Clinical trial · Interventional
Analysis of Re-biopsy Specimens in Advanced NSCLC With Acquired Resistance of EGFR-TKI Targeted Therapy
Analysis of Re-biopsy Specimens in Advanced Non-small Cell Lung Cancer With Acquired Resistance of Epidermal Growth Factor Receptor-Tyrosine Kinase Inhibitor Targeted Therapy
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The objective of the study is to reveal the acquired resistance mechanism of the first and second generation Epidermal Growth Factor Receptor-Tyrosine Kinase Inhibitor (EGFR-TKI) in tissue and plasma using Next Generation Sequencing (NGS) and the difference of ctDNA in plasma and DNA in biopsy samples is compared and the consistency of two samples was observed. At the same time, the sensitivity, specificity and the consistency of detecting T790M mutation using ddPCR, Cobas and NGS were compared.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lung Cancer | Malignant Lung Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Miseq sequencer | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Re-biopsy tissue sample
- description
- The gene testing of re-biopsy tissue sample diagnosed with NSCLC will be performed with NGS using Illumina Miseq squencer and Cobas.
- interventionNames
- Device: Miseq sequencer
- type
- EXPERIMENTAL
- label
- Peripheral blood sample
- description
- The peripheral blood sample will be extracted with DNA and performed with NGS using Illumina Miseq squencer and ddPCR.
- interventionNames
- Device: Miseq sequencer
Primary outcomes (1)
- measure
- Compare the differences of gene mutation between tissue sample and peripheral blood sample by NGS
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: 1. EGFR mutations were confirmed by molecular pathology. 2. Patients who were treated by the first and the second generation EGFR-TKI. 3. Patients were evaluated PD according to RECIST imaging standard. 4. Patients with functional status score (Performance Status, PS) for 0-2 points according to the Eastern Cooperative Oncology Group (ECOG) . 5. Patients can receive histological / cytological specimens through microsurgical biopsy techniques, including but not limited to transbronchial biopsy (TBB), transbronchial lung biopsy (TBLB), transabonchial needle aspiration (TBNA), CT / ultrasound guided thoracic needle aspiration biopsy (CT / ultrasound guided-TTNA), ultrasound-guided superficial lymph node biopsy. Exclusion Criteria: 1. Patients received blood transfusion within 1 month. 2. Patients suffering from autoimmune diseases, including but not limited to systemic lupus erythematosus, class of wet arthritis, Sjogren's syndrome. 3. Patients with severe disease is not suitable for medical biopsy. 4. Patients refused to participate in clinical trials. 5. Researchers consider that the patient is not suitable for participating in this clinical trial.
References
Publications (1)
- DERIVEDZhang Y, Xiong L, Xie F, Zheng X, Li Y, Zhu L, Sun J. Next-generation sequencing of tissue and circulating tumor DNA: Resistance mechanisms to EGFR targeted therapy in a cohort of patients with advanced non-small cell lung cancer. Cancer Med. 2021 Jul;10(14):4697-4709. doi: 10.1002/cam4.3948. Epub 2021 Jun 25. PMID 34173341