Clinical trial NCT06394674: High-dose Furmonertinib in the Treatment in Patients With Advanced, Metastatic NSCLC With Progressed After First- or Second-line Treatment With Osimertinib
Official 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Non-Small Cell Lung Cancer
Keywords: furmonertinib
Lead sponsor: Changhai Hospital
Sponsor class: OTHER
Collaborators: name: The General Hospital of Eastern Theater Command
name: Shanghai Chest Hospital
name: Fujian Provincial Hospital
name: Shanghai Changzheng Hospital
name: The First Affiliated Hospital of Bengbu Medical University
name: The First People's Hospital of Changzhou
name: Second Affiliated Hospital of Wannan Medical College
First posted: 2024-05-01
Enrollment: 84
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel Assignment
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Objective Response Rate(ORR)
timeFrame: Analysis will occur when PFS maturity is observed at approximately 12 months from the first patient begin study treatment
Secondary outcomes:
measure: Progression-free survival (PFS)
timeFrame: 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
measure: Disease Control Rate (DCR)
timeFrame: Analysis will occur when PFS maturity is observed at approximately 12 months from the first patient begin study treatment
measure: Duration of Response (DoR)
timeFrame: 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
Other outcomes:
measure: Adverse Events
timeFrame: From the start of study drug to 30 days after the last dose of study drug
Locations:
city: Shanghai
country: China
facility: Changhai Hospital
Study officials:
References: