A Phase 1b/2 Open-Label Clinical Study to Evaluate the Safety and Efficacy of MK-6070 and Ifinatamab Deruxtecan (I-DXd) in Participants With Relapsed/Refractory Extensive-Stage Small Cell Lung Cancer

Plain English Summary

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) is a Phase 2 clinical trial sponsored by Merck Sharp & Dohme LLC studying Small Cell Lung Cancer. This trial tests two new drugs, Gocatamig and Ifinatamab Deruxtecan (I-DXd), alone and in combination with each other or another immunotherapy (Durvalumab). It is for adults with extensive-stage small cell lung cancer that has returned or not responded to previous treatment. Participation involves receiving one of the study treatments via IV infusion and regular medical check-ups. Standard chemotherapy or other targeted therapies are current alternatives for this type of cancer. The trial aims to enroll 262 participants.

Official 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. Durvalumab is a different type of immunotherapy that also destroys cancer cells. Researchers want to know if giving gocatamig, I-DXd, and gocatamig with I-DXd or durvalumab can treat SCLC that did not respond or stopped responding to a prior treatment. The goals of this study are to learn: * If gocatamig alone, I-DXd alone, and gocatamig with I-DXd or durvalumab are safe and well tolerated * If people who receive gocatamig alone, I-DXd alone, and gocatamig with I-DXd or durvalumab have their SCLC get smaller or go away

Who Can Participate

Here is what you need to know about eligibility for this trial. Adults with extensive-stage small cell lung cancer that has progressed after at least one prior treatment. Must be able to provide a tumor tissue sample. Individuals with well-controlled HIV on medication can participate. Cannot have current or past lung inflammation (pneumonitis/ILD), significant heart problems, untreated brain metastases, or active serious infections. This trial is studying Small Cell Lung Cancer, so participants generally need a confirmed diagnosis. The trial is currently accepting new participants.

What They're Measuring

The primary outcomes will show how safe these new drug combinations are, whether they cause serious side effects, and if they can shrink tumors or make them disappear, indicating they are working. The specific primary outcome measures are: Number of Participants Who Experience an Adverse Event (AE) (Up to approximately 44 months); Number of Participants Who Experience One or More Dose-Limiting Toxicities (DLTs) (Up to approximately 3 weeks); Number of Participants Who Discontinue Study Intervention Due to an AE (Up to approximately 44 months); Part 1: Objective Response Rate (ORR) (Up to approximately 44 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 more effective treatments for relapsed or refractory extensive-stage small cell lung cancer, a challenging disease with limited options. Phase 2 success would typically lead to larger Phase 3 trials needed for regulatory approval. This research targets Small Cell Lung Cancer, where improved treatment options are needed.

Investor Insight

This trial targets a significant unmet need in lung cancer, with potential for novel combination therapies to improve outcomes, suggesting a promising area for investment if efficacy is demonstrated. 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 combination of drugs you might receive and what to expect during treatment. Be prepared for regular clinic visits for infusions, blood tests, and scans to monitor your health and the cancer's response. Understand that this is an open-label study, meaning both you and your doctor will know which treatment you are receiving. This trial is currently recruiting participants. The trial is being conducted at 20 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: 262 participants

Interventions

• BIOLOGICAL: Gocatamig — IV infusion
• BIOLOGICAL: Ifinatamab Deruxtecan (I-DXd) — IV infusion
• BIOLOGICAL: Durvalumab — IV infusion

Primary Outcomes

• Number of Participants Who Experience an Adverse Event (AE) (Up to approximately 44 months)
• Number of Participants Who Experience One or More Dose-Limiting Toxicities (DLTs) (Up to approximately 3 weeks)
• Number of Participants Who Discontinue Study Intervention Due to an AE (Up to approximately 44 months)
• Part 1: Objective Response Rate (ORR) (Up to approximately 44 months)

Secondary Outcomes

• Part 1, Part 2 (Arm 5, Arm 6, and Arm 8), and Part 3 (Arm 7): Duration of Response (DOR) (Up to approximately 44 months)
• Part 1, Part 2 (Arm 6 and Arm 8), and Part 3 (Arm 7): Progression-Free Survival (PFS) (Up to approximately 44 months)
• Part 2 (Arm 5, Arm 6, and Arm 8) and Part 3 (Arm 7): ORR (Up to approximately 44 months)
• Maximum Concentration (Cmax) of gocatamig (At designated timepoints (up to approximately 44 months))
• Cmax of ifinatamab deruxtecan (I-DXd) (At designated timepoints (up to approximately 44 months))

Full 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 tumor 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 interstitial lung disease (ILD)/pneumonitis irrespective of steroid use or has current or suspected pneumonitis/ILD that cannot be ruled out by imaging at screening
* Has clinically severe pulmonary compromise resulting from intercurrent pulmonary illnesses
* 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
* History of arterial thrombosis (eg, stroke or transient ischemic attack) within 6 months before the first dose of study intervention
* 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
* Receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of chronic immunosuppressive therapy within 7 days prior to the first dose of study intervention
* 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: Anticancer hormonal treatment (except luteinizing hormone-releasing hormone \[LHRH\]) within 2 weeks before start of study intervention
* Part 1 only: Systemic anticancer therapy (except antibody-based anticancer therapy) or investigational agents within 3 weeks or 5 half-lives, whichever is longer
* 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
* Part 1 only: Has other uncontrolled or significant protocol-specified cardiovascular disease

Trial Locations

• University of Colorado Anschutz Medical Campus ( Site 1110), Aurora, Colorado, United States
• University of Miami Hospital and Clinics, Sylvester Cancer Center ( Site 1111), Miami, Florida, United States
• University of Chicago ( Site 1108), Chicago, Illinois, United States
• Dana Farber Cancer Institute ( Site 1105), Boston, Massachusetts, United States
• John Theurer Cancer Center at Hackensack University Medical Center ( Site 1103), Hackensack, New Jersey, United States
• Roswell Park Cancer Institute ( Site 1107), Buffalo, New York, United States
• Providence Portland Medical Center ( Site 1101), Portland, Oregon, United States
• Sarah Cannon Research Institute ( Site 7001), Nashville, Tennessee, United States
• Medical College of Wisconsin ( Site 1112), Milwaukee, Wisconsin, United States
• Hospital Universitario Austral ( Site 2204), Pilar, Buenos Aires, Argentina
• ...and 10 more locations

Frequently Asked Questions

Related Conditions

• Small Cell Lung Cancer
• Extensive-Stage Lung Cancer
• Relapsed Cancer
• Refractory Cancer
• Lung Cancer
• Thoracic Oncology
• Oncology
• Immunotherapy
• Targeted Therapy
• Cancer Treatment

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