Stage III unresectable non-small cell lung cancer
Conditions
Interventions
Treatment group:Adebrelimab combined with SHR-A2102
Sponsors
Shanghai Chest Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1) Age of 18-75 years old, male or female; 2) Histologically or cytologically confirmed, oncologic unresectable stage III (UICC/AJCC, 9th edition, T1-4N2-3M0) squamous or non-squamous non-small cell lung cancer assessed by MDT; 3) At least one measurable lesion according to Response Evaluation Criteria in Solid Tumors v1.1 (RECIST v1.1); 4) Eastern Cooperative Oncology Group (ECOG) performance status 0-1; 5) FEV1>1.0L, FEV1%>40% within 3 months; 6) Adequate function of major organs; 7) Life expectancy > 6 months; 8) Women of childbearing age must have a negative serum pregnancy test within 3 days before the first dose of medication. Female participants of childbearing age and male participants whose partner was a woman of childbearing age had to agree to use a highly effective method of contraception for the duration of the study and for 180 days after the last dose of study medication; 9) Fully understand and voluntarily sign the informed consent form for this study; 10) PD-L1 tumor proportion score (TPS) <50%.
Exclusion criteria
Exclusion criteria: 1) mixed small cell lung cancer, neuroendocrine carcinoma and sarcoma components; 2) with actionable driver mutations (e.g., EGFR, ALK, ROS1, RET); 3) any previous antineoplastic treatment for the current lung cancer (e.g., radiotherapy, targeted therapy, ablation, or other systemic or local antineoplastic treatment); 4) patients with prior thoracic RT; 5) a history of (noninfectious) pneumonitis/interstitial lung disease requiring steroid treatment or current pneumonitis/interstitial lung disease requiring steroid treatment; 6) known history of active TB; 7) severe allergic reactions to other monoclonal antibodies; 8) any unstable systemic illness, including active infection, uncontrolled hypertension (systolic blood pressure >= 140 mmHg or diastolic blood pressure >= 90 mmHg despite optimal medical therapy), unstable angina, angina episodes within the previous 3 months, liver disease, renal disease, or metabolic disease requiring medical treatment; 9) Cardiac function and disease meet one of the following conditions: ? Arrhythmias deemed by the investigator to be clinically significant and significantly abnormal and not eligible for enrollment in the trial, including but not limited to complete left bundle branch conduction abnormality, degree II atrioventricular block; ? 12-lead electrocardiogram (ECG), QTc interval >= 450ms in men and >= 470ms in women; ? New York Heart Association (NYHA) grade>= 3 cardiac dysfunction or echocardiography: left ventricular ejection fraction (LVEF) = 3) within 4 weeks before the first dose of medication, including but not limited to infectious complications requiring hospitalization, bacteremia, severe pneumonia, etc.; 14) subjects with major surgery or serious injury within 2 months before the first dose; 15) clinically significant bleeding symptoms or obvious bleeding tendency within 1 month before the first dose, such as gastrointestinal bleeding, gastric ulcer bleeding, or angiitis; 16) pregnant or lactating women; 17) vaccinated with live/attenuated vaccine within 30 days before the first dose; 18) active autoimmune disease requiring systemic therapy (e.g., disease-modifying agents, corticosteroids, or immunosuppressive agents) within 2 years before the first dose. Intermittent use of inhaled steroids or topical injections of steroids was allowed. Alternative therapies (e.g., thyroxine, insulin, or physiological corticosteroids for adrenal or pituitary insufficiency) are not considered systemic treatments; 19) diagnosis of immunodeficiency or receiving systemic glucocorticoids or any other form of immunosuppressive therapy not directly related to cancer therapy within 7 days before the first study dose; Physiologic doses of gluc
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective Response Rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| R0 resection rate;Pathological complete response;Major Pathological response;Lymph node downstaging rate;Event-free survival;Overall survival;Adverse event; | — |
Countries
China
Contacts
Public ContactFeng Yao/Hua Zhong
Shanghai Chest Hospital
Outcome results
None listed