Non-small Cell Lung Cancer, Oligoprogressive
Conditions
Keywords
non-small cell lung cancer, oligoprogressive, Furmonertinib combined with radiotherapy
Brief summary
This Phase II randomized study is to explore the efficacy and safety of Furmonertinib combined with radiotherapy for non-small cell lung cancer with oligoprogression after first-line EGFR-TKI therapy.
Detailed description
This Phase II randomized study is to explore the efficacy and safety of Furmonertinib combined with radiotherapy for non-small cell lung cancer with oligoprogression after first-line EGFR-TKI therapy. The first group will enroll NSCLC patients with oligoprogression after using the first/second generation EGFR-TKI. The participants will receive Furmonertinib 80mg and local radiotherapy as the following therapy. The other group will enroll NSCLC patients with oligoprogression after using the third generation EGFR-TKI. The participants will receive Furmonertinib 160mg and local radiotherapy as the following therapy.
Interventions
DRUGFurmonertinib
The different dose of furmonertinib will be given according to the generation of EGFR-TKI used as the first-line therapy. The doses and target volume of radiotherapy will be decided according to the oligoprogressive sites.
Sponsors
Sun Yat-sen University
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Patients with locally advanced or metastatic NSCLC who are diagnosed by histology or cytology and are not suitable for surgery or radiotherapy; * After receiving the first or second generation of EGFR-TKI treatment, the disease is oligoprogressive with 3-5 lesions (with imaging evidence), and the mutation is T790M+ (histological or hematological specimens, ARMS detection method); * After receiving osimertinib treatment in the past, the disease is oligoprogressive with 3-5 lesions (with imaging evidence), and the patient refused chemotherapy; * 18-80 years old; * ECOG PS 0-2 scores; * Organ and bone marrow functions were generally normal within 30 days before enrollment, including:AST, ALT ≤ 2.5 × ULN or ≤ 5 × ULN (with liver metastasis); total bilirubin ≤ 1.5 × ULN; neutrophils absolute value ≥ 1500 cells/mm3; Creatinine clearance ≥45 mL/min; Platelets ≥ 100,000 cells/mm3; Hemoglobin ≥90g/L. * The baseline has measurable lesions defined by the RECIST 1.1 standard, and the progressive lesions should be treated with local radiotherapy; the definition of the lesion number includes: 1. When there are lesions on both adrenal glands, it is considered to be 2 metastases; 2. Two consecutive vertebral lesions and a paravertebral lesion within 6 cm can be considered as one metastasis, and the non-contiguous vertebral lesions should be counted separately; 3. The adjacent lesions in the liver, lung, and mediastinum can be considered as a metastasis if one isocenter can be used for irradiation; 4. Intracranial lesions are counted as 1 metastasis. * The patient signed an informed consent form.
Exclusion criteria
* Severe or uncontrolled hypertension, diabetes, coronary artery stenosis, aortic dissection, aneurysm or acute bleeding disease; * Any situation that increases the risk of QTc prolongation or arrhythmia; * Left ventricular ejection fraction \<50%; * History of interstitial lung disease; * FEV1%\<30% or DLCO%\<40%; * Insertion of EGFR exon 20; * The researcher believes that the patient is inappropriate to participate in this trial.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| progression-free survival | 2-year | From the first day of treatment to the day of progression or the day of death. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall survival | 2-year | It was calculated from the first day of treatment to the day of death. |
| Failure pattern | 2-year | Disease progression such as local recurrence or distant metastasis. |
| Safety evaluation | 2 year after therapy | Adverse effects are graded according to the CTCAE 5.0 version, including multiple organs and tissues, such as gastrointestinal disease and symptom, cardiovascular disease, respiratory diseases and so on. |
Countries
China
Contacts
Primary ContactBo Qiu
Outcome results
None listed