AzTrials
AzTrials

MRDPhase 2NCT05536505

Adjuvant Treatment Based on MRD for EGFR Mutant NSCLC

A Phase 2 study testing Adjuvant treatment for MRD positivity in people with MRD, run by Guangdong Association of Clinical Trials at 16 sites in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

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). Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
MRD
What is being tested?
Adjuvant treatment for MRD positivity
Could I receive a placebo?
No, everyone receives an active treatment
How many people
180 participants
Where
16 sitesChina
Study dates
13 Sep 2022to 1 Oct 2030
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Written informed consent provided.
  • Males or females aged ≥18 years, < 80 years.
  • Able to comply with the required protocol and follow-up procedures, and able to receive oral medications.
  • 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.
  • Patients who have recovered from R0 resection including lobectomy, sleeve surgery and pneumonectomy.
  • ECOG performance status 0-1.
Show all 11Show fewer
  • Life expectancy ≥12 weeks.
  • 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).
  • 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.
  • Adequate renal function: Serum creatinine ≤ 1.25 x ULN, or ≥ 60 ml/min.
  • Female subjects should not be pregnant or breast-feeding.

Who cannot join

  • Known severe hypersensitivity to icotinib, osimertinib or any of the excipients of this product.
  • Inability to comply with protocol or study procedures.
  • A serious concomitant systemic disorder that, in the opinion of the investigator, would compromise the patient's ability to complete the study.
  • A serious cardiac condition, such as myocardial infarction within 6 months, angina, or heart disease.
  • Interstitial pneumonia.
  • Patients with prior exposure to agents directed at the HER axis (e.g. erlotinib, gefitinib, icotinib, cetuximab, trastuzumab).
Show all 13Show fewer
  • Patients with prior chemotherapy or therapy with systemic anti-tumour therapy (e.g. monoclonal antibody therapy).
  • Patients with prior radiotherapy to primary lesion or lymph nodes.
  • 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.
  • 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).
  • Eye inflammation or eye infection not fully treated or conditions predisposing the subject to this.
  • 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.
  • 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.

Trial locations and contacts

16 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Yi-Long Wu, MD contact

020-83827812

syylwu@live.cn

Ri-Qiang Liao contact

16 sites in 1 country

China16 sites, 16 recruiting

  • Beijing Friendship Hospital, Capital Medical University

    Beijing

    Yong Cui

    Not yet recruiting

  • Chongqing University Three Gorges Hospital

    Chongqing

    Yi Liu, MD

    Not yet recruiting

  • The First People's Hospital of Foshan

    Foshan

    Wei-Quan Gu, MD

    Not yet recruiting

  • Fujian Medical University Union Hospital

    Fuzhou

    Not yet recruiting

  • Affiliated Cancer Hospital of Guangzhou Medical University

    Guangzhou

    Jian Zhao, MD

    Not yet recruiting

  • Nanfang Hospital Southern Medical University

    Guangzhou

    Kai-Can M Cai, MD

    Not yet recruiting

  • Guangdong Provincial People's Hospital

    Guanzhou

    Ri-Qiang Liao, MD

    Si-Yang M. Liu, MD

    Recruiting

  • The Second Affiliated Hospital Zhejiang University School of Medicine

    Hangzhou

    Jun-Qiang Fan, MD

    Not yet recruiting

  • The First Affiliated Hospital of USTC Anhui Provincial Hospital

    Hefei

    Li Ke

    Not yet recruiting

  • The Affiliated Hospital of Inner Mongolia Hospital

    Hohhot

    Zhan-Lin Guo

    Not yet recruiting

  • The Affiliated Hospital of Qingdao University

    Qingdao

    Zhuang Yu, MD

    Not yet recruiting

  • Zhongshan Hospital Fudan University

    Shanghai

    Di Ge, MD

    Not yet recruiting

  • Shenzhen People's Hospital

    Shenzhen

    Guang-Suo Wang

    Not yet recruiting

  • Tongji Hospital Tongji College of HUST

    Wuhan

    Xiang-Ning Fu, MD

    Not yet recruiting

  • The First Affiliated Hospital of Xiamen University

    Xiamen

    Guo-Jun Geng

    Not yet recruiting

  • Zhongshan City People's Hospital

    Zhongshan

    Yi Liang, MD

    Not yet recruiting

Other trials in China

About this study

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

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).

Read the detailed description

All subjects enrolled in this clinical trial will receive peripheral blood MRD status assessment within 1 week and 1 month after surgery, and will be divided into MRD positive group (+) and MRD negative group (-) according to their results , followed by MRD status assessment every 12 weeks.

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.

The MRD negative group (-) directly entered the follow-up observation period. When the MRD status of peripheral blood turned positive, the subjects received osimertinib treatment. When the MRD turned negative again, the subjects entered the drug withdrawal observation period.

Conditions
MRD
Being tested
Adjuvant treatment for MRD positivity
Keywords
NSCLC, Adjuvant, EGFR mutation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Adjuvant treatment for MRD positivityGenetic

    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.

Study groups in NCT05536505
Study groupRoleWhat they receive
MRD Positivity Post OperationExperimentalIf MRD confirmed Positivity at either of the two timepoints (Time point 1: blood draw from the 3rd day to 7th day post operation. Time point 2: blood draw on the 28th day post operation), patients would receive icotinib until MRD turned Negativity. During MRD monitoring, icotinib would rechallenge
Receives: Genetic: Adjuvant treatment for MRD positivity
MRD Negativity Post OperationNo interventionIf MRD confirmed negativity at both of the two timepoints (Time point 1: blood draw from the 3rd day to 7th day post operation. Time point 2: blood draw on the 28th day post operation), patients would receive ctDNA MRD monitoring.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Disease Free Survival

    Disease free survival (DFS)- defined as the time from operation to the first documented disease progression or death, whichever occurs first.

    Measured: From date of opeartion until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months

  2. 3 yeas DFS rate

    To compare 3y-DFS rates between the two arms

    Measured: From date of opeartion until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months

Secondary outcomes (1)

  1. Overall survival

    To evaluate the overall survival of both arms

    Measured: OS is defined as the time from opeartion to death, regardless of disease recurrence, assessed up to 100 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Sep 2022
  2. Study start13 Sep 2022
  3. Primary completion1 Oct 2025 (estimated)
  4. Study completion1 Oct 2030 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
180 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05536505
Sponsor's protocol ID
CTONG2105
Status last verified
Sep 2022
First submitted
21 Jul 2022
Last updated
14 Sep 2022
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Adjuvant treatment for MRD positivity in people with MRD, run by Guangdong Association of Clinical Trials at 16 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 14 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 16 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Yi-Long Wu, MD (020-83827812, syylwu@live.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Disease Free Survival (time frame: From date of opeartion until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05536505.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2022.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in