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

ConditionNon-Small Cell Lung Cancer

Trial statusRecruiting

Trial phaseNot listed

Trial typeObservational

Biological sexAll

AgeNot listed

SponsorBaohui Han

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

Aged 18 and above, male or female

Pathologically diagnosed with advanced or metastatic inoperable non-small cell lung cancer

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

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)

Disqualifiers

Patients who do not meet any of the necessary inclusion criteria

Presence of other pulmonary diseases that require treatment or are severe, including but not limited to active pulmonary tuberculosis, interstitial lung disease, etc.

Presence of active infections that require systemic treatment

History of drug abuse or alcohol abuse, or mental illness, or suspected allergy or intolerance to the study drug or any of its components

Trial population

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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

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

Treatment groups

508 Participants

are divided into 2 treatment groups

Group A: Driver gene-positive patients with targeted therapy.1 intervention

Group B: Driver gene-positive patients without targeted therapy.1 intervention

Trial outcomes

Primary outcomes

The proportion of patients with advanced or metastatic inoperable NSCLC who test positive for driver genes upon re-testing with DNA+RNA NGS

Time frame

2026.1

ORR

Time frame

2027.1

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Baohui Han

Lead sponsor

Shanghai Chest Hospital

Sponsor institution

Source ClinicalTrials.gov

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