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

Primary Purpose

Non-small Cell Lung Cancer, Oligoprogressive

Status

Recruiting

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

Furmonertinib

About this trial

This is an interventional treatment trial for Non-small Cell Lung Cancer focused on measuring non-small cell lung cancer, oligoprogressive, Furmonertinib combined with radiotherapy

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Sun yat-sen University Cancer CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Furmonertinib 80mg combined with radiotherapy

Furmonertinib 160mg combined with radiotherapy

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

progression-free survival

From the first day of treatment to the day of progression or the day of death.

Secondary Outcome Measures

Overall survival

It was calculated from the first day of treatment to the day of death.

Failure pattern

Disease progression such as local recurrence or distant metastasis.

Safety evaluation

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.

Full Information

NCT ID

NCT04970693

First Posted

June 26, 2021

Last Updated

July 10, 2021

Sponsor

Sun Yat-sen University

1. Study Identification

Unique Protocol Identification Number

NCT04970693

Brief Title

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

2. Study Status

Record Verification Date

July 2021

Overall Recruitment Status

Recruiting

Study Start Date

June 1, 2021 (Actual)

Primary Completion Date

January 31, 2024 (Anticipated)

Study Completion Date

May 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Sun Yat-sen University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Non-small Cell Lung Cancer, Oligoprogressive

Keywords

non-small cell lung cancer, oligoprogressive, Furmonertinib combined with radiotherapy

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

64 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Furmonertinib 80mg combined with radiotherapy

Arm Type

Experimental

Arm Description

Arm Title

Furmonertinib 160mg combined with radiotherapy

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

Furmonertinib

Other Intervention Name(s)

Radiotherapy

Intervention Description

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.

Primary Outcome Measure Information:

Title

progression-free survival

Description

From the first day of treatment to the day of progression or the day of death.

Time Frame

2-year

Secondary Outcome Measure Information:

Title

Overall survival

Description

It was calculated from the first day of treatment to the day of death.

Time Frame

2-year

Title

Failure pattern

Description

Disease progression such as local recurrence or distant metastasis.

Time Frame

2-year

Title

Safety evaluation

Description

Time Frame

2 year after therapy

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

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: When there are lesions on both adrenal glands, it is considered to be 2 metastases; 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; The adjacent lesions in the liver, lung, and mediastinum can be considered as a metastasis if one isocenter can be used for irradiation; 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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Bo Qiu

Phone

+86-020-87343031

qiubo@sysucc.org.cn

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Hui Liu

Organizational Affiliation

Sun yat-sen universtiy cancer center

Official's Role

Principal Investigator

Facility Information:

Facility Name

Sun yat-sen University Cancer Center

City

Guangzhou

State/Province

Guangdong

ZIP/Postal Code

510000

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Bo Qiu, Professor

Phone

020-87343031

qiubo@sysucc.org.cn

12. IPD Sharing Statement

Citations:

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23407558

Citation

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Results Reference

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Citation

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Citation

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

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