FurmOnertinib Mesylate With or Without Chemotherapy +/- bevacizUmab as firSt Line Treatment in Advanced Non-small Cell Lung Cancer Patients With Uncleared Epidermal Growth Factor Receptor (EGFR) Mutation Positive Circulating Tumor Cell DNA
EGFR mutation positive advanced NSCLC patients with uncleared ctDNA have poor prognosis, whether they can benefit from combination therapy has not been reported. This study aims to investigate the efficacy and safety of combination therapy compared with furmonertinib monotherapy in advanced EGFR mutant NSCLC with uncleared circulating tumor cell DNA.
• Provide informed consent prior to any study specific procedures;
• at least 18 years of age;
• ECOG PS of 0 to 1 at screening with no clinically significant deterioration in the previous 2 weeks, life expectancy ≥12 weeks;
• Pathologically confirmed non-squamous Non-Small Cell Lung Cancer (NSCLC);
• Locally advanced or metastatic Non-Small Cell Lung Cancer (NSCLC) not amenable to curative surgery or radiotherapy;
• Patient with EGFR 19Del or L858R mutation diagnosed histologically or cytologically and confirmed by ctDNA, the reports must be issued or recognized by Tier 3A hospitals. The mutations above may exist alone or together;
• Patients must have untreated advanced Non-Small Cell Lung Cancer (NSCLC) not amenable to curative surgery or radiotherapy;
• According to RECIST 1.1, patients have at least one tumor lesion at baseline that meets the following requirements: accurately and repeatably measurable at baseline;
• For premenopausal women with childbearing potential, a pregnancy test must be performed within 7 days before the first dose, and the pregnancy test (blood or urine test) must be negative; female subjects must not be lactating;
⁃ Willing to use contraception as appropriate during the study and for a period after discontinuing study treatment;
⁃ Voluntary and agree to follow the study treatment protocol as well as follow-up plan, and can accept the oral medicine treatment;
⁃ Voluntary and agree to sign the informed consent for genetic research, and provide enough fresh blood samples for central NGS testing.