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Tests treatment safety and results for Small Cell Lung Cancer
Official title A Study to Evaluate the Safety and Efficacy of Gocatamig (MK-6070) and Ifinatamab Deruxtecan (I-DXd) in Participants With Relapsed/Refractory Extensive-Stage Small Cell Lung Cancer (MK-6070-002)
ClinicalTrials.gov ID: NCT06780137
What this study is testing
What is Gocatamig?
Gocatamig is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for small cell lung cancer.
Also referred to as HPN328, MK-6070.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Researchers are looking for new ways to treat people with extensive-stage small cell lung cancer (SCLC) that has relapsed or is refractory. Gocatamig is a new type of immunotherapy that uses a person's immune system to find and destroy cancer cells.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Has histologically or cytologically confirmed SCLC that is extensive stage (defined as Stage IV (T any, N any, M1a/b/c) following at least 1 prior...
- Must be able to provide archival tumor tissue sample or fresh biopsy tissue sample
- Human immunodeficiency virus (HIV) infected participants must have well controlled HIV on antiretroviral therapy (ART)
You likely can't join if
- Pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedure
- Any history of interstitial lung disease (ILD)/pneumonitis irrespective of steroid use except for a history of radiation pneumonitis that did not...
- Current history of ILD or clinical or radiographic suspicion of ILD for which the diagnosis of ILD cannot be ruled out
- Has clinically severe pulmonary compromise resulting from intercurrent pulmonary illnesses
- Active or history of immune deficiency with the exception of HIV-infected participants with well controlled HIV on ART
- History within 6 months before the first dose of study intervention of coronary/peripheral artery bypass graft and/or any coronary/peripheral...
See the full eligibility criteria
- Has histologically or cytologically confirmed SCLC that is extensive stage (defined as Stage IV (T any, N any, M1a/b/c) following at least 1 prior line of systemic therapy that included platinum-based chemotherapy
- Must be able to provide archival tumor tissue sample or fresh biopsy tissue sample
- Human immunodeficiency virus (HIV) infected participants must have well controlled HIV on antiretroviral therapy (ART)
- Pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedure
- Any history of interstitial lung disease (ILD)/pneumonitis irrespective of steroid use except for a history of radiation pneumonitis that did not require steroids
- Current history of ILD or clinical or radiographic suspicion of ILD for which the diagnosis of ILD cannot be ruled out
- Has clinically severe pulmonary compromise resulting from intercurrent pulmonary illnesses
- Active or history of immune deficiency with the exception of HIV-infected participants with well controlled HIV on ART
- History within 6 months before the first dose of study intervention of coronary/peripheral artery bypass graft and/or any coronary/peripheral angioplasty or clinically significant cardiovascular disease such as...
- History of arterial thrombosis (eg, stroke or transient ischemic attack) within 6 months before the first dose of study intervention
- Active clinically significant infection requiring systemic therapy
- History of allogeneic tissue/solid organ transplant
- History of leptomeningeal disease
- Received prior radiotherapy within 2 weeks of start of study intervention, or has radiation-related toxicities, requiring corticosteroids
- Receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of chronic immunosuppressive therapy within 7 days prior to the first dose of study intervention
- Known additional malignancy that is progressing or has required active treatment within the past 3 years
- Untreated or symptomatic brain metastases
- Active viral hepatitis, defined as hepatitis A (hepatitis A virus immunoglobulin M [IgM] positive in the setting of associated signs/symptoms), hepatitis B (hepatitis B virus surface antigen [HbsAg] positive and/or...
- Part 1 only: Radiation therapy to the lung \>30 Gy within 6 months before the start of study intervention
- Part 1 only: Abdominal radiation within 4 weeks before start of study intervention
- Part 1 only: Anticancer hormonal treatment (except luteinizing hormone-releasing hormone [LHRH]) within 2 weeks before start of study intervention
- Part 1 only: Systemic anticancer therapy (except antibody-based anticancer therapy) or investigational agents within 3 weeks or 5 half-lives, whichever is longer
- Part 1 only: Antibody-based cancer therapy within 3 weeks before start of study intervention
- Part 1 only: Chloroquine/hydroxychloroquine within 2 weeks before start of study intervention
- Part 1 only: Clinically significant corneal disease
- Part 1 only: Has other uncontrolled or significant protocol-specified cardiovascular disease
The study team makes the final eligibility decision.
Where it's taking place
- Aurora, Colorado, United States
- Miami, Florida, United States
- Chicago, Illinois, United States
- Boston, Massachusetts, United States
- Hackensack, New Jersey, United States
- Buffalo, New York, United States
- Portland, Oregon, United States
- Nashville, Tennessee, United States
- Milwaukee, Wisconsin, United States
- Pilar, Buenos Aires, Argentina
- Rosario, Santa Fe Province, Argentina
- Woolloongabba, Queensland, Australia
- Clayton, Victoria, Australia
- Santiago, Region M. de Santiago, Chile
- Beijing, Beijing Municipality, China
- Fuzhou, Fujian, China
- Nanjing, Jiangsu, China
- Shanghai, Shanghai Municipality, China
- Chengdu, Sichuan, China
- Hangzhou, Zhejiang, China
+ 21 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Aurora, Colorado, United States; Miami, Florida, United States; Chicago, Illinois, United States; Boston, Massachusetts, United States; Hackensack, New Jersey, United States; Buffalo, New York, United States and 35 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.