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Extensive-stage Small-cell Lung CancerPhase 2MGC018-SCLCNCT06227546

MGC018 in Patients With Relapsed or Refractory Extensive-Stage Small-Cell Lung Cancer

A Phase 2 study testing MGC018 in people with Extensive-stage Small-cell Lung Cancer, run by Georgetown University at 1 site in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

The goal of this clinical trial is to test MGC018 in patients with relapsed or refractory Extensive-Stage Small-Cell Lung Cancer (ES-SCLC). The main question it aims to answer is: Does the administration of MGC018 achieve a clinically meaningful response rate of 25% in patients with relapsed or refractory ES-SCLC?… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Extensive-stage Small-cell Lung Cancer
What is being tested?
MGC018
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
9 participants
Where
1 siteUnited States
Study dates
15 Apr 2024to Apr 2027
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

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

  • Age greater than or equal to 18 years at time of signing Informed consent form (ICF)
  • Ability to comply with the study protocol, in the investigator's judgment.
  • Histologically or cytologically confirmed advanced small cell lung cancer that is not amenable to definitive therapy. Patients with epidermal growth factor receptor (EGFR)-mutant Non Small Cell Lung Cancer (NSCLC) that has transformed to Small Cell Lung Cancer (SCLC) will be allowed if their SCLC has progressed following treatment with platinum-based chemotherapy.
  • Disease progression during or following treatment with platinum-based chemotherapy.
  • Patients could have received any number of therapies for relapsed or progressive disease.
  • Measurable disease per RECIST v1.1
Show all 29Show fewer
  • Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-2
  • Adequate hematologic and end-organ function, defined by the following laboratory test results, obtained within 14 days prior to initiation of study treatment:
  • Absolute Neutrophil Count (ANC) greater than or equal to (>/=) 1.0 x 10^9/L (1000/uL) without granulocyte colony-stimulating factor support
  • Platelet count >/=100 x 10^9/L (100,000/uL) without transfusion
  • Hemoglobin >/= 80 g/L (8 g/dL) (1) Patients may be transfused to meet this criterion.
  • Aspartate Aminotransferase (AST), Alanine Transaminase (ALT), and alkaline phosphatase (ALP) less than or equal to (</=) 2.5 x upper limit of normal (ULN), with the following exceptions:
  • Patients with documented liver metastases: AST and ALT </= 5 x ULN
  • Patients with documented liver or bone metastases: ALP </= 5 x ULN
  • Serum bilirubin </= 1.5 x ULN with the following exception:
  • Patients with known Gilbert disease: serum bilirubin </= 3 x ULN
  • Creatinine clearance >/= 30 mL/min (calculated using the Cockcroft-Gault formula)
  • For patients not receiving therapeutic anticoagulation: international normalized ratio (INR) and Partial Thromboplastin Time, Activated (aPTT) </= 1.5 x ULN
  • Ability to understand and the willingness to sign a written informed consent document.
  • Availability of pre-treatment tumor tissue via a fresh biopsy. If biopsy is not considered safe and medically feasible by the Investigator, the patient may be approved for enrollment after consultation with the Principal Investigator.
  • For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive methods, and agreement to refrain from donating eggs, as defined below:
  • Women must remain abstinent or use contraceptive methods with a failure rate of less than (<) 1% per year during the treatment period and for 6 months after the final dose of study treatment. Women must refrain from donating eggs during this same period.
  • A woman is considered to be of childbearing potential if she is postmenarchal, has not reached a postmenopausal state ( >/= 12 continuous months of amenorrhea with no identified cause other than menopause), and has not undergone surgical sterilization (removal of ovaries and/or uterus). The definition of childbearing potential may be adapted for alignment with local guidelines or requirements.
  • Examples of contraceptive methods with a failure rate of < 1% per year include bilateral tubal ligation, male sterilization, hormonal contraceptives that inhibit ovulation, hormone-releasing intrauterine devices, and copper intrauterine devices.
  • The reliability of sexual abstinence should be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the patient. Periodic abstinence (e.g., calendar, ovulation, symptothermal, or postovulation methods) and withdrawal are not adequate methods of contraception.
  • For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures, and agreement to refrain from donating sperm, as defined below:
  • With a female partner of childbearing potential who is not pregnant, men who are not surgically sterile must remain abstinent or use a condom plus an additional contraceptive method that together result in a failure rate of < 1% per year during the treatment period and for 90 days after the final dose of MGC018. Men must refrain from donating sperm during this this same period.
  • With a pregnant female partner, men must remain abstinent or use a condom during the treatment period and 90 days after the final dose of MGC018 to avoid potential exposure to the embryo.
  • The reliability of sexual abstinence should be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the patient. Periodic abstinence (e.g., calendar, ovulation, symptothermal, or postovulation methods) and withdrawal are not adequate methods of contraception.

Who cannot join

  • Patients with treated brain metastases are eligible if they are symptomatically stable while off steroid therapy for a minimum of 7 days
  • History of leptomeningeal disease
  • Patient who are receiving any other investigational agents
  • Major surgical procedure, other than for diagnosis, within 4 weeks prior to initiation of study treatment, or anticipation of need for a major surgical procedure during the study
  • Diagnosis of another malignancy. However, patients with prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial.
  • Evidence of pleural and/or pericardial effusion. A small and/or asymptomatic effusion is not exclusionary.
  • Any other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding that, in the view of the investigator, contraindicates the use of an investigational drug, may affect the interpretation of the results, or may render the patient at high risk from treatment complications.
  • Pregnancy or breastfeeding, or intention of becoming pregnant during study treatment or within 6 months after the final dose of study treatment.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Lombardi Comprehensive Cancer Center, Georgetown University

    Washington D.C., District of Columbia, 20007

Other trials in United States

About this study

Official title: A Phase II Study of MGC018 in Patients With Relapsed or Refractory Extensive-Stage Small-Cell Lung Cancer (ES-SCLC)

The goal of this clinical trial is to test MGC018 in patients with relapsed or refractory Extensive-Stage Small-Cell Lung Cancer (ES-SCLC). The main question it aims to answer is:

  • Does the administration of MGC018 achieve a clinically meaningful response rate of 25% in patients with relapsed or refractory ES-SCLC?

Participants enrolled in the trial will receive MGC018 through an intravenous (IV) infusion, every 28 days until disease progression or unacceptable toxicity. Tumor assessment will be done every 2 cycles (28 day cycles). Blood samples will be taken for biomarker analysis before treatment, on cycle 3 day 1, and at progression. A pretreatment biopsies will be done.

Being tested
MGC018
Medical subject headings
Small Cell Lung Carcinoma

What participants receive

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

  • MGC018Drug

    Intravenous (IV) Infusion, 2.7 mg/kg on Day 1 of each 28 day cycle

Study groups in NCT06227546
Study groupRoleWhat they receive
MCG018ExperimentalNot described
Receives: Drug: MGC018

What is being measured

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

  1. Objective Response Rate (ORR)

    Investigator-Assessed ORR per Response Evaluation Criteria In Solid Tumors (RECIST v1.1) for target lesions as assessed by CT or magnetic resonance imaging (MRI) scans (with IV contrast unless contraindicated) of the chest, abdomen, and pelvis every 2 cycles (each cycle is a 28 day cycle). Reported as the number of patients with a complete response (CR) or partial response (PR); ORR = CR+PR; CR = Disappearance of all target lesions.Any pathological lymph nodes (whether target ornon-target) must have reduction in short axis to<10 mm. PR= At least a 30% decrease in the sum ofdiameters of target lesions, taking as reference the baseline sum diameters.

    Measured: 1 year

Secondary outcomes (5)

  1. Incidence of Adverse Events

    Number of participants with Investigator assessed treatment emergent adverse events per Common terminology criteria for adverse effects (CTCAE) version 5.0

    Measured: from start of treatment through 60 days after last treatment, approximately 1 year

  2. Duration of Response (DOR)

    Defined as the time from response to disease progression or death in patients who achieve complete or partial response.

    Measured: 1 year

  3. Progression-free Survival (PFS) Median

    Defined as the time from study drug initiation until progression event or death as assessed using the Kaplan-Meier method.

    Measured: 1 year

  4. Progression-free Survival (PFS) 6 Months

    Defined as the time from study drug initiation until progression event or death as assessed using the Kaplan-Meier method.

    Measured: 6 months

  5. Overall Survival (OS)

    Defined as time from study drug initiation to death as assessed using the Kaplan-Meier method.

    Measured: 3 years

Timeline

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

  1. First posted29 Jan 2024
  2. Study start15 Apr 2024
  3. Primary completion28 Mar 2025
  4. Study completionApr 2027 (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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
9 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06227546
Sponsor's protocol ID
STUDY00007316
Acronym
MGC018-SCLC
Status last verified
Jun 2026
First submitted
18 Jan 2024
Last updated
25 Jun 2026
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing MGC018 in people with Extensive-stage Small-cell Lung Cancer, run by Georgetown University at 1 site in United States.

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 29 inclusion and 8 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: under way, not looking for participants, as of the sponsor's last update on 25 Jun 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 United States. 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?

Yes. Results are posted in the registry (first posted 13 Apr 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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) (time frame: 1 year). 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 NCT06227546.

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 25 Jun 2026.

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