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)
NCT06780137 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 262
Last updated 2026-04-20
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
Conditions
Interventions
- BIOLOGICAL
-
Gocatamig
IV infusion
- BIOLOGICAL
-
Ifinatamab Deruxtecan (I-DXd)
IV infusion
- BIOLOGICAL
-
IV infusion
Sponsors & Collaborators
- collaborator INDUSTRY
- lead INDUSTRY
Principal Investigators
-
Medical Director · Merck Sharp & Dohme LLC
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-02-27
- Primary Completion
- 2029-08-31
- Completion
- 2030-01-17
- FDA Drug
- Yes
Countries
- United States
- Argentina
- Australia
- Chile
- China
- Israel
- Japan
- South Korea
- Spain
- Taiwan
- Turkey (Türkiye)
- United Kingdom
Study Locations
More Related Trials
-
DS-3201b and Irinotecan for Patients With Recurrent Small Cell Lung Cancer
NCT03879798 ·Status: TERMINATED ·Phase: PHASE1/PHASE2
-
Phase II Study of Platinum/Etoposide Plus Ivonescimab for Extensive-Stage Small Cell Lung Cancer
NCT07057791 ·Status: RECRUITING ·Phase: PHASE2
-
Atezolizumab and Cobimetinib in Treating Patients With Metastatic, Recurrent, or Refractory Non-small Cell Lung Cancer
NCT03600701 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE2
-
Substudy 01I: A Study of Investigational Agents in Participants With Previously Treated Stage IV Squamous Non-small Cell Lung Cancer (NSCLC) (MK-3475-01I/KEYMAKER-U01I)
NCT06780098 ·Status: RECRUITING ·Phase: PHASE2
-
Study of Pembrolizumab (MK-3475) Monotherapy in Advanced Solid Tumors and Pembrolizumab Combination Therapy in Advanced Non-small Cell Lung Cancer/ Extensive-disease Small Cell Lung Cancer (MK-3475-011/KEYNOTE-011)
NCT01840579 ·Status: COMPLETED ·Phase: PHASE1
-
Combination Chemotherapy in Treating Patients With Recurrent or Refractory Small Cell Lung Cancer
NCT00005972 ·Status: COMPLETED ·Phase: PHASE2
-
SC0245 and Irinotecan in Treating Patients With Relapsed Extensive-Stage Small Cell Lung Cancer (ES-SCLC)
NCT05731518 ·Status: RECRUITING ·Phase: PHASE1/PHASE2
-
A Study of Pembrolizumab (MK-3475) in Combination With Chemotherapy or Immunotherapy in Participants With Non-small Cell Lung Cancer (MK-3475-021/KEYNOTE-021)
NCT02039674 ·Status: COMPLETED ·Phase: PHASE1/PHASE2
-
Study of Pemetrexed+Platinum Chemotherapy With or Without Pembrolizumab (MK-3475) in Participants With First Line Metastatic Nonsquamous Non-small Cell Lung Cancer (MK-3475-189/KEYNOTE-189)
NCT02578680 ·Status: COMPLETED ·Phase: PHASE3
-
A Study of I-DXd in Combination With Atezolizumab With or Without Carboplatin as First-Line Induction or Maintenance in Subjects With Extensive Stage-Small Cell Lung Cancer (IDeate-Lung03)
NCT06362252 ·Status: RECRUITING ·Phase: PHASE1/PHASE2
-
Combination Immunotherapy-Ipilimumab-Nivolumab-Dendritic Cell p53 Vac - Patients With Small Cell Lung Cancer (SCLC)
NCT03406715 ·Status: TERMINATED ·Phase: PHASE2
-
Study of DCC-3084 in Participants With Advanced Malignancies Driven by the Mitogen-Activated Protein Kinase (MAPK) Pathway
NCT06287463 ·Status: TERMINATED ·Phase: PHASE1
-
Phase I Clinical Study of α-PD-L1/DLL3 CAR-T in Patients With R/R SCLC
NCT06348797 ·Status: RECRUITING ·Phase: PHASE1
-
Dinutuximab and Irinotecan Versus Irinotecan to Treat Subjects With Relapsed or Refractory Small Cell Lung Cancer
NCT03098030 ·Status: COMPLETED ·Phase: PHASE2/PHASE3
-
MGC018 in Patients With Relapsed or Refractory Extensive-Stage Small-Cell Lung Cancer
NCT06227546 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE2
-
Phase I/II Study of Nivolumab and Ipilimumab Combined With Nintedanib in Non Small Cell Lung Cancer
NCT03377023 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE1/PHASE2
-
A Study Evaluating the Efficacy and the Safety of First-line Chemotherapy Combined With the Therapeutic Vaccine Named TG4010 and Nivolumab in Patients With Advanced Non-squamous Non-Small Cell Lung Cancer (NSCLC)
NCT03353675 ·Status: COMPLETED ·Phase: PHASE2
-
KRT-232 in Subjects With Relapsed or Refractory Small Cell Lung Cancer
NCT05027867 ·Status: TERMINATED ·Phase: PHASE2
-
S0119: Combination Chemotherapy in Treating Patients With Extensive-Stage Small Cell Lung Cancer
NCT00030433 ·Status: COMPLETED ·Phase: PHASE2
-
Study of Pembrolizumab (MK-3475) in Participants With Advanced Non-small Cell Lung Cancer (MK-3475-025/KEYNOTE-025)
NCT02007070 ·Status: COMPLETED ·Phase: PHASE1
-
Study of Two Doses of Pembrolizumab (MK-3475) Versus Docetaxel in Previously Treated Participants With Non-Small Cell Lung Cancer (MK-3475-010/KEYNOTE-010)
NCT01905657 ·Status: COMPLETED ·Phase: PHASE2/PHASE3
-
Irinotecan Liposome(II) Combined With Ivonescimab as Second-line Treatment for Small Cell Lung Cancer : A Prospective, Single-arm, Multicenter Clinical Study
NCT06820762 ·Status: NOT_YET_RECRUITING ·Phase: PHASE2
-
Irinotecan Plus Lobaplatin Versus Irinotecan in the Second-line Treatment of Small Cell Lung Cancer
NCT03613753 ·Status: UNKNOWN ·Phase: PHASE2
-
Volociximab and Erlotinib in Treating Patients With Stage III or Stage IV Non-Small Cell Lung Cancer
NCT00278187 ·Status: UNKNOWN ·Phase: PHASE2
-
Irinotecan and Carboplatin in Treating Patients With Newly Diagnosed Extensive-Stage Small Cell Lung Cancer
NCT00104793 ·Status: COMPLETED ·Phase: PHASE2