Histologically or cytologically confirmed as locally advanced or metastatic NSCLC (including patients with recurrence after prior surgical treatment or initial diagnosis of IIIB/C and IV stages according to the AJCC 9th edition lung cancer staging criteria). Confirmed as locally advanced or metastatic NSCLC without prior systemic therapy. Patients who have received local treatment may participate
Conditions
Interventions
Treatment group:Chemotherapy combined with targeted therapy and immunotherapy
Sponsors
Second Xiangya Hospital of CSU
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1.Age between 18-75 years. 2.Histologically or cytologically confirmed as locally advanced or metastatic NSCLC (including patients with prior surgical treatment who have recurred or were initially diagnosed as IIIB/C and IV stages according to the AJCC 9th edition lung cancer staging criteria). 3.Have not received any systemic treatment after the diagnosis of locally advanced or metastatic NSCLC. For patients who have received local treatment, if the target lesion is not within the scope of local treatment, the patient may participate in the study. 4.The tissue sample or blood sample of the tumor confirmed by laboratory tests as EGFR sensitive mutations (including exon 19 deletion or exon 21 L858R mutation, which can exist alone or together with other mutations in the EGFR gene). If the tumor tissue is available, it is recommended to submit the tumor tissue; if the tumor tissue is not available or the patient cannot tolerate biopsy, the blood sample should be submitted. 5.ECOG PS score of 0 or 1 and no deterioration within the past 2 weeks, with a minimum expected survival of at least 12 weeks. 6.The patient has at least one tumor lesion that has not been previously treated with radiation or other local therapies, and has not been screened within the past 2 weeks, and the longest diameter is >=10 mm (if it is a lymph node, the shortest diameter is >=15 mm). The measurement method selected is suitable for accurate repeated measurement, which can be computed tomography (CT) or magnetic resonance imaging (MRI). If only one measurable lesion exists and has not been previously treated with radiation or other local therapies, it may be accepted as a target lesion and evaluated for baseline status at least 14 days after diagnostic biopsy. 7.Vital organ function meets the following requirements (Note: no blood components and hematopoietic growth factors such as leukopenia, thrombocytopenia, and anemia correction drugs are allowed within 14 days before screening) : A. Absolute neutrophil count (ANC) >=1.5×10^9/L; B. Platelet count >=100×10^9/L; C. hemoglobin >=9 g/dL; D. serum albumin >=2.8g/dL; E. Bilirubin 1.5×ULN and creatinine clearance 1.5×ULN. H. Activated partial thromboplastin time (APTT) 10 mg per day or equivalent) were discontinued for at least 2 weeks before enrollment. 10.The subjects voluntarily participated in the study, signed the in
Exclusion criteria
Exclusion criteria: 1.Accompanied by any of the following disease conditions: A. Small cell lung cancer components or sarcomatoid lesions were confirmed by tumor histology or cytology. B. Patients with known leptomeningeal metastases; C. Spinal cord compression or brain metastases, unless asymptomatic, in stable condition, and not requiring steroids for at least 2 weeks prior to the first treatment; D. Uncontrolled pleural effusion, pericardial effusion, or ascites that requires repeated drainage (once a month or more); Subjects with stable symptoms for at least two weeks after drainage were eligible for enrollment. 2.Received any of the following treatments: A. Having received any EGFR-TKIs treatment; B. Major surgery or severe trauma within 4 weeks before the first treatment; C. Irradiation of more than 30% of bone marrow or large area of radiation within 4 weeks before the first dose of treatment; D. Use of a CYP3A4 strong inhibitor, inducer, or drug with a narrow therapeutic window as a CYP3A4 sensitive substrate within 7 days before the first dose of the study drug; E. Use of immunosuppressive drugs for other diseases within 2 weeks before the first treatment; F. Patients with advanced NSCLC who have received any previous systemic anti-tumor therapy, including chemotherapy, biological therapy, immunotherapy, or any investigational drug, which is not suitable for radical surgery or radiotherapy; G. Patients with any complications or other malignancies requiring treatment or major surgery within 2 years of initial treatment. 3.Residual toxicity from previous therapy (e.g., adjuvant chemotherapy) that was not responsive to CTCAE grade 1 or greater at the time of initiation of study treatment; Patients with alopecia and grade 2 neurotoxicity from previous chemotherapy were excluded. 4.Any other malignancy diagnosed within 5 years before the first use of study drug, except those with a low risk of metastasis and death (5-year survival rate > 90%), with the exception of adequately treated basal or squamous cell skin cancer or cervical carcinoma in situ. 5.Refractory nausea, vomiting, chronic gastrointestinal diseases, inability to swallow drugs, or a history of major bowel resection may affect oral drug intake, transport, or absorption. 6.Confirmed or suspected history of interstitial lung disease or idiopathic pulmonary fibrosis, drug-induced pneumonia, idiopathic pneumonia, or other moderate-to-severe pulmonary diseases that severely affect lung function (except grade =1 radiation pneumonitis). 7.Active autoimmune disease, history of autoimmune disease (e.g., interstitial pneumonia, colitis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism, including but not limited to these diseases or syndromes); Exceptions: a. subjects with vitiligo or cured childhood asthma/allergy without any intervention in adulthood; b. subjects with autoimmune-mediated hypothyroidism treated with stable doses of thyroid replacement hormone; c. Subjects treated with stable doses of insulin for type I diabetes. 8.A history of immunodeficiency, including testing positive for HIV or other acquired or congenital immunodeficiency disorders, or a history of organ transplantation and allogeneic bone marrow transplantation or autologous hematopoietic stem-cell transplantation. 9.Subjects with active pulmonary tuberculosis infection detected by medical history or CT examination, or with a history of active pulmonary tuberculosis infection within 1 year before
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Any adverse events that occurred during treatment;objective response rate, ORR;disease control rate, DCR;DepOR;Overall survival, OS;Duration of relief, DoR; | — |
Countries
China
Contacts
Public ContactJinan Ma
Second Xiangya Hospital of CSU
Outcome results
None listed