Clinical trial · Observational
Concordance of Key Actionable Genomic Alterations as Assessed in Tumor Tissue and Plasma in Non Small Cell Lung Cancer
A Study to Determine the Concordance of Key Actionable Genomic Alterations as Assessed in Tumor Tissue and Plasma From Patients With Non Small Cell Lung Carcinoma (NSCLC)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Business decision
Summary
Brief summary (as posted)
A study to determine the concordance of key actionable genomic alterations as assessed in tumor tissue and plasma from patients with non small cell lung carcinoma (NSCLC)
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 |
|---|---|---|---|
| Non Small Cell Lung Carcinoma | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (2)
- label
- A
- description
- Patients with non-squamous NSCLC either newly diagnosed or progressing on any therapy (except erlotinib, gefitinib, or afatinib)
- label
- B
- description
- Patients with non-squamous NSCLC who are progressing on erlotinib, gefitinib, or afatinib
Primary outcomes (1)
- measure
- Concordance of Genomic Alterations in EGFR Detected in Plasma Versus Tumor Tissue in Stage IV Non Squamous NSCLC Patients Who Are Newly Diagnosed or Progressing on Treatment
- timeFrame
- Time between patient tumor tissue biopsy and and blood collection, up to 8 weeks
- description
- Assess concordance of genomic alterations in EGFR detected in plasma (using the OncotypeSEQ Liquid Select assay) versus tumor tissue (assessed centrally using FoundationOne, or locally based on the patient's clinic) in stage IV non squamous NSCLC patients who are newly diagnosed or progressing on treatment.
Secondary outcomes (2)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Subjects must be 18 years or older. * Patients with stage IV non squamous NSCLC who are either newly diagnosed or progressing on any treatment (progression defined as increasing tumor size or new metastatic lesions on clinical or imaging assessment). * Patients with available tissue sample from a metastatic site or, if the patient presents with stage IV disease at diagnosis, from the primary tumor or a metastatic site. If a patient is progressing on EGFR targeted therapy (erlotinib, gefitinib, afatinib), tumor tissue sample is required only if available. * No new systemic anti-tumor therapy administered in the interval between the tissue biopsy and collection of the blood sample. (interval not to exceed eight weeks). Local radiation therapy is permitted. * Able and willing to read, understand and sign an informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization, or equivalent privacy law, where this is applicable. Exclusion Criteria: * Patients who are currently receiving therapy (targeted, immune- or chemotherapy) without sign of progression. * Patients with squamous NSCLC. * Patients with more than 8 weeks between collection of tumor specimen and collection of blood sample for analysis. (Not applicable for patients progressing on EGFR targeted therapy with no biopsy at progression) * Patients changing EGFR therapy due to toxicity or preference without documented disease progression. * Patients progressing on Osimertinib treatment. * Patients with brain metastases only. * Inability to comply with study and/or follow-up procedures. * Unable or unwilling to provide written informed consent.
References
Publications (0)
Data not yet available