FOCUS-A: Furmonertinib Combined With Anlotinib as the First-line Treatment in Patients With EGFR Mutation-positive NSCLC
Study Details
Study Description
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 with sensitive EGFR mutations.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 2 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Furmonertinib Plus Anlotinib Furmonertinib (80mg) plus Anlotinib (10mg) |
Drug: Furmonertinib
80mg/day orally on a continuous dosing schedule. If subjects suffer from AEs, they can get declined dosage (40mg).
Other Names:
Drug: Anlotinib
10mg/day orally from day 1 to 14 of a 21-day cycle. If subjects suffer from AEs, they can get declined dosage (8mg).
|
Outcome Measures
Primary Outcome Measures
- Objective Response Rate (ORR) [Approximately 3 years following the first dose of study drugs]
Proportion of subjects whose tumors were assessed as complete response(CR) or partial response(PR) according to RECIST 1.1.
Secondary Outcome Measures
- Disease Control Rate (DCR) [Approximately 3 years following the first dose of study drugs]
Proportion of subjects whose tumors were assessed as CR, PR or stable disease (SD) according to RECIST 1.1.
- Duration of Response (DOR) [Approximately 3 years following the first dose of study drugs]
The time from objective tumor remission (CR or PR) to the progression of the disease or death for any reason.
- Disease progression free survival (PFS) [Approximately 3 years following the first dose of study drugs]
The time from the first does of the study drugs to the progression of the disease or death for any reason.
- Adverse Events [Until 30 days from the last dose of study drugs or initiation of a new anticancer treatment]
Number of participants with adverse events as a measure of safety and tolerability.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Subjects have voluntarily participated, signed and dated informed consent;
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Male or female subjects aged ≥18 and ≤75 years old;
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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;
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ECOG score 0-1, and life expectancy no less than 12 weeks according to the investigator's assessment;
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The tumour harbours one of the most common EGFR mutations (19del or L858R) ;
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According to RECIST 1.1, subjects have at least one measurable tumor lesion at baseline, and had not received radiotherapy previously;
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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;
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Subjects with stable clinical symptoms of pleural effusion or ascites after symptomatic treatment;
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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:
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Not lung adenocarcinoma, including lung squamous carcinoma, or mixed histology, etc;
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Subjects are expected to participate in other clinical studies during this trial period;
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Imaging evidence showed that the tumor had invaded critical blood vessels;
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Subjects who receive systemic anti-tumor therapy used for locally advanced or metastatic NSCLC previously;
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With other malignant tumors at present or history of other malignant tumors within 5 years;
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Leptomeningeal metastases or central nervous system metastasis requiring emergency treatment;
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At the beginning of study treatment, any unresolved toxic reaction to prior treatment (e.g., adjuvant chemotherapy) exceeds CTCAE Grade 1;
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History of ILD, drug-induced ILD, radiation pneumonitis which require steroid treatment, or with suspected clinical manifestations of ILD or high risk factors;
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Severe gastrointestinal dysfunction may affect the intake, transport or absorption of the study drugs;
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Recent active digestive diseases or other conditions that may cause gastrointestinal bleeding or perforation;
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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;
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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；
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Any of the following cardiac criteria is met：
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At rest, the mean corrected QT interval (QTc) by ECG > 470 msec；
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Seriously abnormal of heart rhythm, conduction, or morphology of resting ECG;
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Any factors that may increase the risk of prolonged QTc or risk of arrhythmic events;
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Left ventricular ejection fraction (LVEF) < 50%;
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Uncontrollable hypertension (systolic blood pressure≥150 mmHg and/or diastolic blood pressure≥100 mmHg);
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With active infection diseases, such as HBV, HCV and HIV;
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Known or suspected to be allergic to Furmonertinib and Anlotinib and / or other components of their preparations;
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Pregnancy or lactation;
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Subjects who are considered ineligible for the study for other reasons according to the investigator's assessment.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Shanghai Chest Hospital | Shanghai | Shanghai | China | 200000 |
Sponsors and Collaborators
- Shanghai Chest Hospital
- Allist Pharmaceuticals, Inc.
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
- AST-PMR2002