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New combo therapy shows promise for advanced lung cancer patients

NCT ID NCT04165083

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 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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026

Summary

This study tested a combination of the immunotherapy drug pembrolizumab with two investigational drugs (MK-4830 or MK-0482) in 102 people with advanced non-small cell lung cancer that had not been treated before and tested positive for a protein called PD-L1. The main goal was to see how many patients' tumors shrank or disappeared. The study is complete and results help guide future treatment options.

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

102 people

The number who actually took part.

Started

Dec 2019

Finished

Oct 2025

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: * Has a histologically- or cytologically-confirmed diagnosis of Stage IV squamous or non-squamous NSCLC * Has non-squamous NSCLC and is not eligible for an approved targeted therapy * Is able to provide archival tumor tissue sample collected either within 5 years or within the interval from completion of last treatment but before entering the screening period or newly obtained core or excisional biopsy of a tumor lesion not previously irradiated obtained within 90 days of treatment initiation * Has not received prior systemic treatment for metastatic NSCLC * Has programmed cell death ligand 1 (PD-L1) tumor proportion score (TPS) ≥1% * Is able to complete all screening procedures within the 35-day screening window. * Male participants must agree to use contraception and refrain from donating sperm during the treatment period and for at least 120 days after the last dose of study treatment * Female participants must not be pregnant or breastfeeding, and at least one of the following conditions apply: 1. Not a woman of childbearing potential (WOCBP) OR 2. A WOCBP who agrees to use contraception during the treatment period and for at least 120 days after the last dose of study treatment * Has adequate organ function within 10 days of initiation of study treatment Exclusion Criteria: * Has a diagnosis of small cell lung cancer * Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days before the first dose of study treatment * Has a known additional malignancy that is progressing or has required active treatment within the past 2 years * Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis * Has an active autoimmune disease that has required systemic treatment in the past 2 years * Has a history of (noninfectious) pneumonitis that required steroids or has current pneumonitis * Has an active infection requiring systemic therapy * Has clinically significant cardiac disease, including unstable angina, acute myocardial infarction within 6 months from Day 1 of study treatment, or New York Heart Association Class III or IV congestive heart failure * Has a known history of Human Immunodeficiency Virus (HIV) infection * Has a known history of Hepatitis B or known active Hepatitis C virus infection * Has known psychiatric or substance abuse disorders that would interfere with cooperating with the requirements of the study * Has had major surgery \<3 weeks before the first dose of study treatment * Has received prior radiation therapy to the lung that is \>30 Gray (Gy) within 6 months of the first dose of study treatment * Has received any prior immunotherapy and was discontinued from that treatment due to a severe or worse immune-related adverse event (irAE) * Has had chemotherapy or biological cancer therapy within 4 weeks before the first dose of study treatment or has not recovered to Common Terminology Criteria for Adverse Events (CTCAE) Grade 1 or better from the AEs due to cancer therapeutics administered more than 4 weeks before the first dose of study treatment (including participants who had previous immunomodulatory therapy with residual irAEs) * Has received a live vaccine within 30 days before the first dose of study treatment. Any licensed COVID-19 vaccine (including for Emergency Use) in a particular country is allowed as long as they are messenger ribonucleic acid (mRNA) vaccines, adenoviral vaccines, or inactivated vaccines. Investigational vaccines (ie, those not licensed or approved for Emergency Use) are not allowed * Has received prior systemic cytotoxic chemotherapy or other targeted or biological antineoplastic therapy for metastatic disease. * Has received prior therapy with an anti-programmed cell death receptor 1 (PD-1), anti-programmed cell death receptor ligand 1 (PD-L1), or anti-programmed cell death receptor ligand 2 (PD-L2) agent or prior therapy targeting other immuno-regulatory receptors or mechanisms * Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks before the first dose of study treatment * Has had a severe hypersensitivity reaction to treatment with monoclonal antibodies (including pembrolizumab) and/or any of their excipients * Is pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the study, starting with the screening visit through 120 days after the last dose of study treatment * Has had an allogenic tissue/solid organ transplant

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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

Contacts and locations

Locations

  • Abramson Cancer Center of the University of Pennsylvania ( Site 0010)

    Philadelphia, Pennsylvania, 19104, United States

  • Azienda Ospedaliera Universitaria Careggi ( Site 0173)

    Florence, Firenze, 50134, Italy

  • Banner MD Anderson Cancer Center ( Site 0001)

    Gilbert, Arizona, 85234, United States

  • Chaim Sheba Medical Center ( Site 0070)

    Ramat Gan, 5262000, Israel

  • City of Hope ( Site 0014)

    Duarte, California, 91010, United States

  • Cleveland Clinic Main ( Site 0006)

    Cleveland, Ohio, 44195, United States

  • Dana Farber Cancer Institute ( Site 0002)

    Boston, Massachusetts, 02215, United States

  • Dartmouth Hitchcock Medical Center ( Site 0016)

    Lebanon, New Hampshire, 03766, United States

  • Georgetown University ( Site 0036)

    Washington D.C., District of Columbia, 20007, United States

  • Hospital Universitario Quiron Madrid ( Site 0091)

    Madrid, 28223, Spain

  • ICO L Hospitalet ( Site 0090)

    L'Hospitalet de Llobregat, Barcelona, 08907, Spain

  • IRCCS Ospedale San Raffaele ( Site 0171)

    Milan, 20132, Italy

  • John Theurer Cancer Center at Hackensack University Medical Center ( Site 0037)

    Hackensack, New Jersey, 07601, United States

  • Jász-Nagykun-Szolnok Vármegyei Hetényi Géza Kórház ( Site 0061)

    Szolnok, Jász-Nagykun-Szolnok, 5004, Hungary

  • Laura and Isaac Perlmutter Cancer Center at NYU Langone Health ( Site 0034)

    New York, New York, 10016, United States

  • Massachusetts General Hospital ( Site 0003)

    Boston, Massachusetts, 02114, United States

  • MedStar Franklin Square Medical Center ( Site 0033)

    Baltimore, Maryland, 21237, United States

  • Meir Medical Center ( Site 0071)

    Kfar Saba, 4428132, Israel

  • Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Klinika Nowotworow Pluca i Klatki Pier ( Site 0151)

    Warsaw, Masovian Voivodeship, 02-781, Poland

  • Ohio State University Comprehensive Cancer Center ( Site 0015)

    Columbus, Ohio, 43210, United States

  • Oncology Hematology West, PC DBA Nebraska Cancer Specialists ( Site 0031)

    Omaha, Nebraska, 68130, United States

  • Orszagos Koranyi Pulmonologiai Intezet ( Site 0060)

    Budapest, 1121, Hungary

  • Petz Aladar Megyei Oktato Korhaz ( Site 0062)

    Győr, Győr-Moson-Sopron, 9024, Hungary

  • Policlinico Gemelli di Roma ( Site 0174)

    Roma, 00168, Italy

  • Rabin Medical Center ( Site 0074)

    Petah Tikva, 4941492, Israel

  • Rambam Health Care Campus-Oncology ( Site 0076)

    Haifa, 3109601, Israel

  • Samsung Medical Center ( Site 0082)

    Seoul, 06351, South Korea

  • Sanford Cancer Center ( Site 0038)

    Sioux Falls, South Dakota, 57104, United States

  • Sanford Fargo Medical Center ( Site 0039)

    Fargo, North Dakota, 58102, United States

  • Seoul National University Bundang Hospital ( Site 0081)

    Seongnam-si, Kyonggi-do, 13620, South Korea

  • Severance Hospital ( Site 0080)

    Seoul, 03722, South Korea

  • Shaare Zedek Medical Center ( Site 0075)

    Jerusalem, 9103102, Israel

  • Soroka Medical Center ( Site 0072)

    Beersheba, 8457108, Israel

  • Sourasky Medical Center ( Site 0077)

    Tel Aviv, 6423906, Israel

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

    Koszalin, West Pomeranian Voivodeship, 75-581, Poland

  • The University of Texas MD Anderson Cancer Center ( Site 0009)

    Houston, Texas, 77030, United States

  • UCSF Medical Center at Mission Bay ( Site 0007)

    San Francisco, California, 94158, United States

  • University of Kentucky Markey Cancer Center ( Site 0019)

    Lexington, Kentucky, 40536-0293, United States

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

    Gdansk, Pomeranian Voivodeship, 80-952, Poland

More trials for these conditions

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