Clinical trial · Interventional
Efficiency of Icotinib in Plasma ctDNA EGFR Mutation-positive Patients Diagnosed With Lung Cancer
Efficiency of Icotinib in Plasma ctDNA EGFR Mutation-positive Patients Diagnosed With Lung Cancer:a Single Arm,Multi-center,Open-label Study
NCT03346811CI-TRIAL-00030382CHALLENGEunknownPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- 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 single arm,open-label,multi-center study is aimed to evaluate the efficiency of icotinib in plasma ctDNA EGFR mutation-positive patients diagnosed with lung cancer
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 |
|---|---|---|---|
| Plasma EGFR Mutation-positive Lung Cancer | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Icotinib | Drug | Icotinib | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Experimental: icotinib
- description
- Patients diagnosed with lung cancer with plasma EGFR mutation-positive are arranged to receive icotinib with a dose of 125 mg three times per day, till progressive disease or unaccepted toxicity
- interventionNames
- Drug: Icotinib
Primary outcomes (1)
- measure
- ORR
- timeFrame
- 12 weeks
- description
- Objective Response Rate
Secondary outcomes (3)
- measure
- PFS
- timeFrame
- 12 months
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Clinical diagnosis of peripheral lung cancer, but the pathological diagnosis is not yet clear. * Plasma EGFR mutations (EGFR 19del and/or 21L858R) positive (simultaneously detected by Super-ARMS, ddPCR and NGS,any positive). * unavailable of radical surgery or radical radiotherapy. * not previously received anticancer therapy like surgery, chemotherapy, radiation therapy, and biotherapy etc. * Palliative radiotherapy for bone metastases is permitted, but there is no continuous toxicity associated with radiation therapy. * Age 18-75 years old with performance status of 0 to 3. * With a measurable disease(longest diameters \>=10mm with Spiral computed tomography (CT)) according to RECIST Criteria.None of the lesions treated with radiotherapy could be used as target lesions. * Adequate hematological, biochemical and organ functions. Exclusion Criteria: * Severe systemic disease out of control such as unstable or uncompensated respiratory,cardiac,liver,renal diseases. * Evidence of interstitial lung diseases * Evidence of any other significant clinical disorder or laboratory finding that makes it undesirable for the subject to participate in the study * Other situations researchers think not appropriate to enter the group
References
Publications (1)
- DERIVEDXu J, Liu Z, Bai H, Dong G, Zhong J, Wan R, Zang A, Li X, Li Q, Guo J, Du N, Zhong D, Huang Y, Lv Q, Zhang J, Zhao Y, Gao L, Li L, Zhang C, Zhao J, Li B, Liu Z, Yang Z, Ji D, Wang T, Duan J, Wang Z, Wang J. Evaluation of Clinical Outcomes of Icotinib in Patients With Clinically Diagnosed Advanced Lung Cancer With EGFR-Sensitizing Variants Assessed by Circulating Tumor DNA Testing: A Phase 2 Nonrandomized Clinical Trial. JAMA Oncol. 2022 Sep 1;8(9):1328-1332. doi: 10.1001/jamaoncol.2022.2719. PMID 35862035