Effectiveness and safety of T-DXd in Chinese patients with HER2 mutation-positive lung cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to assess the effectiveness and safety of trastuzumab deruxtecan (T-DXd) in Chinese patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring HER2 mutations. It will collect real-world data on patients who have received T-DXd as a treatment option, focusing on those who are in the ≥ second-line setting. The study will evaluate overall survival and tolerability of T-DXd in a diverse patient population, as no prior real-world data exists for this specific group in China.

Why it matters

Who can join: the full rules

The key inclusion criteria for this study are:

1. Age ≥18 years at signing informed consent form (ICF).
2. Pathologically documented unresectable and/or metastatic non-squamous NSCLC.
3. Documented any known activating HER2 mutation.
4. Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-2.
5. Patients who receive T-DXd based on physicians' discretion (Newly received or just have started the first dose no longer than 2 months before enrollment).

The key exclusion criteria for this study are:

1. Previously treated with HER2-targeted/directed therapies, including:

   * tyrosine kinase inhibitors \[TKIs\] targeting HER2 mutations, except for pan-HER class TKIs.
   * an ADC, containing a chemotherapeutic agent targeting topoisomerase I
2. Has spinal cord compression or clinically active CNS metastases, defined as untreated and symptomatic, or requiring therapy with corticosteroids or anticonvulsants to control associated symptoms.
3. Any evidence of severe or uncontrolled systemic diseases, including uncontrolled hypertension active bleeding diatheses, etc.

Where it's running

• The History of Beijing Tiantan Hospital, Capital Medical University
  Beijing, China Recruiting
• Peking University International Hospital
  Beijing, China Recruiting
• Beijing Cancer Hospital
  Beijing, China Recruiting
• Peking University Third Hospital
  Beijing, China Recruiting
• Beijing Chest Hospital, Capital Medical University
  Beijing, China Recruiting
• Hunan Second People's Hospital
  Changsha, China Recruiting

Study contacts

• Study coordinator: Contact for Clinical Trial Information
• Email: CTRinfo_us@daiichisankyo.com
• Phone: 908-992-6400

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.