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

Baohui Han

Status: Enrolling

Conditions: Non-Small Cell Lung Cancer

Treatments: Other: This study did not include intervention between the two cohorts

Study type: Observational

Funder types: Other

Identifiers

NCT06846762

ShanghaiChestIS25009

Details and patient eligibility

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.

Enrollment: 508 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Aged 18 and above, male or female
2. Pathologically diagnosed with advanced or metastatic inoperable non-small cell lung cancer
3. Prior genetic testing [DNA-NGS] results show no mutations in EGFR, BRAF, MET, HER2, KRAS, FGFR2/3，no amplifications in MET and HER2 and no fusions in ALK, ROS1, RET, NTRK, NRG1, EGFR, MET, BRAF, FGFR2/3
4. Based on negative driver gene results, received first-line non-targeted therapy with rapid progression or intolerance, with a progression-free survival (PFS) of ≤6 months (regardless of drug exposure time, calculated from the first day of medication)
5. Have retained tumor tissue samples prior to first-line treatment
6. Patients are from medical centers that can ethically affiliate and have accessible clinical follow-up data.

Exclusion criteria

1. Patients who do not meet any of the necessary inclusion criteria
2. Presence of other pulmonary diseases that require treatment or are severe, including but not limited to active pulmonary tuberculosis, interstitial lung disease, etc.
3. Presence of active infections that require systemic treatment
4. History of drug abuse or alcohol abuse, or mental illness, or suspected allergy or intolerance to the study drug or any of its components
5. Any other conditions deemed unsuitable for entry into this study by the investigator.

Trial design

508 participants in 2 patient groups

Driver gene-positive patients with targeted therapy.

Description:

Patients who tested positive by DNA+RNA-NGS voluntarily choose to receive targeted therapy

Treatment:

Other: This study did not include intervention between the two cohorts

Driver gene-positive patients without targeted therapy.

Description:

Patients who tested positive by DNA+RNA-NGS voluntarily choose to receive non-targeted therapy

Treatment:

Other: This study did not include intervention between the two cohorts