Clinical trial · Interventional
T790M Plasma Testing Methodology Comparison and Clinical Validation
Detect EGFR T790M Mutation in ctDNA of Chinese Advanced/Metastatic NSCLC Patients by Cobas, Super-ARMS, Digital PCR and NGS and Evaluate Clinical Outcomes of T790M Mutation Positive Patients Who Had AZD9291 Monotherapy
- 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 aim of this study is to evaluate concordance of T790M mutation plasma testing between the Cobas test and each of other platforms: Super-ARMS, digital PCR or NGS. And to assess the efficacy of AZD9291 monotherapy by assessment of PFS in adult patients with advanced or metastatic NSCLC, who have received prior EGFR-tyrosine kinase inhibitor (TKI) therapy and are T790M mutation positive detected by any one of the four plasma testing platforms: Cobas/Super-ARMS/ digital PCR/NGS.
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 (6)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| AZD9291 Dosing | Drug | — | UNRESOLVED |
| Baseline ECG | Procedure | — | UNRESOLVED |
| Baseline Visit Blood & Urine Testing | Procedure | — | UNRESOLVED |
| Plasma AZD9291 testing | Procedure | — | UNRESOLVED |
| T790M+ Testing | Procedure | — | UNRESOLVED |
| Visual Slit-Lamp Testing | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- AZD9291
- description
- Single arm of AZD9291, starting dose of 80mg
- interventionNames
- Procedure: T790M+ Testing
- Procedure: Baseline Visit Blood & Urine Testing
- Procedure: Baseline ECG
- Procedure: Visual Slit-Lamp Testing
- Drug: AZD9291 Dosing
- Procedure: Plasma AZD9291 testing
Primary outcomes (2)
- measure
- Concordance
- timeFrame
- Up to 6 months
- description
- To evaluate concordance of T790M plasma mutation testing between the Cobas test and each of other platforms: Super-ARMS, digital PCR or NGS.
- measure
- PFS Using Investigator Assessments According to RECIST v1.1
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 130 Years
Show eligibility criteria text
Inclusion Criteria: 1. Provision of informed consent prior to any study specific procedures. 2. Adults (according to China regulations for age of majority) 3. Histological or cytological confirmed locally advanced NSCLC (stage IIIB) or metastatic (stage IV) NSCLC, not amenable to curative surgery or radiotherapy. 4. Patients who have progressed following prior therapy with an EGFR-TKI agent. Exclusion Criteria: 1. Patients who disagree to participate this study. 2. Patients whose medical objection was recorded to use the existing data from medical practice for scientific research.
References
Publications (0)
Data not yet available