furmonertinib combined with anlotinib as the first-line treatment in patients with egfr mutation-positive nsclc

Conditions: Non-Small-Cell Lung Cancer

Summary: the aim of this phase ⅱ study is to evaluate the efficacy and safety of furmonertinib combined with anlotinib as the first-line treatment in locally advanced or metastatic non-small cell lung cancer with sensitive egfr mutations.


Eligibility criteria:
inclusion criteria: 1. subjects have voluntarily participated, signed and dated informed consent; 2. male or female subjects aged ≥18 and ≤75 years old; 3. locally advanced or metastatic adenocarcinoma nsclc confirmed by histology or cytology (according to the 8th edition of the ajcc staging system), not suitable for surgery or radiotherapy; 4. ecog score 0-1, and life expectancy no less than 12 weeks according to the investigator's assessment; 5. the tumour harbours one of the most common egfr mutations (19del or l858r) ; 6. according to recist 1.1, subjects have at least one measurable tumor lesion at baseline, and had not received radiotherapy previously; 7. no previous systemic anti-tumor therapy for locally advanced or metastatic nsclc. for recurrent disease, adjuvant therapy or neoadjuvant therapy may be accepted, but recurrence occurs ≥6 months from stopping treatment; 8. subjects with stable clinical symptoms of pleural effusion or ascites after symptomatic treatment; 9. for premenopausal women with fertility, the result of serum or urine pregnancy test should be negative within 7 days before the first dose. exclusion criteria: 1. not lung adenocarcinoma, including lung squamous carcinoma, or mixed histology, etc; 2. subjects are expected to participate in other clinical studies during this trial period; 3. imaging evidence showed that the tumor had invaded critical blood vessels; 4. subjects who receive systemic anti-tumor therapy used for locally advanced or metastatic nsclc previously; 5. with other malignant tumors at present or history of other malignant tumors within 5 years; 6. leptomeningeal metastases or central nervous system metastasis requiring emergency treatment; 7. at the beginning of study treatment, any unresolved toxic reaction to prior treatment (e.g., adjuvant chemotherapy) exceeds ctcae grade 1; 8. history of ild, drug-induced ild, radiation pneumonitis which require steroid treatment, or with suspected clinical manifestations of ild or high risk factors; 9. severe gastrointestinal dysfunction may affect the intake, transport or absorption of the study drugs; 10. recent active digestive diseases or other conditions that may cause gastrointestinal bleeding or perforation; 11. presence of bleeding constitution or active bleeding; any bleeding event ≥ctcae grade 3, unhealed wounds, ulcers, or fractures occurred within 28 days prior to the first dose; 12. any of the following organ function criteria is met (no blood or blood product transfusions, no hematopoietic stimulating factors, no albumin or blood product transfusions within 7 days prior to examination): absolute value of neutrophil (ne)\ 1.5 × uln, aspartate aminotransferase (ast) and/or alanine aminotransferase (alt)\>2.5 × uln (for liver metastases or gilbert syndrome, tbil\>3 × uln, and ast and/or alt\>5 × uln); serum creatinine (scr)\>1.5 × uln, or creatinine clearance\ 1.0g; international normalized ratio（inr）\>1.5 and activated partial thromboplastin time (aptt)\>1.5 uln; fasting blood glucose \>10mmol/l； 13. any of the following cardiac criteria is met： * at rest, the mean corrected qt interval (qtc) by ecg \> 470 msec； * seriously abnormal of heart rhythm, conduction, or morphology of resting ecg; * any factors that may increase the risk of prolonged qtc or risk of arrhythmic events; * left ventricular ejection fraction (lvef) \< 50%; * uncontrollable hypertension (systolic blood pressure≥150 mmhg and/or diastolic blood pressure≥100 mmhg); 14. with active infection diseases, such as hbv, hcv and hiv; 15. known or suspected to be allergic to furmonertinib and anlotinib and / or other components of their preparations; 16. pregnancy or lactation; 17. subjects who are considered ineligible for the study for other reasons according to the investigator's assessment.

Keywords: egfr mutations; furmonertinib; anlotinib; non-squamous nsclc