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RecruitingNCT06846762

DREAM Study: DNA/RNA-NGS Co-Testing in Driver-Negative, Treatment-Resistant NSCLC

Real-world Study of DNA + RNA-NGS Co-testing in Patients with Driver Gene-negative, First-line Non-targeted Therapy-resistant Primary NSCLC (Dream Study)

Sponsor

Baohui Han

Enrollment

508 participants

Start Date

Mar 1, 2025

Study Type

OBSERVATIONAL

Conditions

Non-small Cell Lung Cancer

Summary

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.

Eligibility

Plain Language Summary

Simplified for easier understanding

This study is testing whether adding RNA-based genetic testing (RNA-NGS) to standard DNA testing can uncover hidden genetic drivers in people with advanced non-small cell lung cancer (NSCLC) who tested negative for all known mutations but whose cancer progressed quickly on standard immunotherapy treatment. **You may be eligible if...** - You are 18 or older with confirmed advanced or metastatic non-small cell lung cancer that cannot be surgically removed - Your previous DNA genetic test showed no targetable mutations (EGFR, BRAF, MET, HER2, KRAS, FGFR2/3 — and no ALK, ROS1, RET, NTRK fusions) - Your cancer progressed quickly (within 6 months) on first-line non-targeted treatment **You may NOT be eligible if...** - Your cancer has a known targetable mutation - You have had extensive prior chemotherapy that would prevent participation - You have significant other health conditions that would interfere with the study Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERThis study did not include intervention between the two cohorts

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, with subsequent treatment regimens determined at the discretion of the patients without any intervention measures.

Locations(1)

Shanghai Chest Hospital

Shanghai, Shanghai Municipality, China

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NCT06846762

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