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New hope for lung cancer: drug cocktail trial launches

NCT ID NCT06731907

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 19, 2026 · Updated 3 times

Summary

This phase 2 trial is testing whether adding a targeted drug called HER3-DXd to standard immunotherapy (pembrolizumab) and chemotherapy can help people with advanced non-small cell lung cancer that hasn't been treated yet. About 90 participants will receive different combinations to see which works best and is safest. The goal is to improve tumor shrinkage and control the disease longer.

What this could mean

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

Active substance
pembrolizumab (Keytruda) plus chemotherapy and/or HER3-DXd (patritumab deruxtecan)
What this could lead to
If successful, this could lead to a more effective first-line treatment for advanced non-small cell lung cancer, potentially improving response rates and survival.
What could go wrong
This is an early phase 2 study with only 90 participants, so results may not apply to all patients. Adding new drugs also raises the risk of side effects.

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 90 people

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

Started

Mar 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 squamous or non-squamous non-small cell lung cancer (NSCLC) per American Joint Committee on Cancer (AJCC) Staging Manual Version 8. * Has an Eastern Cooperative Oncology Group (ECOG) performance status of either 0 or 1 as assessed within 7 days before randomization. * Has archival tumor tissue sample or newly obtained core, incisional, or excisional biopsy of a tumor lesion not previously irradiated has been provided. * Human immunodeficiency virus (HIV)-infected participants must have well controlled HIV on ART. * Participants who are hepatitis B surface antigen (HBsAg) positive are eligible if they have received hepatitis B virus (HBV) antiviral therapy for at least 4 weeks and have undetectable HBV viral load prior to treatment randomization. Exclusion Criteria: The main exclusion criteria include but are not limited to the following: * Has a diagnosis of small cell lung cancer or, for mixed tumors, presence of small cell elements. * Participants with squamous histology are excluded if there is a known tumor-activating epidermal growth factor receptor (EGFR) mutation or anaplastic lymphoma kinase (ALK) or c ros oncogene 1 (ROS1) gene rearrangement. * Is HIV-infected with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease * Clinically severe pulmonary compromise resulting from intercurrent pulmonary illnesses including, but not limited to, any underlying pulmonary disorder, or any autoimmune, connective tissue, or inflammatory disorders with pulmonary involvement. * Has evidence of any leptomeningeal disease. * Has known history of, or active, neurologic paraneoplastic syndrome. * Has clinically significant corneal disease. * Has myocardial infarction within 6 months. * Has New York Heart Association (NYHA) Classes 3 or 4 congestive heart failure. * Has uncontrolled angina pectoris within 6 months. * Has cardiac arrhythmia requiring ongoing antiarrhythmic treatment. * Has history of clinically relevant ventricular arrhythmias, such as ventricular tachycardia, ventricular fibrillation, or Torsade de Pointes. * Has bradycardia of less than 50 beats per minute (bpm) unless the participant has a pacemaker. * Has history of second- or third-degree heart block. Candidates with a history of heart block may be eligible if they currently have pacemakers and have no history of fainting or clinically relevant arrhythmia with pacemakers. * Has coronary/peripheral artery bypass graft within 6 months. * Has complete left bundle branch block. * Has inadequate washout period from prior concomitant therapy as specified in protocol before randomization. * Has received prior treatment with a topoisomerase I inhibitor or an anti-HER3 antibody and/or ADC that consists of an exatecan derivative that is a topoisomerase I inhibitor. * Has received prior systemic anticancer therapy for their metastatic NSCLC. * Has received prior therapy with an anti- programmed cell death 1 protein (anti-PD-1), anti- programmed cell death ligand 1 protein (anti-PD-L1), or anti- programmed cell death ligand 2 protein (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 randomization, has radiation related toxicity requiring corticosteroids, or has had radiation pneumonitis. * Has received radiation therapy to the lung that is \>30 gray within 6 months of start of study intervention. * 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 or any other form of immunosuppressive therapy within 7 days prior to the first dose of study intervention. * Has known additional malignancy that is progressing or has required active treatment within the past 3 years. * Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis. * Has severe hypersensitivity to any of the study interventions and/or any of their excipients. * Has active autoimmune disease that has required systemic treatment in the past 2 years. * Has active infection requiring systemic therapy. * Has concurrent active Hepatitis B and Hepatitis C virus infection. * Have not adequately recovered from major surgery or have ongoing surgical complications.

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Conditions

The condition(s) this trial relates to.

lung neoplasm non-small cell lung carcinoma

As listed by the trial registrant

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

Non-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

    38 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

  • Abramson Cancer Center ( Site 0010)

    RECRUITING

    Philadelphia, Pennsylvania, 19104, United States

  • Ankara Bilkent Şehir Hastanesi ( Site 0142)

    RECRUITING

    Ankara, 06530, Turkey (Türkiye)

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

    ACTIVE_NOT_RECRUITING

    Adana, 01250, Turkey (Türkiye)

  • Bradfordhill ( Site 0160)

    RECRUITING

    Santiago, Region M. de Santiago, 8420383, Chile

  • CNCE Precarpathian Clinical Oncologic Center ( Site 0131)

    RECRUITING

    Ivano-Frankivsk, Ivano-Frankivsk Oblast, 76018, Ukraine

  • CNE CC of Oncology Hematol ( Site 0130)

    ACTIVE_NOT_RECRUITING

    Cherkasy, Cherkasy Oblast, 18009, Ukraine

  • Centro de Estudios Clínicos SAGA ( Site 0162)

    RECRUITING

    Santiago, Region M. de Santiago, 7500653, Chile

  • Chang Gung Medical Foundation-Linkou Branch ( Site 0182)

    RECRUITING

    Taoyuan, 33305, Taiwan

  • Changhua Christian Hospital ( Site 0181)

    RECRUITING

    Changhua, 50006, Taiwan

  • Communal Noncommercial Enterprise "Podillia Regional Oncology Center Of Vinnytsia Regional Council" ( Site 0133)

    RECRUITING

    Vinnytsia, Vinnytsia Oblast, 21029, Ukraine

  • European Interbalkan Medical Center-Oncology Department ( Site 0205)

    RECRUITING

    Thessaloniki, 570 01, Greece

  • FALP ( Site 0161)

    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

  • HOSPITAL CLÍNIC DE BARCELONA ( Site 0092)

    RECRUITING

    Barcelona, 08008, Spain

  • Hacettepe Universite Hastaneleri ( Site 0140)

    RECRUITING

    Ankara, 06410, Turkey (Türkiye)

  • Hospital Universitario Quiron Madrid ( Site 0091)

    RECRUITING

    Madrid, 28223, Spain

  • IRCCS Ospedale San Raffaele ( Site 0171)

    RECRUITING

    Milan, 20132, Italy

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

    RECRUITING

    L'Hospitalet de Llobregat, Barcelona, 08908, Spain

  • Jasz-Nagykun-Szolnok Megyei Hetenyi Gyula 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

  • Municipal Enterprise "Bukovinian сlinical oncology сenter" ( Site 0136)

    RECRUITING

    Chernivtsi, Chernivetska Oblast, 58013, Ukraine

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

    RECRUITING

    Warsaw, Masovian Voivodeship, 02-781, Poland

  • Országos Korányi Pulmonológiai Intézet ( Site 0060)

    RECRUITING

    Budapest, 1121, Hungary

  • 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

  • Sanford Cancer Center ( Site 0038)

    RECRUITING

    Sioux Falls, South Dakota, 57104, United States

  • Sanford Fargo Medical Center ( Site 0039)

    RECRUITING

    Fargo, North Dakota, 58102, United States

  • Shaare Zedek Medical Center ( Site 0075)

    RECRUITING

    Jerusalem, 9103102, Israel

  • Shalimov Institute of Surgery and Transplantation ( Site 0135)

    RECRUITING

    Kyiv, 03126, Ukraine

  • Sheba Medical Center ( Site 0070)

    RECRUITING

    Ramat Gan, 5262000, Israel

  • Sourasky Medical Center ( Site 0077)

    RECRUITING

    Tel Aviv, 6423906, Israel

  • Szpital Wojewódzki im. Mikoaja Kopernika w Koszalinie-Oddzial Dzienny Chemioterapii ( Site 0152)

    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

  • Taipei Medical University Hospital ( Site 0180)

    RECRUITING

    Taipei, 110, Taiwan

  • University of Kentucky ( Site 0019)

    RECRUITING

    Lexington, Kentucky, 40536, United States

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

    RECRUITING

    Gdansk, Pomeranian Voivodeship, 80-214, Poland

  • VISION PARTNER Medical Centre ( Site 0134)

    ACTIVE_NOT_RECRUITING

    Kyiv, Kyivska Oblast, 03022, Ukraine

  • Wielkopolskie Centrum Pulmonologii i Torakochirurgii-Oddzial Onkologii Klinicznej z Pododdzialem Dz ( Site 0153)

    RECRUITING

    Poznan, Greater Poland Voivodeship, 60-569, Poland

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