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)
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
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years and older
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
Not stated in the study description — ask the study team about visits and procedures.
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study tests gocatamig alone, ifinatamab deruxtecan (I-DXd) alone, and gocatamig with I-DXd or durvalumab. It is for people with small cell lung cancer that has spread widely and did not respond or stopped responding to treatment. Researchers want to see if these treatments are safe and can shrink the cancer or make it go away.
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
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Have small cell lung cancer confirmed by a tissue or cell test that has spread widely (stage 4).
- Have had at least one prior drug treatment that included platinum-based chemotherapy.
- Can provide a stored tumor sample or a new sample taken from the tumor.
- If you have HIV, it must be well controlled with HIV medicines.
Who can't join
- Fluid around the lungs or heart, or in the belly, that needs repeated draining.
- Past or current lung inflammation or scarring, or suspected disease of this kind. Past lung inflammation from radiation is allowed if it did not need steroids. Severe lung problems from other lung illnesses also exclude you.
- A weak immune system, except for well-controlled HIV, or a past tissue or organ transplant from a donor.
- Certain heart or blood vessel problems within the past 6 months, including bypass surgery, procedures to open arteries, a heart attack, stroke, or mini-stroke.
- A serious active infection needing medicines that work throughout the body, or active hepatitis A, B, or C. Treated hepatitis B or C is allowed if the virus cannot be detected.
- Cancer that has spread to the brain and is untreated or causing symptoms; past cancer in the lining around the brain or spinal cord; or another cancer that is growing or needed treatment in the past 3 years.
- Radiation within 2 weeks before study treatment, or radiation side effects needing steroids. Ongoing immune-suppressing medicines or steroid doses above the equivalent of 10 mg of prednisone daily within 7 days before treatment also exclude you.
- For Part 1 only, extra limits apply to recent radiation, cancer treatments, experimental drugs, and chloroquine or hydroxychloroquine. Certain heart conditions or serious disease of the clear front of the eye also exclude you.
Simplified for readability. The official criteria below are what the study team uses.
Official 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 * Any history of interstitial lung disease (ILD)/pneumonitis irrespective of steroid use except for a history of radiation pneumonitis that did not require steroids * Current history of ILD or clinical or radiographic suspicion of ILD for which the diagnosis of ILD cannot be ruled out * 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
Study sites (9)
CO
- University of Colorado Anschutz Medical Campus ( Site 1110) · Aurora, CO 80045Study Coordinator · Study contact · 303-724-6268More trials in Aurora
FL
- University of Miami Hospital and Clinics, Sylvester Cancer Center ( Site 1111) · Miami, FL 33136Study Coordinator · Study contact · 305-243-1754More trials in Miami
IL
- University of Chicago ( Site 1108) · Chicago, IL 60637Study Coordinator · Study contact · 773-702-6149More trials in Chicago
MA
- Dana Farber Cancer Institute ( Site 1105) · Boston, MA 02215Study Coordinator · Study contact · 617-632-6049More trials in Boston
NJ
- John Theurer Cancer Center at Hackensack University Medical Center ( Site 1103) · Hackensack, NJ 07601Study Coordinator · Study contact · 551-996-5863More trials in Hackensack
NY
- Roswell Park Cancer Institute ( Site 1107) · Buffalo, NY 14263Study Coordinator · Study contact · 716-845-3167More trials in Buffalo
OR
- Providence Portland Medical Center ( Site 1101) · Portland, OR 97213Study Coordinator · Study contact · 503-215-5696More trials in Portland
TN
- Sarah Cannon Research Institute ( Site 7001) · Nashville, TN 37203Study Coordinator · Study contact · 844-482-4812More trials in Nashville
WI
- Medical College of Wisconsin ( Site 1112) · Milwaukee, WI 53226Study Coordinator · Study contact · 414-805-8900More trials in Milwaukee