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)

Conditions

• Small Cell Lung Cancer

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

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

Study Details

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

Key Dates

First listed

Jan 17, 2025

Start date

Feb 27, 2025

Status verified

Aug 2026

Primary completion

Apr 27, 2029

Completion

Apr 27, 2029

Study Design

Enrollment

327 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Part 1 Arm 1: Gocatamig and I-DXd
  Participants will receive gocatamig and I-DXd at a determined dose until documented disease progression or discontinuation criteria are met.
• Experimental: Part 1 Arm 2: Gocatamig and I-DXd
  Participants will receive gocatamig and I-DXd at a determined dose until documented disease progression or discontinuation criteria are met.
• Experimental: Part 1 Arm 3a: I-DXd Monotherapy
  Participants will receive I-DXd until documented disease progression or discontinuation criteria are met.
• Experimental: Part 1 Arm 3b: Gocatamig and I-DXd
  Participants will receive gocatamig and I-DXd at a determined dose until documented disease progression or discontinuation criteria are met.
• Experimental: Part 2 Arm 4: Gocatamig Monotherapy in Japan
  Participants in Japan will receive escalating doses of gocatamig until documented disease progression or discontinuation criteria are met.
• Experimental: Part 2 Arm 5: Gocatamig Monotherapy in China
  Participants in China will receive escalating doses of gocatamig until documented disease progression or discontinuation criteria are met.
• Experimental: Part 2 Arm 6: Gocatamig
  Participants will receive gocatamig at a determined dose until documented disease progression or discontinuation criteria are met.
• Experimental: Part 3 Arm 7: Gocatamig and Durvalumab
  Participants will receive gocatamig and durvalumab at a determined dose until documented disease progression or discontinuation criteria are met.
• Experimental: Part 2 Arm 8: Gocatamig (Alternate Presentation)
  Participants will receive an alternate presentation of gocatamig at a determined dose until documented disease progression or discontinuation criteria are met.

Primary Outcome Measure

Number of Participants Who Experience an Adverse Event (AE) [ Time Frame: Up to approximately 44 months ]

Central Contacts

• Toll Free Number
  1-888-577-8839
  [email protected]

Locations (9)

Find similar trials in Aurora, CO

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