Overview
Disitamab Vedotin Combined Therapy for Locally Advanced or Metastatic NSCLC Patients With HER2 Alterations
Status:
Not yet recruiting
Not yet recruiting
Trial end date:
2025-05-01
2025-05-01
Target enrollment:
0
0
Participant gender:
All
All
Summary
Disitamab Vedotin combined therapy locally advanced or metastatic NSCLC Patients with HER2 Alterations.Phase:
Phase 2Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
Sun Yat-sen UniversityTreatments:
Carboplatin
Criteria
Inclusion Criteria:1. Age: 18 (inclusive) or above, regardless of gender.
2. Histologically or cytologically confirmed locally advanced or metastatic NSCLC, not
suitable for radical surgery or radiotherapy (TNM 8th Edition).".
3. Biomarker:
- Arm 1: HER2 alterations, no other driver gene mutations;
- Arm 2: EGFR mutations accompanied by HER2 alterations;
- Arm 3: HER2 gene mutations, no other driver gene alterations;
4. Number of treatment lines:
- Arm 1-2: patients who have not previously received systemic treatment for
advanced diseases;
- Arm3:Failed with at least one line of standard treatment or intolerance;
5. Patients who have previously undergone neoadjuvant chemotherapy, adjuvant
chemotherapy, radiotherapy, or radiochemotherapy for the purpose of curing non
metastatic diseases must have a disease-free interval of 6 months from the last
chemotherapy and/or radiotherapy to the randomization date.
6. There is at least one measurable lesion that meets the definition of the RECIST 1.1
standard at baseline.
7. ECOG fitness status score: 0 or 1 point.
8. Estimated survival time ≥ 3 months.
Exclusion Criteria:
1. Central nervous system metastasis or meningeal metastasis with clinical symptoms.
2. Have a history of autoimmune diseases, immunodeficiency, including HIV positive, or
other acquired or congenital immunodeficiency diseases, or a history of organ
transplantation.
3. Active hepatitis B (hepatitis B virus titer>1000 copies/ml or 200 IU/ml); Hepatitis C
virus and syphilis infection.
4. Have undergone major organ surgery (excluding puncture biopsy) or have experienced
significant trauma within 3 weeks before the first use of the study drug.
5. Known hypersensitivity or intolerance to any component of the study protocol drug or
its excipients.