Small cell lung cancer that has transformed after failure of EGFR-TKI and platinum-based chemotherapy
Conditions
Interventions
Sponsors
Dongguan People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Age >= 18 years, regardless of gender. 2. Patients with histologically or cytologically confirmed EGFR-positive NSCLC. 3. Confirmed presence of an EGFR sensitizing mutation (including exon 19 deletion or exon 21 L858R point mutation) by tumor histology/cytology or liquid biopsy. 4. Disease progression after EGFR-TKI therapy necessitated a repeat tissue biopsy, which confirmed the presence of an SCLC component by tumor histology. 5. Prior treatment with an EGFR-TKI for locally advanced or metastatic NSCLC with radiographic disease progression, meeting one of the following criteria: a) Disease progression after treatment with a 1st or 2nd generation EGFR-TKI, with a confirmed negative T790M mutation status post-progression; OR b) Disease progression after treatment with a 3rd generation EGFR-TKI, regardless of T790M mutation status. Note: For patients who received prior EGFR-TKI as neoadjuvant or adjuvant therapy, if disease progression occurred within = 12 weeks. 10. Adequate organ and bone marrow function (defined below), without transfusion, thrombopoietin, or colony-stimulating factor support within 2 weeks prior to the first dose: a. Hematological: Absolute Neutrophil Count (ANC) >= 1.5 × 10?/L; Platelets (PLT) >= 100 × 10?/L; Hemoglobin (Hb) >= 9 g/dL. b. Hepatic: Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) = 3 g/dL; Total Bilirubin (TBIL) = 60 mL/min (using the standard Cockcroft-Gault formula). d. Coagulation: International Normalized Ratio (INR), Activated Partial Thromboplastin Time (APTT), and Prothrombin Time (PT) <= 1.5 × ULN. 11. For fertile female patients and male patients with fertile partners: use of effective medical contraception during the study treatment period and for 6 months after the last dose. 12. The subject voluntarily participates in the study, signs the informed consent form, and is able to comply with the scheduled visits and related procedures outlined in the protocol.
Exclusion criteria
Exclusion criteria: 1. Patients with confirmed or coexisting small cell lung cancer or carcinosarcoma components in the initial histologic or cytologic diagnosis of NSCLC. 2. Patients who have received local radiotherapy for brain metastases can only be enrolled if they have been neurologically stable for =14 days after radiotherapy completion. 3. History of other malignancies within 3 years prior to the first dose, except for cured local tumors such as basal cell carcinoma of the skin, squamous cell carcinoma of the skin, carcinoma in situ of the cervix, etc. 4. Prior treatment with any TROP2-targeted therapy. 5. Previous participation in any clinical trial involving SKB264. 6. Prior treatment with any drug therapy targeting topoisomerase I, including Antibody-Drug Conjugate (ADC) therapy. 7. Major surgery within 4 weeks prior to the first dose, or anticipated requirement for major surgery during the study period. 8. Evidence of any severe or uncontrolled systemic disease, including but not limited to uncontrolled hypertension, diabetes, active bleeding, etc., which in the investigator's judgment would preclude patient participation or compromise protocol compliance; or active infection (including patients receiving IV treatment for infection), including Hepatitis B, Hepatitis C, and Human Immunodeficiency Virus (HIV). Active Hepatitis B infection at a minimum includes all patients positive for Hepatitis B surface antigen based on serologic evaluation. 9. Toxicities from previous anti-tumor therapy have not recovered to <= Grade 2 (CTCAE criteria) at the start of study treatment. 10. History of Interstitial Lung Disease (ILD), drug-induced ILD, history of radiation pneumonitis requiring steroid treatment, or any evidence of active ILD. 11. If a subject is receiving EGFR-TKI treatment, they may continue this treatment after signing the informed consent form until 7 days before the first dose of study drug. 12. Pregnancy or lactation. 13.Patients judged by the investigator as ineligible for this study, such as those unlikely to comply with the study protocol, procedures, and require;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective Response Rate (ORR); | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival (OS);Disease Control Rate (DCR);Safety indicators;Duration of Response;Progression-free survival (PFS); | — |
Countries
China
Contacts
Public ContactGuanming Jiang
Dongguan People's Hospital
Outcome results
None listed