Actively Recruiting
Lurbinectedin or in Combination with Irinotecan Versus Topotecan in Patients with Relapsed SCLC
Led by Luye Pharma Group Ltd. · Updated on 2024-12-12
180
Participants Needed
1
Research Sites
197 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Multicenter, open-label, randomized, controlled phase III clinical trial to evaluate and compare the activity and safety of two experimental arms consisting of Lurbinectedin monotherapy or Lurbinectedin + Irinotecan combined therapy versus Topotecan comparator in Small-cell Lung Cancer (SCLC) patients who failed one prior platinum-containing line.
CONDITIONS
Official Title
Lurbinectedin or in Combination with Irinotecan Versus Topotecan in Patients with Relapsed SCLC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Voluntary informed consent with good compliance to treatment and visits
- Men or women aged 18 years or older
- Confirmed diagnosis of Small Cell Lung Cancer by tissue or cell analysis
- Life expectancy of at least 12 weeks
- ECOG performance status score of 0 to 2
- One prior treatment with etoposide plus platinum chemotherapy, with or without anti-PD-1 or anti-PD-L1 therapy
- Chemotherapy-free interval of at least 30 days since last platinum-based treatment
- At least one measurable tumor lesion
- Adequate organ function including hemoglobin ≥ 9.0 g/dL, neutrophil count ≥ 2.0 × 10⁹/L, platelet count ≥ 100 × 10⁹/L, liver enzymes ≤ 3 times upper limit, bilirubin ≤ 1.5 times upper limit, albumin ≥ 3.0 g/dL, and creatinine clearance ≥ 40 mL/min
- At least 3 weeks since last anti-tumor therapy with recovery from side effects to specified levels
- Negative pregnancy test for women of childbearing potential and agreement to use effective contraception during treatment and for months after last dose
- Male patients with partners of childbearing potential agree to use effective contraception during treatment and for months after last dose
You will not qualify if you...
- Central nervous system metastases unless treated and stable for at least 4 weeks, asymptomatic, and no recent steroid use
- Patients who have not received platinum chemotherapy or have had more than one prior chemotherapy regimen
- Prior use of Lurbinectedin, Trabectedin, PM14, or topoisomerase I inhibitors like Irinotecan or Topotecan
- Use of strong or moderate CYP3A4 inhibitors within 2 weeks before starting study treatment
- Recent prophylactic cranial irradiation or radiotherapy within 2 weeks before randomization
- Limited-stage disease patients planning local or regional treatment during the study
- Candidates for radiotherapy for bone metastasis or risk of spinal cord compression at screening
- History of bone marrow, stem cell, or allogeneic transplantation
- Received live or attenuated vaccines within 30 days before first dose
- Unstable heart conditions, symptomatic arrhythmia, or need for continuous oxygen recently
- Lung diseases like diffuse interstitial lung disease or pulmonary fibrosis
- Rapidly increasing pleural or pericardial effusions needing urgent therapy
- Liver cirrhosis with Child-Pugh score B or C, Gilbert's disease, or chronic liver disease needing treatment
- Chronic inflammatory bowel disease or intestinal obstruction
- Active uncontrolled infections requiring recent intravenous antibiotics
- Severe wounds, ulcers, fractures, or external drainage
- Recent invasive fungal infection requiring treatment
- Positive HIV antibody test
- History of other malignant tumors unless treated and disease-free for more than 3 years
- Any major disease increasing study risk per investigator judgment
- Allergy or hypersensitivity to study drugs or their ingredients
- Drug or alcohol abuse (more than 14 alcohol units per week in last 3 months)
- Pregnant or breastfeeding women and patients unable to use effective contraception
- Inability to comply with study treatment or protocol as judged by investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Jilin Provincial Tumor Hospital
Jilin, China
Actively Recruiting
Research Team
C
Chunjiao Wu, Doctor
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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