Actively Recruiting
DREAM Study: DNA/RNA-NGS Co-Testing in Driver-Negative, Treatment-Resistant NSCLC
Led by Baohui Han · Updated on 2025-02-26
508
Participants Needed
1
Research Sites
95 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The study is divided into two parts, Part A and Part B. The purpose of Part A is to reveal the proportion of NSCLC patients who are primarily resistant to first-line non-targeted therapy due to the omission of driver genes (especially fusion variations) by DNA-NGS, the median PFS of patients in the first line, and clinical characteristics through synchronous co-testing of DNA and RNA NGS. The purpose of Part B is to compare the difference in ORR between patients with driver gene positivity identified through synchronous co-testing of DNA and RNA NGS who receive and do not receive targeted therapy.
CONDITIONS
Official Title
DREAM Study: DNA/RNA-NGS Co-Testing in Driver-Negative, Treatment-Resistant NSCLC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged 18 and above, male or female
- Pathologically diagnosed with advanced or metastatic inoperable non-small cell lung cancer
- Prior genetic testing [DNA-NGS] shows no mutations in EGFR, BRAF, MET, HER2, KRAS, FGFR2/3; no amplifications in MET and HER2; no fusions in ALK, ROS1, RET, NTRK, NRG1, EGFR, MET, BRAF, FGFR2/3
- Received first-line non-targeted therapy based on negative driver gene results with rapid progression or intolerance, with progression-free survival of 6 months or less
- Retained tumor tissue samples prior to first-line treatment
- Patients are from medical centers with ethical approval and accessible clinical follow-up data
You will not qualify if you...
- Do not meet any of the inclusion criteria
- Have other pulmonary diseases requiring treatment or severe conditions, including active pulmonary tuberculosis or interstitial lung disease
- Have active infections requiring systemic treatment
- History of drug abuse, alcohol abuse, mental illness, or suspected allergy or intolerance to the study drug or components
- Any conditions deemed unsuitable for study participation by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Shanghai Chest Hospital
Shanghai, Shanghai Municipality, China, 200030
Actively Recruiting
Research Team
Y
Yuqing Lou
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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