NCT06846762

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)

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 508 (estimated)
• Sponsor: Baohui Han · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

• Non-Small Cell Lung Cancer

Interventions

Type	Name	Description
OTHER	This 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.

Timeline

• Start date: 2025-03-01
• Primary completion: 2026-01-01
• Completion: 2027-01-01
• First posted: 2025-02-26
• Last updated: 2025-02-26

Locations

1 site across 1 country: China