Using Crizotinib for Advanced Lung Cancer with ROS1 Mutation
A Real World Study to Evaluate the Efficacy and Safety of First Line Crizotinib in ROS1-rearranged Non-squamous Non-small Cell Lung Cancer
This study tests how well Crizotinib works as a first treatment for people with advanced lung cancer that has a specific genetic change called ROS1 mutation.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 40 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Hunan Province Tumor Hospital Academic / other |
| Drugs / interventions | Kazolinib, chemotherapy, Crizotinib, clozotinib |
| Locations | 1 site (Changsha, Hunan) |
| Trial ID | NCT03646994 on ClinicalTrials.gov |
What this trial studies
This observational study investigates the effectiveness and safety of Crizotinib as a first-line treatment for patients with advanced non-squamous non-small cell lung cancer (NSCLC) that has a ROS1 rearrangement. It involves a retrospective analysis of 40 patients, focusing on the consistency of gene testing results from tissue and plasma samples, as well as exploring the mechanisms of drug resistance associated with Crizotinib. The study aims to develop a risk model for disease progression based on dynamic gene mutation analysis.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with advanced non-squamous NSCLC confirmed by histopathology and a positive ROS1 rearrangement detected by NGS.
Not a fit: Patients who have previously received antitumor treatment or have contraindications to chemotherapy will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into effective treatment strategies for patients with ROS1 rearranged advanced lung cancer.
How similar studies have performed: Other studies have shown promising results with Crizotinib in similar patient populations, indicating a potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * ≥18，Advanced Non-squamous Non-small Cell Lung Cancer Confirmed by Histopathology * ROS1 Arranged Positive * ROS1 Arranged Detection Method is NGS * First Diagnosis and Treatment * Treatment Plan is Kazolinib 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.