Combining chemotherapy with immunotherapy for advanced lung cancer with HER2 changes
Chemotherapy or Chemotherapy Plus PD-1 Antibody in HER 2 Insertion or Amplification Advanced Non-small Cell Lung Cancer
This study is testing if combining chemotherapy with a specific immunotherapy can help adults with advanced lung cancer that has certain HER2 changes feel better after standard treatments have failed.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 70 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Hunan Province Tumor Hospital Academic / other |
| Drugs / interventions | Chemotherapy |
| Locations | 1 site (Changsha, Hunan) |
| Trial ID | NCT04324125 on ClinicalTrials.gov |
What this trial studies
This study investigates the effectiveness and safety of chemotherapy alone or in combination with a PD-1 antibody for patients with advanced non-small cell lung cancer (NSCLC) characterized by HER2 insertion or amplification. Eligible participants are those who have not previously received PD-1/PD-L1 antibody treatment and have failed standard chemotherapy. The study focuses on patients aged 18 and older who have a confirmed diagnosis of advanced non-squamous NSCLC. The goal is to determine the best treatment approach for this specific patient population.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with advanced non-squamous NSCLC confirmed by histopathology and exhibiting HER2 insertion or amplification.
Not a fit: Patients who have previously received antitumor treatment or have contraindications to chemotherapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new treatment option for patients with advanced NSCLC that has specific genetic alterations.
How similar studies have performed: While this approach is exploring a specific combination of treatments, similar studies have shown promise in targeting HER2 alterations in other cancers, suggesting potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * ≥18，Advanced Non-squamous Non-small Cell Lung Cancer Confirmed by Histopathology * HER 2 Insertion or Amplification * First Diagnosis and Treatment * Treatment Plan is Chemotherapy or Chemotherapy plus PD-1 antibody Exclusion Criteria: * Patients received antitumor treatment before * Patients with contraindication of chemotherapy * Pregnant or breast feeding women
Where this trial is running
Changsha, Hunan
- Yongchang Zhang — Changsha, Hunan, China (Recruiting)
Study contacts
- Principal investigator: Yongchang Zhang, MD — Hunan Cancer Hospital
- Study coordinator: Yongchang Zhang, MD
- Email: zhangyongchang@csu.edu.cn
- Phone: +8613873123436
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.