Combining PD-1 and Pyrotinib for Advanced Lung Cancer with HER2 Mutation
the Effectiveness and Safety Study on PD-1 Combined With Pyrotinib for First-line Chemotherapy Failed HER2 Insertion Mutation Advanced Non-small Cell Lung Cancer
This study is testing whether combining two cancer treatments can help people with advanced lung cancer that has a specific genetic mutation and hasn’t improved with previous chemotherapy.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Hunan Province Tumor Hospital Academic / other |
| Drugs / interventions | Pyrotinib, chemotherapy |
| Locations | 1 site (Changsha, Hunan) |
| Trial ID | NCT04144569 on ClinicalTrials.gov |
What this trial studies
This study evaluates the safety and effectiveness of combining PD-1 inhibitors with Pyrotinib in patients with advanced non-small cell lung cancer (NSCLC) who have a HER2 insertion mutation and have failed first-line chemotherapy. The approach aims to target specific genetic mutations in cancer cells to improve treatment outcomes. Participants will be monitored for measurable lesions to assess the treatment's impact on tumor progression.
Who should consider this trial
Good fit: Ideal candidates are patients with advanced NSCLC who have a confirmed HER2 insertion mutation and have experienced failure with first-line chemotherapy.
Not a fit: Patients without measurable tumor lesions or those who have previously received PD-1 or Pyrotinib will not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with advanced NSCLC who have limited treatment choices after chemotherapy failure.
How similar studies have performed: While this approach is innovative, similar studies combining targeted therapies with immunotherapy have shown promise in other cancer types, suggesting potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Advanced non-small cell lung cancer confirmed by histology or cytology * HER2 insertion mutation-positive * Failure with first-line standard chemotherapy * with measurable lesions. Exclusion Criteria: * no measurable tumor lesions * Patients received PD-1 or Pyrotinib before
Where this trial is running
Changsha, Hunan
- Hunan Provincal Tumor Hospital — Changsha, Hunan, China (Recruiting)
Study contacts
- Principal investigator: Yongchang Zhang, MD — Hunan Province Tumor 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.