Exploring Crizotinib for Lung Cancer with ALK Mutations
A Real World Study to Evaluate the Efficacy and Safety of First Line Crizotinib in ALK Rearranged Advanced Non Squamous Non-small Cell Lung Cancer
This study is testing if Crizotinib can effectively treat advanced lung cancer with ALK mutations in real-world patients and how gene changes might affect treatment outcomes.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 120 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Hunan Province Tumor Hospital Academic / other |
| Drugs / interventions | Crizotinib, chemotherapy, clozotinib |
| Locations | 1 site (Changsha, Hunan) |
| Trial ID | NCT03647111 on ClinicalTrials.gov |
What this trial studies
This observational study investigates the efficacy and safety of Crizotinib as a first-line treatment for advanced non-squamous non-small cell lung cancer (NSCLC) with ALK-positive mutations in a real-world setting. It aims to analyze the drug's effectiveness based on next-generation sequencing (NGS) results and to understand the mechanisms of drug resistance. The study will involve a retrospective analysis of 120 patients who have been diagnosed with ALK-positive advanced NSCLC and will assess the role of plasma dynamic detection of gene mutations in predicting disease progression. The focus is on gathering real-world evidence to support the use of Crizotinib in this patient population.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older with pathologically confirmed ALK-positive advanced non-squamous non-small cell lung cancer who have not received prior antitumor treatment.
Not a fit: Patients who have previously undergone antitumor treatment or have contraindications to chemotherapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into the effectiveness of Crizotinib for patients with ALK-positive lung cancer, potentially improving treatment outcomes.
How similar studies have performed: Other studies have shown promising results with Crizotinib in similar patient populations, indicating that this approach is supported by existing evidence.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * ≥18，Pathologically proven ALK positive mutation in advanced non squamous non small cell lung cancer * ALK rearrangement detection method is NGS and Ventana * Primary treatment of first diagnosis * The treatment was Crizotinib 250mg po bid Exclusion Criteria * Patients received antitumor treatment before * Patients with contraindication of chemotherapy * Pregnant or breast feeding women
Where this trial is running
Changsha, Hunan
- Hunan Cancer Hospital — 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.