Adjuvant treatment for EGFR mutant non-small cell lung cancer based on MRD status

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

This study is testing if a specific cancer treatment can help people with a certain type of lung cancer after surgery, based on whether they have leftover cancer cells in their body.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 180 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Guangdong Association of Clinical Trials (Academic / other)
• Drugs / interventions: cetuximab, trastuzumab, icotinib, osimertinib, erlotinib, gefitinib, chemotherapy
• Locations: 16 sites (Beijing and 15 other locations)
• Trial ID: NCT05536505 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the effectiveness of postoperative adjuvant therapy using EGFR-TKIs in patients with stage IB-IIIB EGFR-mutant non-squamous non-small cell lung cancer (NSCLC) based on their minimal residual disease (MRD) status. Participants will undergo MRD assessments shortly after surgery and will be categorized into MRD positive or negative groups. Those in the MRD positive group will receive icotinib, with treatment adjustments based on their MRD status, while the MRD negative group will be monitored and treated with osimertinib if their MRD status changes. The primary endpoints focus on disease-free survival rates.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-80 with completely resected stage IB-IIIB EGFR-mutant non-squamous NSCLC.

Not a fit: Patients with non-EGFR mutations or those who have not undergone complete surgical resection may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly improve disease-free survival rates for patients with EGFR-mutant NSCLC.

How similar studies have performed: Other studies have shown promising results with similar approaches targeting MRD in cancer treatment, indicating potential for success.

Eligibility criteria

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.

Where this trial is running

Beijing and 15 other locations

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

Study contacts

• Study coordinator: Yi-Long Wu, MD

Conditions MRD; NSCLC; Adjuvant; EGFR mutation