Lomustine Combined With Anlotinib as Interventional Therapy for Extensive-stage Small Cell Lung Cancer Resistant to Second-line and Above Treatment (Aurora003)
A Single-arm, Phase II Interventional Study to Evaluate the Efficacy and Safety of Lomustine Combined With Anlotinib in Patients With Extensive-stage Small Cell Lung Cancer Resistant to Second-line and Further Lines of Treatment
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
Type d'étude
Inscription (Estimé)
Phase
- Phase 2
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
La description
Inclusion Criteria:
1: Aged 18-75 years, without gender restriction.
2: Histologically or cytologically confirmed diagnosis of small cell lung cancer (SCLC), classified as extensive-stage disease according to the Veterans Administration Lung Study Group (VALSG) staging system.
3: Has received at least two lines of prior systemic antitumor therapy.
4: Has at least one measurable lesion as defined by RECIST 1.1 criteria.
5: Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.
6: Adequate organ function meeting the following criteria: Hematological function: Absolute neutrophil count (ANC) ≥ 1.5×10⁹/L; platelet count (PLT) ≥ 100×10⁹/L; hemoglobin (Hb) ≥ 90 g/L. Hepatic and renal function: Alanine transaminase (ALT) and aspartate transaminase (AST) ≤ 2.5×ULN (≤ 5×ULN for patients with liver metastases); serum creatinine (Cr) ≤ 1.5×ULN; estimated glomerular filtration rate (eGFR) ≥ 60 mL/min/1.73m². Coagulation function: International normalized ratio (INR) ≤ 1.5; activated partial thromboplastin time (APTT) ≤ 1.5×ULN.
7: Expected survival time ≥ 3 months.
8: Voluntarily signs the informed consent form and is willing and able to comply with the study protocol and follow-up requirements.
Exclusion Criteria:
1: Previous treatment with lomustine, anlotinib, or other similar anti-angiogenic TKIs.
2: Uncontrolled central nervous system (CNS) metastases (e.g., unstable or symptomatic brain metastases, or those requiring ongoing glucocorticoid therapy).
3: Active bleeding or high bleeding risk (e.g., history of massive gastrointestinal hemorrhage or cerebral hemorrhage within the past 6 months, or presence of unhealed wounds or ulcers).
4: Uncontrolled hypertension (systolic blood pressure ≥ 160 mmHg or diastolic blood pressure ≥ 100 mmHg) or severe cardiovascular diseases (e.g., myocardial infarction, severe arrhythmia, heart failure within the past 6 months).
5: Active infection (such as pneumonia, sepsis) or uncontrolled systemic diseases (such as uncontrolled diabetes, autoimmune diseases).
6: Pregnant or lactating females. Female participants must use effective contraception during treatment and for 6 months after the last dose of study treatment; male participants must use effective contraception during treatment and for 3 months after the last dose of study treatment.
7: History of other malignant tumors within the past 5 years, except for cured basal cell carcinoma of the skin, carcinoma in situ of the cervix, and other cured malignancies.
8: Known hypersensitivity to lomustine, anlotinib, or any excipient in their formulations.
9: Any other condition deemed inappropriate for participation in this study by the investigator (e.g., mental disorders, inability to comply with follow-up procedures).
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: N / A
- Modèle interventionnel: Affectation à un seul groupe
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: lomustine combined with anlotinib
Oral lomustine 60 mg/m² once daily on day 1 every 6 weeks, combined with oral anlotinib.
The initial dose of anlotinib is determined by the investigator, with optional doses of 12 mg, 10 mg or 8 mg once daily on days 1 to 14 every 3 weeks.
|
Oral lomustine 60 mg/m² once daily on day 1, every 6 weeks
Oral administration, initial dose 12 mg, 10 mg or 8 mg once daily on days 1-14 of every 3-week cycle
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Objective Response Rate
Délai: Baseline at screening, after every 2 treatment cycles (each cycle is 21 days), end of treatment, up to disease progression, assessed up to approximately 24 months
|
Investigator-assessed ORR per RECIST 1.1 in ES-SCLC patients treated with Lomustine combined with anlotinib
|
Baseline at screening, after every 2 treatment cycles (each cycle is 21 days), end of treatment, up to disease progression, assessed up to approximately 24 months
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Événement indésirable (EI)
Délai: De la signature du consentement éclairé jusqu'à l'achèvement de l'étude et au suivi de sécurité, évalué jusqu'à environ 24 mois
|
Enregistrez tous les nouveaux événements médicaux défavorables ou leur aggravation, classez-les et calculez l'incidence selon CTCAE 5.0
|
De la signature du consentement éclairé jusqu'à l'achèvement de l'étude et au suivi de sécurité, évalué jusqu'à environ 24 mois
|
|
Taux de contrôle de la maladie (TCM)
Délai: Délai : Au départ et après chaque 2 cycles de traitement (chaque cycle dure 21 jours), jusqu'à la progression de la maladie, le décès ou le retrait de l'étude, selon la première éventualité, évalué jusqu'à environ 24 mois
|
Selon RECIST 1.1, proportion des sujets atteignant une RC, une RP ou une maladie stable (MS) dans la population totale inscrite
|
Délai : Au départ et après chaque 2 cycles de traitement (chaque cycle dure 21 jours), jusqu'à la progression de la maladie, le décès ou le retrait de l'étude, selon la première éventualité, évalué jusqu'à environ 24 mois
|
|
progression free survival
Délai: Date of first study treatment to date of disease progression or death from any cause, last follow-up, assessed up to approximately 24 months
|
Time from first treatment to disease progression or death from any cause, whichever occurs first
|
Date of first study treatment to date of disease progression or death from any cause, last follow-up, assessed up to approximately 24 months
|
|
Quality of Life Score（QOL Score）
Délai: At baseline, every 6 weeks during treatment until disease progression or death，assessed up to approximately 24 months
|
The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) was adopted for patient self-assessment.
The scale consists of 30 items, including 5 functional scales, 9 symptom scales and 1 global health status / quality of life scale.
Each item is scored on a 1-4 Likert scale, and all scale scores are standardized to a range of 0-100.
Higher scores in functional and global quality of life scales and lower scores in symptom scales indicate better quality of life and health status of patients.
|
At baseline, every 6 weeks during treatment until disease progression or death，assessed up to approximately 24 months
|
Collaborateurs et enquêteurs
Parrainer
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Estimé)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 2026LY0102
- MR-31-26-032631 (Autre identifiant: National Medical Research Registration and Filing System)
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
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