Clinical trial · Interventional
Correlation Between Efficacy of Osimertinib and EGFR T790M Status and Ratio Via ddPCR in NSCLC
Research on the Correlation Between Efficacy of Osimertinib and EGFR T790M Status and Ratio Via Digital Droplet PCR (ddPCR) From Peripheral Blood in NSCLC Patients
- 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)
Liquid biopsy is emerging as an essential tool in tumor monitoring and a potential alternative and supplement to tissue biopsy for tumor genotyping, especially in relapsed or metastatic diseases. Liquid biopsy methods for detecting T790M in ctDNA can be qualitative or quantitative, including amplification refractory mutation system PCR (ARMS-PCR), digital droplet polymerase chain reaction (ddPCR), and next generation sequencing (NGS)-based methods. Comparison of multiple detecting platform for EGFR mutations in plasma samples has been undertaken in studies to determine the most feasible assay in clinical practice. In this study, we will investigate the usefulness of ddPCR for quantitative detection of EGFR T790M mutation in peripheral blood, and compared the utility of ddPCR and NGS for guiding decisions regarding osimertinib therapy in NSCLC patients who had develop resistance to first- or second generation EGFR-TKIs.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| ddPCR | — | UNRESOLVED | — |
| EGFR T790M | — | UNRESOLVED | — |
| Non-small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
| Osimertinib | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Osimertinib | Drug | Osimertinib | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Osimertinib
- description
- Osimertinib 80mg po daily
- interventionNames
- Drug: Osimertinib
- type
- SHAM_COMPARATOR
- label
- Other treatments
- description
- chemotherapy or continuation of TKI monotherapy or in combination of anti-angiogenic agents
- interventionNames
- Drug: Osimertinib
Primary outcomes (1)
- measure
- PFS
- timeFrame
- up to 1 year
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * histologically/cytologically confirmed stage IV NSCLC patients harboring sensitizing EGFR mutations; * progression from first or second-generation EGFR-TKI confirmed by radiographic imaging; * received both NGS test and ddPCR from peripheral blood simultaneously. Exclusion Criteria: * progression from first- or second-generation EGFR-TKIs as adjuvant therapy; * having received third-generation EGFR-TKIs prior to the gene tests; * having received NGS test only or ddPCR test only.
References
Publications (1)
- DERIVEDXu Z, Li Y, Wang L, Hao X, Ying J, Li J, Xing P. Efficacy of third-generation epidermal growth factor receptor-tyrosine kinase inhibitors in advanced NSCLC with different T790M statuses tested via digital droplet polymerase chain reaction ddPCR and next-generation sequencing. Expert Rev Anticancer Ther. 2024 Mar-Apr;24(3-4):183-192. doi: 10.1080/14737140.2024.2334807. Epub 2024 Apr 17. PMID 38526910