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New combo therapy shows promise for hard-to-treat lung cancer

NCT ID NCT05186974

Disease control Sponsor: Gilead Sciences 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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 11, 2026 · Updated 1 time

Summary

This study tests a drug called sacituzumab govitecan combined with pembrolizumab (and sometimes chemotherapy) as a first treatment for people with advanced or metastatic non-small-cell lung cancer that lacks specific genetic changes. About 193 participants will receive these combinations to see if tumors shrink and how long that effect lasts. The goal is to find a better way to control the disease and improve survival.

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

193 people

The number who actually took part.

Started

May 2022

Expected to finish

Mar 2027

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.

Key Inclusion Criteria: * Individuals with pathologically documented evidence of Stage IV non-small cell lung Cancer (NSCLC) disease at the time of enrollment * Measurable disease by computed tomography (CT) or magnetic resonance imaging (MRI) as per RECIST Version 1.1 criteria by investigator * No prior systemic treatment for metastatic NSCLC * Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1 * Adequate hematologic counts * Adequate hepatic function Key Exclusion Criteria: * Mixed SCLC and NSCLC histology * Active second malignancy * NSCLC that is eligible for definitive local therapy alone * Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy * Has an active autoimmune disease that has required systemic treatment in past 2 years * Has had an allogenic tissue/solid organ transplant. * Has severe (≥ Grade 3) hypersensitivity to SG, pembrolizumab, carboplatin, or cisplatin, their metabolites, or formulation excipient * Has received radiation therapy to the lung * Individuals may not have received systemic anticancer treatment within the previous 6 months * Is currently participating in or has participated in a study of an investigational agent * Clinically severe pulmonary compromise resulting from intercurrent pulmonary illnesses * Known active central nervous system (CNS) metastases * History of cardiac disease * Active chronic inflammatory bowel disease * Active serious infection requiring antibiotics * Active or chronic hepatitis B infection * Positive hepatitis C antibody * Positive serum pregnancy test or women who are lactating Note: Other protocol defined Inclusion/Exclusion criteria may apply.

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Conditions

The condition(s) this trial relates to.

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

Contacts and locations

Locations

  • AOU Policlinico Vittorio Emanuele - POG Rodolico

    Catania, 95125, Italy

  • APHP - Hôpital Ambroise Paré

    Boulogne-Billancourt, 92100, France

  • ASST Spedali Civili di Brescia

    Brescia, 25123, Italy

  • Alaska Oncology and Hematology, LLC.

    Anchorage, Alaska, 99508, United States

  • Asan Medical Center

    Seoul, 05505, South Korea

  • Ashford Cancer Centre Research

    Windsor Gardens, South Australia, 5087, Australia

  • Asklepios Fachkliniken Munchen-Gauting, Zentrum fur Pneumologie und Thoraxchirugie

    Gauting, 82131, Germany

  • Azienda Ospedaliero-Universitaria di Parma

    Parma, 43126, Italy

  • Beverly Hills Cancer Center

    Beverly Hills, California, 90211, United States

  • CHRU de Brest - Hopital Morvan

    Brest, 29609, France

  • CHU de Bordeaux Hopital Haut leveque

    Pessac, 33604, France

  • CHU de CAEN

    Caen, 14000, France

  • CIUSSS Saguenay Lac St-Jean

    Québec, G7H 5H6, Canada

  • Centre Francois Baclesse

    Caen, 14000, France

  • Centre Georges-François Leclerc

    Dijon, 21000, France

  • Centre Jean Perrin - 58 rue Montalembert

    Clermont-Ferrand, 63011, France

  • Chang Gung Memorial Hospital (CGMH)

    Taoyuan City, 33305, Taiwan

  • Changhua Christian Hospital

    Changhua, 500-06, Taiwan

  • Chi Mei Hospital - Liouying

    Liouying Dist., Taiwan

  • Chungbuk National University Hospital

    Cheongju-si, 28644, South Korea

  • Clinica Universidad de Navarra - Pamplona

    Pamplona, 31008, Spain

  • Clinique Victor Hugo

    Le Mans, 72000, France

  • Complejo Hospitalario Universitario A Coruna. Hospital Teresa Herrera

    A Coruña, 15006, Spain

  • Complejo Hospitalario Universitario de Santiago de Compostela CHUS_Hospital Clinico Universitario

    Santiago de Compostela, 15706, Spain

  • Department of Clinical Oncology, The Chinese University of Hong Kong, Prince of Wales Hospital

    Hong Kong, 852, Hong Kong

  • E-DA Hospital

    Kaohsiung City, 824, Taiwan

  • Evangelische Lungenklinik Berlin Krakenhausbetriebs GmBH

    Berlin, 13125, Germany

  • FirstHealth Outpatient Cancer Center

    Pinehurst, North Carolina, 28374, United States

  • Flinders Medical Centre

    Bedford Park, South Australia, 5042, Australia

  • Gachon University Gil Medical Center

    Inchon, 21565, South Korea

  • Georgetown University Medical Center

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

  • Great Lakes Cancer Care

    Williamsville, New York, 14226, United States

  • Guy's and St Thomas' NHS Foundation Trust

    London, SE1 9RT, United Kingdom

  • Hong Kong United Oncology Center

    Kowloon, Hong Kong

  • Hospices Civils de Lyon, Centre Hospitalier Lyon-Sud

    Pierre-Bénite, 69495, France

  • Hospital Clinic de Barcelona

    Barcelona, 08036, Spain

  • Hospital Duran i Reynals

    Barcelona, 08908, Spain

  • Hospital General Universitario Gregorio Maranon

    Madrid, 28007, Spain

  • Hospital Kuala Lumpur

    Kuala Lumpur, 50586, Malaysia

  • Hospital Raja Perempuan Zainab II

    Kota Bharu, 15586, Malaysia

  • Hospital Regional Universitario de Malaga-Hospital Civil

    Rincón de la Victoria, 29011, Spain

  • Hospital Tengku Ampuan Afzan

    Kuantan, 25100, Malaysia

  • Hospital Universitari Germans Trias i Pujol

    Badalona, 08916, Spain

  • Hospital Universitari Vall d'Hebrón

    Barcelona, 08035, Spain

  • Hospital Universitari i Politecnic La Fe

    Valencia, 46026, Spain

  • Hospital Universitario Puerta de Hierro de Majadahonda

    Majadahonda, 28660, Spain

  • Hospital Universitario Virgen Macarena

    Seville, 41009, Spain

  • Hospital Universitario Virgen de Valme

    Seville, 41001, Spain

  • IRCCS Instituto Clinico Humanitas

    Rozzano, 20089, Italy

  • IRCCS Istituti Fisioterapicic Ospitalieri - Istituto Nazionale Tumori Regina Elena

    Rome, 00144, Italy

  • Institut Curie

    Paris, 75248, France

  • Institut Kanser Negara

    Putrajaya, 62250, Malaysia

  • Institut de Cancérologie de l'Ouest

    Saint-Herblain, 44805, France

  • Joondalup Health Campus

    Joondalup, Western Australia, 6027, Australia

  • Kansas City VA Medical Center

    Kansas City, Missouri, 64128, United States

  • Kansas City Veterans Affairs Medical Center

    Westwood, Kansas, 66205, United States

  • Kaohsiung Chang Gung Memorial Hospital

    Kaohsiung City, 83301, Taiwan

  • Kaohsiung Medical University Chung-Ho Memorial Hospital

    Kaohsiung City, 80756, Taiwan

  • Klinikum Chemnitz gGmbH

    Chemnitz, 9116, Germany

  • Klinikum Esslingen GmbH, Klinik fur Kardiologie, Angiologie und Pneumologie

    Esslingen am Neckar, 73730, Germany

  • LKI Lungenfachklinik Immenhausen

    Immenhausen, 34376, Germany

  • LungenClinic Grosshansdorf

    Großhansdorf, 22927, Germany

  • Martha-Maria Krankenhaus Halle Dölau gGmbH

    Halle, 06120, Germany

  • McGill University Health Centre

    Québec, H4A 3J1, Canada

  • Moffitt Cancer Center

    Tampa, Florida, 33612, United States

  • National Cheng Kung University Hospital

    Tainan, Taiwan

  • National Taiwan University Hospital

    Taipei, Taiwan

  • Northside Hospital Central Research Department

    Atlanta, Georgia, 30342, United States

  • Northwestern Memorial Hospital

    Chicago, Illinois, 60611, United States

  • OSU Brain & Spine Hospital

    Columbus, Ohio, 43220, United States

  • Orchard Healthcare Research Inc.

    Skokie, Illinois, 60077, United States

  • Peninsula Health - Frankston Hospital

    Frankston, Victoria, 3199, Australia

  • Pindara Private Hospital

    Benowa, Queensland, 4217, Australia

  • Queen Elizabeth Hospital

    Hong Kong, Hong Kong

  • Queen Mary Hospital

    Hong Kong, Hong Kong

  • Rush University Medical Center

    Chicago, Illinois, 60612, United States

  • Saint Vincents Hospital Sydney

    Darlinghurst, New South Wales, 2010, Australia

  • Sarawak General Hospital

    Kuching, 93586, Malaysia

  • Seoul Metropolitan Government - Seoul National University Boramae Medical Center

    Seoul, 07061, South Korea

  • Severance Hospital, Yonsei University Health System

    Seoul, 120-752, South Korea

  • Siouxland Regional Cancer Center dba June E. Nylen Cancer Center

    North Sioux City, South Dakota, 51101, United States

  • Southern Highlands Cancer Centre

    Bowral, New South Wales, 2576, Australia

  • St George Private Hospital

    Kogarah, New South Wales, 2217, Australia

  • Stanford Cancer Institute

    Stanford, California, 94305, United States

  • Sultan Ismail Hospital

    Johor Bahru, 81100, Malaysia

  • Sunshine Coast University Private Hospital

    Birtinya, Queensland, 4575, Australia

  • Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation

    Taipei, 110, Taiwan

  • Taipei Veterans General Hospital

    Taipei, 10002, Taiwan

  • The Catholic University of Korea St. Vincent's Hospital

    Suwon, 16247, South Korea

  • UC Irvine Health

    Orange, California, 92868, United States

  • UCLA Hematology/Oncology - Santa Monica

    Los Angeles, California, 90404, United States

  • USC/Norris Comprehensive Cancer Center

    Los Angeles, California, 90033, United States

  • Universitatsklinikum Frankfurt

    Frankfurt, 60590, Germany

  • Universitatsklinikum Koln, Klinik I fur Innere Medizin

    Cologne, 50937, Germany

  • University Hospital Cleveland Medical Center

    Cleveland, Ohio, 44106, United States

  • University Hospitals Birmingham NHS Foundation Trust

    Birmingham, B9 5SS, United Kingdom

  • University Malaya Medical Centre

    Kuala Lumpur, 59100, Malaysia

  • University of Colorado Hospital - Anschutz Cancer Pavilion (ACP)

    Aurora, Colorado, 80045, United States

  • Wake Forest Baptist Health - High Point Medical Center

    High Point, North Carolina, 27262, United States

  • Weill Cornell Medical/New York-Presbyterian Hospital

    New York, New York, 10065, United States

  • Western Health - Sunshine Hospital

    Melbourne, Victoria, 3021, Australia

More trials for these conditions

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