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CAR T-cell Therapy

Autologous LN-145 for Lung Cancer

Phase 2
Recruiting
Research Sponsored by Iovance Biotherapeutics, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Have historically or pathologically confirmed diagnosis of metastatic Stage IV NSCLC without EGFR, ALK, or ROS genomic alterations
ECOG performance status of 0 or 1
Must not have
Patients who are on systemic steroid therapy ≥ 10 mg/day of prednisone or equivalent
Patients who have symptomatic, untreated brain metastases
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 60 months
Awards & highlights

Summary

This trial tests LN-145, a treatment using a patient's own lab-prepared immune cells, in patients with advanced lung cancer that has spread. The process includes reducing existing immune cells, infusing enhanced ones, and boosting their activity.

Who is the study for?
This trial is for adults with Stage IV non-small-cell lung cancer (NSCLC) without certain genetic mutations. Participants must have had disease progression after first-line therapy, be in good physical condition (ECOG status of 0 or 1), and have at least one tumor that can be surgically removed for treatment development. They should not have more than two prior lines of therapy and must agree to use effective birth control.
What is being tested?
The study is testing LN-145, a new potential treatment developed from the patient's own immune cells. It's an open-label phase 2 trial, meaning both researchers and participants know what treatment is being given, focusing on those with metastatic NSCLC who meet specific criteria.
What are the potential side effects?
While specific side effects are not listed here, treatments like LN-145 may cause immune-related reactions due to enhanced activity of the body’s own cells. This could potentially lead to inflammation in various organs, fatigue, fever-like symptoms, or allergic reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My lung cancer is stage IV and does not have EGFR, ALK, or ROS mutations.
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I am fully active or can carry out light work.
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My heart functions well and I have no symptoms of heart failure.
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My lungs work well enough for normal activities.
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I've had an approved targeted therapy for my cancer mutation, excluding EGFR, ALK, or ROS.
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I have at least one tumor that can be surgically removed and another that can be measured.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am taking 10 mg or more of prednisone daily or its equivalent.
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I have brain metastases that have not been treated and are causing symptoms.
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I have had another type of cancer in the last 3 years.
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My cancer has EGFR, ALK, or ROS mutations.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 60 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 60 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Secondary study objectives
Adverse Events
Complete Response Rate
Core Biopsies
+5 more

Side effects data

From 2022 Phase 2 trial • 64 Patients • NCT03083873
75%
Chills
63%
Pyrexia
63%
Hyponatraemia
63%
Hypotension
50%
Lymphopenia [2]
50%
Thrombocytopenia [4]
50%
Anaemia
50%
Hypophosphataemia
38%
Leukopenia [1]
38%
Neutropenia [3]
38%
Vomiting
38%
Fatigue
38%
Hypokalaemia
25%
Sinus tachycardia
25%
Tachycardia
25%
Diarrhoea
25%
Febrile neutropenia
25%
Pneumonia
25%
Mucosal infection
25%
Aspartate aminotransferase increased
25%
Hypocalcaemia
25%
Cough
25%
Dyspnoea
13%
Myocardial infarction
13%
Alopecia
13%
Monocytosis
13%
Neutrophilia
13%
Thrombocytosis
13%
Eye haemorrhage
13%
Constipation
13%
Dysphagia
13%
Dry mouth
13%
Nausea
13%
Influenza like illness
13%
Localised oedema
13%
Biliary obstruction
13%
Device related infection
13%
Dehydration
13%
Somnolence
13%
Aspiration
13%
Hypoxia
13%
Basophilia
13%
Pneumonia aspiration
13%
Contusion
13%
Infusion related reaction
13%
Alanine aminotransferase increased
13%
Blood alkaline phosphatase decreased
13%
Blood bilirubin increased
13%
Blood creatine phosphokinase increased
13%
Blood culture positive
13%
Troponin increased
13%
Weight increased
13%
Weight decreased
13%
Hypercalcaemia
13%
Hypochloraemia
13%
Hypomagnesaemia
13%
Muscular weakness
13%
Dizziness
13%
Dysgeusia
13%
Headache
13%
Tremor
13%
Anxiety
13%
Depression
13%
Insomnia
13%
Urinary incontinence
13%
Urine flow decreased
13%
Nasal congestion
13%
Nasal dryness
13%
Pleural effusion
13%
Pulmonary oedema
13%
Erythema
13%
Pruritus
13%
Rash
13%
Hypertension
100%
80%
60%
40%
20%
0%
Study treatment Arm
Cohort 1
Cohort 3
Cohort 2
Cohort 5
Cohort 4

Trial Design

5Treatment groups
Experimental Treatment
Group I: Retreatment CohortExperimental Treatment1 Intervention
Patients who were previously treated with LN-145 in Cohort 1, 2, 3, or 4.
Group II: Cohort 4Experimental Treatment1 Intervention
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.
Group III: Cohort 3Experimental Treatment1 Intervention
Patients, regardless of tumor PD-L1 TPS prior to ICI treatment, who are unable to safely undergo a surgical tumor resection for TIL generation
Group IV: Cohort 2Experimental Treatment1 Intervention
Patients whose tumors expressed PD-L1 TPS ≥1% prior to ICI treatment
Group V: Cohort 1Experimental Treatment1 Intervention
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
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
LN-145
2017
Completed Phase 2
~70

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
The most common treatments for Non-Small Cell Lung Cancer (NSCLC) include chemotherapy, targeted therapy, immunotherapy, and Tumor-Infiltrating Lymphocytes (TIL) therapy like LN-145. Chemotherapy kills rapidly dividing cells, including cancer cells, but also affects normal cells. Targeted therapy uses drugs to specifically target genetic mutations or proteins that drive cancer growth, offering a more personalized treatment. Immunotherapy enhances the body's immune response against cancer cells by blocking proteins that suppress immune activity. TIL therapy involves extracting and expanding a patient's own immune cells that have infiltrated the tumor, then re-infusing them to attack the cancer. These treatments are crucial for NSCLC patients as they provide various options tailored to the specific characteristics of their cancer, potentially improving outcomes and quality of life.

Find a Location

Who is running the clinical trial?

Iovance Biotherapeutics, Inc.Lead Sponsor
23 Previous Clinical Trials
1,655 Total Patients Enrolled
Iovance Biotherapeutics Study TeamStudy DirectorIovance Biotherapeutics
4 Previous Clinical Trials
823 Total Patients Enrolled

Media Library

Non-Small Cell Lung Cancer Research Study Groups: Cohort 4, Retreatment Cohort, Cohort 1, Cohort 2, Cohort 3
~110 spots leftby Dec 2030
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