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)

Conditions: Small Cell Lung Cancer

Summary: 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. ifinatamab deruxtecan (also known as i-dxd) is a drug which binds to a specific target on cancer cells and delivers treatment to destroy those cells. researchers want to know if giving gocatamig and/or i-dxd can treat sclc that did not respond or stopped responding to a prior treatment. the goals of this study are to learn: * if gocatamig and i-dxd are safe and well tolerated * if people who receive gocatamig and i-dxd have their sclc get smaller or go away

this study will consist of two parts. part 1 will assess the safety, tolerability, and efficacy of gocatamig and i-dxd at dosing intervals of once every 2 weeks (q2w) and/or once every 3 weeks (q3w) at doses determined in study mk-6070-001 (nct: nct04471727). part 2 will assess the safety and tolerability of gocatamig in japanese participants.

Eligibility criteria:
inclusion 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 tissue sample or fresh biopsy tissue sample * human immunodeficiency virus (hiv) infected participants must have well controlled hiv on antiretroviral therapy (art) exclusion criteria: * pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedure * history of (noninfectious) pneumonitis/interstitial lung disease (ild) that required steroids or has current pneumonitis/ild, and or suspected ild/pneumonitis * has clinically severe pulmonary compromise resulting from intercurrent pulmonary illnesses * history of clinically significant intracranial bleeding or spinal cord bleeding * active neurologic paraneoplastic syndrome * 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 myocardial infarction, symptomatic congestive heart failure (chf) (new york heart association \> class ii), and/or uncontrolled cardiac arrhythmia * has other uncontrolled or significant protocol-specified cardiovascular disease * history of arterial thrombosis (eg, stroke or transient ischemic attack) within 6 months before the first dose of study intervention * chronic liver disease, including liver cirrhosis of child-pugh class b or c * 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 * ongoing treatment with immunosuppressive medications, with protocol-specified exceptions * 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 detectable hepatitis b virus (hbv) deoxyribonucleic acid \[dna\]), or hepatitis c (hepatitis c virus \[hcv\] antibody positive and detectable hcv ribonucleic acid). participants with hbv with undetectable viral load after treatment are eligible. participants with hcv with undetectable virus after treatment are eligible. * 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: other anticancer therapy, including cytotoxic agents, targeted agents, immunotherapies, antibody, retinoid, transplant, or anticancer hormonal treatment (except luteinizing hormone-releasing hormone \[lhrh\]) within 2 weeks before start of study intervention * 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