Actively Recruiting
Efficacy and Safety of Almonertinib Combined With Stereotactic Body Radiotherapy (SBRT) in the Treatment of Non-small Cell Lung Cancer With EGFR Sensitive Mutation: a Single-arm, Open-label Clinical Trial
Led by Chongqing University Cancer Hospital · Updated on 2024-09-04
30
Participants Needed
1
Research Sites
105 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The goal of this clinical trial is to learn if first-line Almonertinib plus upfront stereotactic ablative body radiotherapy (SABR) works to treat EGFR-mutated advanced non-small cell lung cancer. The main questions it aims to answer are: Does first-line Almonertinib plus upfront stereotactic ablative body radiotherapy to residual primary lung lesions prolong the progression-free survival of EGFR-mutated advanced non-small cell lung cancer. Participants will: Take first-line Almonertinib for 2-4 months, then deliver SABR to residual primary lung lesions, after that go on Almonertinib maintenance treatment； Visit the hospital once every 3 months for checkups and tests； Keep a diary of their symptoms ；
CONDITIONS
Official Title
Efficacy and Safety of Almonertinib Combined With Stereotactic Body Radiotherapy (SBRT) in the Treatment of Non-small Cell Lung Cancer With EGFR Sensitive Mutation: a Single-arm, Open-label Clinical Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged 18 years or older and up to 75 years
- Histologically or cytologically confirmed unresectable NSCLC, stage IIIB-IV
- Up to 5 brain oligometastatic lesions measurable by MRI
- No prior systemic therapy after NSCLC diagnosis or no progression after 1-2 chemotherapy cycles
- EGFR-sensitive mutation confirmed by tumor tissue or blood sample
- ECOG physical status score of 0 or 1 with no worsening in past 2 weeks and expected survival of at least 12 weeks
- At least one lung tumor lesion measurable by CT or MRI, suitable for SBRT after targeted therapy
- Women of childbearing potential must use adequate contraception and have a negative pregnancy test or meet defined postmenopausal or sterilization criteria
- Male patients must use barrier contraception from screening until 3 months after treatment ends
- Voluntary participation with signed informed consent
You will not qualify if you...
- Patients with postoperative recurrence
- Prior treatment with EGFR tyrosine kinase inhibitors or lung radiotherapy
- Major surgery within 4 weeks before study drug start
- Use of strong CYP3A4 inhibitors, inducers, or sensitive substrates within 7 days before study drug
- Other malignancies requiring treatment or surgery within 2 years
- Patients eligible for surgical resection
- Progression within 3 months of targeted therapy
- Unresolved toxicity from prior therapy above grade 1 except alopecia and certain neurotoxicity
- Uncontrolled pleural or pericardial effusion
- Serious or poorly controlled systemic diseases
- Severe nausea, vomiting, gastrointestinal disorders, or swallowing difficulties
- Certain cardiac abnormalities or risk factors for arrhythmia
- History or evidence of interstitial lung disease
- Inadequate bone marrow or organ function based on lab tests
- Breastfeeding women or positive pregnancy test within 3 days before treatment
- Allergic reactions to almonertinib or similar drugs
- Serious uncontrolled eye conditions
- Poor compliance or safety concerns as judged by investigator
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Chongqing University Cancer Hospital
Chongqing, Chongqing Municipality, China, 400030
Actively Recruiting
Research Team
D
Dan Tao, Dr.
CONTACT
W
Wei Zhou, Dr.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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