RecruitingPhase 1 / Phase 2

A Clinical Study of Gocatamig (MK-6070) and Infinatamab Deruxtecan (MK-2400) in People With Small Cell Lung Cancer (MK-6070-003)

A Phase 1b/2 Open-label Study Evaluating Different MK-6070 and Ifinatamab Deruxtecan (MK-2400)-Based Regimens in First-line Extensive Stage Small Cell Lung Cancer

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests gocatamig and I-DXd together for small cell lung cancer that has spread widely. Researchers will check safety, side effects, and whether the cancer shrinks or goes away. They will also test the study medicines with usual treatment.

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

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Have extensive-stage small cell lung cancer confirmed by a tissue or cell test.
  • For the maintenance-only group: finished 3 to 4 rounds of platinum and etoposide chemotherapy with an approved immune treatment within 6 weeks before joining. Maintenance treatment is given after the first treatment.
  • For the maintenance-only group: scans show the cancer has not grown or spread, and you have had no other whole-body treatment for this cancer. Repeating earlier treatment counts as another treatment.
  • For groups starting with initial treatment: have had no previous whole-body treatment for extensive-stage small cell lung cancer.
  • Earlier limited-stage small cell lung cancer is allowed if more than 6 months passed between finishing treatment and the cancer getting worse.
  • Can provide a stored or new tumor sample from an area not treated with radiation.
  • Have cancer that can be measured on scans. Cancer in an area treated with radiation must have grown since radiation ended.

Who can't join

  • Have fluid around the lungs or heart, or in the belly, that needs repeated draining; serious breathing problems; or current, past, or suspected lung inflammation called ILD or pneumonitis.
  • Have had serious bleeding in the brain or spinal cord, or have an active nerve disorder caused by cancer.
  • Have certain serious heart or blood vessel problems, including an artery blood clot within the past 6 months.
  • Have long-term liver disease, a past organ or tissue transplant from another person, or HIV with a history of Kaposi’s sarcoma or Multicentric Castleman’s disease.
  • Have had cancer in the layers around the brain or spinal cord, or have active cancer spread to the brain or spinal cord.
  • Have received certain immune treatments, including PD-1 or PD-L1 drugs. The listing also requires an approved immune treatment for the maintenance-only group, so ask the study team which rule applies to you.
  • Have another cancer that is growing or needed treatment within 3 years, or an illness where the immune system attacks the body that needed whole-body treatment within 2 years, except replacement treatment.
  • Had radiation within 2 weeks or have radiation side effects needing steroids; had major surgery within 4 weeks or minor surgery within 2 weeks of study assignment or the first dose; or expect to need major surgery during the study.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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 * 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

Study sites (13)

CA

CO

FL

KY

MO

NJ

OR

SD

TN

TX

  • Houston Methodist Hospital - Houston Methodist Neal Cancer Center ( Site 0113) · Houston, TX 77030Study Coordinator · Study contact · 646-407-2086More trials in Houston

VA