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

Phase 2RecruitingNCT06394674

Changhai Hospital84 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Non-Small Cell Lung Cancer

Interventions

Furmonertinib

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Objective Response Rate(ORR)

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

Time frame: Analysis will occur when PFS maturity is observed at approximately 12 months from the first patient begin study treatment

Secondary Outcomes

Progression-free survival (PFS)

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.

Time frame: 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

Disease Control Rate (DCR)

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.

Time frame: Analysis will occur when PFS maturity is observed at approximately 12 months from the first patient begin study treatment

Duration of Response (DoR)

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.

Time frame: 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