DNA and RNA testing for treatment-resistant lung cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study investigates the prevalence of primary resistance to first-line non-targeted therapy in patients with advanced non-small cell lung cancer (NSCLC) who lack driver gene mutations. It consists of two parts: Part A assesses the proportion of patients resistant due to undetected driver genes through DNA and RNA next-generation sequencing (NGS), while Part B compares the outcomes of patients with identified driver gene positivity who receive targeted therapy versus those who do not. The study aims to enhance understanding of treatment resistance and improve patient management strategies.

Why it matters

Who can join: the full rules

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.

Where it's running

• Shanghai Chest Hospital
  Shanghai, Shanghai Municipality, China Recruiting

Study contacts

• Study coordinator: Yuqing Lou
• Email: louyq@hotmail.com
• Phone: 13917197711

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.