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NCT Number: NCT06394674

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

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.

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Key information

Conditions

Non-small Cell Lung Cancer Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Furmonertinib

Drug

Drug: Furmonertinib

Other names: AST2818

Primary outcomes

  1. Objective Response Rate(ORR)

    Time frame: 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 outcomes

  1. Progression-free survival (PFS)

    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

    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.

  2. Disease Control Rate (DCR)

    Time frame: 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.

  3. Duration of Response (DoR)

    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

    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.

Other outcomes

  1. Adverse Events

    Time frame: From the start of study drug to 30 days after the last dose of study drug

    The number of patients with adverse events and the severity according to CTCAE v5.0.

Sponsors and collaborators

Lead sponsor

Changhai Hospital

Other

Collaborators

  • Fujian Provincial Hospital
  • Second Affiliated Hospital of Wannan Medical College
  • Shanghai Changzheng Hospital
  • Shanghai Chest Hospital
  • The First Affiliated Hospital of Bengbu Medical University
  • The First People's Hospital of Changzhou
  • The General Hospital of Eastern Theater Command

Registry information

Official study title

A Prospective, Randomized, Phase ll Clinical Trial of Single-agent Treatment With Different Doses of Sulfamethoxazole Furmonertinib in Patients With Advanced, Metastatic Lung Adenocarcinoma Who Have Progressed After First- or Second-line Treatment With EGFR-TKl Osimertinib

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
May 1, 2024
Registry last updated
Jul 26, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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