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- Essai clinique NCT04882345
Almonertinib Treats Advanced NSCLC Patients With EGFR Mutations Who Are Safety Intolerant After Osimertinib Treatment (ACTIVE)
Evaluate the Safety and Efficacy of Almonertinib in the Treatment of Advanced NSCLC Patients With EGFR-sensitive Mutations Who Are Safety Intolerant After Osimertinib Treatment: a Prospective, Multi-center, Single-arm Clinical Trial
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
Type d'étude
Inscription (Anticipé)
Phase
- Phase 2
Contacts et emplacements
Coordonnées de l'étude
- Nom: Shun Lu, Doctor
- Numéro de téléphone: 13601813062
- E-mail: shun_lu@hotmail.com
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
- Over 18 years old (including 18 years old) and under 75 years old (including 75 years old)
- Histologically or cytologically diagnosed as locally advanced or metastatic NSCLC.
- The CTCAE ≥ grade 3 AE related to osimertinib treatment in previous treatment with osimertinib, or platelet count <75×109 / L (≥CTCAE grade 2), white blood cell count <3×109 / L (≥ CTCAE grade 2), total bilirubin> 1.5×ULN (≥CTCAE grade 2), transaminase (ALT/AST)>3.0×ULN (≥CTCAE grade 2), and the toxic reaction has been alleviated or restored to ≤CTCAE grade 1 patient.
- Tumor tissue samples diagnosed as locally advanced or metastatic NSCLC are confirmed to be EGFR sensitive mutations (including exon 19 deletion or L858R, both alone or coexist with other EGFR mutations). If the tumor tissue is accessible, it is recommended to send the tumor tissue for examination; if the tumor tissue is not accessible or the patient cannot accept a tissue biopsy, a blood sample is also acceptable.
- The Eastern Cooperative Oncology Group (ECOG) physical status score is 0 to 1, and it has not deteriorated in the previous 2 weeks, and the minimum expected survival is 12 weeks.
- The patient has at least one tumor lesion that can be accurately measured at baseline, and the longest diameter at baseline is ≥10 mm (if it is a lymph node, the short diameter is required to be ≥15 mm). The selected measurement method is suitable for accurate repeat measurement, which can be computed tomography (CT) or magnetic resonance scan (MRI). If there is only one measurable lesion, it can be accepted as the target lesion, and a baseline assessment of the tumor lesion should be performed at least 14 days after the diagnostic biopsy.
Women of childbearing age should take appropriate contraceptive measures from screening to 3 months after stopping the study treatment and should not breastfeed. Before starting the administration, the pregnancy test is negative, or meeting one of the following criteria proves that there is no risk of pregnancy:
- Postmenopausal is defined as amenorrhea for at least 12 months after the age is greater than 50 years and all exogenous hormone replacement therapy is stopped.
- For women younger than 50 years old, if the amenorrhea is 12 months or more after stopping all exogenous hormone treatments, and the luteinizing hormone (LH) and follicle stimulating hormone (FSH) levels are within the laboratory postmenopausal reference value range, also It can be considered post-menopausal.
- Have received irreversible sterilization, including hysterectomy, bilateral ovariectomy or bilateral fallopian tube resection, except for bilateral fallopian tube ligation.
- Male patients should use barrier contraception (i.e. condoms) from screening to 3 months after stopping the study treatment.
- The subjects themselves participated voluntarily and signed an informed consent form in writing.
Exclusion Criteria:
Have received any of the following treatments:
- Have previously received any EGFR tyrosine kinase inhibitor treatment except osimertinib;
- The patient had undergone major surgery within 4 weeks before the first administration;
- Accept other test drugs, and within 5 half-lives;
- Within 7 days before the first administration of the study drug, CYP3A4 strong inhibitors, inducers, or drugs with a narrow therapeutic window that are CYP3A4 sensitive substrates have been used.
- Patients with other malignant tumors who need standard treatment or major surgery within 2 years after the first administration of the study treatment.
- As judged by the investigator, there are any serious or poorly controlled systemic diseases, such as poorly controlled hypertension, active bleeding-prone constitution, or active infection. No need to check for chronic diseases.
- Refractory nausea, vomiting or chronic gastrointestinal disease, inability to swallow study drugs or having undergone extensive bowel resection may affect the full absorption of Almonertinib.
- A history of interstitial lung disease, a history of drug-induced interstitial lung disease, a history of interstitial pneumonia requiring steroid therapy, or any evidence of clinically active interstitial lung disease.
Meet any of the following cardiac examination results:
- The average corrected QT interval (QTc)> 470 msec obtained from 3 ECG examinations in the resting state, the Fridericia formula is used for QT interval correction (QTcF);
- Resting ECG suggests that there are various clinically significant rhythms, conduction or ECG morphological abnormalities (such as complete left bundle branch block, 3 degree atrioventricular block, 2 degree atrioventricular block, and PR between Period> 250 msec);
- There are any factors that increase the risk of QTc prolongation or arrhythmia events, such as heart failure, hypokalemia, congenital long QT syndrome, family history of long QT syndrome, or unexplained sudden death or prolonged QT of immediate family members under 40 Any concomitant drugs in the interval;
- Left ventricular ejection fraction (LVEF) ≤50%.
Insufficient bone marrow reserve or organ function, reaching the following laboratory limits:
- Absolute neutrophil count <1.5×109 / L;
- Platelet count <100×109 / L;
- Hemoglobin <90 g/L (<9 g/dL);
- Alanine aminotransferase> 2.5 times the upper limit of normal (ULN)
- Aspartate aminotransferase> 2.5×ULN
- Total bilirubin> 1.5×ULN; or Gilbert syndrome (unconjugated hyperbilirubinemia)
- Creatinine>1.5×ULN and creatinine clearance rate<50 mL/min (calculated by Cockcroft-Gault formula); only when creatinine>1.5×ULN, creatinine clearance rate needs to be confirmed.
- Women who are breastfeeding or whose blood or urine pregnancy test results are positive within 3 days before the first dose of study treatment.
- Active fungal, bacterial and/or viral infections requiring systemic treatment.
- Have a history of hypersensitivity to any active or inactive ingredients of Almonertinib or to drugs with similar chemical structure to Almonertinib or the same class of Almonertinib.
- Any serious or uncontrolled eye disease may increase the safety risk of the patient as judged by the doctor.
- Patients who are judged by the investigator who may not comply well with the procedures and requirements of the study.
- The investigator judges that there are any patients with conditions that endanger the safety of the patient or interfere with the evaluation of the study.
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: Almonertinib group
Patients meeting the criteria for inclusion and exclusion were included in the Almonertinib treatment group and received 110 mg of Almonertinib orally once a day.
|
Almonertinib is a class 1 new drug,the third-generation small molecule EGFR TKI, which can irreversibly and highly selectively inhibit EGFR sensitive mutations (such as exon 19 deletion and L858R mutation) and T790M resistance mutations. Patients meeting the criteria for inclusion and exclusion were included in the Almonertinib treatment group and received 110 mg of Almonertinib orally once a day.
Autres noms:
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Assess the safety of Almonertinib: Number of AEs/SAEs
Délai: Continuously throughout the study until 28 days after Termination of the treatment
|
Number of adverse events (AEs)/serious adverse events (SAEs)
|
Continuously throughout the study until 28 days after Termination of the treatment
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Assess the anti-tumor activity: Progression Free Survival (PFS)
Délai: From date of baseline until the date of disease progression or discontinuation from study, assessed up to 24 months
|
To assess the efficacy of Almonertinib in the treatment of advanced NSCLC patients with EGFR-sensitive mutations who are intolerant to safety after osimertinib treatment by assessment of progression free survival (PFS) using Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1). From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months. |
From date of baseline until the date of disease progression or discontinuation from study, assessed up to 24 months
|
Assess the anti-tumor activity: Objective response rate (ORR)
Délai: From date of baseline until the date of disease progression or discontinuation from study, assessed up to 24 months
|
ORR is defined as the percentage of patients who have at least 1 response of CR or PR prior to any evidence of progression assessed up to 24 months.
|
From date of baseline until the date of disease progression or discontinuation from study, assessed up to 24 months
|
Assess the anti-tumor activity: Disease control rate (DCR)
Délai: From date of baseline until the date of disease progression or discontinuation from study, assessed up to 24 months
|
The DCR is defined as the proportion of patients with a best overall response of CR, PR, or SD assessed up to 24 months.
|
From date of baseline until the date of disease progression or discontinuation from study, assessed up to 24 months
|
Assess the anti-tumor activity: Duration of response (DoR)
Délai: the time from date of documented progression or death in the absence of disease progression assessed up to 24 months.
|
DoR is defined as the time from the date of first documented response until the date of documented progression or death in the absence of disease progression assessed up to 24 months.
|
the time from date of documented progression or death in the absence of disease progression assessed up to 24 months.
|
Assess the anti-tumor activity: Overall survival (OS)
Délai: an average of 4 years
|
Start of study drug to Survival Endpoint through study completion, an average of 4 years.
|
an average of 4 years
|
Assess the anti-tumor activity: Depth of Remission (DepOR)
Délai: through study completion, an average of 1 year
|
The depth of remission (change in tumor size) refers to the amount of change in the sum of the length of the longest diameter of the target lesion defined by RECIST 1.1 when no new lesions appear or no non-target lesions have progressed compared with the baseline.
|
through study completion, an average of 1 year
|
Collaborateurs et enquêteurs
Parrainer
Collaborateurs
Les enquêteurs
- Chercheur principal: Meiqi Shi, Jiangsu Cancer Institute & Hospital
- Chercheur principal: Yongsheng Li, The Affiliated Cancer Hospital of Chongqing University
- Chercheur principal: Jianying Zhou, Zhejiang University
- Chercheur principal: Xiuyu Cai, Sun Yat-sen University
- Chercheur principal: Yueyin Pan, The First Affiliated Hospital of University of Science and Technology of China
- Chercheur principal: Wenxiu Yao, Sichuan Cancer Hospital and Research Institute
- Chercheur principal: Chun Huang, Tianjin Cancer Hospital
- Chercheur principal: Minglei Zhuo, Peking University Cancer Hospital & Institute
- Chercheur principal: Conghua Xie, Wuhan University
- Chercheur principal: Qibin Song, Hubei Provincial People's Hospital
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Anticipé)
Achèvement primaire (Anticipé)
Achèvement de l'étude (Anticipé)
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
Autres numéros d'identification d'étude
- YX-L-202109
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Informations sur les médicaments et les dispositifs, documents d'étude
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Essais cliniques sur Almonertinib
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Jiangsu Hansoh Pharmaceutical Co., Ltd.Actif, ne recrute pasCancer du poumon non à petites cellulesChine
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Jiangsu Hansoh Pharmaceutical Co., Ltd.Recrutement
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Suzhou Suncadia Biopharmaceuticals Co., Ltd.Pas encore de recrutementCancer du poumon non à petites cellules en rechute ou avancé
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Guangzhou Institute of Respiratory DiseaseRecrutementMauvais état des performances | Tumeur maligne du poumonChine
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Tianjin Medical University Cancer Institute and...Pas encore de recrutement
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Shanghai Cancer Hospital, ChinaRecrutementCancer du poumon non à petites cellules métastatiqueChine
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The First Affiliated Hospital with Nanjing Medical...Pas encore de recrutementCancer du poumon non à petites cellules
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Qianfoshan HospitalRecrutementCancer du poumon non à petites cellules avancéChine
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Yuan ChenRecrutement
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Sun Yat-sen UniversityInscription sur invitationInnocuité de l'almonertinibChine