Actively Recruiting

Phase 2
Age: 18Years - 70Years
All Genders
NCT04614103

Autologous LN-145 in Patients With Metastatic Non-Small-Cell Lung Cancer

Led by Iovance Biotherapeutics, Inc. · Updated on 2026-04-15

170

Participants Needed

91

Research Sites

551 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This is a prospective, open-label, multi-cohort, non-randomized, multicenter phase 2 study evaluating LN-145 in patients with metastatic non-small-cell lung cancer

CONDITIONS

Official Title

Autologous LN-145 in Patients With Metastatic Non-Small-Cell Lung Cancer

Who Can Participate

Age: 18Years - 70Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 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 �b1 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
Not Eligible

You will not qualify if you...

  • 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 �b9 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

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 91 locations

1

Banner Health MD Anderson

Gilbert, Arizona, United States, 85234

Actively Recruiting

2

City of Hope

Duarte, California, United States, 91010

Withdrawn

3

UC San Diego Moores Cancer Center

La Jolla, California, United States, 92037

Withdrawn

4

University of Southern California

Los Angeles, California, United States, 90033

Withdrawn

5

Christiana Care Health System

Newark, Delaware, United States, 19713

Withdrawn

6

University of Florida Health Cancer Center

Gainesville, Florida, United States, 32610

Withdrawn

7

Sylvester Comprehensive Cancer Center

Miami, Florida, United States, 33136

Actively Recruiting

8

AdventHealth Cancer Institute

Orlando, Florida, United States, 32804

Withdrawn

9

H Lee Moffitt Cancer Center and Research Institute

Tampa, Florida, United States, 33612

Actively Recruiting

10

Augusta University

Augusta, Georgia, United States, 30912

Actively Recruiting

11

Rush University Medical Center

Chicago, Illinois, United States, 60612

Withdrawn

12

University of Illinois Hospital & Health Sciences System

Chicago, Illinois, United States, 60612

Withdrawn

13

Advocate Aurora Health

Park Ridge, Illinois, United States, 60068

Actively Recruiting

14

University of Kentucky-Markey Cancer Center

Lexington, Kentucky, United States, 40536

Actively Recruiting

15

University of Louisville

Louisville, Kentucky, United States, 40202

Actively Recruiting

16

University of Maryland

Baltimore, Maryland, United States, 21201

Actively Recruiting

17

Dana Farber Cancer Institute

Boston, Massachusetts, United States, 02215

Withdrawn

18

Karmanos Cancer Institute

Detroit, Michigan, United States, 48201

Actively Recruiting

19

Henry Ford Health System

Detroit, Michigan, United States, 48202

Withdrawn

20

University of Minnesota

Minneapolis, Minnesota, United States, 55455

Actively Recruiting

21

University of Nebraska Medical Center

Omaha, Nebraska, United States, 68198

Actively Recruiting

22

MD Anderson Cooper

Camden, New Jersey, United States, 08103

Withdrawn

23

Roswell Park Cancer Institute

Buffalo, New York, United States, 14263

Withdrawn

24

New York University Langone Medical Center

New York, New York, United States, 10016

Actively Recruiting

25

Icahn School of Medicine at Mount Sinai

New York, New York, United States, 10029

Withdrawn

26

Memorial Sloan Kettering Cancer Center

New York, New York, United States, 10065

Actively Recruiting

27

University of Rochester Medical Center

Rochester, New York, United States, 14642

Withdrawn

28

University of North Carolina

Chapel Hill, North Carolina, United States, 27514

Actively Recruiting

29

Novant Health - Charlotte

Charlotte, North Carolina, United States, 28204

Withdrawn

30

Novant Health - Winston-Salem

Winston-Salem, North Carolina, United States, 27103

Actively Recruiting

31

Atrium Health Wake Forest University Health Sciences

Winston-Salem, North Carolina, United States, 27157

Withdrawn

32

Sanford Roger Maris Cancer Center

Fargo, North Dakota, United States, 58102

Actively Recruiting

33

University of Cincinnati Medical Center

Cincinnati, Ohio, United States, 45219

Actively Recruiting

34

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, United States, 43210

Actively Recruiting

35

University of Oklahoma

Oklahoma City, Oklahoma, United States, 73104

Withdrawn

36

Oregon Health and Science University

Portland, Oregon, United States, 97239

Actively Recruiting

37

Allegheny General Hospital

Natrona Heights, Pennsylvania, United States, 15065

Actively Recruiting

38

Fox Chase Cancer Center

Philadelphia, Pennsylvania, United States, 19111

Withdrawn

39

Sanford Cancer Center

Sioux Falls, South Dakota, United States, 57102

Actively Recruiting

40

Avera Medical Group Cancer Institute

Sioux Falls, South Dakota, United States, 57105

Withdrawn

41

University of Tennessee Medical Center

Knoxville, Tennessee, United States, 37920

Actively Recruiting

42

Baptist Cancer Center

Memphis, Tennessee, United States, 38120

Actively Recruiting

43

Texas Oncology-Baylor Charles A. Sammons Cancer Center

Dallas, Texas, United States, 75246

Withdrawn

44

Houston Methodist

Houston, Texas, United States, 77030

Withdrawn

45

VCU Medical Center (Virginia Commonwealth University)

Richmond, Virginia, United States, 23298

Actively Recruiting

46

Seattle Cancer Care Alliance

Seattle, Washington, United States, 98109

Actively Recruiting

47

St. Vincent's Hospital

Darlinghurst, New South Wales, Australia, 2010

Actively Recruiting

48

Westmead Hospital

Westmead, New South Wales, Australia, 2145

Actively Recruiting

49

Hollywood Private Hospital Ramsay

Nedlands, Western Australia, Australia, 6009

Actively Recruiting

50

Centre Hospitalier de l'Universite de Montreal (CHUM)

Montreal, Canada, QC H2X 3E4

Actively Recruiting

51

Princess Margaret Cancer Centre

Toronto, Canada, M5G 2C1

Withdrawn

52

Institut Paoli Calmettes

Marseille, France, 13009

Actively Recruiting

53

CHU Nantes

Nantes, France, 44093

Actively Recruiting

54

CHU Nice

Nice, France, 06001

Actively Recruiting

55

Centre Hospitalier Lyon Sud

Pierre-Bénite, France, 69310

Actively Recruiting

56

CHRU de Poitiers La Miletrie

Poitiers, France, 90577

Actively Recruiting

57

Gustave Roussy Cancer Campus

Villejuif, France, 94805

Actively Recruiting

58

Charite- Universitätsklinikum Berlin

Berlin, Germany, 13353

Actively Recruiting

59

Universitätsklinikum Bonn

Bonn, Germany, 53127

Actively Recruiting

60

Universitätsklinikum Carl Gustav Carus, MK I

Dresden, Germany, 01307

Actively Recruiting

61

Universitätsklinikum Mannheim

Mannheim, Germany, 68167

Actively Recruiting

62

Azienda Ospedaliera Universitaria Careggi

Florence, Italy, 50134

Actively Recruiting

63

Fondazione IRCCS Policlinico San Matteo di Pavia

Pavia, Italy, 27100

Actively Recruiting

64

Azienda Ospedaliera Ospedali Riuniti Marche Nord

Pesaro, Italy, 61122

Actively Recruiting

65

IRCCS Fondazione del Piemonte per l'Oncologia

Piemonte, Italy, 10060

Actively Recruiting

66

Het Nederlands Kanker Instituut Antoni Van Leeuwenhoek Ziekenhuis

Amsterdam, Netherlands, 1066

Actively Recruiting

67

National Cancer Centre Singapore

Singapore, Singapore, 168583

Actively Recruiting

68

Samsung Medical Center

Seoul, Gangnam-gu, South Korea, 6351

Actively Recruiting

69

Gachon Unversity Gil Medical Center

Incheon, South Korea, 21565

Actively Recruiting

70

Severance Hospital, Yonsei University

Seoul, South Korea, 3722

Actively Recruiting

71

Hospital Universitario A Coruña

A Coruña, Spain, 15006

Actively Recruiting

72

Instituto Oncologico Rosell

Barcelona, Spain, 08028

Actively Recruiting

73

Hospital Clinic de Barcelona

Barcelona, Spain, 08036

Actively Recruiting

74

C.H. Regional Reina Sofia

Córdoba, Spain, 14004

Actively Recruiting

75

Hospital Universitario Ramon y Cajal

Madrid, Spain, 28034

Actively Recruiting

76

Hospital Universitario 12 de Octubre

Madrid, Spain, 28041

Actively Recruiting

77

Hospital Universitario La Paz

Madrid, Spain, 28046

Actively Recruiting

78

Hospital Universitario Madrid Sanchinarro - Centro Integral Oncologico Clara Campal

Madrid, Spain, 28050

Actively Recruiting

79

Hospital Regional Universitario de Malaga

Málaga, Spain, 29016

Actively Recruiting

80

Clinical Universitaria de Navarra

Pamplona, Spain, 31008

Actively Recruiting

81

Hospital Universitario de Salamanca

Salamanca, Spain, 90577

Actively Recruiting

82

Hospital Universitario Virgen del Rocio

Seville, Spain, 41013

Actively Recruiting

83

Hospital Clinico Universitario de Valencia

Valencia, Spain, 46010

Actively Recruiting

84

Consorcio Hospital General Universitario de Valencia

Valencia, Spain, 46014

Actively Recruiting

85

Centre Hospitalier Universitaire Vaudois Lausanne

Lausanne, Canton of Vaud, Switzerland, 1011

Actively Recruiting

86

University Hospital of Zurich/ Universitätsspital Zürich

Zurich, Switzerland, 8091

Withdrawn

87

Royal Marsden Hospital

Chelsea, England, United Kingdom, SW36JJ

Actively Recruiting

88

Sarah Cannon Research Institute

London, England, United Kingdom, W1G 6AD

Actively Recruiting

89

University College London

London, England, United Kingdom, WC1E 68T

Actively Recruiting

90

The Christie NHS Foundation Trust

Manchester, England, United Kingdom, M10 4BX

Actively Recruiting

91

Guy's Hospital

London, United Kingdom, SE1 9RT

Actively Recruiting

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Research Team

I

Iovance Biotherapeutics Study Team lungcelltherapy.com

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

5

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