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

NCT04970693 | Unknown Phase 2

• 1 other identifier: GASTO-1079
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

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.

Conditions

Non-small Cell Lung Cancer; Oligoprogressive

Keywords

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

Outcome Measures

Primary Outcomes (1)

• progression-free survival

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

  2-year

Secondary Outcomes (3)

• Overall survival

  2-year

• Failure pattern

  2-year

• Safety evaluation

  2 year after therapy

Study Arms (2)

Furmonertinib 80mg combined with radiotherapy

EXPERIMENTAL

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.

Drug: Furmonertinib

Furmonertinib 160mg combined with radiotherapy

EXPERIMENTAL

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.

Drug: Furmonertinib

Interventions

Furmonertinib DRUG

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.

Also known as: Radiotherapy

Furmonertinib 160mg combined with radiotherapy; Furmonertinib 80mg combined with radiotherapy

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (1)

Sun yat-sen University Cancer Center

Guangzhou, Guangdong, 510000, China

RECRUITING

Related Publications (9)

• Yu HA, Sima CS, Huang J, Solomon SB, Rimner A, Paik P, Pietanza MC, Azzoli CG, Rizvi NA, Krug LM, Miller VA, Kris MG, Riely GJ. Local therapy with continued EGFR tyrosine kinase inhibitor therapy as a treatment strategy in EGFR-mutant advanced lung cancers that have developed acquired resistance to EGFR tyrosine kinase inhibitors. J Thorac Oncol. 2013 Mar;8(3):346-51. doi: 10.1097/JTO.0b013e31827e1f83.

  PMID: 23407558 BACKGROUND

• Schmid S, Klingbiel D, Aeppli S, Britschgi C, Gautschi O, Pless M, Rothschild S, Wannesson L, Janthur W, Foerbs D, Demmer I, Jochum W, Fruh M. Patterns of progression on osimertinib in EGFR T790M positive NSCLC: A Swiss cohort study. Lung Cancer. 2019 Apr;130:149-155. doi: 10.1016/j.lungcan.2019.02.020. Epub 2019 Feb 19.

  PMID: 30885336 BACKGROUND

• Shah R, Lester JF. Tyrosine Kinase Inhibitors for the Treatment of EGFR Mutation-Positive Non-Small-Cell Lung Cancer: A Clash of the Generations. Clin Lung Cancer. 2020 May;21(3):e216-e228. doi: 10.1016/j.cllc.2019.12.003. Epub 2019 Dec 20.

  PMID: 32014348 BACKGROUND

• Mu Y, Hao X, Xing P, Hu X, Wang Y, Li T, Zhang J, Xu Z, Li J. Acquired resistance to osimertinib in patients with non-small-cell lung cancer: mechanisms and clinical outcomes. J Cancer Res Clin Oncol. 2020 Sep;146(9):2427-2433. doi: 10.1007/s00432-020-03239-1. Epub 2020 May 8.

  PMID: 32385709 BACKGROUND

• Eide IJZ, Helland A, Ekman S, Mellemgaard A, Hansen KH, Cicenas S, Koivunen J, Gronberg BH, Brustugun OT. Osimertinib in T790M-positive and -negative patients with EGFR-mutated advanced non-small cell lung cancer (the TREM-study). Lung Cancer. 2020 May;143:27-35. doi: 10.1016/j.lungcan.2020.03.009. Epub 2020 Mar 12.

  PMID: 32200138 BACKGROUND

• Qiu B, Liang Y, Li Q, Liu G, Wang F, Chen Z, Liu M, Zhao M, Liu H. Local Therapy for Oligoprogressive Disease in Patients With Advanced Stage Non-small-cell Lung Cancer Harboring Epidermal Growth Factor Receptor Mutation. Clin Lung Cancer. 2017 Nov;18(6):e369-e373. doi: 10.1016/j.cllc.2017.04.002. Epub 2017 Apr 12.

  PMID: 28465010 BACKGROUND

• Weickhardt AJ, Scheier B, Burke JM, Gan G, Lu X, Bunn PA Jr, Aisner DL, Gaspar LE, Kavanagh BD, Doebele RC, Camidge DR. Local ablative therapy of oligoprogressive disease prolongs disease control by tyrosine kinase inhibitors in oncogene-addicted non-small-cell lung cancer. J Thorac Oncol. 2012 Dec;7(12):1807-1814. doi: 10.1097/JTO.0b013e3182745948.

  PMID: 23154552 BACKGROUND

• Shi Y, Zhang S, Hu X, Feng J, Ma Z, Zhou J, Yang N, Wu L, Liao W, Zhong D, Han X, Wang Z, Zhang X, Qin S, Ying K, Feng J, Fang J, Liu L, Jiang Y. Safety, Clinical Activity, and Pharmacokinetics of Alflutinib (AST2818) in Patients With Advanced NSCLC With EGFR T790M Mutation. J Thorac Oncol. 2020 Jun;15(6):1015-1026. doi: 10.1016/j.jtho.2020.01.010. Epub 2020 Jan 30.

  PMID: 32007598 BACKGROUND

• Shi Y, Hu X, Zhang S, Lv D, Wu L, Yu Q, Zhang Y, Liu L, Wang X, Cheng Y, Ma Z, Niu H, Wang D, Feng J, Huang C, Liu C, Zhao H, Li J, Zhang X, Jiang Y, Gu C. Efficacy, safety, and genetic analysis of furmonertinib (AST2818) in patients with EGFR T790M mutated non-small-cell lung cancer: a phase 2b, multicentre, single-arm, open-label study. Lancet Respir Med. 2021 Aug;9(8):829-839. doi: 10.1016/S2213-2600(20)30455-0. Epub 2021 Mar 26.

  PMID: 33780662 BACKGROUND

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

aflutinib; Radiotherapy

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Hui Liu

  Sun yat-sen universtiy cancer center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Bo Qiu

CONTACT

+86-020-87343031; qiubo@sysucc.org.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 26, 2021
• First Posted: July 21, 2021
• Study Start: June 1, 2021
• Primary Completion: January 31, 2024
• Study Completion: May 31, 2024
• Last Updated: July 21, 2021

Record last verified: 2021-07

Locations

CN (1)