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

Phase 2

• Conditions: Non-small Cell Lung Cancer; Oligoprogressive
• Interventions: Drug: Furmonertinib

• Registration Number: NCT04970693
• Lead Sponsor: Sun Yat-sen University

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.

Study Timeline

• Study Start: 2021-06-01
• Study First Submitted: 2021-06-26
• Status Verified: 2021-07
• Study First Submitted QC: 2021-07-10
• Last Update Submitted: 2021-07-10
• Study First Posted: 2021-07-21
• Last Update Posted: 2021-07-21
• Primary Completion: 2024-01-31
• Study Completion: 2024-05-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 64

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Furmonertinib 80mg combined with radiotherapy	Furmonertinib	This group will enroll NSCLC patients who are oligoprogressive after first/second generation EGFR-TKI therapy. These patients will receive furmonertinib 80mg combined with radiotherapy as following therapy.
Furmonertinib 160mg combined with radiotherapy	Furmonertinib	This group will enroll NSCLC patients who are oligoprogressive after third generation EGFR-TKI therapy. These patients will receive furmonertinib 160mg combined with radiotherapy as following therapy.

Primary Outcome Measures

Name	Time	Method
progression-free survival	2-year	From the first day of treatment to the day of progression or the day of death.

Secondary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Sun yat-sen University Cancer Center; 🇨🇳 Guangzhou, Guangdong, China