Liposomal irinotecan plus anlotinib as a second-line treatment for recurrent small cell lung cancer

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

This trial tests whether combining liposomal irinotecan with the oral drug anlotinib helps people whose small cell lung cancer came back within six months after platinum chemotherapy.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 39 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Fudan University (Academic / other)
• Drugs / interventions: bevacizumab, anlotinib, chemotherapy, immunotherapy, radiation
• Locations: 1 site (Shanghai, Shanghai Municipality)
• Trial ID: NCT06258642 on ClinicalTrials.gov

What this trial studies

This is a single-arm, multicenter, prospective trial enrolling adults with relapsed small cell lung cancer after platinum-based first-line therapy. Participants receive irinotecan liposome 70 mg/m^2 IV on Day 1 of a 14-day cycle plus oral anlotinib 12 mg daily for two weeks on and one week off. Treatment continues until disease progression or unacceptable toxicity, with tumor response measured by RECIST 1.1 and safety monitored by CTCAE criteria. Eligible patients must have measurable disease, ECOG performance status 0–2, and adequate organ function.

Who should consider this trial

Good fit: Adults aged 18–75 with histologically or cytologically confirmed small cell lung cancer that recurred or progressed within six months of platinum-based first-line therapy, with ECOG 0–2, measurable disease, and adequate organ function are ideal candidates.

Not a fit: Patients with poor performance status (ECOG >2), inadequate organ function, prior severe intolerance to irinotecan or anti-angiogenic drugs, or those unable to attend the Shanghai treatment site are unlikely to benefit from this trial.

Why it matters

Potential benefit: If successful, this regimen could offer a more effective second-line option that prolongs disease control for patients with early-relapsing small cell lung cancer.

How similar studies have performed: Anlotinib has shown benefit in previously treated small cell lung cancer and liposomal irinotecan has activity in other tumor types, but the specific combination for early-relapsing SCLC is relatively novel with limited prior data.

Eligibility criteria

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:

  ① 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；

  ② Hepatic function: total bilirubin≤1.5×upper limit of normal value(ULN)；ALT and AST≤2.5×ULN，liver metastasis：≤5×ULN；

  ③ Renal function: serum creatinine ≤1.5×ULN and creatinine clearance rate ≥60 mL/min;

  ④ Coagulation function：Activated partial thromboplastin time(APTT)、International normalized ratio(INR)、prothrombin time (PT)≤1.5×ULN；

  ⑤ 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.

Where this trial is running

Shanghai, Shanghai Municipality

• Cancer hospital Fudan University — Shanghai, Shanghai Municipality, China (Recruiting)

Study contacts

• Principal investigator: Jialei Wang, Doctor — Fudan University
• Study coordinator: Jialei Wang, Doctor

Conditions Small Cell Lung Cancer Recurrent; Small Cell Lung Cancer; liposomal irinotecan