECIST v1.1.

Time frame
Up to approximately 2 years
3

Overall survival (OS)

OS is the time from the date of randomization or first dosing date to death due to any cause.

Time frame
Up to approximately 2 years
4

Treatment related adverse events (TRAEs)

The incidence and severity of TRAEs graded according to NCI-CTCAE v5.0

Time frame
Up to 30 days after last treatment

Other outcomes

Sponsors and contacts

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

The Second Affiliated Hospital of Dalian Medical University

Lead sponsor

Shengjing Hospital

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: