- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04519983
Efficacy of SRT as Salvage Therapy in Patients With Brain Oligo-progression of EGFR-mutant Non-small Cell Lung Cancer After Failure of the Third-generation EGFR-TKIs
March 16, 2023 updated by: Shanghai Cancer Hospital, China
Efficacy of SRT as Salvage Therapy in Patients With Brain Oligo-progression of EGFR-mutant Non-small Cell Lung Cancer After Failure of the Third-generation EGFR-TKIs: A Multicenter, Open Label, Phase II Clinical Study
About 20%-40% of NSCLC patients develop intracranial metastases, and most clinical studies suggest that the survival of lung cancer patients will be significantly shortened once they develop intracranial metastases.
EGFR tyrosine kinase inhibitors (EGFR-TKIs) remain the standard first-line therapy for patients with advanced EGFR-mutated NSCLC, including brain metastases(EGFR BMs).
The survival rate of NSCLC patients with EGFR BMs was significantly improved compared with that of mutation-free patients.
Third-generation EGFR-TKIs have unique advantages in the treatment of NSCLC BMs due to their improved blood-brain barrier permeability, and with the development of radiotherapy technology, stereotactic radiation therapy (SRT) has also demonstrated its remarkable qualities of high efficiency and low toxicity in a limited number of intracranial metastases.
The clinical mechanisms of resistance to third-generation EGFR-TKIs are far more complex than those of first-generation TKIs, and the treatment paradigm for disease progression including intracranial progression is challenging.
It would be interesting to design prospective clinical studies of patients with EGFR BMs treated with the third-generation TKIs followed by salvage SRT for oligo-progression.
Therefore, the investigator designed this prospective, phase II clinical study of intracranial oligo-progression applied with stereotactic radiotherapy as salvage therapy in EGFR BMs patients after failure of the third-generation EGFR-TKIs.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
40
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: JIAYAN CHEN
- Phone Number: +8618121299483
- Email: chenjiayan2008@126.com
Study Locations
-
-
Shanghai
-
Shanghai, Shanghai, China, 200032
- Recruiting
- Fudan University Shanghai Cancer Center
-
Contact:
- Jiayan Chen, MD
- Phone Number: 18121299483
- Email: chenjiayan2008@126.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
15 years to 75 years (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Age ≥ 18 and ≤ 75.
- Life expectancy exceeding 3 months.
- Histologic or cytologic pathology confirmed non-small cell lung cancer. However, sputum cytology results alone are not acceptable. The cytology results of tracheal swabbing, tracheal irrigation fluid and needle aspiration are acceptable.
- Investigators have confirmed the presence of at least one intracranial measurable lesion according to RECIST 1.1 criteria.
- Patients with stage IV NSCLC with intracranial metastases at MR baseline.
- Eastern Oncology Collaborative Group (ECOG) fitness status score of 0 or 1.
- Genetic testing suggests EGFR driver gene positivity, which can be accompanied by other driver gene positivity.
- Oligo-progression of intracranial tumors at the most recent evaluation following treatment with third- generation TKIs.
- Good hematopoiesis, defined as an absolute neutrophil count ≥1.5 × 109/L, platelet count ≥100 ×109/L, blood erythropoietin ≥ 90 g/L [7 days without transfusion or erythropoietin (EPO-dependent).
- Good liver function, defined as total bilirubin levels ≤ 1.5 times the upper limit of normal (ULN); inpatients without hepatic metastases, glutinous rice straw is used as a supplement.
- Aminotransferase (AST) and alanine aminotransferase (ALT) levels ≤ 2.5 times ULN; for patients with documented liver metastases. AST and ALT levels ≤5 times ULN.
- Good renal function, defined as serum creatinine ≤ 1.5 times ULN or calculated creatinine clearance ≥60 ml/min
- (Cockcroft-Gault formula); less than 2+ urine protein on routine urinalysis, or 24-hour urine protein quantification <1 g.
- Good coagulation, defined as an International Standardized Ratio (INR) or Prothrombin Time (PT) ≤ 1.5times ULN; if the subject is receiving anticoagulant therapy, provided that the PT is within the intended range of use of the anticoagulant.
- For female subjects of childbearing age, within 3 days prior to receiving the first study drug administration (Week 1, Day 1) A negative urine or serum pregnancy test is performed. If a negative urine pregnancy test cannot be confirmed, a blood pregnancy test may be ordered test.
- High-performance contraception (i.e., methods with a failure rate of less than 1 per cent per year) for both male and female patients if there is a risk of conception.
Exclusion Criteria:
- NSCLC EGFR driver gene negativity.
- Patients who cannot be examined by MR.
- Pathological examination of a mixture of small cell lung cancer components.
- Currently participating in an interventional clinical research treatment or have received another investigational drug within 4 weeks prior to the first administration of the drug.
- Use of third-generation TKIs or major surgical procedures within 3 weeks prior to the first dose of the drug.
- Received palliative intracranial radiotherapy prior to first administration.
- Presence of clinically active diverticulitis, abdominal abscesses, gastrointestinal obstruction.
- Have received a transplant of a solid organ or blood system.
- Presence of clinically uncontrollable pleural effusion/abdominal fluid.
- Known severe allergic reaction (≥ grade 3) to TKIs.
- Have not sufficiently recovered from toxicity and/or complications from any of the interventions prior to initiating treatment (i.e. ≤ grade 1 or at baseline, not including weakness or hair loss).
- Diagnosis of other malignancies within 5 years prior to the first dose, with exceptions including radically treated basal cell carcinoma of the skin, squamous cell carcinoma of the skin, and/or radically resected carcinoma in situ.
- Active infections that require systemic treatment.
- The known existence of a mental illness or substance abuse condition that may affect compliance with the test requirements.
- Known history of human immunodeficiency virus (HIV) infection (i.e., HIV 1/2 antibody positive).
- Evidence of a medical history or illness that could interfere with the results of the trial, prevent the subject from participating throughout the study, abnormal values for treatment or laboratory tests, or other circumstances that, in the opinion of the investigator, make enrollment unsuitable.
- Breastfeeding women.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Upfront TKI + Salvage SRT
Patients With Brain metastases of EGFR-mutant Non-small Cell Lung Cancer should receive Aumolertinib as upfront treatment.
SRT(32Gy/4fx) is given to progressive or recurrent intracranial lesions as salvage therapy after intracranial failure.
|
Aumolertinib 110 mg p.o. qd+ SRT(32Gy/4fx)
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Intracranial objective response rate (iORR)
Time Frame: 2 years
|
the rate at which intracranial lesions experience complete and partial remission compared to baseline
|
2 years
|
Intracranial progression-free survival (iPFS)
Time Frame: 2 years
|
the time between receiving treatment, observing intracranial disease progression or occurrence of death from any cause, two orders of iPFS will be available in this study analysis.
Patients who are still alive at the time of analysis will have the date of their last contact as the cut-off date.
|
2 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Overall survival (OS)
Time Frame: 2years
|
the time between receiving treatment, observing disease progression at any site, or occurrence of death from any cause, there will be two orders of PFS available for analysis in this study.
Patients who are still alive at the time of analysis will have the date of their last contact as their cut-off date.
|
2years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 2022
Primary Completion (Anticipated)
December 1, 2023
Study Completion (Anticipated)
December 15, 2023
Study Registration Dates
First Submitted
August 17, 2020
First Submitted That Met QC Criteria
August 17, 2020
First Posted (Actual)
August 20, 2020
Study Record Updates
Last Update Posted (Actual)
March 20, 2023
Last Update Submitted That Met QC Criteria
March 16, 2023
Last Verified
March 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- FUSCC-BMSA
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Lung Cancer Stage IV
-
Jerome Canady, M.D.Active, not recruitingStage IV Lung Cancer | Stage IV Bladder Cancer | Stage IV Pancreatic Cancer | Recurrent Malignant Solid Neoplasm | Stage IV Breast Cancer | Stage IV Renal Cell Cancer | Stage IV Prostate Cancer | Stage IV Colon Cancer | Stage IV Rectal Cancer | Stage IV Gastric Cancer | Stage IV Non-small Cell Lung Cancer | Stage... and other conditionsUnited States
-
Vestre Viken Hospital TrustOdense University Hospital; Karolinska University Hospital; Oslo University Hospital and other collaboratorsRecruitingCancer | Lung Cancer | NSCLC Stage IV | Mutation | NSCLC, Stage III | Lung Cancer Stage IV | Cancer, LungNorway
-
Seoul National University HospitalNational Cancer Center, Korea; Chonbuk National University Hospital; Asan Medical... and other collaboratorsCompletedStage IV Lung Cancer | Stage IV Pancreatic Cancer | Stage IV Breast Cancer | Pediatric Brain Tumor | Stage IV Colon Cancer | Stage IV Gastric Cancer | Stage IV Liver Cancer | Malignant Hematologic Neoplasm | Pediatric Solid Tumor | Pediatric Lymphoma | Biliary Cancer Metastatic | Pediatric LeukemiaKorea, Republic of
-
Holy Cross Hospital, MarylandWithdrawn
-
Washington University School of MedicineWashington University Department of Psychological and Brain SciencesTerminatedStage III Gynecologic Cancer | Stage IV Gynecologic CancerUnited States
-
Biomea Fusion Inc.RecruitingColorectal Cancer | Pancreatic Cancer | NSCLC | Non Small Cell Lung Cancer | Stage III Pancreatic Cancer | Stage IV Pancreatic Cancer | CRC | KRAS Mutation-Related Tumors | Relapsed Cancer | Refractory Cancer | Stage IV Non-small Cell Lung Cancer | Stage IV Colorectal Cancer | Stage III Non-small Cell Lung Cancer | Stage III NSCLC and other conditionsUnited States, Korea, Republic of
-
Rutgers, The State University of New JerseyNational Cancer Institute (NCI)CompletedStage IV Lung Cancer | Stage IV Skin Melanoma | Stage IIIB Skin Melanoma | Stage IIIC Skin Melanoma | Stage III Uterine Corpus Cancer | Stage IV Uterine Corpus Cancer | Stage IV Breast Cancer | Stage IIIA Breast Cancer | Stage IIIB Breast Cancer | Malignant Female Reproductive System Neoplasm | Stage III... and other conditionsUnited States
-
Maastricht Radiation OncologyAmsterdam UMC, location VUmcCompleted
-
Wake Forest University Health SciencesNational Cancer Institute (NCI)Not yet recruitingStage IV Lung Cancer | Stage III Lung Cancer | Stage II Lung Cancer
-
Ohio State University Comprehensive Cancer CenterNational Cancer Institute (NCI)RecruitingStage IVA Lung Cancer AJCC v8 | Stage IVB Lung Cancer AJCC v8 | Anatomic Stage IV Breast Cancer AJCC v8 | Prognostic Stage IV Breast Cancer AJCC v8 | Metastatic Lung Carcinoma | Stage IV Lung Cancer AJCC v8 | Metastatic Malignant Solid Neoplasm | Metastatic Breast CarcinomaUnited States
Clinical Trials on Aumolertinib Oral Tablet
-
Baohui HanJiangsu Hansoh Pharmaceutical Co., Ltd.Recruiting
-
The First Affiliated Hospital of Guangzhou Medical...Recruiting
-
Tianjin Medical University Cancer Institute and...Not yet recruitingNSCLC | EGFR Activating Mutation | Anlotinib | TP53 | Aumolertinib
-
EQRx, Inc.CompletedNSCLC | Healthy Volunteers | PharmacokineticsUnited States, New Zealand
-
Jiangsu Hansoh Pharmaceutical Co., Ltd.Recruiting
-
EstetraICON Clinical ResearchCompletedVasomotor Symptoms | Menopausal SymptomsUnited States, Canada
-
Kunming Medical UniversityRecruitingNon-Small Cell Lung Cancer With Mutation in Epidermal Growth Factor ReceptorChina
-
EQRx International, Inc.CompletedSevere Hepatic ImpairmentUnited States
-
EicOsis Human Health Inc.RecruitingHealthy SubjectsNew Zealand
-
Cara Therapeutics, Inc.CompletedChronic Kidney Diseases | PruritusUnited States