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)

Merck Sharp & Dohme (MSD)

Status and phase: Enrolling; Phase 2; Phase 1

Conditions: Small Cell Lung Cancer

Treatments: Biological: Gocatamig; Biological: Ifinatamab Deruxtecan (I-DXd)

Study type: Interventional

Funder types: Industry

Identifiers

NCT06780137

2024-517926-25-00 (Registry Identifier)

6070-002

MK-6070-002 (Other Identifier)

Details and patient eligibility

About

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

Full description

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.

Enrollment: 138 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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138 participants in 5 patient groups

Part 1 Arm 1: Gocatamig and I-DXd Q3W

Experimental group

Description:

Participants will receive gocatamig and I-DXd Q3W at the determined dose until documented disease progression or discontinuation criteria are met.

Treatment:

Biological: Ifinatamab Deruxtecan (I-DXd)

Biological: Gocatamig

Part 1 Arm 2: Gocatamig Q2W and I-DXd Q3W

Experimental group

Description:

Participants will receive gocatamig Q2W and I-DXd Q3W at the determined dose until documented disease progression or discontinuation criteria are met.

Treatment:

Biological: Ifinatamab Deruxtecan (I-DXd)

Biological: Gocatamig

Part 1 Arm 3a: I-DXd Monotherapy Q2W

Experimental group

Description:

Participants will receive I-DXd Q2W until documented disease progression or discontinuation criteria are met.

Treatment:

Biological: Ifinatamab Deruxtecan (I-DXd)

Part 1 Arm 3b: Gocatamig and I-DXd Q2W

Experimental group

Description:

Participants will receive gocatamig and I-DXd Q2W at the determined dose until documented disease progression or discontinuation criteria are met.

Treatment:

Biological: Ifinatamab Deruxtecan (I-DXd)

Biological: Gocatamig

Part 2 Arm 4: Gocatamig Monotherapy

Experimental group

Description:

Participants in Japan will receive escalating doses of gocatamig until documented disease progression or discontinuation criteria are met.

Treatment:

Biological: Gocatamig