Is NCT07227597 recruiting in Edgewood, KY?

Yes, NCT07227597 is currently recruiting participants at its Edgewood, KY location. This small cell lung cancer extensive stage clinical trial is actively enrolling qualified participants.

Is participation in this Edgewood clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

Small Cell Lung Cancer Extensive Stage Clinical Trial in Edgewood, KY

Q: How do I join the small cell lung cancer extensive stage clinical trial in Edgewood?

To join this clinical trial in Edgewood, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

About This Small Cell Lung Cancer Extensive Stage Study in Edgewood

Researchers are looking for new ways to treat extensive-stage small cell lung cancer (ES-SCLC). ES-SCLC is a type of lung cancer that has spread throughout the lung, to the other lung, or to other parts of the body. A standard (usual) treatment for ES-SCLC uses both chemotherapy and immunotherapy. * Chemotherapy is a treatment that works to destroy cancer cells or stop them from growing. * Immunotherapy is a treatment that helps the immune system fight cancer. Gocatamig and I-DXd (short for ifinatamab deruxtecan) are study medicines. Researchers want to know if giving gocatamig and I-DXd together can treat ES-SCLC. Researchers will also look at giving the study medicines with standard treatment. Gocatamig is a T-cell engager therapy. I-DXd is an antibody drug conjugate. * T-cell engager therapy is a certain type of immunotherapy that uses T-cells to find and destroy cancer cells. * A T-cell is a type of white blood cell, which are cells that help the body fight infection. * An antibody drug conjugate (ADC) is a treatment that attaches to a protein on cancer cells and delivers treatment to destroy those cells. The goals of this study are to learn: * About the safety of combining gocatamig and I-DXd and if people tolerate them together * If people who receive gocatamig and I-DXd have ES-SCLC respond, which means the cancer gets smaller or goes away

Sponsor: Merck Sharp & Dohme LLC

Who Can Participate

Inclusion Criteria

The main inclusion criteria include but are not limited to the following:

Has a histologically or cytologically confirmed diagnosis of extensive-stage small cell lung cancer (ES-SCLC)

For participants receiving gocatamig + ifinatamab deruxtecan (I-DXd) in maintenance only:

Completed 3 to 4 cycles of platinum + etoposide chemotherapy with concurrent approved anti-programmed cell death 1/Ligand 1 (anti PD-1/L1) as first line (1L) treatment of ES-SCLC within 6 weeks prior to enrollment

No radiological disease progression per Response Evaluation Criteria In Solid Tumors version 1.1 (RECIST 1.1)

No other prior systemic ES-SCLC therapy allowed

Rechallenge therapy counts as an additional line and leads to

Exclusion Criteria

For participants receiving gocatamig + I-DXd in induction and maintenance, or gocatamig + I-DXd in induction followed by gocatamig + atezolizumab in maintenance, or carboplatin + etoposide + atezolizumab in induction followed by atezolizumab in maintenance: No prior systemic ES-SCLC treatment allowed

Applicable to all participants: prior limited-stage small cell lung cancer (SCLC) is allowed if \> 6 months have passed since the end of previous therapy and progression

Must be able to provide a pretreatment archival tumor tissue sample or newly obtained core, incisional, or excisional biopsy of a tumor lesion not previously irradiated

Measurable disease by RECIST 1.1 as assessed by the local site investigator/radiology. Lesions situated in a previously irradiated area are considered measurable if growth has been shown in such lesions since the completion of radiation Exclusion Criteria: The main exclusion criteria include but are not limited to the following:

Has pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures

Has any history of interstitial lung disease (ILD)/pneumonitis irrespective of steroid use, current ILD, ILD that cannot be ruled out by imaging at screening, or suspected ILD

Has clinically severe pulmonary compromise resulting from intercurrent pulmonary illnesses

Has history of clinically significant intracranial bleeding or spinal cord bleeding

Has active neurologic paraneoplastic syndrome

Has history of coronary/peripheral artery bypass graft and/or any coronary/peripheral angioplasty or clinically significant cardiovascular disease such as myocardial infarction, symptomatic congestive heart failure (CHF), and/or uncontrolled cardiac arrhythmia within 6 months before the first dose of study intervention

Has other uncontrolled or significant protocol specified cardiovascular disease

Has history of arterial thrombosis within 6 months before the first dose of study intervention

Has chronic liver disease

Has history of allogeneic tissue/solid organ transplant

Has history of leptomeningeal disease

Is infected with human immunodeficiency virus (HIV) and has a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease

Has received prior therapy with an anti-programmed cell death protein 1 (anti-PD-1), anti-programmed cell death ligand 1 (anti-PD-L1), or anti-programmed cell death ligand 2 (anti-PD-L2) agent or with an agent directed to another stimulatory or coinhibitory T-cell receptor

Has received prior radiotherapy within 2 weeks of start of study intervention, or has radiation-related toxicities, requiring corticosteroids

Has known additional malignancy that is progressing or has required active treatment within the past 3 years

Has active autoimmune disease that has required systemic treatment in the past 2 years except replacement therapy

Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis

Has major surgery within 4 weeks or minor surgery within 2 weeks of allocation/randomization (or first dose), or is anticipated to require a major surgical procedure during the study

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Edgewood?

Yes, this clinical trial (NCT07227597) has an active research site in Edgewood, KY that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Small Cell Lung Cancer Extensive Stage Treatment Options in Edgewood, KY

If you're searching for small cell lung cancer extensive stage treatment options in Edgewood, KY, this clinical trial (NCT07227597) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Edgewood research site is actively enrolling participants for this clinical trial. You'll receive care from experienced small cell lung cancer extensive stage specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all small cell lung cancer extensive stage clinical trials near you to find additional studies recruiting in your area.

Small Cell Lung Cancer Extensive Stage Clinical Trial in Edgewood, KY

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