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New hope for lung cancer: drug cocktail trial launches

NCT ID NCT04165070

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 6 times

Summary

This study tests several new drug combinations, including pembrolizumab (an immunotherapy), with or without chemotherapy, in people with advanced non-small cell lung cancer who have not had prior treatment. The goal is to see if these combinations can shrink tumors and control the disease. About 450 participants will be enrolled, and the study is currently recruiting.

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 450 people

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

Started

Dec 2019

Expected to finish

Oct 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: * Has histologically- or cytologically-confirmed diagnosis of Stage IV squamous or nonsquamous NSCLC * Participants with nonsquamous NSCLC who are 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 their metastatic NSCLC * Is able to complete all screening procedures within the 35-day screening window for Part A and 28-day screening window for Part B Exclusion Criteria: The main exclusion criteria include but are not limited to the following: * 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 administration, or New York Heart Association Class III or IV congestive heart failure * Has a known history of human immunodeficiency virus (HIV) infection. Well-controlled HIV with anti-retroviral therapy (ART) is not excluded * Has a known history of Hepatitis B (HPV) or known active Hepatitis C virus infection. Hepatitis B surface antigen (HBsAg) positive is eligible if on HBV antiviral therapy for at least 4 weeks and HBV viral load is undetectable prior to randomization * Has had major surgery \<3 weeks before the first dose of study treatment * Is expected to require any other form of antineoplastic therapy while on study * Has a history or current evidence of a gastrointestinal (GI) condition (e.g. inflammatory bowel disease, Crohn's disease, ulcerative colitis) or impaired liver function or diseases that in the opinion of the investigator may significantly alter the absorption or metabolism of oral medications * Is getting chemotherapy and has clinically active diverticulitis, intra-abdominal abscess, GI obstruction, or peritoneal carcinomatosis * Has preexisting neuropathy that is moderate in intensity * Has received prior systemic cytotoxic chemotherapy or other targeted or biological antineoplastic therapy for metastatic disease * Is unable or unwilling to take folic acid or vitamin B12 supplementation, for participants who will receive pemetrexed * Has a known sensitivity to any component of carboplatin, paclitaxel, pemetrexed or any of their excipients * 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 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 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) * 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 * Previously had a severe hypersensitivity reaction to treatment with monoclonal antibodies (including pembrolizumab) and/or any of their excipients * 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

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

    15 sites in 4 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 of the University of Pennsylvania ( Site 0010)

    RECRUITING

    Philadelphia, Pennsylvania, 19104, United States

  • Azienda Ospedaliera Universitaria Careggi ( Site 0173)

    COMPLETED

    Florence, Firenze, 50134, Italy

  • Banner MD Anderson Cancer Center ( Site 0001)

    COMPLETED

    Gilbert, Arizona, 85234, United States

  • COMMUNAL NONPROFIT ENTERPRISE CLINICAL CENTER OF ONCOLOGY, HEMATOLOGY, TRANSPLANTOLOGY AND PALLIATI ( Site 0463)

    RECRUITING

    Cherkasy, Cherkasy Oblast, 18009, Ukraine

  • Chaim Sheba Medical Center ( Site 0070)

    RECRUITING

    Ramat Gan, 5262000, Israel

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

    RECRUITING

    Taoyuan, 33305, Taiwan

  • Changhua Christian Hospital ( Site 0181)

    RECRUITING

    Changhua, 50006, Taiwan

  • City of Hope ( Site 0014)

    COMPLETED

    Duarte, California, 91010, United States

  • Cleveland Clinic Main ( Site 0006)

    COMPLETED

    Cleveland, Ohio, 44195, United States

  • Communal Non-Commercial Enterprise "Prykarpatski Clinical On-Surgery department #2 ( Site 0460)

    RECRUITING

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

  • Dana Farber Cancer Institute ( Site 0002)

    COMPLETED

    Boston, Massachusetts, 02215, United States

  • Dartmouth Hitchcock Medical Center ( Site 0016)

    RECRUITING

    Lebanon, New Hampshire, 03766, United States

  • Georgetown University ( Site 0036)

    COMPLETED

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

  • Hospital Universitario Quiron Madrid ( Site 0091)

    COMPLETED

    Madrid, 28223, Spain

  • ICO L Hospitalet ( Site 0090)

    COMPLETED

    L'Hospitalet de Llobregat, Barcelona, 08907, Spain

  • IRCCS Ospedale San Raffaele ( Site 0171)

    COMPLETED

    Milan, 20132, Italy

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

    COMPLETED

    Hackensack, New Jersey, 07601, United States

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

    COMPLETED

    Szolnok, Jász-Nagykun-Szolnok, 5004, Hungary

  • Laura and Isaac Perlmutter Cancer Center ( Site 0034)

    COMPLETED

    New York, New York, 10016, United States

  • ME RIVNE REGIONAL ANTITUMOR CENTER ( Site 0461)

    RECRUITING

    Rivne, Rivne Oblast, 33010, Ukraine

  • Massachusetts General Hospital ( Site 0003)

    COMPLETED

    Boston, Massachusetts, 02114, United States

  • MedStar Franklin Square Medical Center ( Site 0033)

    COMPLETED

    Baltimore, Maryland, 21237, United States

  • Meir Medical Center ( Site 0071)

    COMPLETED

    Kfar Saba, 4428132, Israel

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

    COMPLETED

    Warsaw, Masovian Voivodeship, 02-781, Poland

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

    COMPLETED

    Omaha, Nebraska, 68130, United States

  • Orszagos Koranyi Pulmonologiai Intezet ( Site 0060)

    COMPLETED

    Budapest, 1121, Hungary

  • Petz Aladar Megyei Oktato Korhaz ( Site 0062)

    COMPLETED

    Győr, Győr-Moson-Sopron, 9024, Hungary

  • Policlinico Gemelli di Roma ( Site 0174)

    COMPLETED

    Roma, 00168, Italy

  • Rabin Medical Center ( Site 0074)

    COMPLETED

    Petah Tikva, 4941492, Israel

  • Rambam Health Care Campus-Oncology ( Site 0076)

    COMPLETED

    Haifa, 3109601, Israel

  • Samsung Medical Center ( Site 0082)

    COMPLETED

    Seoul, 06351, South Korea

  • 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

  • Seoul National University Bundang Hospital ( Site 0081)

    COMPLETED

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

  • Severance Hospital ( Site 0080)

    COMPLETED

    Seoul, 03722, South Korea

  • Shaare Zedek Medical Center ( Site 0075)

    RECRUITING

    Jerusalem, 9103102, Israel

  • Soroka Medical Center ( Site 0072)

    COMPLETED

    Beersheba, 8457108, Israel

  • Sourasky Medical Center ( Site 0077)

    COMPLETED

    Tel Aviv, 6423906, Israel

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

    ACTIVE_NOT_RECRUITING

    Koszalin, West Pomeranian Voivodeship, 75-581, Poland

  • Taipei Medical University Hospital ( Site 0180)

    RECRUITING

    Taipei, 110301, Taiwan

  • The James Cancer Hospital and Solove Research Institute at The Ohio State University Comprehensive C ( Site 0015)

    RECRUITING

    Columbus, Ohio, 43210, United States

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

    RECRUITING

    Houston, Texas, 77030, United States

  • UCSF Medical Center at Mission Bay ( Site 0007)

    COMPLETED

    San Francisco, California, 94158, United States

  • University of Kentucky Markey Cancer Center ( Site 0019)

    COMPLETED

    Lexington, Kentucky, 40536-0293, United States

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

    COMPLETED

    Gdansk, Pomeranian Voivodeship, 80-952, Poland

  • Uzhhorod Multispecialty City Clinical Hospital ( Site 0462)

    RECRUITING

    Uzhhorod, Zakarpattia Oblast, 88017, Ukraine

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