Irinotecan Liposome Combined With Anlotinib as Second-line Regimen for SCLC

Small Cell Lung Cancer Recurrent Clinical Trial

Official title:

Study of Irinotecan Liposome Combined With Anlotinib as Second-line Regimen in Patients With Small Cell Lung Cancer

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06258642
• Other study ID #: CSPC-DEY-SCLC-K01
• Status: Not yet recruiting
• Phase: N/A
• Start date: February 2024
• Est. completion date: December 2025

Study information

• Verified date: February 2024
• Source: Fudan University
• Contact: Jialei Wang, Doctor
• Phone: 021-64175590
• Email: luwangjialei[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study is a single arm, multi-center, prospective clinical trial. The purpose of this study is to evaluate the efficacy and safety of liposomal irinotecan combined with anlotinib hydrochloride for relapsed small-cell lung cancer, who have progressed on or less than 6 month after platinum-based first-line therapy.

Description:

Patients will receive irinotecan liposome injection at 70 mg/m^2 intravenously, on Days 1 of every 14-day cycle and anlotinib (12 mg/day) for 2 consecutive weeks and then discontinued for 1 week. The treatment is continued until disease progression or intolerable toxicity.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 39
• Est. completion date: December 2025
• Est. primary completion date: April 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• 1) Aged =18 and =75 years old;
• 2) Histologically or cytologically confirmed small cell lung cancer;
• 3) At least one measurable lesion according to the Response Evaluation Criteria in Solid Tumours (RECIST) 1.1;
• 4) Radiologically confirmed recurrence or progression within 6months after platinum-based, first-line chemotherapy or chemoradiation therapy;
• 5) Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2;
• 6) Expected survival of more than 3 months;
• 7) Recovered from the effects of any prior chemotherapy, surgery, radiotherapy or other anti-neoplastic therapy (recovered to no more than Grade 1 of CTCAE 5.0 criteria or baseline, with the exception of alopecia or other toxicity without safety concerns by the investigators' judgment);
• 8) Adequate major organ function, patients should meet the following criteria:

? Bone marrow function: absolute neutrophile count (ANC)=1.5×109/L,platelet (PLT)=100×109/L, hemoglobin (Hb)=90g/L, white blood cell (WBC)=3.0×109/L; ? Hepatic function: total bilirubin=1.5×upper limit of normal value(ULN);ALT and AST=2.5×ULN,liver metastasis:=5×ULN; ? Renal function: serum creatinine =1.5×ULN and creatinine clearance rate =60 mL/min; ? Coagulation function:Activated partial thromboplastin time(APTT)?International normalized ratio(INR)?prothrombin time (PT)=1.5×ULN; ? urine routines show urine protein < 2+(when urine protein >2+, urine protein quantity< 1.0 g during 24 hours before 7 days);

• 9) Patients fully understood and volunteered to participate in the study.

Exclusion Criteria:

• 1) Patients with large cell neuroendocrine lung carcinoma or combined small cell lung carcinoma;
• 2) Patients with asymptomatic central nervous system (CNS) metastases prior to enrollment or those who have CNS disease requiring increase in the dose of steroid. (Patients with controlled CNS metastasis can participate in the trial);
• 3) Patients with uncontrolled pleural effusion, abdominal effusion and pericardial effusion after repeated drainage or other treatment within 2 weeks prior to the first dose of this study, and those judged by the clinicians to be unsuitable for the study;
• 4) Diagnosed with any other cancer within the past 5 years (except for cured basal cell carcinoma and in situ cancer);
• 5) Patients who have received prior irinotecan/ liposomal irinotecan and anti-angiogenic drugs such as anlotinib and bevacizumab , etc.
• 6) Concomitant use of strong CYP3A4 inducers within 2 weeks or strong CYP3A4 inhibitors or strong UGT1A1 inhibitors within 1 week of the first dose of the study drug;
• 7) Patients who have received other anti-tumor treatments(including radiotherapy, chemotherapy, immunotherapy, etc.) within 4 weeks before the first dose;
• 8) Combined with uncontrolled systemic diseases, including unstable angina, myocardial infarction, congestive heart failure, severe ventricular arrhythmia , etc.
• 9) Severe pulmonary disease within 6 months prior to enrolment, such as interstitial pneumonia, pulmonary fibrosis, radiation induced pneumonitis requiring steroid therapy, and other moderate and severe lung diseases which affect lung function;
• 10) Arterial/venous thrombosis within 6 months prior to enrollment, e.g. cerebrovascular accident (include temporary ischemic attack), deep venous thrombosis, pulmonary embolism.
• 11) Symptoms or propensity to bleed within 3 months prior to screening (include gastrointestinal hemorrhage, ulcerative gastric bleeding, fecal occult blood 2+ or above, vasculitis);
• 12) Patients had undergone major surgical procedure(except for diagnostic surgery) within 4 weeks before dosing or was scheduled to receive major procedure during the study;
• 13) unhealed wounds, ulcers or fractures;
• 14) Imaging showed tumors have involved important blood vessels or by investigators determine likely during the follow-up study and cause fatal hemorrhage;
• 15) Active and uncontrolled bacterial, viral, fungal infection requiring systemic treatment;
• 16) Active hepatitis B/C, or HIV infection;
• 17) Known intolerance or allergy to therapeutic drugs and their excipients;
• 18) Clinically significant gastrointestinal disorder, including hepatic disorders, bleeding, inflammation, occlusion, or diarrhea > grade 1;
• 19) Pregnant or breast feeding;
• 20) Patient is not suitable for the study in the investigator's opinion.

Related Conditions & MeSH terms

• Lung Neoplasms
• Small Cell Lung Cancer Recurrent
• Small Cell Lung Carcinoma

Intervention

Drug:
• Irinotecan Liposome
70 mg/m^2 , d1, Q2W, iv
• Anlotinib
12 mg, qd, po for 2 consecutive weeks and then discontinued for 1 week.

Locations

Country	Name	City	State
China	Cancer hospital Fudan University	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Fudan University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Objective response rate(ORR)	To evaluate anti-tumor efficacy	From date of first dose until the date of first documented progression, assessed up to 24 months
Secondary	Disease control rate (DCR)	To evaluate anti-tumor efficacy	From date of first dose until the date of first documented progression, assessed up to 24 months
Secondary	Duration of Response(DoR)	To evaluate anti-tumor efficacy	From date of first dose until the date of first documented progression, assessed up to 24 months
Secondary	Progression-Free Survival (PFS)	To evaluate anti-tumor efficacy	From date of first dose until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months
Secondary	Overall Survival (OS)	To evaluate anti-tumor efficacy	From date of first dose until the date of death from any cause , assessed up to 24 months
Secondary	Incidence and severity of adverse events	To evaluate the safety	date of the first dose to 28 days after permanent treatment termination