UnknownPhase 2

Disitamab Vedotin Combined Therapy for Locally Advanced or Metastatic NSCLC Patients With HER2 Alterations

China95 participantsStarted 2023-05

Plain-language summary

Disitamab Vedotin combined therapy locally advanced or metastatic NSCLC Patients with HER2 Alterations.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Age: 18 (inclusive) or above, regardless of gender.
✓. Histologically or cytologically confirmed locally advanced or metastatic NSCLC, not suitable for radical surgery or radiotherapy (TNM 8th Edition).".
✓. Biomarker:
✓. Number of treatment lines:
✓. 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.
✓. There is at least one measurable lesion that meets the definition of the RECIST 1.1 standard at baseline.
✓. ECOG fitness status score: 0 or 1 point.
✓. Estimated survival time ≥ 3 months.

Exclusion criteria

✕. Central nervous system metastasis or meningeal metastasis with clinical symptoms.
✕. Have a history of autoimmune diseases, immunodeficiency, including HIV positive, or other acquired or congenital immunodeficiency diseases, or a history of organ transplantation.
✕. Active hepatitis B (hepatitis B virus titer\>1000 copies/ml or 200 IU/ml); Hepatitis C virus and syphilis infection.
✕. Have undergone major organ surgery (excluding puncture biopsy) or have experienced significant trauma within 3 weeks before the first use of the study drug.
✕. Known hypersensitivity or intolerance to any component of the study protocol drug or its excipients.

What they're measuring

Percentage of Participants With Objective Response Rate (ORR) Based on Investigator Assessment Following Treatment in Participants With HER2 alterations Non-Small-Cell Lung Cancer (NSCLC)

Timeframe: Up to 24 months (data cut-off)

Trial details

NCT IDNCT05847764

SponsorSun Yat-sen University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-10

Contact for this trial

Li PI Zhang, MD

020-87343421 zhangli@sysucc.org.cn

View on ClinicalTrials.gov More Non Small Cell Lung Cancer trials