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New hope for tough lung cancer: dual-drug attack shows promise

NCT ID NCT06780137

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Sep 10, 2026 · Updated 5 times

Summary

This study tests two experimental drugs, MK-6070 and ifinatamab deruxtecan (I-DXd), alone or together, in people with advanced small cell lung cancer that stopped responding to standard treatment. The goal is to see if these combinations can shrink tumors and are safe. About 262 adults will take part in this early-phase trial.

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 327 people

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

Started

Feb 2025

Expected to finish

Apr 2029

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: * 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

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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

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

    44 sites in 11 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

  • Aichi Cancer Center ( Site 5000)

    RECRUITING

    Nagoya, Aichi-ken, 464-8681, Japan

  • Ankara Bilkent Sehir Hastanesi ( Site 3412)

    RECRUITING

    Ankara, 06800, Turkey (Türkiye)

  • Beijing Cancer Hospital ( Site 5401)

    RECRUITING

    Beijing, Beijing Municipality, 100142, China

  • Bradfordhill ( Site 2101)

    RECRUITING

    Santiago, Region M. de Santiago, 8420383, Chile

  • Cancer Institute Hospital of JFCR ( Site 5002)

    RECRUITING

    Koto, Tokyo, 135-8550, Japan

  • Dana Farber Cancer Institute ( Site 1105)

    RECRUITING

    Boston, Massachusetts, 02215, United States

  • FALP ( Site 2100)

    RECRUITING

    Santiago, Region M. de Santiago, 7500921, Chile

  • Fujian Cancer Hospital ( Site 5413)

    RECRUITING

    Fuzhou, Fujian, 350014, China

  • HOSPITAL CLÍNIC DE BARCELONA ( Site 3310)

    RECRUITING

    Eixample, Barcelona, 08036, Spain

  • Hacettepe Universite Hastaneleri ( Site 3410)

    RECRUITING

    Ankara, 06230, Turkey (Türkiye)

  • Hospital Clinico San Carlos... ( Site 3316)

    RECRUITING

    Madrid, Madrid, Comunidad de, 28040, Spain

  • Hospital Universitari Vall d'Hebron ( Site 3311)

    RECRUITING

    Barcelona, 08035, Spain

  • Hospital Universitario Austral ( Site 2204)

    RECRUITING

    Pilar, Buenos Aires, B1629WWA, Argentina

  • Hospital Universitario Fundación Jiménez Díaz-START Madrid-FJD ( Site 3315)

    RECRUITING

    Madrid, 28040, Spain

  • Hospital Universitario HM Sanchinarro ( Site 3313)

    RECRUITING

    Madrid, 28050, Spain

  • Hospital Universitario Virgen de la Victoria ( Site 3312)

    RECRUITING

    Málaga, 29010, Spain

  • Institut Català d'Oncologia - L'Hospitalet ( Site 3317)

    RECRUITING

    L'Hospitalet de Llobregat, Barcelona, 08907, Spain

  • John Theurer Cancer Center at Hackensack University Medical Center ( Site 1103)

    RECRUITING

    Hackensack, New Jersey, 07601, United States

  • Kansai Medical University Hospital ( Site 5004)

    RECRUITING

    Hirakata, Osaka, 573-1191, Japan

  • Medical College of Wisconsin ( Site 1112)

    RECRUITING

    Milwaukee, Wisconsin, 53226, United States

  • Monash Health ( Site 5301)

    RECRUITING

    Clayton, Victoria, 3168, Australia

  • Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School-Oncology ( Site 5403)

    RECRUITING

    Nanjing, Jiangsu, 210008, China

  • National Cancer Center Hospital East ( Site 5001)

    RECRUITING

    Kashiwa, Chiba, 277-0882, Japan

  • National Cheng Kung University Hospital ( Site 5202)

    RECRUITING

    Tainan, 704, Taiwan

  • National Institute for Health Research UCLH Clinical Research Facility ( Site 3902)

    ACTIVE_NOT_RECRUITING

    London, London, City of, W1T 7HA, United Kingdom

  • Pontificia Universidad Catolica de Chile ( Site 2102)

    RECRUITING

    Santiago, Region M. de Santiago, 8330032, Chile

  • Princess Alexandra Hospital ( Site 5300)

    RECRUITING

    Woolloongabba, Queensland, 4102, Australia

  • Providence Portland Medical Center ( Site 1101)

    RECRUITING

    Portland, Oregon, 97213, United States

  • Rabin Medical Center ( Site 3203)

    RECRUITING

    Petah Tikva, 4941492, Israel

  • Rambam Health Care Campus ( Site 3202)

    ACTIVE_NOT_RECRUITING

    Haifa, 3109601, Israel

  • Roswell Park Cancer Institute ( Site 1107)

    RECRUITING

    Buffalo, New York, 14263, United States

  • Samsung Medical Center ( Site 5101)

    RECRUITING

    Seoul, 06351, South Korea

  • Sanatorio Parque ( Site 2203)

    RECRUITING

    Rosario, Santa Fe Province, S2000DSV, Argentina

  • Sarah Cannon Research Institute ( Site 7001)

    RECRUITING

    Nashville, Tennessee, 37203, United States

  • Seoul National University Hospital ( Site 5100)

    RECRUITING

    Seoul, 03080, South Korea

  • Severance Hospital, Yonsei University Health System ( Site 5102)

    RECRUITING

    Seoul, 03722, South Korea

  • Shaare Zedek Medical Center ( Site 3200)

    RECRUITING

    Jerusalem, 9103102, Israel

  • Shanghai Chest Hospital ( Site 5400)

    RECRUITING

    Shanghai, Shanghai Municipality, 200030, China

  • Shanghai Pulmonary Hospital ( Site 5405)

    RECRUITING

    Shanghai, Shanghai Municipality, 200433, China

  • Sheba Medical Center ( Site 3201)

    RECRUITING

    Ramat Gan, 5265601, Israel

  • Taipei Medical University Hospital ( Site 5201)

    RECRUITING

    Taipei, 11030, Taiwan

  • The Christie NHS Foundation Trust ( Site 3901)

    ACTIVE_NOT_RECRUITING

    Manchester, M20 4BX, United Kingdom

  • The Clatterbridge Cancer Centre ( Site 3903)

    ACTIVE_NOT_RECRUITING

    Liverpool, L7 8YA, United Kingdom

  • The First Affiliated Hospital, Zhejiang University ( Site 5404)

    RECRUITING

    Hangzhou, Zhejiang, 310000, China

  • University of Chicago ( Site 1108)

    RECRUITING

    Chicago, Illinois, 60637, United States

  • University of Colorado Anschutz Medical Campus ( Site 1110)

    RECRUITING

    Aurora, Colorado, 80045, United States

  • University of Miami Hospital and Clinics, Sylvester Cancer Center ( Site 1111)

    RECRUITING

    Miami, Florida, 33136, United States

  • West China Hospital of Sichuan University ( Site 5416)

    RECRUITING

    Chengdu, Sichuan, 610041, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.