Advanced lung adenocarcinoma
Conditions
Interventions
Experimental group:Sildenafil in addition to tirelizumab and pemetrexed plus Carboplatin chemotherapy
Sponsors
Sichuan Academy of Medical Sciences, Sichuan Provincial People's Hospital
Eligibility
Sex/Gender
Male
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Subjects meeting all of the following criteria are eligible to participate in this study: 1.1 Male aged over 18 years. 1.2 Histologically or cytologically confirmed recurrent or stage IV* lung adenocarcinoma. *Stage IV: Defined according to the 8th edition TNM staging criteria of the International Association for the Study of Lung Cancer (IASLC). 1.3 Subjects who have not previously received systemic treatment for the recurrent or metastatic stage. a) Subjects who have previously received neoadjuvant or adjuvant chemotherapy/radiotherapy and have been free of recurrence or metastasis for >6 months since completion of treatment are eligible. b) Subjects with locally advanced disease who have previously received radical radiotherapy and/or chemotherapy, with the last use of chemotherapy or radiotherapy (whichever occurred last) at least 6 months before recruitment, are eligible. 1.4 Subjects with documented absence of EGFR activating mutations or ALK fusion gene abnormalities. 1.5 ECOG PS: 0-1. 1.6 Subjects must have at least one measurable lesion according to the RECIST 1.1 criteria (lesions that have received prior radiotherapy must demonstrate clear progression before being considered measurable). 1.7 Expected survival period >3 months. 1.8 Vital organ functions must meet the following requirements (no use of any blood components or cell growth factors allowed within 2 weeks before the start of the study treatment): a) Absolute neutrophil count (ANC) =1.5×109/L; b) Platelet count =100×109/L; c) Hemoglobin =9g/dL; d) Serum albumin =2.8g/dL; e) Bilirubin =1.5 times the upper limit of normal (ULN), ALT and AST =2.5 times ULN; in the presence of liver metastasis, ALT and AST =5 times ULN; f) Creatinine clearance =50mL/min. 1.9 Male patients with female partners of reproductive age must agree to use highly effective contraception methods during the study and for 6 months after the last administration of the study drug. 1.10 Patients must voluntarily participate in this study, sign the informed consent form (ICF), have good compliance, and cooperate with follow-up.
Exclusion criteria
Exclusion criteria: 2.1 Histologically or cytologically confirmed presence of small cell carcinoma, neuroendocrine carcinoma, sarcomatous components, or squamous cell carcinoma components exceeding 10%. 2.2 Patients with any active autoimmune disease or a history of autoimmune disease, with exceptions to this criterion including: a) Patients with vitiligo or alopecia; b) Patients with hypothyroidism who are on hormone replacement therapy and are clinically stable (e.g., after Hashimoto's syndrome); c) Any chronic skin disease that does not require systemic treatment; d) Patients who have not had active disease for the past 5 years and are assessed by the clinician to be eligible for inclusion in the study. 2.3 Patients who are currently using immunosuppressive agents or systemic hormone therapy for immunosuppression purposes, with exceptions to this criterion including: a) Intranasal, inhaled, topical steroid administrations or local steroid injections (e.g., intra-articular injections); b) Systemic corticosteroid treatment not exceeding 10 mg/day of prednisone or its equivalent physiological dose; c) Steroids given prophylactically for hypersensitivity reactions (e.g., prophylactic dosing for CT scans). 2.4 History or current presence of interstitial pneumonia, pneumonia requiring systemic glucocorticoid treatment (e.g., radiation-induced pneumonitis); patients with active pneumonia or severe impairment of lung function confirmed by pulmonary function tests. 2.5 History of allogeneic organ transplantation, excluding corneal transplantation. 2.6 Uncontrolled concomitant diseases, including but not limited to: a) Persistent or active infection; b) Symptomatic congestive heart failure; c) Symptomatic hypotension and uncontrolled hypertension; d) Unstable angina, myocardial infarction, or uncontrolled arrhythmia; e) Severe chronic gastrointestinal disease with diarrhea; f) Psychiatric/social conditions that may limit compliance with study requirements, significantly increase the risk of adverse events, or affect the subject's ability to provide written informed consent. 2.7 History of another primary malignant neoplasm, with exceptions to this criterion including: a) Malignancies that have been treated with curative intent, with no known active disease for =5 years prior to the first dose of study treatment and a low potential for recurrence; b) Adequately treated non-melanoma skin cancer or malignant melanocytic lesions without evidence of disease. 2.8 Presence of active primary immunodeficiency disease; known history of human immunodeficiency virus (HIV) infection; known active syphilis infection; active pulmonary tuberculosis. 2.9 Untreated active hepatitis B, with exceptions for subjects who have a hepatitis B virus (HBV) load below the detection limit of our hospital before the first dose and who receive anti-HBV treatment throughout the study to prevent reactivation of the virus. 2.10 Subjects with active hepatitis C (HCV) infection are eligible for the study only if HCV RNA is negative by polymerase chain reaction (PCR) and HCV antibodies are positive. 2.11 Symptomatic brain metastases or leptomeningeal metastases; asymptomatic brain metastases or brain metastases that are stable after treatment are allowed in the study. 2.12 Known allergy or hypersensitivity to any study drug or any excipients of the study drug. 2.13 Administration of nitrates or other medications that should not be taken concurrently with
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Non-hematological Toxicities;Hematological Toxicities; | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression-Free Survival (PFS);Objective Response Rate (ORR);Disease Control Rate (DCR);Overall Survival (OS); | — |
Countries
China
Contacts
Public ContactChuan Xu
Sichuan Academy of Medical Sciences, Sichuan Provincial People's Hospital
Outcome results
None listed