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

NCT06846762 | Recruiting

• 1 other identifier: ShanghaiChestIS25009
• Study Type: observational
• Target: 508
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

NSCLC; Primary Resistance; DNA+RNA-NGS; Driver Gene Testing; Targeted Therapy

Outcome Measures

Primary Outcomes (2)

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

  2026.1

• ORR

  2027.1

Study Arms (2)

Driver gene-positive patients with targeted therapy.

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

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

Driver gene-positive patients without targeted therapy.

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

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

Interventions

This study did not include intervention between the two cohorts OTHER

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.

Driver gene-positive patients with targeted therapy.; Driver gene-positive patients without targeted therapy.

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Baohui Han: lead

Study Sites (1)

Shanghai Chest Hospital

Shanghai, Shanghai Municipality, 200030, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Formalin-Fixed Paraffin-Embedded (FFPE) samples

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Central Study Contacts

Yuqing Lou

CONTACT

13917197711; louyq@hotmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: director

Study Record Dates

• First Submitted: February 20, 2025
• First Posted: February 26, 2025
• Study Start: March 1, 2025
• Primary Completion: January 1, 2026
• Study Completion (Estimated): January 1, 2027
• Last Updated: February 26, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will share

Locations

CN (1)