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NCT07122882Enrolling by invitation

Integrated Genomics in Oncogene-driven NSCLC With Acquired Resistance

Integrated Genomics in Oncogene-driven Non-small Cell Lung Cancer With Acquired Resistance to Tyrosine Kinase Inhibitors

Source: ClinicalTrials.gov · Last updated 17 Mar 2026

Brief summary (registry, in English)

Currently, tyrosine kinase inhibitor (TKI) remains the standard of care for oncogene-driven non-small cell lung cancer (NSCLC). However, almost all oncogene-driven NSCLCs would develop acquired resistance against TKI in clinical practice. Therefore, understanding the molecular mechanisms underlying the acquired resistance is a critical issue in lung cancer. Based on the literature, acquired resistance mechanism against EGFR TKI includes EGFR secondary mutation (T790M, C797X, L792X, G796X, L718Q, and exon 20 insertions), MET amplification, HER2 amplification, acquired gene fusions, and other complex alterations. From the perspective of mutagenesis, the acquired resistance against TKI may be associated with APOBEC mutational processes, kataegis, chromothripsis, extrachromosomal DNA (ecDNA), and the interaction among them. However, still 30% to 50% of oncogene-driven NSCLCs had no identified mechanism attributed to the acquired resistance. Previous studies mostly used targeted-gene sequencing, which may overlook some structural variation and the transcriptomic dynamics. This study aims to investigate the genomic alterations, mutational processes, and the transcriptomic landscape underlying the acquired resistance using integrated genomics.

Status (registry)
Enrolling by invitation
Study type
Observational
Enrollment
40 (estimated)
First submitted
8 Aug 2025
Start date
1 Sept 2025
Primary completion date
11 May 2027
Lead sponsor
Chang Gung Memorial Hospital
Diseases
Lung cancer
NCT number
NCT07122882

What you commit to

  • Study type: Observational
  • Planned participants: 40
  • From 1 Sept 2025 to the primary completion date, 11 May 2027
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Patient had not received TKI or did not have documented disease progression during TKI treatment.

Other

  • Tumor tissue was unavailable for DNA extraction or the DNA quality did not meet the sequencing requirement.

Who the study is looking for

  • Histologically confirmed NSCLC, with at least one of the known oncogene mutation prior to systemic treatment: EGFR exon 18-21 activating mutation, MET exon-14-skipping mutation, ERBB2 activating mutation, ALK fusion, ROS1 fusion, RET fusion, NTRK1 fusion, NTRK2 fusion, NTRK3 fusion, BRAF V600 mutation, or KRAS G12C mutation
  • Patient had received tyrosine kinase inhibitor (TKI) with progressive disease, as assessed by the treating physician
  • Had tumor tissue available for DNA extraction and sequencing.
  • Eligible for withdrawal of a blood sample for DNA extraction and sequencing.

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Chang Gung Memorial Hospital, Linkou Branch
Coordinator of this site? Confirm its status
TaoyuanTaiwanUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.