Status:
UNKNOWN
Furmonertinib Combined With Anlotinib as the First-line Treatment in Patients With EGFR Mutation-positive NSCLC
Lead Sponsor:
Shanghai Chest Hospital
Collaborating Sponsors:
Allist Pharmaceuticals, Inc.
Conditions:
Non-Small-Cell Lung Cancer
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief 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 w...
Eligibility Criteria
Inclusion
- Subjects have voluntarily participated, signed and dated informed consent;
- Male or female subjects aged ≥18 and ≤75 years old;
- 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;
- ECOG score 0-1, and life expectancy no less than 12 weeks according to the investigator's assessment;
- The tumour harbours one of the most common EGFR mutations (19del or L858R) ;
- According to RECIST 1.1, subjects have at least one measurable tumor lesion at baseline, and had not received radiotherapy previously;
- 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;
- Subjects with stable clinical symptoms of pleural effusion or ascites after symptomatic treatment;
- For premenopausal women with fertility, the result of serum or urine pregnancy test should be negative within 7 days before the first dose.
Exclusion
- Not lung adenocarcinoma, including lung squamous carcinoma, or mixed histology, etc;
- Subjects are expected to participate in other clinical studies during this trial period;
- Imaging evidence showed that the tumor had invaded critical blood vessels;
- Subjects who receive systemic anti-tumor therapy used for locally advanced or metastatic NSCLC previously;
- With other malignant tumors at present or history of other malignant tumors within 5 years;
- Leptomeningeal metastases or central nervous system metastasis requiring emergency treatment;
- At the beginning of study treatment, any unresolved toxic reaction to prior treatment (e.g., adjuvant chemotherapy) exceeds CTCAE Grade 1;
- History of ILD, drug-induced ILD, radiation pneumonitis which require steroid treatment, or with suspected clinical manifestations of ILD or high risk factors;
- Severe gastrointestinal dysfunction may affect the intake, transport or absorption of the study drugs;
- Recent active digestive diseases or other conditions that may cause gastrointestinal bleeding or perforation;
- 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;
- 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 × 109/L, platelet (PLT) count\<90 × 109/L, hemoglobin (HGB)\<90 g/L; Serum total bilirubin (TBIL)\>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\<60ml/min. (According to the Cockcroft and Gault formula); Urinary protein ≥ ++, or 24-hour urine protein\>1.0g; International normalized ratio（INR）\>1.5 and activated partial thromboplastin time (APTT)\>1.5 ULN; Fasting blood glucose \>10mmol/L；
- 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);
- With active infection diseases, such as HBV, HCV and HIV;
- Known or suspected to be allergic to Furmonertinib and Anlotinib and / or other components of their preparations;
- Pregnancy or lactation;
- Subjects who are considered ineligible for the study for other reasons according to the investigator's assessment.
Key Trial Info
Start Date :
October 12 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 30 2023
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT04895930
Start Date
October 12 2021
End Date
November 30 2023
Last Update
January 6 2023
Active Locations (1)
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1
Shanghai Chest Hospital
Shanghai, Shanghai Municipality, China, 200000