Actively Recruiting
Treatment Strategies and Survival Outcome for Non-small Cell Lung Cancer With Oncogenic Mutation
Led by Hunan Province Tumor Hospital · Updated on 2024-10-22
6000
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating treatment strategies and survival outcomes for people with non-small cell lung cancer (NSCLC) that have specific genetic changes called oncogenic mutations. This Phase 2 study includes patients with various mutations such as EGFR, ALK, ROS1, RET, BRAF, NRG1, MET, KRAS, and others. The study aims to understand how different mutations affect treatment response and survival. Participants receive targeted drugs based on their specific mutation group. Treatments include Osimertinib for EGFR mutations, Alectinib or Lorlatinib for ALK fusion, Crizotinib for ROS1 fusion, Savolitinib or Crizotinib for MET alterations, and chemotherapy given intravenously every 21 days. The study has several cohorts grouped by mutation type to assess outcomes for each. During the study, participants are monitored for progression-free survival up to 36 months, overall survival up to 5 years, tumor response rates, adverse events, and patient-reported outcomes. Assessments include imaging to measure lesions and evaluations of side effects and quality of life. The study collects data on treatment effectiveness and safety while participants are followed regularly until the study ends or their condition changes.
CONDITIONS
Brief Title
Treatment Strategies and Survival Outcome for Non-small Cell Lung Cancer With Oncogenic Mutation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Understand the clinical trial requirements and provide signed informed consent
- Age 18 years or older
- Histologically or cytologically confirmed stage IV non-small cell lung cancer
- Confirmed oncogenic mutations such as EGFR, ALK, ROS1 by an accredited laboratory
- ECOG performance status of 0 or 1
- Predicted survival of at least 12 weeks
- Adequate bone marrow and organ function
- Presence of measurable lesions according to RECIST 1.1
You will not qualify if you...
- Not meeting all inclusion criteria
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 36 months from first dose
Participants receive targeted drug treatments or chemotherapy based on their specific oncogenic mutation.
Regular visits as per treatment schedule
Duration - Up to 5 years from first dose
Participants are monitored for survival and adverse events after treatment ends, up to 5 years.
Periodic visits for survival and safety monitoring
Trial Site Locations
Total: 1 location
1
Yongchang Zhang
Changsha, Hunan, China, 410013
Actively Recruiting
Research Team
Y
Yongchang Zhang, MD
N
Nong Yang, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
7
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