A Study of Furmonertinib Combined With Radiotherapy for Non-small Cell Lung Cancer With Oligoprogression

• Status: Recruiting
• Trial end date: 2024-05-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sun Yat-sen University

Criteria

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.