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Updated June 2026 · ClinicalTrials.gov

RECRUITINGPhase 2INTERVENTIONAL

Adjuvant Treatment Based on MRD for EGFR Mutant NSCLC

Adjuvant Treatment Based on Minimal Residual Disease for Resectable Non-squamous Non-Small-Cell-Lung-Cancer With EGFR Mutations

Adjuvant Treatment Based on MRD for EGFR Mutant NSCLC (NCT05536505) is a Phase 2 interventional studying MRD, sponsored by Guangdong Association of Clinical Trials. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

A prospective, multicenter clinical study designed to explore the efficacy of postoperative adjuvant EGFR-TKIs therapy based on MRD status in patients with stage IB-IIIB EGFR-mutant non-squamous non-small cell lung cancer (non-squamous NSCLC). Primary endpoints include 3-year Disease-Free Survival rate (3y-DFS) and median disease-free survival (mDFS).

What Stage of Research Is This?

Phase 2 trials evaluate whether a treatment actually works against MRD and continue monitoring side effects. Phase 2 enrolls larger groups (typically 100–300 patients) and produces the first real efficacy signal. A successful Phase 2 readout is what unlocks the much larger Phase 3 confirmatory trials needed for FDA approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

Target enrollment of 180 participants puts this in the typical range for a Phase 2-style efficacy study or a moderate Phase 3 trial in a focused MRD subpopulation. At this scale, the study has enough statistical power to detect a clear treatment effect but is not the largest cohort in the field.

Who May Be Eligible (Plain English)

Who May Qualify: 1. Written willing to sign a consent form provided. 2. Males or females aged ≥18 years, \< 80 years. 3. Able to comply with the required protocol and follow-up procedures, and able to receive oral medications. 4. Target population is completely resected pathological stage IB-IIIB NSCLC with EGFR exon 19 deletions, L861Q mutation, G719X mutation and exon 21 L858R activating mutation. 5. Patients who have recovered from R0 resection including lobectomy, sleeve surgery and pneumonectomy. 6. You should be able to carry out daily activities with 0 level of ability (ECOG 0)-1. 7. Life expectancy ≥12 weeks. 8. Adequate hematological function: Absolute neutrophil count (ANC) ≥1.8 x 109/L, and Platelet count ≥100 x 109/L, and blood count (hemoglobin) at least 9 g/dL (may be transfused to maintain or exceed this level). 9. Adequate liver function: Total bilirubin ≤ 1.5 x upper limit of normal (ULN), Aspartate aminotransferase (AST), alanine aminotransferase (ALT) ≤ 2.5 x ULN in subjects without liver metastases; ≤ 5 x ULN in subjects with liver metastases. 10. Adequate renal function: Serum creatinine ≤ 1.25 x ULN, or ≥ 60 ml/min. 11. Female subjects should not be pregnant or breast-feeding. Who Should NOT Join This Trial: 1. Known severe hypersensitivity to icotinib, osimertinib or any of the excipients of this product. 2. Inability to comply with protocol or study procedures. 3. A serious concomitant systemic disorder that, in the opinion of the investigator, would compromise the patient's ability to complete the study. 4. A serious cardiac condition, such as myocardial infarction within 6 months, angina, or heart disease. 5. Interstitial pneumonia. 6. Patients with prior exposure to agents directed at the HER axis (e.g. erlotinib, gefitinib, icotinib, cetuximab, trastuzumab). 7. Patients with prior chemotherapy or therapy with systemic anti-tumour therapy (e.g. monoclonal antibody therapy). ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: 1. Written informed consent provided. 2. Males or females aged ≥18 years, \< 80 years. 3. Able to comply with the required protocol and follow-up procedures, and able to receive oral medications. 4. Target population is completely resected pathological stage IB-IIIB NSCLC with EGFR exon 19 deletions, L861Q mutation, G719X mutation and exon 21 L858R activating mutation. 5. Patients who have recovered from R0 resection including lobectomy, sleeve surgery and pneumonectomy. 6. ECOG performance status 0-1. 7. Life expectancy ≥12 weeks. 8. Adequate hematological function: Absolute neutrophil count (ANC) ≥1.8 x 109/L, and Platelet count ≥100 x 109/L, and Hemoglobin ≥9 g/dL (may be transfused to maintain or exceed this level). 9. Adequate liver function: Total bilirubin ≤ 1.5 x upper limit of normal (ULN), Aspartate aminotransferase (AST), alanine aminotransferase (ALT) ≤ 2.5 x ULN in subjects without liver metastases; ≤ 5 x ULN in subjects with liver metastases. 10. Adequate renal function: Serum creatinine ≤ 1.25 x ULN, or ≥ 60 ml/min. 11. Female subjects should not be pregnant or breast-feeding. Exclusion Criteria: 1. Known severe hypersensitivity to icotinib, osimertinib or any of the excipients of this product. 2. Inability to comply with protocol or study procedures. 3. A serious concomitant systemic disorder that, in the opinion of the investigator, would compromise the patient's ability to complete the study. 4. A serious cardiac condition, such as myocardial infarction within 6 months, angina, or heart disease. 5. Interstitial pneumonia. 6. Patients with prior exposure to agents directed at the HER axis (e.g. erlotinib, gefitinib, icotinib, cetuximab, trastuzumab). 7. Patients with prior chemotherapy or therapy with systemic anti-tumour therapy (e.g. monoclonal antibody therapy). 8. Patients with prior radiotherapy to primary lesion or lymph nodes. 9. History of another malignancy in the last 5 years with the exception of the following: Other malignancies cured by surgery alone and having a continuous disease-free interval of 5 years are permitted. Cured basal cell carcinoma of the skin and cured in situ carcinoma of the uterine cervix are permitted. 10. Any unstable systemic disease (including active infection, uncontrolled hypertension (systolic pressure \> 160mmHg, diastolic pressure \> 100mmHg), unstable angina, congestive heart failure, myocardial infarction within the previous year, serious cardiac arrhythmia requiring medication, hepatic, renal, or metabolic disease). 11. Eye inflammation or eye infection not fully treated or conditions predisposing the subject to this. 12. Evidence of any other disease, neurological or metabolic dysfunction, physical examination or laboratory finding giving reasonable suspicion of a disease or condition that contraindicated the use of an investigational drug or puts the subject at high risk for treatment-related complications. 13. Patient who has active serious infection (e.g. pyrexia of or 38.0℃ over) Patients who harboring exon 20 T790M mutation, EGFR 20 insertions, ALK fusion, BRAF V600E mutation, MET amplification and KRAS mutation.

Treatments Being Tested

GENETIC

Adjuvant treatment for MRD positivity

The MRD positive group would receive icotinib as adjuvant treatment. When the peripheral blood MRD turned negative, the subjects entered the drug withdrawal observation period. When the MRD turned positive again, the subjects resumed icotinib treatment. If EGFR T790M mutation was found, researchers would resume medication and choose osimertinib therapy.

Locations (16)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

Beijing Friendship Hospital, Capital Medical University
Beijing, China
Chongqing University Three Gorges Hospital
Chongqing, China
The First People's Hospital of Foshan
Foshan, China
Fujian Medical University Union Hospital
Fuzhou, China
Affiliated Cancer Hospital of Guangzhou Medical University
Guangzhou, China
Nanfang Hospital Southern Medical University
Guangzhou, China
Guangdong Provincial People's Hospital
Guanzhou, China
The Second Affiliated Hospital Zhejiang University School of Medicine
Hangzhou, China
The First Affiliated Hospital of USTC Anhui Provincial Hospital
Hefei, China
The Affiliated Hospital of Inner Mongolia Hospital
Hohhot, China
The Affiliated Hospital of Qingdao University
Qingdao, China
Zhongshan Hospital Fudan University
Shanghai, China
Shenzhen People's Hospital
Shenzhen, China
Tongji Hospital Tongji College of HUST
Wuhan, China
The First Affiliated Hospital of Xiamen University
Xiamen, China
Zhongshan City People's Hospital
Zhongshan, China

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT05536505), the sponsor (Guangdong Association of Clinical Trials), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT05536505 clinical trial studying?

A prospective, multicenter clinical study designed to explore the efficacy of postoperative adjuvant EGFR-TKIs therapy based on MRD status in patients with stage IB-IIIB EGFR-mutant non-squamous non-small cell lung cancer (non-squamous NSCLC). Primary endpoints include 3-year Disease-Free Survival rate (3y-DFS) and median disease-free survival (mDFS). The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT05536505?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT05536505?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT05536505. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT05536505. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-06-07 · Data from ClinicalTrials.gov.