SI-B001 Combined With Chemotherapy in the Treatment of EGFR/ALK WT Recurrent or Metastatic NSCLC.
Non Small Cell Lung Cancer

About this trial
This is an interventional treatment trial for Non Small Cell Lung Cancer focused on measuring NSCLC
Eligibility Criteria
Inclusion Criteria:
- Male or female;
- Age: ≥ 18 years;
- Expected survival time ≥ 3 months;
- Patients with locally advanced or metastatic EGFR wild-type ALK wild-type lung cancer, disease progression or intolerance after first-line treatment with anti-PD-1/PD-L1 antibody, disease progression or intolerance after first-line treatment with anti-PD-1/PD-L1 antibody and platinum-based chemotherapy, or progression or intolerance after first-line treatment with anti-PD-1/PD-L1 monoclonal antibody;
- The subject agrees to provide archival tumor tissue samples or fresh tissue samples of the primary tumor or metastases within 6 months; if the subject is unable to provide tumor tissue samples and the subject is unable to provide the gene sequencing report, the subject shall agree to complete the ctDNAEGFR detection during the screening period, and can be assessed by the investigator if other inclusion criteria are met;
- Must have at least one measurable lesion as defined by RECISTv1.1;
- Performance status score ECOG0 or 1;
- Toxicities from prior anticancer therapy have recovered to grade ≤ 2 as defined by NCI-CTCAEv5.0 (except alopecia);
- No severe cardiac dysfunction, left ventricular score ≥ 50%;
The level of organ function must meet the following criteria:
- Bone marrow function: Absolute neutrophil count (ANC) ≥ 1.5 × 109/L, platelet count ≥ 80 × 109/L, hemoglobin ≥ 90 g/L;
- Liver function: TBIL ≤ 1.5ULN (total bilirubin ≤ 3ULN for subjects with Gilbert's syndrome, liver cancer or liver metastases); AST and ALT ≤ 2.5ULN for subjects without liver metastases; AST and ALT ≤ 5.0ULN for subjects with liver metastases;
- Renal function: creatinine (Cr) ≤ 1.5ULN, or creatinine clearance (Ccr) ≥ 50 mL/min (according to CockcroftandGault formula).
- Coagulation function: international normalized ratio (INR) ≤ 1.5 × ULN, and activated partial thromboplastin time (APTT) ≤ 1.5ULN;
- Urine protein ≤ 2 + (measured by dipstick) or < 1000 mg/24 h (urine);
- Premenopausal women of childbearing potential must have a negative serum or urine pregnancy test 7 before starting treatment and must be non-lactating; all patients (male or female) should take adequate barrier contraception measures throughout the treatment cycle and 6 months after the end of treatment.
Exclusion Criteria:
- Use of chemotherapy, biological therapy, immunotherapy, radical radiotherapy, major surgery before the first dose; 2. Use of palliative radiotherapy, targeted therapy (including small molecule tyrosine kinase inhibitors) and other anti-tumor therapy;
- History of significant cardiac disease, such as: symptomatic congestive heart failure (CHF) ≥ grade 2 (CTCAE 5.0) history, New York Heart Association (NYHA) ≥ grade 2 heart failure, acute coronary syndrome, etc.; QT prolongation (QTc > 450 msec in men or QTc > 470 msec in women), complete left bundle branch block, third degree atrioventricular block;
- Active autoimmune diseases and inflammatory diseases, such as systemic lupus erythematosus, psoriasis requiring systemic treatment, rheumatoid arthritis, inflammatory bowel disease and Hashimoto's thyroiditis, except for type I diabetes, hypothyroidism controllable by replacement therapy only, skin diseases not requiring systemic treatment (such as vitiligo, psoriasis);
- Other malignancies diagnosed within 5 years prior to first dose,Exceptions include: radical basal cell carcinoma of the skin, scaly cell carcinoma of the skin, and/or radical resection of carcinoma in situ;
- Hypertension poorly controlled by two antihypertensive drugs (systolic blood pressure > 150 mmHg or diastolic blood pressure > 100 mmHg);
- Pulmonary disease defined as ≥ grade 3 according to CTCAEv5.0, including resting dyspnea, or requiring continuous oxygen therapy, or patients with a history of interstitial lung disease (ILD);
- Symptoms of active central nervous system metastases.However, patients with stable parenchymal metastases can be stable, and whether it is stable or not is judged by the investigator;
- Patients with a history of hypersensitivity to recombinant humanized antibodies or human-mouse chimeric antibodies or hypersensitivity to SI-B001 or any of the excipient components of Osimertinib;
- History of autologous or allogeneic stem cell transplantation;
- In previous anthracycline (neo) adjuvant therapy, the cumulative dose of anthracycline was > 360 mg/m2;
- Human immunodeficiency virus antibody (HIVAb) positive, active tuberculosis, active hepatitis B virus infection (HBV-DNA copy number > 104) or hepatitis C virus (HCV) infection;
- Active infection requiring systemic treatment, such as severe pneumonia, bacteremia, sepsis, etc.;
- Received other unmarketed clinical study drugs or treatments before participating in the study;
Sites / Locations
- Chongqing University Cancer HospitalRecruiting
- Sun Yat-sen University Cancer Center (SYSUCC)Recruiting
- The Second Affiliated Hospital of Guangzhou Medical UniversityRecruiting
- The Second Affiliated Hospital of Guilin Medical UniversityRecruiting
- Shandong Cancer HospitalRecruiting
- TaiZhou Hospital of Zhejiang ProvinceRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Experimental
Experimental
SI-B001 combined with AP or TP_A
SI-B001 combined with Docetaxel_B
SI-B001 combined with Docetaxel_C
SI-B001 combined with Platinum-based chemotherapy(AP or TP). Patients enrolled with EGFRwt/ALKwt NSCLC progressed or were intolerant after first-line treatment with anti-PD-1 /L1 mab alone.
Patients with EGFRwt/ALKwt non-small cell lung cancer were included and progressed or were intolerant after first-line treatment with platinum-based two-drug chemotherapy plus anti-PD-1 /L1 mab.
Patients enrolled with EGFRwt/ALKwt NSCLC progressed or were intolerant to treatment with anti-PD-1 /PD-L1 monoclonal antibody after first-line or above chemotherapy.