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

Plain English Summary

A Clinical Study of Gocatamig (MK-6070) and Infinatamab Deruxtecan (MK-2400) in People With Small Cell Lung Cancer (MK-6070-003) is a Phase 2 clinical trial sponsored by Merck Sharp & Dohme LLC studying Small Cell Lung Cancer Extensive Stage. This study tests new drug combinations, including Gocatamig and Ifinatamab Deruxtecan, for extensive-stage small cell lung cancer. It is for patients with extensive-stage small cell lung cancer who have not received prior treatment for this stage of the disease. Participation involves receiving study drugs intravenously, with regular check-ups and monitoring for side effects. Standard treatments like chemotherapy and immunotherapy are current alternatives, but this trial explores novel combinations. The trial aims to enroll 170 participants.

Official Summary

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

Who Can Participate

Here is what you need to know about eligibility for this trial. Patients with a confirmed diagnosis of extensive-stage small cell lung cancer can join. Individuals who have already received systemic treatment for extensive-stage small cell lung cancer cannot join. Certain conditions like active brain metastases, significant heart disease, or interstitial lung disease will exclude patients. Patients must be able to provide a tumor tissue sample and have measurable disease. This trial is studying Small Cell Lung Cancer Extensive Stage, so participants generally need a confirmed diagnosis. The trial is currently accepting new participants.

What They're Measuring

The primary outcomes measure how safe the new drug combinations are and how well they shrink or eliminate the cancer. The specific primary outcome measures are: Number of Participants Who Experience an Adverse Event (AE) (Up to approximately 58 months); Number of Participants Who Experience One or More Dose-Limiting Toxicities (DLTs) (Up to approximately 21 days); Number of Participants Who Discontinue Study Intervention Due to an AE (Up to approximately 58 months); Objective Response Rate (ORR) (Up to approximately 58 months). These endpoints are how researchers determine whether the treatment is effective and will form the basis of any future regulatory submissions.

About This Phase

This trial is in Phase 2, which tests whether the treatment actually works against the target condition. Phase 2 trials involve 100-300 patients and continue to monitor safety while evaluating effectiveness. This phase often tests different dosages to find the optimal amount. About 33% of Phase 2 drugs advance to Phase 3. If successful, the treatment will move to large-scale Phase 3 trials needed for FDA approval.

Why This Trial Matters

This trial addresses a critical need for new treatments in extensive-stage small cell lung cancer, a disease with limited effective first-line options. Phase 2 success would typically lead to larger Phase 3 trials needed for regulatory approval. This research targets Small Cell Lung Cancer Extensive Stage, where improved treatment options are needed.

Investor Insight

This trial targets a significant unmet need in lung cancer, with potential for novel therapies to capture a share of the oncology market. Phase 2 trials have approximately a 15-20% chance of eventually gaining FDA approval.

Is This Trial Right for Me?

Ask your doctor about the specific drug combinations being tested and how they might affect you. Be prepared for regular hospital visits for infusions and monitoring, which may occur over several years. Understand that you will be closely monitored for any side effects or changes in your condition. This trial is currently recruiting participants. The trial is being conducted at 10 sites. Always discuss clinical trial participation with your healthcare provider before making any decisions. This information is for educational purposes only and is not medical advice.

AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.

Study Design

• Study Type: INTERVENTIONAL
• Allocation: RANDOMIZED
• Model: PARALLEL
• Masking: NONE
• Enrollment: 170 participants

Interventions

• DRUG: Gocatamig — Intravenous (IV) administration
• DRUG: I-DXd — IV administration
• DRUG: Atezolizumab — IV administration
• DRUG: Carboplatin — IV administration
• DRUG: Etoposide — IV administration

Primary Outcomes

• Number of Participants Who Experience an Adverse Event (AE) (Up to approximately 58 months)
• Number of Participants Who Experience One or More Dose-Limiting Toxicities (DLTs) (Up to approximately 21 days)
• Number of Participants Who Discontinue Study Intervention Due to an AE (Up to approximately 58 months)
• Objective Response Rate (ORR) (Up to approximately 58 months)

Secondary Outcomes

• Disease Control Rate (DCR) (Up to approximately 58 months)
• Duration of Response (DOR) (Up to approximately 58 months)
• Progression-Free Survival (PFS) (Up to approximately 58 months)
• Overall Survival (OS) (Up to approximately 58 months)
• Area Under the Concentration-Time Curve Over the Dosing Interval t (AUCt) of Gocatamig (At designated time points (up to approximately 58 months))

Full Eligibility Criteria

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

Trial Locations

• Orlando Health Cancer Institute ( Site 0108), Orlando, Florida, United States
• Saint Elizabeth Medical Center Edgewood ( Site 0112), Edgewood, Kentucky, United States
• John Theurer Cancer Center at Hackensack University Medical Center ( Site 0101), Hackensack, New Jersey, United States
• Beijing Cancer Hospital ( Site 1604), Beijing, Beijing Municipality, China
• Shanghai East Hospital ( Site 1600), Shanghai, Shanghai Municipality, China
• Taizhou Hospital of Zhejiang Province ( Site 1601), Taizhou, Zhejiang, China
• Rambam Health Care Campus ( Site 0602), Haifa, Israel
• Sheba Medical Center ( Site 0601), Ramat Gan, Israel
• Asan Medical Center ( Site 1404), Seoul, South Korea
• Samsung Medical Center ( Site 1401), Seoul, South Korea

Frequently Asked Questions

Related Conditions

• Small Cell Lung Cancer
• Extensive Stage Small Cell Lung Cancer
• Lung Cancer
• Oncology
• Chemotherapy
• Immunotherapy
• Antibody-Drug Conjugates
• T-cell Engager Therapy
• Cancer Treatment
• Clinical Trials

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