Loading clinical trials...

Study of Irinotecan Liposome Injection as Second-line Regimen in Patients With Small Cell Lung Cancer (SCLC) | Clinical Trials | Clareo Health

COMPLETEDPHASE2

Study of Irinotecan Liposome Injection as Second-line Regimen in Patients With Small Cell Lung Cancer (SCLC)

A Multicenter, Open-label, Single-arm Phase 2 Study of Irinotecan Liposome Injection in Patients With Small Cell Lung Cancer (SCLC) Who Have Progressed After Platinum-based First-line Therapy

NCT04727853•CSPC Ouyi Pharmaceutical Co., Ltd.

View on ClinicalTrials.gov

Summary

This study is a multicenter, open-label, single-arm phase 2 study of irinotecan liposome injection in patients with small cell lung cancer (SCLC) who have progressed after platinum-based first-line therapy. Subjects will receive irinotecan liposome injection until progression or unacceptable toxicity.

Detailed Description

Patients with small cell lung cancer who have progressed after platinum-based first-line therapy will be enrolled in this study. Patients will receive irinotecan liposome injection at 70 mg/m\^2 intravenously, over 90 min on Days 1 of every 14-day cycle until progression or unacceptable toxicity. Imaging assessments will be conducted every three cycles to evaluate the preliminary efficacy of irinotecan liposome injection as second-line regimen in patients with SCLC.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. At least 18 years of age. Males or females.
•2. Histopathologically or cytologically confirmed small cell lung cancer.
•3. At least one measurable lesion as defined by RECIST V1.1 guidelines. A previously irradiated lesion may be counted as a measurable lesion only if there is a clear sign of progression since the irradiation.
•4. Must have recurrence or progression after platinum-based, first-line chemotherapy or chemoradiation therapy for the treatment of SCLC.
•5. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
•6. Life expectancy \>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. Patient should not receive blood transfusion or supportive care (eg. EPO, G-CSF or others) within 14 days before the initiate dose, and laboratory test should meet the following criteria: neutrophile count (ANC) ≥1.5×10\^9/L, platelet count ≥100×10\^9/L, hemoglobin ≥90 g/L or ≥5.6 mmol/L, serum creatinine ≤1.5×ULN and creatinine clearance rate ≥30 mL/min, total bilirubin ≤1×ULN, AST and ALT ≤2.5×ULN (for patients with liver metastasis: ≤5×ULN)
•9. Female or male patient of childbearing age must agree to take effective contraception for the duration of treatment plus six months post-treatment completion; female patient must have a negative serum pregnancy test within 7 days before enrollment and must not be lactating female.
•10. Able to understand and provide an informed consent.

Exclusion Criteria

•1. Patients with large cell neuroendocrine lung carcinoma or combined small cell lung carcinoma.
•2. Patients with history of immunotherapy-induced colitis or pneumonia, confirmed by clinical assessment and/or biopsy.
•3. Patients with central Nervous System (CNS) metastasis meet any of the following criteria: a) Patient who have developed new or progressive brain metastasis following cranial radiation; b) Patients with the symptomatic Central Nervous System (CNS) metastasis who have used cortisol, radiotherapy, dehydration drugs, etc. to control symptoms in the past two weeks; c) Patients with carcinomatous meningitis; d) Patients with brain stem (midbrain, pons, medulla oblongata) or spinal cord metastasis.
•4. Uncontrolled third lacunar effusion, not suitable for enrollment by investigator's assessment.
•5. Previous malignancies in the past five years (except for basal cell carcinoma, squamous cell carcinoma, superficial bladder carcinoma, local prostate carcinoma, carcinoma in situ of cervical, or of others that have been radically resected and have not recurred).
•6. Patients who have received any of the following treatments, a) Patients who have received prior topoisomerase I inhibitor treatment, including irinotecan or other investigational agents; b) Patients who have used any antibody-drug conjugates or molecular targeted preparation alone or in combination setting; c) Patients who have received more than one line of immunotherapy (immunotherapy in first-line as single or combination is permitted).
•7. 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.
•8. Patients who have received any chemotherapy, biological therapy, endocrinotherapy, immunotherapy or investigational therapy within 4 weeks (5 half-lives of the agent, whichever is longer) of the first dose of the study drug, or local palliative radiotherapy or Chinese herbal medicine with anti-tumor indications within 2 weeks of the first dose of the study drug.
•9. Any major surgery or severe trauma within 4 weeks of the first dose, not including biopsy.
•10. Severe cardiovascular disease within 6 months prior to enrollment.
+8 more criteria

Locations (1)

Jilin Cancer Hospital

Changchun, Jilin, China

Key Dates

Start Date

March 1, 2021

Primary Completion Date

April 26, 2022

Completion Date

April 26, 2022

Last Updated

July 10, 2024

Enrollment

ACTUAL participants

Conditions

Small Cell Lung Cancer (SCLC)

Interventions

irinotecan liposome injection

DRUG

A Study of Pembrolizumab (MK-3475) in Combination With Etoposide/Platinum (Cisplatin or Carboplatin) for Participants With Extensive Stage Small Cell Lung Cancer (MK-3475-604/KEYNOTE-604)

NCT03066778

Small Cell Lung Cancer (SCLC)

View study

TERMINATEDNA

Pulmonary Interstitial Lymphography in Early Stage Lung Cancer

NCT01188486

Lung CancerLung Cancer Non-Small Cell Cancer (NSCLC)+2 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 10, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions