NSCLC
Conditions
Interventions
Cohort 1 is planned to enroll approximately 54 metastatic NSCLC patients who harbor EGFR sensitive mutations (Ex19del and/or L858R) and meet the M1c2 category (involvement of multiple extrathoracic or
Cohort 2 is planned to enroll approximately 77 locally advanced or metastatic NSCLC patients who harbor EGFR-sensitive mutations (Ex19del and/or L858R) and have elevated tumor PD-L1 expression, define
Sponsors
Shanghai Chest Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1.Subjects voluntarily participate in the study and sign the informed consent form. 2.Male or female aged 18~75. 3.Pathologically confirmed NSCLC. 4.Cohort 1 only: M1c2 NSCLC per AJCC 9th edition (involvement of multiple extra thoracic organ systems), not amenable to curative surgery or radiotherapy. 5.Cohort 2 only: Locally advanced (clinical stage IIIB, IIIC) or metastatic NSCLC (clinical stage IV) per AJCC 9th edition, not amenable to curative surgery or radiotherapy, with elevated tumor PD-L1 expression, defined as a TPS >= 25%. 6.The tumor harbors 1 of the 2 common EGFR mutations known to be associated with EGFR-TKI sensitivity (Ex19del or L858R) 7.No prior systemic anti-tumor therapy for advanced/metastatic non-small cell lung cancer. 8.At least one measurable tumor lesion at baseline in accordance with the response evaluation criteria in solid tumors (RECIST 1.1). 9.ECOG performance status score is 0-1; subjects with life expectancy >= 3 months judged by the investigator. 10.Adequate bone marrow reserve and organ function as demonstrated by the following laboratory values within 7 days prior to first dose of study treatment: •Hemoglobin (Hb) >= 90g/L. •Absolute neutrophil count (ANC) >= 1.5 × 10^9/L. •Platelet count >= 100 × 10^9/L, independent of platelet infusion. •Total bilirubin = 60 mL/min. •Left ventricular ejection fraction (LVEF) >= 50%. 11.Capacity to adhere to the study requirements and comply with follow-up procedures.
Exclusion criteria
Exclusion criteria: 1.Small Cell Lung Cancer (SCLC), including Combined Small Cell Lung Cancer (CSCLC). 2.Patients with other EGFR mutations (such as T790M and others), unknown mutation status, or those harboring other oncogenic driver mutations. 3.History of any malignancy requiring anti-tumor therapy or radiation within the past five years, excluding cured cervical carcinoma in situ, basal cell carcinoma, or squamous cell carcinoma of the skin. 4.Spinal cord compression or brain metastases unless asymptomatic and not requiring steroids. 5.Unstable systemic conditions, including active infections, thyroid dysfunction, uncontrolled hypertension, unstable angina pectoris, congestive heart failure, myocardial infarction within the past six months, or severe arrhythmias requiring pharmacological intervention. 6.Severe infection current or recent (within 2 weeks). 7.Other medical history, metabolic dysfunction, physical examination findings or clinical laboratory findings that provide reason to suspect that a certain disease or condition would preclude the use of the study treatment, or might affect the interpretation of the study results, or place the patient at high risk of treatment complications. 8.Gastrointestinal diseases, which prevent oral medication intake or require intravenous (IV) nutrition, or previous surgeries that affect drug absorption (such as significant surgical resection of stomach or small bowel). 9.Patients require long-term oxygen therapy. 10.In combination with yellow fever vaccine. 11.Currently pregnant or breast-feeding. 12.History of hypersensitivity to active or inactive excipients of study treatment. 13.Other conditions deemed unsuitable for inclusion in this study by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PFS; | — |
Secondary
| Measure | Time frame |
|---|---|
| ORR;DCR;OS;Safety: Adverse events.Clinically significant abnormality.; | — |
Countries
China
Contacts
Public ContactBaohui Han
Shanghai Chest Hospital
Outcome results
None listed