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Lung cancer Patients' own immune cells could shrink tumors in new trial

NCT ID NCT04614103

Disease control Sponsor: Iovance Biotherapeutics, Inc. 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This phase 2 trial tests a personalized therapy called LN-145, made from a patient's own tumor-fighting immune cells. Researchers take a sample of the tumor, grow the immune cells in a lab, and then infuse them back into the patient after a short course of chemotherapy. The goal is to see if this approach can shrink tumors in people with metastatic non-small-cell lung cancer who have not responded to standard treatments. The study plans to enroll 170 participants across multiple centers.

What this could mean

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

Active substance
LN-145 (tumor infiltrating lymphocytes)
What this could lead to
If successful, this could offer a new treatment option for people with metastatic non-small-cell lung cancer who have not responded to other therapies.
What could go wrong
This is an early-phase trial with only 170 participants, so results may not apply to everyone. The treatment involves intensive chemotherapy and carries risks like infection and immune reactions.

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 170 people

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

Started

May 2021

Expected to finish

Dec 2031

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 to 70 years

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: * Patients who are over 70 years of age may be allowed to enroll after discussion with the Medical Monitor. * Have historically or pathologically confirmed diagnosis of metastatic Stage IV NSCLC without EGFR, ALK, or ROS1 genomic alterations. * For patients who have actionable mutations (other than EGFR, ALK, or ROS1 genomic alterations), 1 additional line of therapy with the appropriate health authority approved targeted therapy is required. * Patients must have documented radiographic disease progression on or after the first-line therapy, including concurrent or sequential ICI and platinum-based chemotherapy ± bevacizumab. No more than 1 prior line is allowed if ICI and platinum-based chemotherapy were administered concurrently and no more than 2 prior lines are allowed for sequential administration of platinum-based chemotherapy and ICI as 2 separate lines. * LN-145 manufacture is allowed for patients who have residual resectable disease after completion of the platinum-based chemotherapy component of the front-line ICI and platinum-based chemotherapy combination and meet all eligibility criteria except documented disease progression. These patients must intend to receive TIL therapy after disease progression * Prior systemic therapy in the adjuvant or neoadjuvant setting, or as part of definitive chemoradiotherapy, will count as a line of therapy if the patient had disease progression during or within 12 months after the completion of such therapy. * At least 1 resectable lesion for TIL production and at least one remaining measurable lesion, as defined by RECIST v1.1 * Have adequate organ function * LVEF \> 45%, NYHA Class 1 * Have adequate pulmonary function * ECOG performance status of 0 or 1 * Patients of childbearing potential or those with partners of childbearing potential must be willing to practice an approved method of highly effective birth control during treatment and up to 12 months after all protocol-related therapy Exclusion Criteria: * Patients who have EGFR, ALK or ROS1 driver mutations * Patients who have symptomatic, untreated brain metastases. * Patients who have had allogeneic organ transplant or prior cell therapy within the past 20 years * Patients who have any form of primary immunodeficiency * Patients who are on systemic steroid therapy ≥ 10 mg/day of prednisone or equivalent. * Patients who have received a live or attenuated vaccination within 28 days prior to the start of treatment * Patients who have had another primary malignancy within the previous 3 years * Participation in another interventional clinical study within 21 days

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Conditions

The condition(s) this trial relates to.

bronchial neoplasm carcinoma lung disorder lung neoplasm non-small cell lung carcinoma

As listed by the trial registrant

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

Metastatic 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

    65 sites in 12 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

  • Advocate Aurora Health

    RECRUITING

    Park Ridge, Illinois, 60068, United States

  • Allegheny General Hospital

    RECRUITING

    Natrona Heights, Pennsylvania, 15065, United States

  • Avera Medical Group Cancer Institute

    ACTIVE_NOT_RECRUITING

    Sioux Falls, South Dakota, 57105, United States

  • Azienda Ospedaliera Ospedali Riuniti Marche Nord

    RECRUITING

    Pesaro, 61122, Italy

  • Azienda Ospedaliera Universitaria Careggi

    RECRUITING

    Florence, 50134, Italy

  • Banner Health MD Anderson

    RECRUITING

    Gilbert, Arizona, 85234, United States

  • Baptist Cancer Center

    RECRUITING

    Memphis, Tennessee, 38120, United States

  • C.H. Regional Reina Sofia

    RECRUITING

    Córdoba, 14004, Spain

  • CHRU de Poitiers La Miletrie

    RECRUITING

    Poitiers, 90577, France

  • CHU Nantes

    RECRUITING

    Nantes, 44093, France

  • CHU Nice

    RECRUITING

    Nice, 06001, France

  • Centre Hospitalier Lyon Sud

    RECRUITING

    Pierre-Bénite, 69310, France

  • Centre Hospitalier Universitaire Vaudois Lausanne

    RECRUITING

    Lausanne, Canton of Vaud, 1011, Switzerland

  • Centre Hospitalier de l'Universite de Montreal (CHUM)

    RECRUITING

    Montreal, QC H2X 3E4, Canada

  • Charite- Universitätsklinikum Berlin

    RECRUITING

    Berlin, 13353, Germany

  • Clinical Universitaria de Navarra

    RECRUITING

    Pamplona, 31008, Spain

  • Consorcio Hospital General Universitario de Valencia

    RECRUITING

    Valencia, 46014, Spain

  • Fondazione IRCCS Policlinico San Matteo di Pavia

    RECRUITING

    Pavia, 27100, Italy

  • Gachon Unversity Gil Medical Center

    RECRUITING

    Incheon, 21565, South Korea

  • Gustave Roussy Cancer Campus

    RECRUITING

    Villejuif, 94805, France

  • Guy's Hospital

    RECRUITING

    London, SE1 9RT, United Kingdom

  • H Lee Moffitt Cancer Center and Research Institute

    RECRUITING

    Tampa, Florida, 33612, United States

  • Het Nederlands Kanker Instituut Antoni Van Leeuwenhoek Ziekenhuis

    RECRUITING

    Amsterdam, 1066, Netherlands

  • Hollywood Private Hospital Ramsay

    RECRUITING

    Nedlands, Western Australia, 6009, Australia

  • Hospital Clinic de Barcelona

    RECRUITING

    Barcelona, 08036, Spain

  • Hospital Clinico Universitario de Valencia

    RECRUITING

    Valencia, 46010, Spain

  • Hospital Regional Universitario de Malaga

    RECRUITING

    Málaga, 29016, Spain

  • Hospital Universitario 12 de Octubre

    RECRUITING

    Madrid, 28041, Spain

  • Hospital Universitario A Coruña

    RECRUITING

    A Coruña, 15006, Spain

  • Hospital Universitario La Paz

    RECRUITING

    Madrid, 28046, Spain

  • Hospital Universitario Madrid Sanchinarro - Centro Integral Oncologico Clara Campal

    RECRUITING

    Madrid, 28050, Spain

  • Hospital Universitario Ramon y Cajal

    RECRUITING

    Madrid, 28034, Spain

  • Hospital Universitario Virgen del Rocio

    RECRUITING

    Seville, 41013, Spain

  • Hospital Universitario de Salamanca

    RECRUITING

    Salamanca, 90577, Spain

  • IRCCS Fondazione del Piemonte per l'Oncologia

    RECRUITING

    Piemonte, 10060, Italy

  • Institut Paoli Calmettes

    RECRUITING

    Marseille, 13009, France

  • Instituto Oncologico Rosell

    RECRUITING

    Barcelona, 08028, Spain

  • Karmanos Cancer Institute

    RECRUITING

    Detroit, Michigan, 48201, United States

  • MD Anderson Cooper

    RECRUITING

    Camden, New Jersey, 08103, United States

  • Memorial Sloan Kettering Cancer Center

    RECRUITING

    New York, New York, 10065, United States

  • National Cancer Centre Singapore

    RECRUITING

    Singapore, 168583, Singapore

  • New York University Langone Medical Center

    RECRUITING

    New York, New York, 10016, United States

  • Novant Health - Winston-Salem

    ACTIVE_NOT_RECRUITING

    Winston-Salem, North Carolina, 27103, United States

  • Ohio State University Comprehensive Cancer Center

    RECRUITING

    Columbus, Ohio, 43210, United States

  • Oregon Health and Science University

    RECRUITING

    Portland, Oregon, 97239, United States

  • Queen Elizabeth Hospital Birmingham

    RECRUITING

    Birmingham, B15 2GW, United Kingdom

  • Royal Marsden Hospital

    RECRUITING

    Chelsea, England, SW36JJ, United Kingdom

  • Rush University Medical Center

    ACTIVE_NOT_RECRUITING

    Chicago, Illinois, 60612, United States

  • Samsung Medical Center

    RECRUITING

    Seoul, Gangnam-gu, 6351, South Korea

  • Sanford Cancer Center

    RECRUITING

    Sioux Falls, South Dakota, 57102, United States

  • Sanford Roger Maris Cancer Center

    RECRUITING

    Fargo, North Dakota, 58102, United States

  • Sarah Cannon Research Institute

    RECRUITING

    London, England, W1G 6AD, United Kingdom

  • Seattle Cancer Care Alliance

    RECRUITING

    Seattle, Washington, 98109, United States

  • Severance Hospital, Yonsei University

    RECRUITING

    Seoul, 3722, South Korea

  • St. Vincent's Hospital

    RECRUITING

    Darlinghurst, New South Wales, 2010, Australia

  • Sylvester Comprehensive Cancer Center

    ACTIVE_NOT_RECRUITING

    Miami, Florida, 33136, United States

  • The Christie NHS Foundation Trust

    RECRUITING

    Manchester, England, M10 4BX, United Kingdom

  • University College London

    RECRUITING

    London, England, WC1E 68T, United Kingdom

  • University of Cincinnati Medical Center

    RECRUITING

    Cincinnati, Ohio, 45219, United States

  • University of Illinois Hospital & Health Sciences System

    ACTIVE_NOT_RECRUITING

    Chicago, Illinois, 60612, United States

  • University of Louisville

    RECRUITING

    Louisville, Kentucky, 40202, United States

  • University of Maryland

    ACTIVE_NOT_RECRUITING

    Baltimore, Maryland, 21201, United States

  • University of Minnesota

    RECRUITING

    Minneapolis, Minnesota, 55455, United States

  • University of Nebraska Medical Center

    RECRUITING

    Omaha, Nebraska, 68198, United States

  • University of North Carolina

    RECRUITING

    Chapel Hill, North Carolina, 27514, United States

  • University of Tennessee Medical Center

    RECRUITING

    Knoxville, Tennessee, 37920, United States

  • Universitätsklinikum Carl Gustav Carus, MK I

    RECRUITING

    Dresden, 01307, Germany

  • Universitätsklinikum Frankfurt

    RECRUITING

    Frankfurt, 60591, Germany

  • Universitätsklinikum Mannheim

    RECRUITING

    Mannheim, 68167, Germany

  • VCU Medical Center (Virginia Commonwealth University)

    RECRUITING

    Richmond, Virginia, 23298, United States

  • Westmead Hospital

    RECRUITING

    Westmead, New South Wales, 2145, Australia

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