High-dose Furmonertinib in the Treatment in Patients With Advanced, Metastatic NSCLC With Progressed After First- or Second-line Treatment With Osimertinib

Phase 2

Recruiting

• Conditions: Non-Small Cell Lung Cancer
• Interventions: Drug: Furmonertinib

• Registration Number: NCT06394674
• Lead Sponsor: Changhai Hospital

Brief Summary

This is a prospective, randomised, uncontrolled phase II clinical trial planned to include 84 subjects with metastatic lung adenocarcinoma that had progressed after first- or second-line treatment with Osmertinib, who were randomly assigned to trial group 1 and trial group 2, and were given Furmonertinib 160 mg and 240 mg once/day, orally, respectively, with efficacy evaluated every 6 weeks until disease progression, intolerable toxic side effects, or Subjects voluntarily withdrew informed consent.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-04-27
• Study First Submitted QC: 2024-04-27
• Status Verified: 2024-05
• Study Start: 2024-05-01
• Study First Posted: 2024-05-01
• Last Update Submitted: 2024-07-25
• Last Update Posted: 2024-07-26
• Primary Completion: 2025-06
• Study Completion: 2026-09

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 84

Inclusion Criteria

• Histologically or cytologically confirmed metastatic lung adenocarcinoma
• Progression of imaging-confirmed extracranial lesions after first- or second-line treatment with Osimertinib
• Previous genetic testing for a definite EGFR-sensitive mutation and imaging-confirmed extracranial lesion progression after first-line treatment with Osimertinib; or previous genetic testing for a definite T790M mutation and imaging-confirmed extracranial lesion progression after second-line treatment with Osimertinib.
• Pre-existing clinical benefit after treatment with Osimertinib, including CR, PR, SD (duration >6 months);
• Patients with at least 1 measurable lesion according to the criteria for evaluating the efficacy of solid tumors (RECIST 1.1)
• Normal functioning of major organs
• Pre-menopausal women of childbearing potential with a negative serum or urine pregnancy test within 7 days prior to the first dose of the drug
• Subjects volunteered and signed a written informed consent form.

Exclusion Criteria

• Previous chemotherapy or immunotherapy
• Patients with non-lung adenocarcinoma, including squamous lung cancer or mixed histological types
• Progression of imaging-confirmed extracranial lesions after prior Osimertinib treatment with accessible treatment options after genetic testing
• Patients with symptomatic brain metastases, meningeal metastases or spinal cord compression
• Any unrecovered CTCAE > grade 1 toxicity reaction following prior Osimertinib treatment at the start of study drug therapy
• Other malignant tumors within 5 years or history of other malignant tumours; except effectively controlled basal cell carcinoma of the skin, carcinoma in situ of the uterine cervix, ductal carcinoma in situ of the breast, papillary carcinoma of the thyroid, superficial bladder tumors, etc.
• History of interstitial pneumonia with previous diagnosis
• Other circumstances that, in the judgement of the investigator, make them unsuitable for inclusion in the study

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group A: Furmonertinib 160mg QD	Furmonertinib	Furmonertinib (AST2818) 160mg QD. All patients enrolled into this group will receive furmonertinib 160mg daily.
Group B: Furmonertinib 240mg QD	Furmonertinib	Furmonertinib (AST2818) 240mg QD. All patients enrolled into this group will receive furmonertinib 240mg daily.

Primary Outcome Measures

Name	Time	Method
Objective Response Rate(ORR)	Analysis will occur when PFS maturity is observed at approximately 12 months from the first patient begin study treatment	Objective Response Rate (ORR) (per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) using Investigator assessments) is defined as the number (%) of patients with response

Secondary Outcome Measures

Name	Time	Method
Progression-free survival (PFS)	The primary analysis of Progression-free survival (PFS) based on investigator assessment will occur when PFS maturity is observed at approximately 12 months after the first patient begin study treatment	Progression-free survival (PFS) using Investigator assessment as defined by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1). Progression-free survival (PFS) is defined as the time from beginning of study treatment until the date of objective disease progression or death (by any cause in the absence of progression), regardless of whether the patient withdraws from randomized therapy or receives another anti-cancer therapy prior to progression. Patients who have not progressed or died at the time of analysis will be censored at the time of the latest date of assessment from their last evaluable Response Evaluation Criteria in Solid Tumors (RECIST) assessment.
Disease Control Rate (DCR)	Analysis will occur when PFS maturity is observed at approximately 12 months from the first patient begin study treatment	Disease control rate (DCR) is defined as the percentage of subjects who have a best overall response of Complete Response (CR) or Partial Response (PR) or Stable Disease (SD) by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) as assessed by the Investigator.
Duration of Response (DoR)	Duration of Response analysis will occur when Progression-free survival (PFS) maturity is observed at approximately 12 months from the first patient begin study treatment	Duration of Response is defined as the time from the date of first documented response until the date of documented progression or death in the absence of disease progression.

Trial Locations

Locations (1)

Changhai Hospital; 🇨🇳 Shanghai, China