Non-squamous, squamous or adenosquamous NSCLC with locally advanced unresectable (Stage III) disease
Conditions
Interventions
Experimental Group:Osimertinib treatment
Sponsors
Guangdong Provincial People's Hospital(Guangdong Academy of Medical Sciences)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Age 1. When signing the informed consent form, the age should be >= 18 years old or reach the legal consent age in the jurisdiction of the research institution. Type of subject and disease characteristics 2. Histologically confirmed as NSCLC (mainly non-squamous, squamous, and adenosquamous pathological types) and being locally advanced and unresectable (III stage, according to the 8th edition of the IASLC thoracic tumor staging manual). It is recommended (but not mandatory) to confirm the lymph node status as N2 or N3 (except for obvious cT4 diseases) through biopsy (by bronchial endoscopy, mediastinoscopy, or thoracoscopic examination), or through whole-body enhanced CT scan if no biopsy is available. 3. For subjects who have experienced recurrence after complete tumor resection in I/II/III stages or incomplete tumor resection, if they have not received any chemotherapy, radiotherapy, immunotherapy, targeted therapy, or trial drugs, they can also be enrolled in the study. 4. HBV subjects are eligible for enrollment in the study only if they meet all of the following criteria: (1) Proven without co-infection with HCV or HCV infection history; (2) Proven without HIV co-infection; (3) For active HBV infection subjects, they need to meet the following criteria: 1) Received antiviral treatment for at least 6 weeks before the study treatment, with HBV DNA suppressed to 350 cells/µL (4) No history of opportunistic infections defined by acquired immune deficiency syndrome in the past 12 months (5) Stable treatment with the same anti-HIV drugs for at least 4 weeks 6. There is available EGFRm test result to confirm that the tumor carries one of the two common EGFR mutations (Ex19del and L858R) known to be associated with EGFR-TKI sensitivity, either as a single mutation or coexisting with other EGFR mutations (including the primary T790M point mutation) 7. WHO performance status is 0, 1, or 2, and there is no deterioration at the baseline of the screening period and 2 weeks before the first administration. 8. The subject has been evaluated by the doctor and is suitable for RT and plans to receive RT. 9. The subject refuses chemotherapy or is evaluated by the doctor as not suitable for chemotherapy. 10. On the first day, the expected lifespan should be at least 12 weeks. 11. Baseline has >= 1 measurable lesion that can be accurately measured: CT or MRI shows the longest diameter >= 10 mm (except for lymph nodes, the short axis of lymph nodes must be >= 15 mm), and is suitable for repeated accurate measurement. Gender and Contraception/Barrier Requirements 12. Male and/or Female: The
Exclusion criteria
Exclusion criteria: Condition 1. The histological type is small cell lung cancer and mixed small cell/non-small cell lung cancer. 2. There is a history of ILD, drug-induced ILD, or need for hormone therapy for radiation pneumonitis, or any clinical evidence of active ILD. 3. There is any evidence of serious or uncontrolled systemic diseases as perceived by the investigator (including uncontrolled hypertension and active bleeding constitution), or active infection (such as a subject receiving anti-infection treatment, including HCV, HIV, and tuberculosis), or uncontrolled active HBV infection. Note: No screening for chronic diseases is required. 4. Has refractory nausea and vomiting, chronic gastrointestinal diseases, inability to swallow preparations, or previous major intestinal resection (which may affect the adequate absorption of osimertinib). 5. Has a history of other primary malignant tumors, unless the tumor has received radical treatment and there is no known active disease for at least 2 years before the first administration of the study intervention, and the recurrence risk is low. Exceptional cases include fully resected non-melanoma skin cancer and cured carcinoma in situ. Patients who have received overlapping field RT (for example, a cured breast cancer) must be excluded. 6. Meets any of the following cardiac criteria: Clinical Study Protocol - 1.0 (1) The average resting QTc value obtained from 3 ECGs is > 470 ms (based on the QTc value obtained from the screening outpatient electrocardiogram machine). (2) There are any clinically significant abnormalities in the rhythm, conduction, or morphology of the resting ECG, such as complete left bundle branch block, third-degree heart block, and second-degree heart block. (3) There are any factors that increase the risk of QTc prolongation or the risk of arrhythmia events, such as electrolyte abnormalities, including: hypokalemia, CTCAE >= 2 grade heart failure, congenital long QT syndrome, long QT syndrome family history, or unexplained sudden death in a first-degree relative under 40 years old, or the use of any known drugs that can prolong the QT interval and cause torsades de pointes at the time of the first administration of the study intervention. Electrolyte abnormalities must be corrected and recorded before the first administration. 7. Indicates bone marrow reserve or organ dysfunction, and meets any of the following laboratory test values: (1) Absolute neutrophil count 2.5 × ULN without liver metastasis, > 5 × ULN with liver metastasis; (5) Aspartate aminotransferase > 2.5 × ULN without liver metastasis, > 5 × ULN with liver metastasis; (6) Total bilirubin > 1.5 × ULN without liver metastasis, or Gilbert syndrome [non-conjugated hyperbilirubinemia] or > 3 × ULN with liver metastasis; (7) Creatinine > 1.5 × ULN and creatinine clearance rate 1.5 × ULN. Previous/Concurrent Therapy 8. Is currently receiving (or unable to discontinue before the first administration of the study intervention) a known CYP3A4 strong inducer drug or herbal supplement (at least 3 weeks before administration) (Appendix G). All patients should try to avoid using any known drugs, herbal supplements, and/or foods that can induce CYP3A4. 9. Before commencing the treatment, any toxicity
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-Free Survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Adverse enents;Disease control Rate;Overall Survival;Objective Response Rate; | — |
Countries
China
Contacts
Public ContactYilong Wu
Guangdong Provincial People's Hospital(Guangdong Academy of Medical Sciences)
Outcome results
None listed