The Efficacy of Double-dose Furmonertinib in the Treatment of Patients With Slow Osimertinib-resistant NSCLC

NCT06117644 | Not Yet Recruiting DMC

• 1 other identifier: Posterior-coast
• Study Type: observational
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study is a single-center, prospective, single-arm study of the efficacy of double-dose Furmonertinib in the treatment of patients with slow Osimertinib-resistant non-small cell lung cancer, mainly in patients with advanced non-small cell lung cancer with EGFR-sensitive mutations in stage IIIB or IV, slow drug resistance after treatment with Osimertinib, and no therapeutic target was found by secondary biopsy after drug resistance.

Conditions

Non Small Cell Lung Cancer; EGFR Gene Mutation; Non Small Cell Lung Cancer Stage IIIA; Non-small Cell Lung Cancer Stage IV

Keywords

Non Small Cell Lung Cancer; EGFR Gene Mutation; Furmonertinib; Drug Resistance

Outcome Measures

Primary Outcomes (1)

• ORR

  Objective response rate (ORR) including rate of CR and PR on based of RECIST 1.1

  Observation time 1-2 months.

Secondary Outcomes (4)

• OS

  through study completion (36 months)

• PFS

  through study completion (36 months)

• DCR

  through study completion (36 months)

• AE

  through study completion (36 months)

Study Arms (1)

Furmonertinib

The subjects will be treated with Furmonertinib (double dose, 160mg). The subjects were treated with drugs for 24 months until the tumor progressed (worsened) or died.

Drug: Furmonertinib

Interventions

Furmonertinib DRUG

Furmonertinib 40 mg/tablet, 4 tablets, QD

Furmonertinib

Eligibility Criteria

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

Study Population

Mainly targeted at IIIB or IV stage EGFR sensitive mutation advanced non-small cell lung cancer patients with slow drug resistance after Osimertinib treatment, and no treatable target was found by secondary biopsy after drug resistance.

You may qualify if:

• Age ≥ 18 years old;
• EGFRm NSCLC of local progression (IIIB stage) or metastasis (IV stage);
• previously confirmed to have EGFR (Ex19del or L858R) mutation, or T790M, received Osimertinib treatment. According to Recist 1.1 imaging findings, the focus progressed slowly and there was no systemic explosive progress (definition of slow progress: disease control \> 6 months, slightly increased tumor load and symptom score ≤ 1);
• patients who intend to use Furmonertinib (double dose, 160mg) anticancer therapy;
• At least one tumor lesion in the patient can meet the following requirements: it has not been irradiated in the past and can be accurately measured, the longest diameter of the baseline phase is ≥ 10mm (in the case of lymph nodes, short axis ≥ 15mm is required), and the measurement method can be chest CT or PET-CT, as long as repeated measurements can be completed accurately;
• No treatable target was found in the second biopsy after drug resistance;
• The survival time was more than 3 months;

You may not qualify if:

• Patients who have been treated with Furmonertinib;
• Patients who intend to use anticancer therapy other than Furmonertinib recently;
• Contraindications for the use of Furmonertinib;

Sponsors & Collaborators

• Daping Hospital and the Research Institute of Surgery of the Third Military Medical University: lead

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

aflutinib

Condition Hierarchy (Ancestors)

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

Central Study Contacts

He Yong, MD

CONTACT

86-23-68757791; heyong8998@126.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 31, 2023
• First Posted: November 7, 2023
• Study Start: November 1, 2023
• Primary Completion: November 1, 2025
• Study Completion (Estimated): October 1, 2026
• Last Updated: November 7, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share