Advanced lung cancer
Conditions
Interventions
Experimental group (SHR-A1811 in combination with QL1706):Treatment with SHR-A1811 in combination with QL1706
Sponsors
Shanghai Pulmonary Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: (1) Voluntarily participate in the study and sign the informed consent form. This study requires the participants to agree to participate in the exploratory biomarker part of the research, including the collection of biological samples (such as plasma, serum, archived and obtained tumor specimens during the study) and the exploratory analysis of biomarkers. The results will be used to explore the correlation between disease activity, drug effects, and clinical outcomes; (2) The investigator determines that the participant can comply with the research protocol; (3) The participant signs the informed consent form at the age of 18-75 years old, both male and female are acceptable; (4) Histological or cytological diagnosis of non-small cell lung cancer (NSCLC), and the participant is at the local advanced stage or has metastasis (judged according to the 8th edition of the American Joint Committee on Cancer staging manual); (6) The participant has not received standard treatment previously; (7) At least one measurable lesion that can be accurately measured by CT (according to the RECIST v1.1 requirements, the spiral CT scan long diameter of the measurable lesion is >= 10 mm or the short diameter of the enlarged lymph node is >= 15 mm). The tumor imaging evaluation is conducted within 28 days before the first medication. The participant needs to provide historical imaging examination results for comparison, and the study investigator reviews to determine the occurrence of PD during the front-line treatment and rule out the possibility of pseudo-progression; (8) The participant should cooperate with biopsy during the screening period and efficacy assessment period, provide fresh and sufficient tumor tissue for tumor tissue next-generation sequencing, and immunohistochemical detection indicates overexpression of HER2 protein (IHC 2+ or 3+) or CTC (circulating tumor cells) detection indicates positive HER2 expression (2+ or 3+); (9) No EGFR/ALK/ROS1/HER2 gene mutations; (10) ECOG PS score: 0-1 point; (11) Expected survival period >= 6 months; (12) All screening period laboratory tests are conducted as required by the protocol, and need to be performed within 14 days before the first medication. The values of the laboratory tests conducted during the screening must meet the following standards: 1) Blood routine examination: (within 14 days before the first medication, no use of any blood components, cell growth factors for correction treatment) a) Hemoglobin (HB) >= 90 g/L; b) Absolute neutrophil count (ANC) >= 1.5 × 10^9/L; c) White blood cell count (WBC) >= 4.0 × 10^9/L and = 100 × 10^9/L; 2) Biochemical examination: (within 14 days before screening, no blood transfusion or albumin) e) ALB >= 30 g/L; f) AST and ALT = 60 mL/min (Cockcroft-Gault formula); urine protein = 2+, an additional 24-hour urine protein quantification test is required, and a participant with 24-hour urine protein quantification < 1 g can be enrolled in the study); j) APTT <= 1.5 × ULN, and INR or PT <=1.5 × ULN (no anticoagulation treatment); k) Thyroid stimulating hormone (TSH) <= 1 × ULN (if abnormal, FT3 and FT4 levels should also be examined, if FT3 and FT4 levels are normal, can be enrolled); 3) Card
Exclusion criteria
Exclusion criteria: 1. Target disease exclusion criteria: (1) Subjects without measurable lesions will be excluded. (2) Pregnant or breastfeeding women will be excluded. (3) Subjects who are unable to comply with the treatment according to the protocol provided by the investigator will be excluded. 2. Medical history and comorbidities: (1) Subjects who are currently participating in another clinical study, or whose first dose in this study is less than 4 weeks (or 5 half-lives of the investigational product, whichever is longer) from the end of the previous clinical study (last dose), will be excluded. (2) Subjects who are expected to require any other form of anti-tumor treatment during the study (including maintenance therapy with other SCLC drugs, radiotherapy, and/or surgical resection) will be excluded. (3) Subjects who have received major surgery within 4 weeks before the first dose; radiotherapy >30 Gy outside the thoracic region within 4 weeks before the first dose; thoracic radiotherapy >30 Gy within 24 weeks before the first dose; or palliative radiotherapy <=30 Gy within 2 weeks before the first dose, and have not recovered from related toxicities and/or complications to NCI-CTCAE Grade <=1 (except alopecia and fatigue), will be excluded. Palliative radiotherapy for symptom control is allowed, but must be completed at least 2 weeks before study treatment, and there must be no planned additional radiotherapy to the same lesion. (4) Subjects who require concurrent treatment for other active malignancies will be excluded. (5) Subjects with a history of malignancy will be excluded, except for basal cell carcinoma of the skin, superficial bladder cancer, squamous cell carcinoma of the skin, or carcinoma in situ of the cervix that has achieved complete remission for at least 5 years before screening and will not require additional treatment during the study. (6) Subjects with severe cardiovascular or cerebrovascular diseases will be excluded, including conditions meeting NYHA Class II or above, myocardial infarction or cerebrovascular accident (such as cerebral ischemia or symptomatic cerebral infarction) within 3 months before the first dose, or unstable arrhythmia or unstable angina occurring within 1 month before starting study treatment. Subjects with Grade II or above myocardial ischemia or myocardial infarction, or poorly controlled arrhythmias, will also be excluded. 3. Allergic reactions and adverse drug responses: (1) Subjects with a history of hypersensitivity or intolerance to infusion will be excluded. (2) Subjects with a severe allergic history to SHR-A1811 or QL1706 will be excluded. 4. Subjects with psychiatric disorders, alcoholism, inability to abstain from smoking, drug abuse, or substance dependence will be excluded. 5. Based on the investigator’s judgment, subjects with any disease, treatment, or laboratory abnormality that may confound study results, interfere with study participation, or not be in the best interest of the subject will be excluded.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 12-month Progression-Free Survival Rate (12-month PFS rate); | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective Response Rate (ORR);Progression-Free Survival (PFS);Overall Survival (PFS); | — |
Countries
China
Contacts
Public ContactShengxiang Ren
Shanghai Pulmonary Hospital
Outcome results
None listed