A Single Center, Single Arm Clinical Study on the Treatment of Advanced Non-small Cell Lung Cancer With Positive EGFR Sensitive Mutations and Failed EGFR TKIs With the Combination of Enrotinib and Paclitaxel Monoclonal Antibody

Phase 3

Not yet recruiting

• Conditions: Lung Cancer; Pianzumab; TKI Resistance; EGFR Sensitive Mutation; Anlotinib

• Registration Number: NCT06048315
• Lead Sponsor: Degan Lu

Brief Summary

Lung cancer is the second most common malignancy and mortality rate in the world. In the United States and Europe, approximately 10% to 15% of NSCLC patients have epidermal growth factor receptor (EGFR)-sensitive mutations, with higher mutation rates of 30% to 40% in Asia, and objective response rates (ORRs) of 76% to 80% with EGFR Tyrosine Kinase Inhibitor ...

Detailed Description

Non-small cell lung cancer is the most common type of lung cancer, accounting for 80%-85% of all lung cancers, and about 57% of patients with advanced NSCLC have distant metastases at the time of diagnosis, although chemotherapy, targeted therapy and anti-angiogenic drugs have become the cornerstone of the treatment of advanced NSCLC, but the emergence of im...

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Status Verified: 2023-09
• Study Start: 2023-09
• Study First Submitted: 2023-09-10
• Study First Submitted QC: 2023-09-15
• Last Update Submitted: 2023-09-15
• Study First Posted: 2023-09-21
• Last Update Posted: 2023-09-21
• Primary Completion: 2026-06
• Study Completion: 2026-09

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 52

Inclusion Criteria

• Volunteer to participate in clinical research, aged 18-75 years old, regardless of gender, and sign a written informed consent form.
• According to the International Association for the Study of Lung Cancer and the Joint Committee on the American Classification of Cancer, 8th edition TNM staging of lung cancer, locally advanced or metastatic (IIIB, IIIC, IV) NSCLC patients who are confirmed by histology or cytology to be inoperable and unable to undergo radical synchronous radiotherapy and chemotherapy.
• NSCLC patients who have tested positive for EGFR gene sensitive mutations through driver gene testing and have not undergone systematic treatment after EGFR TKI treatment failure.
• Newly treated patients who have not received systemic radiotherapy and chemotherapy in the past, or patients who have relapsed after more than 6 months of follow-up after adjuvant chemotherapy after surgery.
• At least one evaluable lesion judged according to RECIST criteria.
• Men or women aged 18 years ≤ 75 years old.
• ECOG PS 0 or 1.
• The expected survival period is ≥ 12 weeks.
• Adequate blood function: Absolute neutrophil count (ANC) ≥ 1.5 × 109/L and platelet count ≥ 90 × 109/L and hemoglobin ≥ 9 g/dL.
• Adequate liver function: Serum bilirubin ≤ 1.5 times the upper limit of normal value (ULN); AST and ALT ≤ 2.5 times the upper limit of normal value (ULN); Alkaline phosphatase ≤ 5 times the upper limit of normal value (ULN).
• Adequate renal function: serum creatinine ≤ upper limit of normal (ULN) or calculated creatinine clearance rate ≥ 60 mL/min.
• Women of childbearing age must have negative pregnancy test results within 28 days prior to enrollment in the study (unless amenorrhea has occurred for 24 months). If the pregnancy test is more than 7 days after the first administration, a urine pregnancy test is required for validation (within 7 days before the first administration).
• If there is a risk of conception, all patients (whether male or female) are required to use contraceptive measures with an annual failure rate of less than 1% throughout the entire treatment period until 120 days after the last study drug administration.

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Exclusion Criteria

• Known hypersensitivity to any component contained in the formulation of arotinib or piazepril monoclonal antibody;
• Individuals who are intolerant to the treatment of investigational drugs or are known to be allergic to any investigational drug or its excipients.
• Pregnant or lactating women, or female patients with fertility who have not taken contraceptive measures;
• Existing severe acute infections that have not been controlled; Those who may have purulent or chronic infections, and the wound persists without healing;
• Individuals with previously severe heart disease, including congestive heart failure, uncontrollable high-risk arrhythmia, unstable angina, myocardial infarction, severe heart valve disease, and refractory hypertension;
• Those who suffer from uncontrollable neurological, mental disorders or mental disorders, have poor compliance, and are unable to cooperate and describe treatment responses; Patients with primary brain tumors or central nervous system metastases whose condition has not been controlled and who have obvious intracranial hypertension or neuropsychiatric symptoms;
• Have coagulation dysfunction or bleeding tendency, or have a history of thrombotic or hemorrhagic diseases;
• Those undergoing anticoagulation or thrombolysis treatment;
• There are unhealed wounds, ulcers, or fractures;
• Currently participating in interventional clinical research treatment, or receiving other research drugs or using research instruments within 4 weeks before the first administration;
• Has undergone major surgical treatment (excluding surgery for biopsy purposes) within 4 weeks prior to the first study drug administration, or is expected to undergo major surgery during the study period;
• Pulmonary interstitial fibrosis with respiratory failure;
• Patients with chronic obstructive pulmonary disease and respiratory failure;
• Based on chest imaging examination, sputum examination, and clinical examination, it is determined that there is active pulmonary tuberculosis (TB) infection;
• Patients with active, known or suspected autoimmune diseases. Patients with hypothyroidism who only require hormone replacement therapy can be selected;
• Patients who require systemic corticosteroids (with a dose equivalent to>10 mg prednisone/day) or other immunosuppressive drugs within the 14 days prior to enrollment. Patients who use inhaled or topical corticosteroids, as well as patients with adrenal corticosteroid replacement therapy doses equivalent to>10 mg prednisone/day, may participate in the study if there is no active autoimmune disease;
• Previously received PD-1 or PD-L1 antibody treatment for any reason;
• Suffering from other primary malignant tumors before the start of the study;
• Other situations where the researcher believes that patients are not suitable to participate in this trial.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Progress Free Survival	12month	It refers to the time from the patient signing the informed consent form to the earliest occurrence of tumor progression, including death from any cause.

Secondary Outcome Measures

Name	Time	Method
Disease Control Rate	12month	The proportion of patients with partial, complete, and stable efficacy among all patients.
Objective Response Rate	12month	Refers to the proportion of patients with partial and complete remission in all patients.
Overall Survival	12month	It refers to the time from the patient signing the informed consent form for participating in the study to the time of death due to any reason.