This is a multicenter, open Phase II clinical study to evaluate the efficacy, safety, and pharmacokinetic characteristics of BEBT-109 combined with injectable pemetrexed disodium and carboplatin or cisplatin injection as first-line treatment for locally advanced, recurrent, or metastatic non-small cell lung cancer carrying EGFR exon 20 insertion mutations.
Participants have a comprehensive understanding, voluntarily sign the Informed Consent Form (ICF), and are capable of completing all trial procedures;
Age ≥18 years old, both males and females are eligible;
According to the 8th edition of the American Joint Committee on Cancer（AJCC）TNM staging criteria for lung cancer: patients with histologically or cytologically confirmed non-squamous non-small cell lung cancer (NSCLC) that is unresectable and intolerant or refuses radical synchronous radiochemotherapy, with locally advanced (stage IIIB or IIIC), recurrent, or metastatic (stage IV) disease;
No prior systemic treatment for locally advanced (stage IIIB or IIIC) or recurrent/metastatic (stage IV) NSCLC. Note: 1) Neoadjuvant/adjuvant therapy is allowed as long as it has been completed at least 6 months before the disease is diagnosed as locally progressive or metastatic tumor; 2) Participants who have failed treatment with savolitinib in the past are allowed;
History of severe allergic diseases (such as uncontrollable asthma), severe drug (including investigational drugs not yet marketed) allergies, or known allergies or intolerance to any drug or drug component in this study;
Diagnosis of other primary malignant tumors besides NSCLC, except for the following: non-melanoma skin cancer or cervical carcinoma in situ that has been adequately treated and cured, non-metastatic prostate cancer, or other primary malignant tumors that have been clearly recurrence-free for at least 3 years since the last treatment and have a low potential risk of recurrence;
Major surgical procedures within 28 days before the first administration of the study drug, planned surgery during the study period, or postoperative complications from surgery performed within 2 months before the first administration of the study drug (except for minor surgeries that the investigator deems do not affect participation in the trial, such as catheter placement or minimally invasive biopsy);
Presence of pleural effusion, ascites, or pericardial effusion with significant symptoms or requiring drainage;
Parallel
BEBT-109 Capsules
DrugBEBT-109 Capsules: Administration and Dosage: Oral administration, 120mg or 180mg; Frequency and Duration of Administration: Once a day or twice a day,and 21 days as a treatment cycle.
Pemetrexed Disodium for Injection
DrugPemetrexed Disodium for Injection: Administration and Dosage: Intravenous infusion, 500mg/m\^2; Frequency and Duration of Administration: On the first day of each cycle,and 21 days as a treatment cycle.
Carboplatin Injection
DrugCarboplatin Injection: Administration and Dosage: Intravenous infusion, AUC=5 mg/ml.min, with a single dose not exceeding 800 mg; Frequency and Duration of Administration: On the first day of each cycle for the first four cycles, and 21 days as a treatment cycle, totaling four cycles.
Cisplatin Injection
DrugCisplatin Injection: Administration and Dosage: Intravenous infusion, 75 mg/m\^2; Frequency and Duration of Administration: On the first day of each cycle for the first four cycles, and 21 days as a treatment cycle, totaling four cycles.
ORR
Objective response rate
AE
Adverse event
DCR
Disease control rate
DOR
Duration of response
PFS
Progression-free survival
OS
Overall survival
TTR
Time to response
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