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

Naval Military Medical University

Status and phase

Enrolling

Phase 2

Conditions

Non-Small Cell Lung Cancer

Treatments

Drug: Furmonertinib

Study type

Interventional

Funder types

Other

Identifiers

NCT06394674

CHEC2023-155

Details and patient eligibility

About

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.

Enrollment

84 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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