CClinicalTrials.gg
Status unknownNCT05165355ATHEMUpdated Jan 18, 2022

Adjuvant Targeted-therapy for Patients With Resected High-risk EGFR-mutant Stage IB-IIA Non-small Cell Lung Carcinoma

A Phase 2 interventional study of Furmonertinib in NSCLC and EGF-R Positive Non-Small Cell Lung Cancer, sponsored by Tongji University. Status unknown at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2022-01-18.

Sponsored by Tongji University · Phase 2, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jan 2022), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 2
Study type
Interventional
Enrollment
90
Allocation
Not applicable
Ages
18 Years to 75 Years
Sex
All
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Study summary

This is a single-armed study designed to evaluate the safety and efficacy of adjuvant targeted-therapy in patients with epidermal growth factor receptor mutation positive stage IB-IIA non-small cell lung carcinoma and high-risk of recurrence following complete tumor resection.

The primary endpoint: 2-year DFS rate; The second endpoint: DFS

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Conditions studied

  • NSCLC
  • EGF-R Positive Non-Small Cell Lung Cancer

Keywords

  • NSCLC
  • EGFR mutation
  • adjuvant therapy
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In context

Carcinoma, Non-Small-Cell Lung

6,485 studies on the registry are indexed under Carcinoma, Non-Small-Cell Lung; 1,630 are open to participants now.

This study's planned enrollment of 90 is above the median of 62 across 5,211 interventional studies indexed under Carcinoma, Non-Small-Cell Lung.

Browse Carcinoma, Non-Small-Cell Lung studies →

Lead sponsor

Tongji University is the lead sponsor of 38 studies on the registry; 11 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Subjects aged ≥18 and ≤75 years old;
  2. ECOG performance status score 0-1;
  3. Stage ⅠB-ⅡA(according to the 8th Edition of the AJCC Staging system);
  4. Complete surgical resection of the primary NSCLC is mandatory;
  5. Histologically confirmed diagnosis of high-risk pathological subtype (micropapillary, solid pattern or spread through air spaces [STAS], etc.);
  6. The tumour harbours one of the most common EGFR mutations (19del or L858R) ;
  7. Normal organ and bone marrow function measured before the study as defined below:
  1. Hemoglobin (HGB)≥90g/L 2) White blood cell count (WBC) is 4.0\~10×10\^9/L 3) Absolute value of neutrophil (ANC)≥1.5×10\^9/L 4) Platelet (PLT) count≥100×109/L 5) Serum total bilirubin (TBIL)≤1.5×ULN 6) AST and/or ALT≤2.5×ULN 7) International normalized ratio(INR)≤1.5 and activated partial thromboplastin time (APTT) is normal 8) Serum creatinine (SCr)≤1.5 × ULN 8. No previous systemic anti-tumor therapy for malignant tumor, such as chemotherapy, radiotherapy or hormonotherapy. No history of other malignancies, subjects with prostate cancer who received hormone therapy and had more than 5 years of DFS were excluded; 9. Subjects have voluntarily participated, signed and dated informed consent.

Exclusion criteria

Exclusion Criteria:

  1. Double primary lung cancer or multiple primary lung cancer;
  2. Subjects with mental illness;
  3. Presence or concomitant hemorrhagic diseases;
  4. Pregnancy or lactation;
  5. Known or suspected to be allergic to Furmonertinib and / or other components of their preparations.
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Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
90 participants (estimated)

Study arms

  • Experimental
    Experimental group

    Furmonertinib (80 mg orally, once daily) for 3 years.

    Drug: Furmonertinib

Interventions

  • DrugFurmonertinib

    Furmonertinib (80 mg orally, once daily) for 3 years.

06

What researchers measure

Primary outcomes

  1. Disease Free Survival (DFS) rate at 2 years

    Assess the Efficacy of Adjuvant Furmonertinib as Measured by 2-year Disease Free Survival (DFS) rate.

    Time frame: From date of receiving therapy until date of disease recurrence or death (by any cause in the absence of recurrence), up to approximately 4 years. Assessed at 2 years.

Secondary outcomes

  1. Disease Free Survival (DFS)

    Assess the Efficacy of Adjuvant Furmonertinib as Measured by Disease Free Survival (DFS).

    Time frame: From date of receiving therapy until date of disease recurrence or death (by any cause in the absence of recurrence), up to approximately 4 years.

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Study locations

1 of 1 sites recruiting
  • Shanghai General Hospital
    Shanghai, Shanghai 200080, China
    Recruiting
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 18, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05165355
Lead sponsor
Tongji University
Responsible party
Jiang Fan (Director of department of thoracic surgery, Tongji University) — Principal investigator
First posted
Dec 21, 2021
Start date
Dec 28, 2021
Primary completion
Nov 2024 (estimated)
Completion
Feb 2025 (estimated)
Last update
Jan 18, 2022

Study contacts

Jiang Fan, MD
Contact
fan_jiang@tongji.edu.cn
15901013210
Xiao-Long Li, MD
Contact
lixl_810@outlook.com
15121035752
Jiang Fan, MD
principal investigator · Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jan 2022. You cannot join it, but the record below documents what was studied.

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