Non Small Cell Lung CancerPhase 2NCT03419559
Study of Autologous Tumor Infiltrating Lymphocytes (LN-145) In Combo With Durvalumab in Non-Small Cell Lung Cancer
A Phase 2 study testing LN-145 and Durvalumab in people with Non Small Cell Lung Cancer, run by Iovance Biotherapeutics, Inc. at 8 sites in United States.
Trial summary
This study is a Phase 2, open-label, multicenter study evaluating adoptive cell therapy (ACT) with autologous TIL therapy (LN-145) in combination with Anti-PD-L1 inhibitor durvalumab. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non Small Cell Lung Cancer
- What is being tested?
- LN-145 and Durvalumab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 8 sitesUnited States
- Study dates
- 28 Feb 2018to Dec 2024
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Confirmed diagnosis of Stage III or Stage IV NSCLC and progressed after ≤ 3 lines of prior systemic therapy in the locally advanced or metastatic setting
- Have at least 1 lesion resectable for TIL generation
- Measurable disease as defined by RECIST v1.1
- Male or female, ≥ 18 years of age
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1, and estimated life expectancy of ≥ 3 months
- Adequate bone marrow function at screening
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- Adequate organ function at screening
- A washout period from prior anticancer therapy(ies) of a minimum duration is required prior to first study treatment
- Recovered from all prior anticancer therapy-related AEs to Grade 1 or less (per CTCAE v4.03) prior to enrollment
- Female patients of childbearing potential and male patients with partners of childbearing potential patient must agree to use contraception while on study and during the timeframes as specified following the last dose of study drug(s) received, or until the first dose of the subsequent anticancer therapy, whichever is longer
- Evidence of postmenopausal status or negative urine or serum pregnancy test for female premenopausal patients
Who cannot join
- History of other malignancies, except for the following: adequately treated nonmelanoma skin cancer, curatively treated in-situ cancer of the cervix, curatively-treated thyroid cancer, or other solid tumors curatively treated with no evidence of disease for ≥ 3 years
- Patients who have received prior cell therapy
- Patients who have received prior checkpoint inhibitors: such as anti-PD-1, anti-PD-L1 inhibitors, and durvalumab
- Active or prior documented autoimmune or inflammatory disorders
- History of primary or acquired immunodeficiency syndrome, history of allogeneic organ transplant that requires therapeutic immunosuppression
- Received live or attenuated vaccination within 28 days prior to the start of NMA-LD
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- Patients with a history of hypersensitivity to any component of the study drugs
- Mean QT interval ≥ 470 msec
- Patients who have a left ventricular ejection fraction (LVEF) of < 45% or who are New York Heart Association (NYHA) Class 2 or higher
- Serious illnesses or medical conditions, which would pose increased risk for study participation and/or compliance with the protocol
- Patients who have obstructive or restrictive pulmonary disease and have a documented FEV1 (forced expiratory volume in 1 second) of ≤ 60%
- Active central nervous system metastases and/or leptomeningeal disease
- Female patients who are pregnant or breastfeeding
- Active infection including tuberculosis (TB), hepatitis B, hepatitis C, or HIV
- Current or prior use of immunosuppressive medication within 28 days before the first dose of study treatment, with the exceptions of intranasal and inhaled corticosteroids or systemic corticosteroids at physiological doses, which are not to exceed 10 mg/day of prednisone, or an equivalent corticosteroid
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
Karmanos Cancer Institute
Detroit, Michigan, 48201
University of California San Diego, Moores Cancer Center
La Jolla, California, 92093
University of California, Los Angeles, Santa Monica Hematology/Oncology
Los Angeles, California, 90095
University of Louisville James Graham Brown Cancer Center
Louisville, Kentucky, 40202
Morristown Medical Center Atlantic Hematology Oncology
Morristown, New Jersey, 07960
Vanderbilt University
Nashville, Tennessee, 37232
UPMC Cancer Center
Pittsburgh, Pennsylvania, 15232
University of Washington Medical Center
Seattle, Washington, 98195-0001
About this study
Official title: A Phase 2 Study to Assess the Efficacy and Safety of Autologous Tumor Infiltrating Lymphocytes (LN-145) In Combination With Anti-PD-L1 Inhibitor Durvalumab (MEDI4736) in Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC)
This study is a Phase 2, open-label, multicenter study evaluating adoptive cell therapy (ACT) with autologous TIL therapy (LN-145) in combination with Anti-PD-L1 inhibitor durvalumab.
Read the detailed description
LN-145 is an adoptive cell transfer therapy that utilizes an autologous TIL manufacturing process, as originally developed by the NCI. The cell transfer therapy used in this study involves patients receiving a nonmyeloablative (NMA) lymphocyte depleting preparative regimen, followed by infusion of autologous TIL followed by the administration of a regimen of IL-2.
- Conditions
- Non Small Cell Lung Cancer
- Being tested
- LN-145, Durvalumab
- Keywords
- LN-145, Cell Therapy, Autologous Adoptive Cell Transfer, Cellular Immuno-therapy, TIL, IL-2, Durvalumab
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
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
adoptive cell therapy (ACT) with autologous TIL therapy
DurvalumabDrug
Also called MEDI4736
PD-L1 antagonist monoclonal antibody
| Study group | Role | What they receive |
|---|---|---|
| LN-145 in combination with durvalumab | Experimental | After nonmyeloablative (NMA) lymphodepletion, patients are infused with their autologous TIL (LN-145) followed by IL-2 administration. Receives: Biological: LN-145; Drug: Durvalumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate
To evaluate efficacy using the objective response rate (ORR)
Measured: A maximum of 24 months
≥ Grade 3 Treatment-Emergent Adverse Event
To evaluate the safety as measured by any ≥ Grade 3 treatment-emergent adverse event (TEAE) rate
Measured: A maximum of 24 months
Secondary outcomes (3)
Duration of Response
To further evaluate efficacy such as the duration of response (DOR)
Measured: A maximum of 24 months
Progression Free Survival
To further evaluate efficacy such as progression free survival (PFS)
Measured: A maximum of 24 months
Overall Survival
To further evaluate efficacy such as overall survival (OS)
Measured: A minimum of 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2018
- Study start28 Feb 2018
- Primary completionDec 2021 (estimated)
- Study completionDec 2024 (estimated)
Why it stopped: The treatment landscape for NSCLC has evolved in the past year. An additional NSCLC arm will be added to the IOV-COM-202 study using TIL + pembrolizumab.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Iovance Biotherapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Iovance Medical Monitor, Study director, Iovance Biotherapeutics, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03419559
- Sponsor's protocol ID
- IOV-LUN-201
- Status last verified
- Apr 2019
- First submitted
- 14 Jan 2018
- Last updated
- 16 Apr 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Study to Assess the Efficacy and Safety of Autologous Tumor Infiltrating Lymphocytes (LN-145) In Combination With Anti-PD-L1 Inhibitor Durvalumab (MEDI4736) in Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC)
- ClinicalTrials.gov ID
- NCT03419559
- Acronym / sponsor ID
- IOV-LUN-201
- Conditions
- Non Small Cell Lung Cancer
- Keywords
- LN-145, Cell Therapy, Autologous Adoptive Cell Transfer, Cellular Immuno-therapy, TIL, IL-2, Durvalumab
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The treatment landscape for NSCLC has evolved in the past year. An additional NSCLC arm will be added to the IOV-COM-202 study using TIL + pembrolizumab.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Iovance Biotherapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 28 Feb 2018 (actual)
- Primary completion
- Dec 2021 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 5 Feb 2018 (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 study is a Phase 2, open-label, multicenter study evaluating adoptive cell therapy (ACT) with autologous TIL therapy (LN-145) in combination with Anti-PD-L1 inhibitor durvalumab.
Detailed description
LN-145 is an adoptive cell transfer therapy that utilizes an autologous TIL manufacturing process, as originally developed by the NCI. The cell transfer therapy used in this study involves patients receiving a nonmyeloablative (NMA) lymphocyte depleting preparative regimen, followed by infusion of autologous TIL followed by the administration of a regimen of IL-2.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| LN-145 in combination with durvalumab | Experimental | Biological: LN-145, Drug: DurvalumabAfter nonmyeloablative (NMA) lymphodepletion, patients are infused with their autologous TIL (LN-145) followed by IL-2 administration. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Confirmed diagnosis of Stage III or Stage IV NSCLC and progressed after ≤ 3 lines of prior systemic therapy in the locally advanced or metastatic setting
- Have at least 1 lesion resectable for TIL generation
- Measurable disease as defined by RECIST v1.1
- Male or female, ≥ 18 years of age
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1, and estimated life expectancy of ≥ 3 months
Key exclusion criteria (15 listed)
- History of other malignancies, except for the following: adequately treated nonmelanoma skin cancer, curatively treated in-situ cancer of the cervix, curatively-treated thyroid cancer, or other solid tumors curatively treated with no evidence of disease for ≥ 3 years
- Patients who have received prior cell therapy
- Patients who have received prior checkpoint inhibitors: such as anti-PD-1, anti-PD-L1 inhibitors, and durvalumab
- Active or prior documented autoimmune or inflammatory disorders
- History of primary or acquired immunodeficiency syndrome, history of allogeneic organ transplant that requires therapeutic immunosuppression
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 lymphocytesadoptive cell therapy (ACT) with autologous TIL therapy | Biological | LN-145 in combination with durvalumab |
| DurvalumabAlso: MEDI4736PD-L1 antagonist monoclonal antibody | Drug | LN-145 in combination with durvalumab |
Primary outcome
Objective Response Rate
Time frame: A maximum of 24 months
To evaluate efficacy using the objective response rate (ORR)
≥ Grade 3 Treatment-Emergent Adverse Event
Time frame: A maximum of 24 months
To evaluate the safety as measured by any ≥ Grade 3 treatment-emergent adverse event (TEAE) rate
3 secondary outcomes
Duration of Response
Time frame: A maximum of 24 months
Progression Free Survival
Time frame: A maximum of 24 months
Overall Survival
Time frame: A minimum of 5 years
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2019.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Iovance Medical Monitor study director
Iovance Biotherapeutics, Inc.
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing LN-145 and Durvalumab in people with Non Small Cell Lung Cancer, run by Iovance Biotherapeutics, Inc. at 8 sites in United States.
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 11 inclusion and 15 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: withdrawn, as of the sponsor's last update on 16 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States. 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?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective Response Rate (time frame: A maximum of 24 months). The study lists 2 primary outcomes in all. 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 16 Apr 2019; AzTrials last refreshed its copy on 8 Nov 2026.