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Carcinoma, Non-Small-Cell LungPhase 2NCT04838548

A Study to Evaluate the Efficacy and Safety of MRG003 in Patients With EGFR-Positive Advanced Non-Small Cell Lung Cancer

A Phase 2 study testing MRG003 in people with Carcinoma, Non-Small-Cell Lung, run by Lepu Biopharma Co., Ltd. at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The objective of this study is to assess the efficacy, safety of MRG003 as single agent in EGFR-positive advanced non-small cell lung cancer Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Carcinoma, Non-Small-Cell Lung
What is being tested?
MRG003
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
87 participants
Where
1 siteChina
Study dates
16 Apr 2021to 27 Mar 2023
Phase
Phase 2
Are there results?
None posted in the registry

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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Willing to sign the ICF and follow the requirements specified in the protocol.
  • Age: ≥18 years，both genders.
  • Expected survival time≥6 months.
  • Patients with histologically confirmed advanced non-small cell lung cancer, and without histologically confirmed small cell lung cancer (SCLC).
  • Positive EGFR expression in tumor specimen.
  • Failed in the prior second-line or above standard of care therapies.
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  • Archival or biopsy tumor specimens should be provided.
  • Patients must have measurable lesions according to the Response Evaluation Criteria In Solid Tumors (RECIST v1.1).
  • ECOG performance score 0 or 1.
  • AEs related to prior systemic chemotherapy and radical/extensive radiotherapy have recovered to ≤ Grade 1 based on National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0 (NCI CTCAE V5.0).
  • No severe cardiac dysfunction with left ventricular ejection fraction (LVEF) ≥ 50%.
  • Organ functions and coagulation function must meet the basic requirements.
  • Patients with childbearing potential must use effective contraception during the treatment and for 6 months after the last dose of treatment.

Who cannot join

  • History of hypersensitivity to any component of the investigational product.
  • No documented progression after prior treatment, or recurrence during or after prior treatment.
  • Received radiotherapy, chemotherapy, biologicals, immunotherapy or other anti-tumor drugs within 4 weeks prior to the first dose of study treatment.
  • Presence of central nervous system metastasis.
  • Patients with significant clinical symptoms such as pleural, abdominal or pericardial effusion requiring puncture drainage prior to the first dose of study drug.
  • Any severe or uncontrolled systemic disease judged by the investigator.
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  • Patients with poorly controlled heart diseases.
  • Evidence of active infections, including Hepatitis B, Hepatitis C or human immunodeficiency virus (HIV) infection.
  • Active bacterial, viral, fungal, rickettsial, or parasitic infection requiring systemic therapy.
  • Prior history of other primary malignancies.
  • History of the following ophthalmologic abnormalities: severve dry eye syndrome; keratoconjunctivitis sicca; severe exposure keratitis; any other condition that may increase the risk of corneal epithelial damage.
  • History of severe skin disease requiring interruption of previous EGFR targeted therapy; or chronic skin disease requiring oral or intravenous therapy.
  • History of interstitial lung disease (ILD) or pneumonitis, severe chronic obstructive pulmonary disease, severe pulmonary insufficiency, symptomatic bronchospasm, etc.
  • Pulmonary radiotherapy > 30 Gy within 6 months prior to first dose of study drug.
  • Pulmonary embolism or deep vein thrombosis within 3 months prior to the first dose of study drug.
  • Patients with active autoimmune disease or history of autoimmune disease, who are using immunosuppressive agents or systemic hormone therapy and still receiving within 2 weeks prior to enrollment.
  • History of allogeneic tissue or solid organ transplant.
  • Female patients with a positive serum pregnancy test or who are breast feeding or do not agree to take adequate contraceptive measures during the treatment and for 6 months after the last dose of study treatment.
  • Active uncontrolled concomitant diseases that might limit patient's compliance with study requirements, or compromise patient's ability to provide written informed consent.
  • Other conditions inappropriate for participation in this clinical trial, at the discretion of the investigator.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Cancer Hospital Chinese Academy of Medical Sciences

    Beijing, Beijing Municipality, 100000

Other trials in China

About this study

Official title: An Open-Label, Multi-Cohort, Multi-center, Non-Randomized, Phase II Clinical Study to Evaluate the Efficacy and Safety of MRG003 in Patients With EGFR-Positive Advanced Non-Small Cell Lung Cancer

The objective of this study is to assess the efficacy, safety of MRG003 as single agent in EGFR-positive advanced non-small cell lung cancer

Being tested
MRG003
Keywords
MRG003, Antibody Drug Conjugate (ADC), EGFR, Non-Small Cell Lung Cancer (NSCLC)
Medical subject headings
Carcinoma, Non-Small-Cell Lung

What participants receive

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

  • MRG003Drug

    Administered intravenously

Study groups in NCT04838548
Study groupRoleWhat they receive
MRG003ExperimentalOn the first day of every 3 weeks, MRG003 will be administered via intravenous infusion at 2.0 mg/kg calculated based on the actual body weight
Receives: Drug: MRG003

What is being measured

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

  1. Objective Response Rate (ORR) by Investigator

    ORR is defined as the proportions of patients with a complete response (CR) and partial response (PR). ORR will be assessed by investigator according to RECIST v1.1.

    Measured: Baseline to study completion, up to 12 months

Secondary outcomes (6)

  1. Progression Free Survival (PFS)

    PFS is defined as the duration from the start of treatment to the onset of tumor progression or death of any cause.

    Measured: Baseline to study completion, up to 12 months

  2. Duration of Response (DoR)

    DOR is defined as the duration from the initial recording of objective disease response to the first onset of tumor progression, or death of any cause.

    Measured: Baseline to study completion, up to 12 months

  3. Time to Response (TTR)

    TTR is defined as the duration from the start of treatment to the first onset of CR or PR in tumor evaluation.

    Measured: Baseline to study completion, up to 12 months

  4. Disease Control Rate (DCR)

    DCR is defined as the proportions of patients achieving CR, PR, and stable disease (SD) after treatment.

    Measured: Baseline to study completion, up to 12 months

  5. Overall Survival (OS)

    OS is defined as the duration from the start of treatment to death of any cause.

    Measured: Baseline to study completion, up to 12 months

  6. Adverse Events (AEs)

    Any reaction, side effect, or untoward event that occurs during the course of the clinical trial whether or not the event is considered related to the study drug.

    Measured: Baseline to 60 days after the last dose of study treatment

Timeline

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

  1. First posted9 Apr 2021
  2. Study start16 Apr 2021
  3. Primary completion27 Mar 2023
  4. Study completion27 Mar 2023

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
87 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04838548
Sponsor's protocol ID
MRG003-002
Status last verified
Sep 2026
First submitted
7 Apr 2021
Last updated
9 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing MRG003 in people with Carcinoma, Non-Small-Cell Lung, run by Lepu Biopharma Co., Ltd. at 1 site 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 13 inclusion and 20 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: finished, as of the sponsor's last update on 9 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective Response Rate (ORR) by Investigator (time frame: Baseline to study completion, up to 12 months). 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 NCT04838548.

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 9 Sep 2026.

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