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New treatment option for Small Cell Lung Cancer Recurrent
Official title Irinotecan Liposome Combined With Anlotinib as Second-line Regimen for SCLC
ClinicalTrials.gov ID: NCT06258642
What this study is testing
What is Irinotecan Liposome?
Irinotecan Liposome is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for small cell lung cancer recurrent.
Also referred to as Irinotecan liposome injection.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- 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;
You likely can't join if
- 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...
- 3) Patients with uncontrolled pleural effusion, abdominal effusion and pericardial effusion after repeated drainage or other treatment within 2 weeks...
- 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...
See the full eligibility 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...
- 8) Adequate major organ function, patients should meet the following criteria: ① Bone marrow function: absolute neutrophile count (ANC)≥1.5×109/L，platelet (PLT)≥100×109/L, hemoglobin (Hb)≥90g/L, white blood cell...
- 9) Patients fully understood and volunteered to participate in the study.
- 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...
- 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...
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Shanghai, Shanghai Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Shanghai, Shanghai Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.