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

Merck Sharp & Dohme (MSD)

Status and phase: Not yet enrolling; Phase 2; Phase 1

Conditions: Small Cell Lung Cancer Extensive Stage

Treatments: Drug: Etoposide; Drug: Gocatamig; Drug: Carboplatin; Drug: I-DXd; Drug: Rescue Medications; Drug: Atezolizumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT07227597

MK-6070-003 (Other Identifier)

6070-003

Details and patient eligibility

About

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

Full description

In Part A, participants will be allocated to Arm 1 or Arm 2 per investigator's discretion. In Part B, participants will be allocated to Arm 1 per investigator's discretion and randomized to Arms 2, 3, and 4.

Enrollment: 170 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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 history of (noninfectious) pneumonitis/interstitial lung disease (ILD) that required steroids or has current pneumonitis/ILD, and or suspected pneumonitis/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 (or first dose), or is anticipated to require a major surgical procedure during the study

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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170 participants in 4 patient groups

Arm 1, Parts A and B: Gocataming + I-DXd

Experimental group

Description:

Participants who completed standard of care (SOC) induction chemotherapy with concurrent approved anti-programmed cell death 1/ligand 1 protein (anti-PD-1/L1) treatment for ES-SCLC and did not have disease progression per investigator discretion, will receive gocatamig and I-DxD in the maintenance phase, until documented disease progression or meeting other study discontinuation criteria.

Treatment:

Drug: Rescue Medications

Drug: I-DXd

Drug: Gocatamig

Arm 2, Parts A and B: Gocataming + I-DXd

Experimental group

Description:

Participants who did not receive prior systemic treatment for ES-SCLC will receive gocatamig and I-DxD during induction and maintenance phases, until documented disease progression or meeting other study discontinuation criteria.

Treatment:

Drug: Rescue Medications

Drug: I-DXd

Drug: Gocatamig

Arm 3, Part B: Gocataming + I-DXd → gocatamig + atezolizumab

Experimental group

Description:

Participants who did not receive prior systemic treatment for ES-SCLC will receive gocatamig and I-DxD in the induction phase, followed by gocatamig and atezolizumab in the maintenance phase, until documented disease progression or meeting other study discontinuation criteria.

Treatment:

Drug: Atezolizumab

Drug: Rescue Medications

Drug: I-DXd

Drug: Gocatamig

Arm 4, Part B: Carboplatin + etoposide + atezolizumab → atezolizumab

Active Comparator group

Description:

Participants who did not receive prior systemic treatment for ES-SCLC will receive SOC (carboplatin + etoposide + atezolizumab) in the induction phase, followed by atezolizumab in the maintenance phase, until documented disease progression or meeting other study discontinuation criteria.

Treatment:

Drug: Atezolizumab

Drug: Carboplatin

Drug: Etoposide