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

Clinical Effectiveness and Safety of Trastuzumab Deruxtecan in Chinese Patients With HER2 Mutant Metastatic Non-small Cell Lung Cancer: a Prospective, Observational Study (RERUN)

This study is testing how well and safely a drug called T-DXd works for Chinese patients with advanced lung cancer that has HER2 mutations.

Quick facts

• Study type: Observational
• Enrollment: 150 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Daiichi Sankyo (Industry-sponsored)
• Drugs / interventions: Trastuzumab
• Locations: 23 sites (Beijing and 22 other locations)
• Trial ID: NCT06809764 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older with unresectable or metastatic non-squamous NSCLC and documented HER2 mutations who have started T-DXd treatment within the last two months.

Not a fit: Patients who have previously been treated with HER2-targeted therapies or have severe CNS metastases may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide valuable insights into the real-world effectiveness and safety of T-DXd for patients with HER2 mutation-positive NSCLC in China.

How similar studies have performed: While T-DXd has shown efficacy in clinical trials, this study is novel as it seeks to gather real-world data specifically for Chinese patients with HER2 mutations in NSCLC.

Eligibility criteria

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 this trial is running

Beijing and 22 other locations

• Cancer Hospital Chinese Academy of Medical Sciences — Beijing, China (Not_yet_recruiting)
• Peking University International Hospital — Beijing, China (Not_yet_recruiting)
• Beijing Cancer Hospital — Beijing, China (Not_yet_recruiting)
• Hunan Second People's Hospital — Changsha, China (Not_yet_recruiting)
• Fujian Cancer Hospital — Fuzhou, China (Not_yet_recruiting)
• Affiliated Cancer Hospital and Institute of Guangzhou Medical University — Guangzhou, China (Not_yet_recruiting)
• The First Affiliated Hospital of Sun Yat-sen University — Guangzhou, China (Not_yet_recruiting)
• Zhejiang Cancer Hospital — Hangzhou, China (Not_yet_recruiting)
• Anhui Provincial Cancer Hospital — Hefei, China (Not_yet_recruiting)
• First Affiliated Hospital of Shandong First Medical University — Jinan, China (Not_yet_recruiting)
• Cancer Hospital of Shandong First Medical University — Jinan, China (Not_yet_recruiting)
• The First Affiliated Hospital of Jinzhou Medical University — Jinzhou, China (Not_yet_recruiting)
• The First Affiliated Hospital of Nanchang University — Nanchang, China (Not_yet_recruiting)
• Guangxi Medical University Cancer Hospital — Nanning, China (Not_yet_recruiting)
• Ruijin Hospital, Shanghai Jiaotong University School Of Medicine — Shanghai, China (Not_yet_recruiting)
• Zhongshan Hospital Fudan University — Shanghai, China (Not_yet_recruiting)
• The First Hospital of China Medical University — Shenyang, China (Not_yet_recruiting)
• Cancer Hospital Chinese Academy of Medical Sciences, Shenzhen Center — Shenzhen, China (Not_yet_recruiting)
• The Fourth Hospital of Hebei Medical University — Shijiazhuang, China (Not_yet_recruiting)
• Shangxi Provincial Cancer Hospital — Taiyuan, China (Recruiting)
• The First Affiliated Hospital of Xiamen University — Xiamen, China (Not_yet_recruiting)
• Henan Cancer Hospital — Zhengzhou, China (Not_yet_recruiting)
• The First Affiliated Hospital of Zhengzhou University — Zhengzhou, China (Not_yet_recruiting)

Study contacts

• Study coordinator: Contact for Clinical Trial Information

Conditions Non-small Cell Lung Cancer; Locally advanced or metastatic NSCLC; HER2 mutations; T-DXd