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Recruiting NCT06846762

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

— Observational Non-Small Cell Lung Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: This study did not include intervention between the two cohorts.
Who it may be relevant to
Registry conditions: Non-Small Cell Lung Cancer. Basic parameters: No limits · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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)

Overview

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.

Interventions

  • 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 ident

Primary outcome measures

  • 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]

Eligibility criteria

Inclusion criteria

  • 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)
  • Have retained tumor tissue samples prior to first-line treatment
  • Patients are from medical centers that can ethically affiliate and have accessible clinical follow-up data.

Exclusion criteria

  • 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
  • Any other conditions deemed unsuitable for entry into this study by the investigator.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

China · 1 center
  • Shanghai Chest Hospital — Shanghai

Identifiers

NCT: NCT06846762 · ShanghaiChestIS25009

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗