Clinical trial NCT04970693: A Study of Furmonertinib Combined With Radiotherapy for Non-small Cell Lung Cancer With Oligoprogression
Official title: A Phase II Single-arm Study of Furmonertinib Combined With Radiotherapy for Non-small Cell Lung Cancer With Oligoprogression After First-line EGFR-TKI Therapy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Non-small Cell Lung Cancer
Oligoprogressive
Keywords: non-small cell lung cancer
oligoprogressive
Furmonertinib combined with radiotherapy
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2021-07-21
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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.

Primary outcomes:
measure: progression-free survival
timeFrame: 2-year
Secondary outcomes:
measure: Overall survival
timeFrame: 2-year
measure: Failure pattern
timeFrame: 2-year
measure: Safety evaluation
timeFrame: 2 year after therapy
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Sun yat-sen University Cancer Center
state: Guangdong
Study officials:
affiliation: Sun yat-sen universtiy cancer center
name: Hui Liu
role: PRINCIPAL_INVESTIGATOR
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