High-dose Furmonertinib for advanced lung cancer after Osimertinib treatment
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
PHASE2 · Changhai Hospital · NCT06394674
This study is testing if higher doses of Furmonertinib can help people with advanced lung cancer who didn't respond to Osimertinib feel better and live longer.
Quick facts
| Phase | PHASE2 |
|---|---|
| Study type | Interventional |
| Enrollment | 84 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Changhai Hospital (other) |
| Drugs / interventions | Osimertinib, chemotherapy, immunotherapy, Osmertinib, Furmonertinib |
| Locations | 1 site (Shanghai) |
| Trial ID | NCT06394674 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the efficacy of high-dose Furmonertinib in patients with advanced metastatic non-small cell lung cancer (NSCLC) who have shown disease progression after treatment with Osimertinib. The study plans to enroll 84 participants, who will be randomly assigned to receive either 160 mg or 240 mg of Furmonertinib daily. Efficacy will be assessed every six weeks until disease progression, intolerable side effects occur, or participants withdraw consent. The trial aims to determine if higher doses of Furmonertinib can provide a therapeutic benefit in this patient population.
Who should consider this trial
Good fit: Ideal candidates are patients with metastatic lung adenocarcinoma who have progressed after first- or second-line treatment with Osimertinib.
Not a fit: Patients who have not been previously treated with Osimertinib or those with other types of lung cancer may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could offer a new option for patients with advanced NSCLC who have not responded to previous therapies.
How similar studies have performed: Other studies have explored treatments for NSCLC after Osimertinib, but the specific use of high-dose Furmonertinib represents a novel approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Shanghai
- Changhai Hospital — Shanghai, China (RECRUITING)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Non-Small Cell Lung Cancer, furmonertinib