First-Line Treatment for Advanced Non-squamous Non-Small-Cell Lung Cancer With Negative Driver Gene: a Single-center, Single-Arm Trial

Launched by QIANFOSHAN HOSPITAL · Dec 4, 2022

Keywords

ClinConnect Summary

This clinical trial is investigating a combination treatment for patients with advanced non-squamous non-small-cell lung cancer (NSCLC) that does not have specific genetic changes known as driver genes. The treatment being studied combines three medications: sintilimab, bevacizumab, and a type of chemotherapy, given together as the first treatment option for patients whose cancer has spread and cannot be surgically removed. The goal is to see if this combination can help patients live longer without their cancer worsening.

To participate in this trial, patients must be between 18 and 75 years old and have a confirmed diagnosis of advanced non-squamous NSCLC. They should not have received prior chemotherapy or radiation for this cancer, and they need to have at least one measurable tumor. Participants will receive treatment every three weeks and will be monitored closely for their health and response to the therapy. It's important for potential participants to be aware of the eligibility criteria, including not having certain severe medical conditions or allergies to the study drugs. Overall, this trial aims to find a safe and effective treatment to improve outcomes for patients facing this challenging diagnosis.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Metastatic Non-squamous NSCLC is histologically or cytologically proven to be inoperable and cannot receive radical concurrent chemoradiotherapy. The conventional TNM stage was identified as stage IIIa-Ⅳb according to the International Association for the Study of Lung Cancer and the American Joint Committee on the Classification of Cancer 8th edition TNM Staging of Lung Cancer.
• • 2. Patients with driver-negative advanced Non-squamous NSCLC.
• • 3. Patients who had not previously received systemic radiotherapy and chemotherapy or who had relapsed for more than 6 months of follow-up after onset of adjuvant chemotherapy.
• • 4. At least one measurable lesion as determined by RECIST criteria.
• • 5. Male or female patients, age: 18-75 years of age.
• • 6. Performance score 0-1 based on Eastern Cooperative Oncology Group (ECOG) test.
• • 7. Expected survival period ≥12 weeks.
• • 8. Serum absolute number of neutrophils≥ 1.5 x 10\^9/L, platelet ≥ 100 x10\^9/L, and hemoglobin≥ 90g/L.
• • 9. Serum bilirubin≤1.5 times ULNL, aspartate aminotransferase (AST) and adenosine triphosphate(ALT) ≤ 2.5 times ULN, alkaline phosphatase ≤ 5 times ULN.
• • 10. Serum creatinine≤ the ULN or creatinine clearance ≥ 60 mL/min.
• • 11. Patients who had previously undergone surgery have recovered for more than 4 weeks from the beginning of the project.
• • 12. Women with an intact uterus must have a negative pregnancy test within 28 days prior to enrolement in the study (unless it was 24 months after amenorrhea). If the pregnancy test is more than 7 days prior to initial dosing, a urine pregnancy test is required for verification (within 7 days prior to initial dosing).
• • 13. 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 treatment period until 120 days after the last dose of the study drug.
• • 14. Sign the inform consent form with good compliance.
• Exclusion criteria:
• • 1. Those who are known to be allergic to the study drug sintilimab, bevacizumab and and its any components.
• • 2. Intolerance to study drug treatment or allergy to the active ingredients or excipients of combined chemotherapy drugs.
• • 3. Pregnancy or breastfeeding women or women who may be pregnant but are unwilling to take appropriate contraception.
• • 4. Existing severe acute infections that are not under control; Or suppurative and chronic infections with delayed healing.
• • 5. Pre-existing serious heart disease, including: congestive heart failure, uncontrolled high-risk arrhythmias, unstable angina pectoris, myocardial infarction, severe valvular heart disease, and refractory hypertension.
• • 6. People suffering from uncontrollable neuropsychiatric diseases or mental disorders had poor compliance and were unable to cooperate and describe treatment responses; The conditions of patients with primary brain tumor or central nerve metastatic tumor were uncontrollable and the symptoms of cranial hypertension or neuropsychiatric were obvious.
• • 7. Patients with hereditary bleeding tendency or coagulation dysfunction, or history of thrombosis or bleeding, and abnormal detection results of coagulation function related indicators.
• • 8. Patients who are receiving thrombolytic or anticoagulant therapy due to high risk of thrombosis.
• • 9. Patients with unhealed wounds, unhealed ulcers or unhealed fractures.
• • 10. Other conditions that the investigator considers to be inappropriate for the patient to participate in this trial.
• • 11. Currently participating in interventional clinical research treatment, or have received other investigational drugs or used investigational device treatment within 4 weeks before the first dose.
• • 12. Patients who have undergone major surgery within 4 weeks before the start of study treatment or are scheduled to undergo major surgery during the study period (except for surgery such as puncture or lymph node biopsy).
• • 13. Pulmonary interstitial fibrosis with respiratory failure.
• • 14. Chronic obstructive pulmonary disease with respiratory failure.
• • 15. Active pulmonary tuberculosis;
• • 16. Active autoimmune disease requiring systemic therapy (such as the use of disease-modifying drugs, glucocorticoids, or immunosuppressants) within 2 years prior to the first dose. Replacement therapy (such as thyroxine) is not considered systemic therapy;
• • 17. Those who are receiving systemic glucocorticoid therapy (excluding nasal spray, inhalation or other local glucocorticoids) or any other form of immunosuppressive therapy within 14 days before the first dose of the study;
• • 18. Have previously received the following therapies: anti-pd1 drugs, anti-PD-L1 drugs.

Trial Officials