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NCT Number: NCT07227597

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

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

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

CEMIC ( Site 1903), Caba., Buenos Aires, Argentina

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Gocatamig

Drug

Intravenous (IV) administration

Other names: MK-6070, HPN328, DS-3280

I-DXd

Drug

IV administration

Other names: MK-2400, DS-7300a

Atezolizumab

Drug

IV administration

carboplatin

Drug

IV administration

etoposide

Drug

IV administration

Rescue medications

Drug

Participants will receive rescue medications at the investigator's discretion. Recommended rescue medications include tocilizumab for treatment of cytokine release syndrome (CRS); dexamethasone, acetaminophen, and diphenhydramine for CRS/infusion-related reaction (IRR) prophylaxis; and 5-hydroxytryptamine 3 (5-HT3) receptor antagonist, neurokinin 1 (NK-1) receptor antagonist, and corticosteroid for prevention of nausea and vomiting.

Primary outcomes

  1. Number of Participants Who Experience an Adverse Event (AE)

    Time frame: Up to approximately 58 months

    An AE is defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants who experience an AE will be reported.

  2. Number of Participants Who Experience One or More Dose-Limiting Toxicities (DLTs)

    Time frame: Up to approximately 21 days

    DLT will be defined as any drug-related AE observed during the DLT evaluation period (up to 21 days) that meets the protocol-specified DLT criteria. The number of participants who experience at least one DLT will be presented.

  3. Number of Participants Who Discontinue Study Intervention Due to an AE

    Time frame: Up to approximately 58 months

    An AE is defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants who discontinue study intervention due to an AE will be reported.

  4. Objective Response Rate (ORR)

    Time frame: Up to approximately 58 months

    ORR is defined as the percentage of participants with Complete Response (CR: disappearance of all target lesions) or Partial Response (PR: at least a 30% decrease in the sum of diameters of target lesions) per Response Evaluation Criteria In Solid Tumors Version 1.1 (RECIST 1.1). The percentage of participants who experience CR or PR as assessed by Blinded Independent Central Review (BICR) will be presented.

Secondary outcomes

  1. Disease Control Rate (DCR)

    Time frame: Up to approximately 58 months

    DCR is defined, per RECIST 1.1, as the percentage of participants who have a CR or PR or Stable Disease (SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD: At least a 20% increase in the sum of diameters of target lesions and an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered PD). The DCR as assessed by BICR will be presented.

  2. Duration of Response (DOR)

    Time frame: Up to approximately 58 months

    For participants who demonstrate a confirmed CR or PR per RECIST 1.1, DOR is defined as the time from first documented evidence of CR or PR until PD or death due to any cause, whichever occurs first. Per RECIST 1.1, PD is defined as at least a 20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions is also considered PD. DOR as assessed by BICR will be presented.

  3. Progression-Free Survival (PFS)

    Time frame: Up to approximately 58 months

    PFS is defined as the time from randomization (Part B for Arms 2-4) or from the first dose of study treatment (safety run-in Part A and Arm 1 Part B) to the first documented PD or death due to any cause, whichever occurs first as assessed by RECIST 1.1. PD is defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions is also considered PD. PFS as assessed by BICR will be presented.

  4. Overall Survival (OS)

    Time frame: Up to approximately 58 months

    OS is defined as the time from the first dose of study treatment (Part A and Arm 1 Part B) or randomization (Part B for Arms 2-4) to death due to any cause.

  5. Area Under the Concentration-Time Curve Over the Dosing Interval t (AUCt) of Gocatamig

    Time frame: At designated time points (up to approximately 58 months)

    Blood samples will be collected at multiple time points to determine the AUCt of the drug gocatamig.

  6. AUCt of I-DXd

    Time frame: At designated time points (up to approximately 58 months)

    Blood samples will be collected at multiple time points to determine the AUCt of the drug I-DXd.

  7. AUCt of Deruxtecan (DXd)

    Time frame: At designated time points (up to approximately 58 months)

    DXd is the payload released from the drug I-DXd. Blood samples will be collected at multiple time points to determine the AUCt of the drug payload DXd.

  8. AUCt of Anti-B7-H3 Antibody

    Time frame: At designated time points (up to approximately 58 months)

    Blood samples will be collected at multiple time points to determine the AUCt of the anti-B7-H3 antibody.

  9. Area Under the Steady-State Concentration-Time Curve Over the Dosing Interval t (AUCt,ss) of Gocatamig

    Time frame: At designated time points (up to approximately 58 months)

    Blood samples will be collected at multiple time points to determine the AUCt,ss of the drug gocatamig.

  10. AUCt,ss of I-DXd

    Time frame: At designated time points (up to approximately 58 months)

    Blood samples will be collected at multiple time points to determine the AUCt,ss of the drug I-DXd.

  11. AUCt,ss of DXd

    Time frame: At designated time points (up to approximately 58 months)

    DXd is the payload released from the drug I-DXd. Blood samples will be collected at multiple time points to determine the AUCt,ss of the drug payload DXd.

  12. AUCt,ss of Anti-B7-H3 Antibody

    Time frame: At designated time points (up to approximately 58 months)

    Blood samples will be collected at multiple time points to determine the AUCt,ss of the anti-B7-H3 antibody.

  13. Maximum Concentration (Cmax) of Gocatamig

    Time frame: At designated time points (up to approximately 58 months)

    Blood samples will be collected at multiple time points to determine Cmax of the drug gocatamig.

  14. Cmax of I-DXd

    Time frame: At designated time points (up to approximately 58 months)

    Blood samples will be collected at multiple time points to determine Cmax of the drug I-DXd.

  15. Cmax of DXd

    Time frame: At designated time points (up to approximately 58 months)

    DXd is the payload released from the drug I-DXd. Blood samples will be collected at multiple time points to determine Cmax of the drug payload DXd.

  16. Cmax of Anti-B7-H3 Antibody

    Time frame: At designated time points (up to approximately 58 months)

    Blood samples will be collected at multiple time points to determine Cmax of the anti-B7-H3 antibody.

  17. Trough Concentration (Ctrough) of Gocatamig

    Time frame: At designated time points (up to approximately 58 months)

    Blood samples will be collected at multiple time points to determine Ctrough of the drug gocatamig.

  18. Ctrough of I-DXd

    Time frame: At designated time points (up to approximately 58 months)

    Blood samples will be collected at multiple time points to determine Ctrough of the drug I-DXd.

  19. Ctrough of DXd

    Time frame: At designated time points (up to approximately 58 months)

    DXd is the payload released from the drug I-DXd. Blood samples will be collected at multiple time points to determine Ctrough of the drug payload DXd.

  20. Ctrough of Anti-B7-H3 Antibody

    Time frame: At designated time points (up to approximately 58 months)

    Blood samples will be collected at multiple time points to determine Ctrough of the anti-B7-H3 antibody.

  21. Incidence of Anti-Drug Antibodies (ADAs) Against Gocatamig

    Time frame: At designated time points (up to approximately 58 months)

    Blood samples will be collected at multiple time points to determine the ADA response to gocatamig. The incidence of ADAs for gocatamig will be presented.

  22. Incidence of ADAs Against I-DXd

    Time frame: At designated time points (up to approximately 58 months)

    Blood samples will be collected at multiple time points to determine the ADA response to I-DXd. The incidence of ADAs for I-DXd will be presented.

Study contacts

Contact information is provided by the study sponsor or research team.

Toll Free Number

CONTACT

[email protected]

1-888-577-8839

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Collaborators

  • Daiichi Sankyo

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2030
Study completion
2030
First posted
Nov 12, 2025
Registry last updated
Jul 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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