MGC018 in Patients With Relapsed or Refractory Extensive-Stage Small-Cell Lung Cancer (NCT06227546) | Clinical Trial Compass
Active — Not RecruitingPhase 2
MGC018 in Patients With Relapsed or Refractory Extensive-Stage Small-Cell Lung Cancer
United States9 participantsStarted 2024-04-15
Plain-language 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?
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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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.
. Measurable disease per RECIST v1.1
. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-2
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. 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
Exclusion criteria
. 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.