Metastatic Non Small Cell Lung CancerPhase 2NCT04614103
Autologous LN-145 in Patients With Metastatic Non-Small-Cell Lung Cancer
A Phase 2 study testing LN-145 in people with Metastatic Non Small Cell Lung Cancer, run by Iovance Biotherapeutics, Inc. at 71 sites in 12 countries.
Trial summary
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 Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Metastatic Non Small Cell Lung Cancer
- What is being tested?
- LN-145
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 170 participants
- Where
- 71 sitesin 12 countries
- Study dates
- 7 May 2021to Dec 2031
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Show all 12Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
71 sites in 12 countries. Contact the study team or a site near you to ask about taking part.
Iovance Biotherapeutics Study Team lungcelltherapy.com contact
71 sites in 12 countries
United States27 sites, 21 recruiting
- Active, not recruiting
University of Maryland
Baltimore, Maryland, 21201
- Recruiting
MD Anderson Cooper
Camden, New Jersey, 08103
- Recruiting
University of North Carolina
Chapel Hill, North Carolina, 27514
- Active, not recruiting
Rush University Medical Center
Chicago, Illinois, 60612
- Active, not recruiting
University of Illinois Hospital & Health Sciences System
Chicago, Illinois, 60612
- Recruiting
University of Cincinnati Medical Center
Cincinnati, Ohio, 45219
- Recruiting
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210
- Recruiting
Karmanos Cancer Institute
Detroit, Michigan, 48201
- Recruiting
Sanford Roger Maris Cancer Center
Fargo, North Dakota, 58102
- Recruiting
Banner Health MD Anderson
Gilbert, Arizona, 85234
- Recruiting
University of Tennessee Medical Center
Knoxville, Tennessee, 37920
- Recruiting
University of Louisville
Louisville, Kentucky, 40202
- Recruiting
Baptist Cancer Center
Memphis, Tennessee, 38120
- Active, not recruiting
Sylvester Comprehensive Cancer Center
Miami, Florida, 33136
- Recruiting
University of Minnesota
Minneapolis, Minnesota, 55455
- Recruiting
Allegheny General Hospital
Natrona Heights, Pennsylvania, 15065
- Recruiting
New York University Langone Medical Center
New York, New York, 10016
- Recruiting
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
- Recruiting
University of Nebraska Medical Center
Omaha, Nebraska, 68198
- Recruiting
Advocate Aurora Health
Park Ridge, Illinois, 60068
- Recruiting
Oregon Health and Science University
Portland, Oregon, 97239
- Recruiting
VCU Medical Center (Virginia Commonwealth University)
Richmond, Virginia, 23298
- Recruiting
Seattle Cancer Care Alliance
Seattle, Washington, 98109
- Recruiting
Sanford Cancer Center
Sioux Falls, South Dakota, 57102
- Active, not recruiting
Avera Medical Group Cancer Institute
Sioux Falls, South Dakota, 57105
- Recruiting
H Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, 33612
- Active, not recruiting
Novant Health - Winston-Salem
Winston-Salem, North Carolina, 27103
Spain14 sites, 14 recruiting
- Recruiting
Hospital Universitario A Coruña
A Coruña, 15006
- Recruiting
Instituto Oncologico Rosell
Barcelona, 08028
- Recruiting
Hospital Clinic de Barcelona
Barcelona, 08036
- Recruiting
C.H. Regional Reina Sofia
Córdoba, 14004
- Recruiting
Hospital Universitario Ramon y Cajal
Madrid, 28034
- Recruiting
Hospital Universitario 12 de Octubre
Madrid, 28041
- Recruiting
Hospital Universitario La Paz
Madrid, 28046
- Recruiting
Hospital Universitario Madrid Sanchinarro - Centro Integral Oncologico Clara Campal
Madrid, 28050
- Recruiting
Hospital Regional Universitario de Malaga
Málaga, 29016
- Recruiting
Clinical Universitaria de Navarra
Pamplona, 31008
- Recruiting
Hospital Universitario de Salamanca
Salamanca, 90577
- Recruiting
Hospital Universitario Virgen del Rocio
Seville, 41013
- Recruiting
Hospital Clinico Universitario de Valencia
Valencia, 46010
- Recruiting
Consorcio Hospital General Universitario de Valencia
Valencia, 46014
France6 sites, 6 recruiting
- Recruiting
Institut Paoli Calmettes
Marseille, 13009
- Recruiting
CHU Nantes
Nantes, 44093
- Recruiting
CHU Nice
Nice, 06001
- Recruiting
Centre Hospitalier Lyon Sud
Pierre-Bénite, 69310
- Recruiting
CHRU de Poitiers La Miletrie
Poitiers, 90577
- Recruiting
Gustave Roussy Cancer Campus
Villejuif, 94805
United Kingdom6 sites, 6 recruiting
- Recruiting
Queen Elizabeth Hospital Birmingham
Birmingham, B15 2GW
- Recruiting
Royal Marsden Hospital
Chelsea, England, SW36JJ
- Recruiting
Sarah Cannon Research Institute
London, England, W1G 6AD
- Recruiting
University College London
London, England, WC1E 68T
- Recruiting
Guy's Hospital
London, SE1 9RT
- Recruiting
The Christie NHS Foundation Trust
Manchester, England, M10 4BX
Germany4 sites, 4 recruiting
- Recruiting
Charite- Universitätsklinikum Berlin
Berlin, 13353
- Recruiting
Universitätsklinikum Carl Gustav Carus, MK I
Dresden, 01307
- Recruiting
Universitätsklinikum Frankfurt
Frankfurt, 60591
- Recruiting
Universitätsklinikum Mannheim
Mannheim, 68167
Italy4 sites, 4 recruiting
- Recruiting
Azienda Ospedaliera Universitaria Careggi
Florence, 50134
- Recruiting
Fondazione IRCCS Policlinico San Matteo di Pavia
Pavia, 27100
- Recruiting
Azienda Ospedaliera Ospedali Riuniti Marche Nord
Pesaro, 61122
- Recruiting
IRCCS Fondazione del Piemonte per l'Oncologia
Piemonte, 10060
Australia3 sites, 3 recruiting
- Recruiting
St. Vincent's Hospital
Darlinghurst, New South Wales, 2010
- Recruiting
Hollywood Private Hospital Ramsay
Nedlands, Western Australia, 6009
- Recruiting
Westmead Hospital
Westmead, New South Wales, 2145
South Korea3 sites, 3 recruiting
- Recruiting
Gachon Unversity Gil Medical Center
Incheon, 21565
- Recruiting
Samsung Medical Center
Seoul, Gangnam-gu, 6351
- Recruiting
Severance Hospital, Yonsei University
Seoul, 3722
Canada1 site, 1 recruiting
- Recruiting
Centre Hospitalier de l'Universite de Montreal (CHUM)
Montreal, QC H2X 3E4
Netherlands1 site, 1 recruiting
- Recruiting
Het Nederlands Kanker Instituut Antoni Van Leeuwenhoek Ziekenhuis
Amsterdam, 1066
Singapore1 site, 1 recruiting
- Recruiting
National Cancer Centre Singapore
Singapore, 168583
Switzerland1 site, 1 recruiting
- Recruiting
Centre Hospitalier Universitaire Vaudois Lausanne
Lausanne, Canton of Vaud, 1011
About this study
Official title: A Phase 2 Multicenter Study of Autologous Tumor Infiltrating Lymphocytes (TIL or LN-145) in Patients With Metastatic Non-Small-Cell Lung Cancer
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
Read the detailed description
LN-145 is a ready-to-infuse TIL therapy that utilizes an autologous TIL manufacturing process, as originally developed by the NCI and further optimized by Iovance for the treatment of patients with metastatic NSCLC. The cell transfer therapy used in this study involves patients receiving a non-myeloablative (NMA) lymphodepleting preparative regimen, followed by infusion of autologous TIL, then finally followed by the administration of IL-2.
- Conditions
- Metastatic Non Small Cell Lung Cancer
- Being tested
- LN-145
- Keywords
- LN-145, Cell Therapy, Autologous Adoptive Cell Therapy, Cellular Immuno-therapy, Tumor Infiltrating Lymphocytes, TIL, IL-2, Non Small Cell Lung Cancer, NSCLC, Second line Lung Cancer, Bronchial Neoplasms, Carcinoma, Lung Disease, Metastatic Lung Cancer, Metastatic Non Small Cell Lung Cancer, Metastatic NSCLC, Lung Carcinoma, PD-L1, Stage IV Lung Cancer, Stage IV Non-Small Cell Lung Cancer
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Bronchial Neoplasms, Carcinoma, Lung Diseases, Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LN-145Biological
Also called TIL, Autologous Tumor Infiltrating Lymphocytes
A tumor sample is resected from each patient and cultured ex vivo to expand the population of tumor infiltrating lymphocytes. After lymphodepleting chemotherapy including cyclophosphamide and fludarabine, patient is infused with autologous TIL (LN-145), followed by IL-2.
LN-145Biological
Also called TIL, Autologous Tumor Infiltrating Lymphocytes
A tumor sample is obtained by image-guided core biopsy from each patient and cultured ex vivo to expand the population of tumor infiltrating lymphocytes. After lymphodepleting chemotherapy including cyclophosphamide and fludarabine, patient is infused with autologous TIL (LN-145) followed by IL-2.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Experimental | Patients whose tumors did not express programmed cell death-ligand 1 (PD-L1), i.e., tumor proportion score (TPS) < 1% prior to ICI treatment and Patients with no available historical TPS for PD-L1 expression Receives: Biological: LN-145 |
| Cohort 2 | Experimental | Patients whose tumors expressed PD-L1 TPS ≥1% prior to ICI treatment Receives: Biological: LN-145 |
| Cohort 3 | Experimental | Patients, regardless of tumor PD-L1 TPS prior to ICI treatment, who are unable to safely undergo a surgical tumor resection for TIL generation Receives: Biological: LN-145 |
| Cohort 4 | Experimental | Patients, regardless of tumor PD-L1 expression status prior to ICI treatment, who have meet all inclusion/exclusion criteria except the requirement to have documented disease progression may elect to have the tumor harvest procedure and TIL production prior to disease progression on their current anticancer treatment. Documentation of progressive disease and identification of a target lesion for RECIST v1.1 assessment is required at Baseline for these patients. Receives: Biological: LN-145 |
| Retreatment Cohort | Experimental | Patients who were previously treated with LN-145 in Cohort 1, 2, 3, or 4. Receives: Biological: LN-145 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate
To evaluate the efficacy of LN-145 as determined by objective response rate (ORR) in patients with metastatic NSCLC using the Response Evaluation Criteria in Solid Tumors (RECIST v1.1), as assessed by central review for Cohorts 1 and 2 and by the investigator for Cohorts 3, 4 and the Retreatment Cohort
Measured: Up to 60 months
Secondary outcomes (8)
Objective Response Rate
To evaluate the efficacy of LN-145 as determined by objective response rate (ORR) per RECIST v1.1, as assessed by the Investigator for Cohorts 1 and 2
Measured: Up to 60 months
Complete Response Rate
To evaluate efficacy parameters such as Complete Response Rate (CRR) per RECIST v1.1
Measured: Up to 60 months
Duration of Response
To evaluate efficacy parameters such as Duration of Response (DOR) rate per RECIST v1.1
Measured: Up to 60 months
Disease Control Rate
To evaluate efficacy parameters such as Disease Control Rate (DCR) per RECIST v1.1
Measured: Up to 60 months
Progression-Free Survival
To evaluate efficacy parameters such as Progression-Free Survival (PFS) per RECIST v1.1
Measured: Up to 60 months
Overall Survival
To evaluate efficacy parameters such as Overall Survival (OS)
Measured: Up to 60 months
Adverse Events
To characterize the safety profile of LN-145 in patients with non-small-cell lung cancer (NSCLC)
Measured: Up to 60 months
Core Biopsies
To determine the feasibility of generating LN-145 using tumor tissue obtained via image-guided core biopsy
Measured: Up to 60 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2020
- Study start7 May 2021
- Primary completionDec 2030 (estimated)
- Study completionDec 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Non Small Cell Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 170 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Iovance Biotherapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Iovance Biotherapeutics Study Team, Study director, Iovance Biotherapeutics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04614103
- Sponsor's protocol ID
- IOV-LUN-202
- Other IDs
- 2020-003629-45, 2024-510778-26-00
- Status last verified
- Jun 2026
- First submitted
- 21 Oct 2020
- Last updated
- 26 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Multicenter Study of Autologous Tumor Infiltrating Lymphocytes (TIL or LN-145) in Patients With Metastatic Non-Small-Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT04614103
- Acronym / sponsor ID
- IOV-LUN-202
- Conditions
- Metastatic Non Small Cell Lung Cancer
- Keywords
- LN-145, Cell Therapy, Autologous Adoptive Cell Therapy, Cellular Immuno-therapy, Tumor Infiltrating Lymphocytes, TIL, IL-2, Non Small Cell Lung Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 170 participants (estimated)
- Lead sponsor
- Iovance Biotherapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 7 May 2021 (actual)
- Primary completion
- Dec 2030 (estimated)
- Study completion
- Dec 2031 (estimated)
- First posted
- 3 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
LN-145 is a ready-to-infuse TIL therapy that utilizes an autologous TIL manufacturing process, as originally developed by the NCI and further optimized by Iovance for the treatment of patients with metastatic NSCLC. The cell transfer therapy used in this study involves patients receiving a non-myeloablative (NMA) lymphodepleting preparative regimen, followed by infusion of autologous TIL, then finally followed by the administration of IL-2.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Experimental | Biological: LN-145Patients whose tumors did not express programmed cell death-ligand 1 (PD-L1), i.e., tumor proportion score (TPS) < 1% prior to ICI treatment and Patients with no available historical TPS for PD-L1 expression |
| Cohort 2 | Experimental | Biological: LN-145Patients whose tumors expressed PD-L1 TPS ≥1% prior to ICI treatment |
| Cohort 3 | Experimental | Biological: LN-145Patients, regardless of tumor PD-L1 TPS prior to ICI treatment, who are unable to safely undergo a surgical tumor resection for TIL generation |
| Cohort 4 | Experimental | Biological: LN-145Patients, regardless of tumor PD-L1 expression status prior to ICI treatment, who have meet all inclusion/exclusion criteria except the requirement to have documented disease progression may elect to have the tumor harvest procedure and TIL production prior to disease progression on their current anticancer treatment. Documentation of progressive disease and identification of a target lesion for RECIST v1.1 assessment is required at Baseline for these patients. |
| Retreatment Cohort | Experimental | Biological: LN-145Patients who were previously treated with LN-145 in Cohort 1, 2, 3, or 4. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LN-145Also: TIL, Autologous Tumor Infiltrating LymphocytesA tumor sample is resected from each patient and cultured ex vivo to expand the population of tumor infiltrating lymphocytes. After lymphodepleting chemotherapy including cyclophosphamide and fludarabine, patient is infused with autologous TIL (LN-145), followed by IL-2. | Biological | Cohort 1, Cohort 2, Cohort 4, Retreatment Cohort |
| LN-145Also: TIL, Autologous Tumor Infiltrating LymphocytesA tumor sample is obtained by image-guided core biopsy from each patient and cultured ex vivo to expand the population of tumor infiltrating lymphocytes. After lymphodepleting chemotherapy including cyclophosphamide and fludarabine, patient is infused with autologous TIL (LN-145) followed by IL-2. | Biological | Cohort 3 |
Primary outcome
Objective Response Rate
Time frame: Up to 60 months
To evaluate the efficacy of LN-145 as determined by objective response rate (ORR) in patients with metastatic NSCLC using the Response Evaluation Criteria in Solid Tumors (RECIST v1.1), as assessed by central review for Cohorts 1 and 2 and by the investigator for Cohorts 3, 4 and the Retreatment Cohort
8 secondary outcomes
Objective Response Rate
Time frame: Up to 60 months
Complete Response Rate
Time frame: Up to 60 months
Duration of Response
Time frame: Up to 60 months
Disease Control Rate
Time frame: Up to 60 months
Progression-Free Survival
Time frame: Up to 60 months
Overall Survival
Time frame: Up to 60 months
Adverse Events
Time frame: Up to 60 months
Core Biopsies
Time frame: Up to 60 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Iovance Biotherapeutics Study Team lungcelltherapy.com contact
Iovance Biotherapeutics Study Team study director
Iovance Biotherapeutics
71 sites in 12 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing LN-145 in people with Metastatic Non Small Cell Lung Cancer, run by Iovance Biotherapeutics, Inc. at 71 sites in 12 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 71 sites in United States, Spain, France, United Kingdom, Germany and 7 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Iovance Biotherapeutics Study Team lungcelltherapy.com (1-844-845-4682, Clinical.Inquiries@iovance.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective Response Rate (time frame: Up to 60 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2026.