Clinical trial · Observational
Analysis of Circulating Tumor DNA Dynamics to Predict and Monitor Response to TKI in Patients With Advanced NSCLC.
Analysis of Circulating Tumor DNA Dynamics to Predict and Monitor Response to Tyrosine Kinase Inhibitors in Patients With Advanced Non-small Cell Lung Cancer
- 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)
This is an observational study, aiming to investigate whether the ctDNA dynamics analyzed by the K-TrackTM assay could predict early response to Tyrosine kinase inhibitors (TKIs) in patients with advanced non-small cell lung cancer (NSCLC). 1. Determine relationship between ctDNA dynamics and clinical response to TKI, * No response/progressive disease = ctDNA levels increase from baseline * Partial response/stable disease = ctDNA levels decrease from baseline * Complete response = ctDNA clearance. 2. Compare and combine ctDNA dynamics and RECIST1.1 to predict clinical response. 3. Determine relationship between ctDNA dynamics and progression free survival, overall survival.
Conditions
Conditions (5)
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 Cancer | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
| Stage IIIB Non-small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | CURATED_BROADER | 0.78 |
| Stage IIIC Non-Small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | CURATED_BROADER | 0.78 |
| Stage IV Non-small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | CURATED_BROADER | 0.78 |
| Tyrosine Kinase Inhibitors | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (3)
- measure
- Relationship between ctDNA dynamics and clinical response to TKI
- timeFrame
- 24 months following up.
- description
- * No response/progressive disease = ctDNA levels increase from baseline * Partial response/stable disease = ctDNA levels decrease from baseline * Complete response = ctDNA clearance.
- measure
- To compare and combine ctDNA dynamics and RECIST1.1 to predict clinical response.
- timeFrame
- 24 months following up.
- description
- * Correlation between ctDNA dynamics and clinical response * Correlation between RECIST1.1 and clinical response * Combination of ctDNA dynamics and RECIST v1.1 in the prognosis of clinical response.
- measure
- To investigate the relationship between ctDNA dynamics and progression free survival, overall survival.
- timeFrame
- 24 months following up.
- description
- * Correlation between ctDNA dynamics and PFS * Correlation between ctDNA dynamics and OS.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * Patients are diagnosed with advanced non-small cell lung cancer and indicated for TKI (first or second line). TKI combined with chemotherapy is allowed. * FFPE/FNA sample is available. * Compliant with treatment protocol. * Patients consented to participate in the study. Exclusion Criteria: * Patients already started TKI before enrollment. * Patients already started chemotherapy before enrollment. * Medical or psychiatric conditions or occupational responsibilities that may preclude compliance with the protocol. * Patients did not agree to participate in the studies.
References
Publications (15)
- BACKGROUNDYang J, Gong Y, Lam VK, Shi Y, Guan Y, Zhang Y, Ji L, Chen Y, Zhao Y, Qian F, Chen J, Li P, Zhang F, Wang J, Zhang X, Yang L, Kopetz S, Futreal PA, Zhang J, Yi X, Xia X, Yu P. Deep sequencing of circulating tumor DNA detects molecular residual disease and predicts recurrence in gastric cancer. Cell Death Dis. 2020 May 11;11(5):346. doi: 10.1038/s41419-020-2531-z. PMID 32393783
- BACKGROUNDReinert T, Henriksen TV, Christensen E, Sharma S, Salari R, Sethi H, Knudsen M, Nordentoft I, Wu HT, Tin AS, Heilskov Rasmussen M, Vang S, Shchegrova S, Frydendahl Boll Johansen A, Srinivasan R, Assaf Z, Balcioglu M, Olson A, Dashner S, Hafez D, Navarro S, Goel S, Rabinowitz M, Billings P, Sigurjonsson S, Dyrskjot L, Swenerton R, Aleshin A, Laurberg S, Husted Madsen A, Kannerup AS, Stribolt K, Palmelund Krag S, Iversen LH, Gotschalck Sunesen K, Lin CJ, Zimmermann BG, Lindbjerg Andersen C. Analysis of Plasma Cell-Free DNA by Ultradeep Sequencing in Patients With Stages I to III Colorectal Cancer. JAMA Oncol. 2019 Aug 1;5(8):1124-1131. doi: 10.1001/jamaoncol.2019.0528. PMID 31070691
- BACKGROUNDMagbanua MJM, Swigart LB, Wu HT, Hirst GL, Yau C, Wolf DM, Tin A, Salari R, Shchegrova S, Pawar H, Delson AL, DeMichele A, Liu MC, Chien AJ, Tripathy D, Asare S, Lin CJ, Billings P, Aleshin A, Sethi H, Louie M, Zimmermann B, Esserman LJ, van 't Veer LJ. Circulating tumor DNA in neoadjuvant-treated breast cancer reflects response and survival. Ann Oncol. 2021 Feb;32(2):229-239. doi: 10.1016/j.annonc.2020.11.007. Epub 2020 Nov 21. PMID 33232761
- BACKGROUNDChristensen E, Birkenkamp-Demtroder K, Sethi H, Shchegrova S, Salari R, Nordentoft I, Wu HT, Knudsen M, Lamy P, Lindskrog SV, Taber A, Balcioglu M, Vang S, Assaf Z, Sharma S, Tin AS, Srinivasan R, Hafez D, Reinert T, Navarro S, Olson A, Ram R, Dashner S, Rabinowitz M, Billings P, Sigurjonsson S, Andersen CL, Swenerton R, Aleshin A, Zimmermann B, Agerbaek M, Lin CJ, Jensen JB, Dyrskjot L. Early Detection of Metastatic Relapse and Monitoring of Therapeutic Efficacy by Ultra-Deep Sequencing of Plasma Cell-Free DNA in Patients With Urothelial Bladder Carcinoma. J Clin Oncol. 2019 Jun 20;37(18):1547-1557. doi: 10.1200/JCO.18.02052. Epub 2019 May 6. PMID 31059311