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Smart drug missiles take aim at Hard-to-Treat lung cancer

NCT ID NCT06780085

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 26, 2026 · Updated 4 times

Summary

This Phase 2 study tests two new antibody-drug conjugates (R-DXd and I-DXd) against standard chemotherapy in 96 people with advanced nonsquamous non-small cell lung cancer that has worsened after prior immunotherapy and chemotherapy. These 'guided missiles' deliver a cancer-killing drug directly to tumor cells. Researchers will compare how well the tumors shrink and monitor side effects.

What this could mean

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

Active substance
Raludotatug Deruxtecan (R-DXd) and Ifinatamab Deruxtecan (I-DXd)
What this could lead to
If successful, these antibody-drug conjugates could offer a new treatment option for people with advanced nonsquamous lung cancer that has stopped responding to standard therapies.
What could go wrong
This is a Phase 2 trial with only 96 participants, so results are preliminary. The drugs may cause side effects and may not work better than chemotherapy.

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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 96 people

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

Started

May 2025

Expected to finish

Mar 2032

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: * Histologically or cytologically confirmed diagnosis of Stage IV nonsquamous non-small cell lung cancer (NSCLC) * Documented disease progression per RECIST 1.1 after receiving an anti-programmed cell death 1 protein (PD-1)/programmed cell death ligand 1 (PD-L1) treatment and platinum-based chemotherapy * Confirmation per local test report that epidermal growth factor receptor negative (EGFR-), anaplastic lymphoma kinase negative (ALK-), c ros oncogene 1 negative (ROS1-), or other directed therapy is not indicated as primary therapy * Measurable disease per RECIST 1.1 as assessed by investigator and verified by BICR * Life expectancy of at least 3 months * An Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 assessed within 7 days before randomization * Is an individual of any sex/gender who is at least 18 years of age at the time of providing the informed consent * Has adequate organ function * If capable of producing sperm refrains from donating sperm plus either abstains from penile-vaginal intercourse or uses a penile/external condom, with contraceptive use consistent with local regulations * Participant/participants of childbearing potential (POCBP) is not pregnant and has a negative highly sensitive pregnancy test; and is not breastfeeding and uses a highly effective contraceptive method * Archival tumor tissue sample of a tumor lesion not previously irradiated has been provided * Has provided tissue prior to treatment randomization from a newly obtained formalin-fixed sample from a new biopsy * Human Immunodeficiency Virus (HIV)-infected participants must have well controlled HIV on antiretroviral therapy (ART) * Participants who are hepatitis B surface antigen (HBsAg) positive have received hepatitis B virus (HBV) antiviral therapy for at least 4 weeks and have undetectable HBV viral load prior to randomization * Participants with history of hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable at screening Exclusion Criteria: The main exclusion criteria include but are not limited to the following: * Diagnosis of small cell lung cancer or, for mixed tumors, presence of small cell elements * Received radiation therapy to the lung * Has uncontrolled or significant cardiovascular disorder prior to randomization * Has clinically severe pulmonary compromise resulting from intercurrent pulmonary illnesses * Participants who have adverse events (AEs) (other than alopecia) due to previous anticancer therapies must have recovered to ≤Grade 1 or baseline * Has known severe hypersensitivity (≥Grade 3) to study intervention and/or any of its excipients * Has clinically significant corneal disease * Has received prior radiotherapy within 2 weeks of start of study intervention, or radiation related toxicities, requiring corticosteroids * Has inadequate washout period prior to randomization * Has received a live or live-attenuated vaccine within 30 days before the first dose of study intervention * Has diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy * Has previously received docetaxel as monotherapy or in combination with other therapies * Has received an investigational agent or has used an investigational device within 4 weeks prior to study intervention administration * Has known additional malignancy that is progressing or has required active treatment within the past 3 years * Has known untreated central nervous system (CNS) metastases and/or carcinomatous meningitis * Has evidence of any leptomeningeal disease * Has history of interstitial lung disease (ILD)/pneumonitis, current diagnosis of ILD, and/or suspected ILD * Has active autoimmune disease that has required systemic treatment in the past 2 years * Has active infection requiring systemic therapy * HIV-infected participants with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease * Has active inflammatory bowel disease requiring immunosuppressive medication or previous clear history of inflammatory bowel disease * Has known history of, or active, neurologic paraneoplastic syndrome * Has history of allogeneic tissue/solid organ transplant * Have not adequately recovered from major surgery or have ongoing surgical complications

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Conditions

The condition(s) this trial relates to.

autosomal dominant Parkinson disease 4 non-small cell lung carcinoma

As listed by the trial registrant

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

Carcinoma, non-small-cell lung

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

    33 sites in 10 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

  • AHN Cancer Institute - Allegheny General ( Site 9501)

    RECRUITING

    Pittsburgh, Pennsylvania, 15212, United States

  • Ankara Bilkent Şehir Hastanesi. ( Site 0142)

    RECRUITING

    Ankara, 06800, Turkey (Türkiye)

  • Azienda Ospedaliera Universitaria Careggi ( Site 0173)

    RECRUITING

    Florence, 50134, Italy

  • Bacs-Kiskun Varmegyei Oktatokorhaz ( Site 0063)

    RECRUITING

    Kecskemét, Bács-Kiskun county, 6000, Hungary

  • Baskent University Dr. Turgut Noyan Research and Training Center-ONCOLOGY ( Site 0141)

    RECRUITING

    Adana, 01250, Turkey (Türkiye)

  • Bradfordhill ( Site 0162)

    RECRUITING

    Santiago, Region M. de Santiago, 8420383, Chile

  • Centro de Estudios Clínicos SAGA ( Site 0161)

    RECRUITING

    Santiago, Region M. de Santiago, 7500653, Chile

  • Charite-Universitaetsmedizin Berlin ( Site 0191)

    RECRUITING

    Berlin, 13353, Germany

  • Ege Universitesi Hastanesi ( Site 0143)

    RECRUITING

    Izmir, 35100, Turkey (Türkiye)

  • European Interbalkan Medical Center ( Site 0205)

    RECRUITING

    Thessaloniki, 570 01, Greece

  • FALP ( Site 0160)

    RECRUITING

    Santiago, Region M. de Santiago, 7500921, Chile

  • Fondazione IRCCS Istituto Nazionale dei Tumori ( Site 0175)

    RECRUITING

    Milan, Lombardy, 20133, Italy

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Università Cattolica del Sacro Cuore ( Site 0174)

    RECRUITING

    Roma, 00168, Italy

  • Hacettepe Universitesi Tip Fakultesi Hastanesi ( Site 0140)

    RECRUITING

    Ankara, 06230, Turkey (Türkiye)

  • Hospital Universitario Quiron Madrid ( Site 0091)

    RECRUITING

    Madrid, 28223, Spain

  • I. U. Cerrahpasa Tip Fakultesi ( Site 0144)

    RECRUITING

    Istanbul, 34098, Turkey (Türkiye)

  • Institut Català d'Oncologia - L'Hospitalet ( Site 0090)

    RECRUITING

    L'Hospitalet de Llobregat, Barcelona, 08908, Spain

  • Jasz-Nagykun-Szolnok Varmegyei Hetenyi Geza Korhaz-Rendelointezet ( Site 0061)

    RECRUITING

    Szolnok, Jász-Nagykun-Szolnok, 5000, Hungary

  • MedStar Franklin Square Medical Center ( Site 0033)

    RECRUITING

    Baltimore, Maryland, 21237, United States

  • Meir Medical Center ( Site 0071)

    RECRUITING

    Kfar Saba, 4428164, Israel

  • Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy w Warszawie ( Site 0151)

    RECRUITING

    Warsaw, Masovian Voivodeship, 02-781, Poland

  • Ospedale San Raffaele. ( Site 0171)

    RECRUITING

    Milan, 20132, Italy

  • Petz Aladar Egyetemi Oktato Korhaz ( Site 0062)

    RECRUITING

    Győr, Győr-Moson-Sopron, 9024, Hungary

  • Rabin Medical Center ( Site 0074)

    RECRUITING

    Petah Tikva, 4941492, Israel

  • Rambam Health Care Campus ( Site 0076)

    RECRUITING

    Haifa, 3109601, Israel

  • Shaare Zedek Medical Center ( Site 0075)

    RECRUITING

    Jerusalem, 9103102, Israel

  • Sheba Medical Center ( Site 0070)

    RECRUITING

    Ramat Gan, 5265601, Israel

  • Sourasky Medical Center ( Site 0077)

    RECRUITING

    Tel Aviv, 6423906, Israel

  • Szpital Wojewódzki im. Mikoaja Kopernika w Koszalinie ( Site 0152)

    ACTIVE_NOT_RECRUITING

    Koszalin, West Pomeranian Voivodeship, 75-581, Poland

  • THORACIC GENERAL HOSPITAL OF ATHENS "I SOTIRIA"-3rd Dept of Internal Medicine and Laboratory, Oncol ( Site 0204)

    RECRUITING

    Athens, Attica, 115 27, Greece

  • Universitaetsklinik Tuebingen ( Site 0192)

    RECRUITING

    Tübingen, Baden-Wurttemberg, 72076, Germany

  • University of Kentucky Chandler Medical Center ( Site 0019)

    RECRUITING

    Lexington, Kentucky, 40536-0293, United States

  • Uniwersyteckie Centrum Kliniczne-Early Clinical Trials Unit ( Site 0150)

    RECRUITING

    Gdansk, Pomeranian Voivodeship, 80-214, Poland

  • Wielkopolskie Centrum Pulmonologii i Torakochirurgii ( Site 0153)

    RECRUITING

    Poznan, Greater Poland Voivodeship, 60-569, Poland

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