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New drug combo aims to fight tough lung cancer

NCT ID NCT07227597

Disease control Sponsor: Merck Sharp & Dohme LLC Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Aug 21, 2026 · Updated 14 times

Summary

This study tests two experimental drugs, gocatamig and ifinatamab deruxtecan, alone or with standard chemotherapy and immunotherapy, for people with extensive-stage small cell lung cancer. The goal is to see if the combination is safe and can shrink tumors. About 170 participants will take part in this early-phase trial.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
gocatamig (MK-6070) and ifinatamab deruxtecan (I-DXd)
What this could lead to
If successful, this combination could offer a new treatment option for extensive-stage small cell lung cancer, potentially improving response rates.
What could go wrong
This is an early-phase trial (1b/2) with a small number of participants, so safety and effectiveness are not yet proven. Side effects like cytokine release syndrome are possible.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 170 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jan 2026

Expected to finish

Dec 2030

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

small cell lung carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Small cell lung cancer extensive stage

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    52 sites in 12 countries. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • Asan Medical Center ( Site 1404)

    RECRUITING

    Seoul, 05505, South Korea

  • Athens Medical Center ( Site 0504)

    RECRUITING

    Athens, Attica, 151 25, Greece

  • Avera Cancer Institute- Research ( Site 0104)

    RECRUITING

    Sioux Falls, South Dakota, 57105, United States

  • Bangkok Metropolitan Administration Medical College and Vajira Hospital ( Site 3002)

    RECRUITING

    Dusit, Bangkok, 10300, Thailand

  • Beijing Cancer Hospital ( Site 1604)

    RECRUITING

    Beijing, Beijing Municipality, 100142, China

  • Bradfordhill ( Site 0201)

    RECRUITING

    Santiago, Region M. de Santiago, 8420383, Chile

  • CEMIC ( Site 1903)

    RECRUITING

    Caba., Buenos Aires, C1431FWO, Argentina

  • Errikos Dunant Hospital Center ( Site 0501)

    RECRUITING

    Athens, Attica, 115 26, Greece

  • European Interbalkan Medical Center ( Site 0500)

    RECRUITING

    Thessaloniki, 570 01, Greece

  • European Interbalkan Medical Center ( Site 0505)

    RECRUITING

    Thessaloniki, 570 01, Greece

  • FALP ( Site 0200)

    RECRUITING

    Santiago, Region M. de Santiago, 7500921, Chile

  • Faculty of Medicine Siriraj Hospital ( Site 3000)

    RECRUITING

    Bangkoknoi, Bangkok, 10700, Thailand

  • Fondazione IRCCS Istituto Nazionale dei Tumori ( Site 0701)

    RECRUITING

    Milan, 20133, Italy

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Università Cattolica del Sacro Cuore ( Site 0700)

    RECRUITING

    Roma, 00168, Italy

  • Fujian Provincial Cancer Hospital ( Site 1607)

    RECRUITING

    Fuzhou, Fujian, 350014, China

  • Hospital Austral ( Site 1901)

    RECRUITING

    Pilar, Buenos Aires, B1629AHJ, Argentina

  • Hospital San Pedro ( Site 1004)

    RECRUITING

    Logroño, La Rioja, 26006, Spain

  • Hospital Universitari Vall d'Hebron ( Site 1001)

    RECRUITING

    Barcelona, 08035, Spain

  • Hospital Universitario Gregorio Maranon ( Site 1003)

    RECRUITING

    Madrid, 28007, Spain

  • Hospital Universitario Insular de Gran Canaria ( Site 1002)

    RECRUITING

    Las Palmas de Gran Canaria, Las Palmas, 35016, Spain

  • Houston Methodist Hospital - Houston Methodist Neal Cancer Center ( Site 0113)

    RECRUITING

    Houston, Texas, 77030, United States

  • IRCCS - Istituto Romagnolo per lo Studio dei Tumori (IRST) "Dino Amadori" ( Site 0702)

    RECRUITING

    Meldola, Forli-Cesena, 47014, Italy

  • Jiangmen Central Hospital ( Site 1611)

    RECRUITING

    Jiangmen, Guangdong, 529000, China

  • John Theurer Cancer Center at Hackensack University Medical Center ( Site 0101)

    RECRUITING

    Hackensack, New Jersey, 07601, United States

  • Lt. Col. Luke Weathers, Jr. VA Medical Center ( Site 0133)

    RECRUITING

    Memphis, Tennessee, 38105, United States

  • Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie ( Site 0902)

    RECRUITING

    Warsaw, Masovian Voivodeship, 02-781, Poland

  • Orlando Health Cancer Institute ( Site 0108)

    RECRUITING

    Orlando, Florida, 32806, United States

  • Pontificia Universidad Catolica de Chile ( Site 0202)

    RECRUITING

    Santiago, Region M. de Santiago, 8330032, Chile

  • Providence Cancer Institute, Franz Clinic - Eastside ( Site 0107)

    RECRUITING

    Portland, Oregon, 97213, United States

  • Providence Medical Foundation ( Site 0124)

    RECRUITING

    Santa Rosa, California, 95403, United States

  • Rambam Health Care Campus ( Site 0602)

    RECRUITING

    Haifa, 3109601, Israel

  • SCRI Oncology Partners ( Site 7000)

    RECRUITING

    Nashville, Tennessee, 37203, United States

  • Saint Elizabeth Medical Center Edgewood ( Site 0112)

    RECRUITING

    Edgewood, Kentucky, 41017, United States

  • Samsung Medical Center ( Site 1401)

    RECRUITING

    Seoul, 06351, South Korea

  • Sanatorio Parque ( Site 1900)

    RECRUITING

    Rosario, Santa Fe Province, S2000DSV, Argentina

  • Seoul National University Hospital ( Site 1402)

    RECRUITING

    Seoul, 03080, South Korea

  • Severance Hospital Yonsei University Health System ( Site 1403)

    RECRUITING

    Seoul, 03722, South Korea

  • Shanghai East Hospital ( Site 1600)

    RECRUITING

    Shanghai, Shanghai Municipality, 200000, China

  • Sheba Medical Center ( Site 0601)

    RECRUITING

    Ramat Gan, 5265601, Israel

  • Sichuan Cancer hospital. ( Site 1609)

    RECRUITING

    Chengdu, Sichuan, 610213, China

  • Songklanagarind hospital ( Site 3001)

    RECRUITING

    Hat Yai, Changwat Songkhla, 90110, Thailand

  • Southern Medical University Nanfang Hospital ( Site 1608)

    RECRUITING

    Guangzhou, Guangdong, 510515, China

  • THORACIC GENERAL HOSPITAL OF ATHENS "I SOTIRIA" ( Site 0502)

    RECRUITING

    Athens, Attica, 115 27, Greece

  • Taizhou Hospital of Zhejiang Province ( Site 1601)

    RECRUITING

    Taizhou, Zhejiang, 317000, China

  • The First Affiliated Hospital of Nanchang University ( Site 1610)

    RECRUITING

    Nanchang, Jiangxi, 330209, China

  • The University of Tennessee Medical Center ( Site 0120)

    RECRUITING

    Knoxville, Tennessee, 37920, United States

  • The first Affiliated Hospital, Zhejiang University School of Medicine ( Site 1602)

    RECRUITING

    Hangzhou, Zhejiang, 310003, China

  • Universitaetsklinikum Jena ( Site 0403)

    RECRUITING

    Jena, Thuringia, 07747, Germany

  • Universitaetsklinikum Tuebingen-Department of Internal Medicine VIII - Medical Oncology, ECTU, Pne ( Site 0401)

    RECRUITING

    Tübingen, Baden-Wurttemberg, 72076, Germany

  • University of Colorado, Anschutz Cancer Pavilion ( Site 0125)

    RECRUITING

    Aurora, Colorado, 80045, United States

  • University of Virginia Health System ( Site 0122)

    RECRUITING

    Charlottesville, Virginia, 22908, United States

  • Washington University School of Medicine ( Site 0134)

    RECRUITING

    St Louis, Missouri, 63110, United States

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