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Lung cancer combo aims to wipe out tumors before surgery

NCT ID NCT06788912

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 02, 2026 · Updated 2 times

Summary

This phase 2 trial is testing whether giving the immunotherapy drug pembrolizumab (Keytruda) along with chemotherapy before surgery can eliminate all signs of cancer in people with resectable stage II to IIIB non-small cell lung cancer. About 60 participants will receive the combination for four cycles, then have surgery to remove any remaining tumor. The main goals are to see how many people have no cancer cells left in the removed tissue and how much the tumor shrinks.

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 (cisplatin with either gemcitabine or pemetrexed)
What this could lead to
If successful, this approach could increase the chance of eliminating all visible cancer before surgery, potentially improving long-term outcomes for people with early-stage lung cancer.
What could go wrong
This is a small, early-phase study (60 people) with no control group, so results may not apply broadly. Chemotherapy and immunotherapy can cause serious 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 60 people

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

Started

Mar 2025

Expected to finish

Feb 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.

The main inclusion and exclusion criteria include but are not limited to the following: Inclusion Criteria: * Has previously untreated and pathologically confirmed resectable Stage II, IIIA, or IIIB (N2) non-small cell lung cancer (NSCLC) * Able to undergo protocol therapy, including necessary surgery * Confirmation that epidermal growth factor receptor (EGFR) -directed therapy is not indicated as primary therapy * Has an Eastern Cooperative Oncology Group (ECOG) performance status of either 0 or 1 as assessed within 10 days before initiation of study intervention. * Is able to provide archival or newly obtained core/excisional biopsy of the primary lung tumor or lymph node metastasis. Exclusion Criteria: * Has one of the following tumor locations/types: NSCLC involving the superior sulcus, large-cell neuro-endocrine cancer, mixed tumors containing small cell and non-small cell elements, or sarcomatoid tumor. * Has Grade ≥2 peripheral neuropathy. * Has history of documented severe dry eye syndrome, severe Meibomian gland disease and/or blepharitis, or severe corneal disease that prevents/delays corneal healing. * Has active inflammatory bowel disease requiring immunosuppressive medication or previous history of inflammatory bowel disease (eg, Crohn's disease, ulcerative colitis, or chronic diarrhea). * Has uncontrolled, significant cardiovascular disease or cerebrovascular disease. * Received a live or live-attenuated vaccine within 30 days before the first dose of study intervention * Received prior radiotherapy within 2 weeks of start of study intervention, or radiation related toxicities, requiring corticosteroids. * 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 prior to the first dose of study intervention. * Known additional malignancy that is progressing or has required active treatment within the past 5 years. * Severe hypersensitivity (≥Grade 3) to pembrolizumab and/or any of its excipients. * Active autoimmune disease that has required systemic treatment in the past 2 years. Replacement therapy (e.g. thyroxine, insulin, or physiologic corticosteroid) is allowed. * History of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease. * Active infection requiring systemic therapy. * Hepatitis B (defined as hepatitis B surface antigen \[HBsAg\] reactive) or Hepatitis C virus (defined as detectable hepatitis C virus (HCV) ribonucleic acid (RNA) \[qualitative\]) infection. * Known history of human immunodeficiency virus (HIV) infection. * History of allogeneic tissue/solid organ transplant.

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Conditions

The condition(s) this trial relates to.

autosomal dominant Parkinson disease 4 lung cancer lung neoplasm non-small cell lung carcinoma

As listed by the trial registrant

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

Lung neoplasm malignant

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

    39 sites in 9 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

  • ATTIKON GENERAL UNIVERSITY HOSPITAL-Oncology ( Site 0202)

    RECRUITING

    Athens, Attica, 12462, Greece

  • Akdeniz Universitesi Hastanesi-Medical Oncology ( Site 0704)

    RECRUITING

    Antalya, 07059, Turkey (Türkiye)

  • Alexandra General Hospital of Athens Oncology-Hematology Unit ( Site 0203)

    RECRUITING

    Athens, Attica, 115 28, Greece

  • Azienda Ospedaliera Universitaria Careggi ( Site 0173)

    RECRUITING

    Florence, Tuscany, 50134, Italy

  • Baskent University Dr. Turgut Noyan Research and Training Center-ONCOLOGY ( Site 0702)

    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)

    RECRUITING

    Cherkasy, Cherkasy Oblast, 18009, Ukraine

  • Centro de Estudios Clínicos SAGA ( Site 0162)

    RECRUITING

    Santiago, Region M. de Santiago, 7500653, Chile

  • Communal Noncommercial Enterprise "Podillia Regional Oncology Center Of Vinnytsia Regional Council" ( Site 0135)

    RECRUITING

    Vinnytsia, Vinnytsia Oblast, 21029, Ukraine

  • FALP ( Site 0161)

    RECRUITING

    Santiago, Region M. de Santiago, 7500921, Chile

  • Fondazione IRCCS Istituto Nazionale dei Tumori ( Site 0175)

    RECRUITING

    Milan, 20133, Italy

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

    RECRUITING

    Roma, 00168, Italy

  • Greenebaum Comprehensive Cancer Center ( Site 0402)

    RECRUITING

    Baltimore, Maryland, 21201, United States

  • Hacettepe Universite Hastaneleri-oncology hospital ( Site 0700)

    RECRUITING

    Ankara, 06230, Turkey (Türkiye)

  • Hospital Clinic de Barcelona ( Site 0092)

    RECRUITING

    Barcelona, 08008, Spain

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

    RECRUITING

    Szolnok, Jász-Nagykun-Szolnok, 5000, Hungary

  • ME RIVNE REGIONAL ANTITUMOR CENTER ( Site 0460)

    RECRUITING

    Rivne, Rivne Oblast, 33010, Ukraine

  • MNPE LTMU Multidisc. Clin. Hosp. of Emerg. and Intens. Care ( Site 0132)

    RECRUITING

    Lviv, Lviv Oblast, 79059, Ukraine

  • MedStar Franklin Square Medical Center ( Site 0033)

    RECRUITING

    Baltimore, Maryland, 21237, United States

  • Metropolitan Hospital-4th Oncology Dept ( Site 0201)

    RECRUITING

    Athens, Attica, 185 47, Greece

  • Municipal Enterprise "Bukovinian сlinical oncology сenter" ( Site 0139)

    RECRUITING

    Chernivtsi, Chernivetska Oblast, 58013, Ukraine

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

    RECRUITING

    Warsaw, Masovian Voivodeship, 02-781, Poland

  • Oncology Associates of Oregon, P.C.(Willamette Valley Cancer Institute) (WVCI) ( Site 8006)

    RECRUITING

    Eugene, Oregon, 97401, United States

  • Ondokuz Mayıs Universitesi-Oncology department ( Site 0706)

    RECRUITING

    Samsun, 55139, Turkey (Türkiye)

  • Országos Korányi Pulmonológiai Intézet ( Site 0060)

    RECRUITING

    Budapest, 1121, Hungary

  • Ospedale San Raffaele. ( Site 0171)

    RECRUITING

    Milan, 20132, Italy

  • Petz Aladar Egyetemi Oktato Korhaz-Pulmonológia (Dr. Szalai Zsuzsanna) ( Site 0062)

    RECRUITING

    Győr, Győr-Moson-Sopron, 9024, Hungary

  • Rocky Mountain Cancer Centers (RMCC) ( Site 8011)

    RECRUITING

    Lone Tree, Colorado, 80124, United States

  • Sansum Clinic (Ridley Tree) ( Site 8012)

    RECRUITING

    Santa Barbara, California, 93105, United States

  • Shalimov Institute of Surgery and Transplantation ( Site 0138)

    RECRUITING

    Kyiv, 03126, Ukraine

  • Southern Cancer Center (SCC) ( Site 8004)

    RECRUITING

    Daphne, Alabama, 36526, United States

  • Texas Oncology - Central/South Texas ( Site 8009)

    RECRUITING

    Austin, Texas, 78705, United States

  • Texas Oncology - Northeast Texas ( Site 8005)

    RECRUITING

    Tyler, Texas, 75702, United States

  • University General Hospital of Heraklion ( Site 0200)

    RECRUITING

    Heraklion, Irakleio, 71110, Greece

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

    RECRUITING

    Gdansk, Pomeranian Voivodeship, 80-952, Poland

  • Virginia Cancer Specialists (VCS) ( Site 8002)

    RECRUITING

    Fairfax, Virginia, 22031, United States

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

    RECRUITING

    Poznan, Greater Poland Voivodeship, 60-569, Poland

  • İzmir Suat Seren Chest Disease Training & Research Hospital ( Site 0701)

    RECRUITING

    Izmir, 35110, Turkey (Türkiye)

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