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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 60 months
Awards & highlights
Study Summary
This trial is testing a new cancer drug in patients with metastatic non-small-cell lung cancer.
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.Check my eligibility
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.See study design
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 belowSelect...
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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 60 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 60 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Secondary outcome measures
Adverse Events
Complete Response Rate
Core Biopsies
+5 moreSide effects data
From 2022 Phase 2 trial • 64 Patients • NCT0308387371%
Thrombocytopenia [4]
71%
Chills
59%
Pyrexia
41%
Anaemia
35%
Leukopenia [1]
35%
Hypophosphataemia
35%
Hypotension
29%
Hypoalbuminaemia
29%
Lymphopenia [2]
29%
Hyponatraemia
29%
Neutropenia [3]
29%
Hypocalcaemia
24%
Nausea
24%
Diarrhoea
24%
Febrile neutropenia
24%
Dyspnoea
24%
Hypokalaemia
18%
Hypoxia
18%
Hypertension
18%
Tachycardia
18%
Fatigue
18%
Blood bilirubin increased
12%
Constipation
12%
Stomatitis
12%
Sinus tachycardia
12%
Pain
12%
Hyperglycaemia
12%
Oedema peripheral
12%
Hypomagnesaemia
12%
Alopecia
12%
Arthralgia
12%
Wheezing
12%
Procedural pain
12%
Infusion related reaction
12%
Muscular weakness
12%
Erythema
12%
Rash maculo-papular
12%
Flushing
12%
Productive cough
6%
Respiratory tract haemorrhage
6%
Haematuria
6%
Vomiting
6%
Candida infection
6%
Abnormal dreams
6%
Headache
6%
Gastrooesophageal reflux disease
6%
Post procedural haemorrhage
6%
Rash erythematous
6%
Acute kidney injury
6%
Mass
6%
Activated partial thromboplastin time prolonged
6%
Blood lactate dehydrogenase increased
6%
Oropharyngeal pain
6%
Bronchitis
6%
Skin laceration
6%
Pneumonia aspiration
6%
Gastrostomy tube site complication
6%
Paraesthesia
6%
Restlessness
6%
Petechiae
6%
Aspartate aminotransferase increased
6%
Dermatitis acneiform
6%
Bronchitis viral
6%
Decreased appetite
6%
Acute respiratory distress syndrome
6%
Haemolytic anaemia
6%
Vision blurred
6%
Supraventricular tachycardia
6%
Neutropenia [1]
6%
Dysphagia
6%
Embolism
6%
Rash
6%
Odynophagia
6%
Abdominal distension
6%
Anxiety
6%
Metabolic acidosis
6%
Joint swelling
6%
Cyanosis
6%
Mood altered
6%
Hyperhidrosis
6%
Peripheral swelling
6%
Temperature intolerance
6%
Insomnia
6%
Syncope
6%
Proteinuria
6%
Influenza
6%
Blood alkaline phosphatase increased
6%
Musculoskeletal chest pain
6%
Cough
6%
Back pain
6%
Acidosis
6%
Hypersomnia
6%
Pollakiuria
6%
Increased upper airway secretion
6%
Pulmonary congestion
6%
Skin mass
6%
Thrombophlebitis superficial
6%
Pruritus
6%
Deep vein thrombosis
6%
Bacteraemia
6%
Rhinorrhoea
100%
80%
60%
40%
20%
0%
Study treatment Arm
Cohort 2
Cohort 1
Cohort 3
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
Find a Location
Who is running the clinical trial?
Iovance Biotherapeutics, Inc.Lead Sponsor
20 Previous Clinical Trials
1,526 Total Patients Enrolled
Iovance Biotherapeutics Study TeamStudy DirectorIovance Biotherapeutics
2 Previous Clinical Trials
723 Total Patients Enrolled
Media Library
Research Study Groups:
This trial has the following groups:- Group 1: Cohort 4
- Group 2: Retreatment Cohort
- Group 3: Cohort 1
- Group 4: Cohort 2
- Group 5: Cohort 3
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is this experimental procedure currently accepting volunteers?
"According to the clinicaltrials.gov website, this medical experiment is seeking subjects as of now. The initial posting was on May 7th 2021 and it was refreshed on October 20th 2022."
Answered by AI
Can I potentially be part of this medical study?
"This ongoing clinical trial is seeking 95 volunteers aged between 18 and 70, who have been diagnosed with metastatic Stage IV NSCLC. Patients must meet further criteria, including having an LVEF above 45%, being NYHA Class 1 or lower, demonstrating adequate pulmonary function, potentially undergoing TIL therapy after disease progression (if applicable), and having at least one resectable lesion for production of TILs. Furthermore, those over the age of 70 may still be eligible if cleared by a Medical Monitor."
Answered by AI
Does this research trial cater to individuals of advanced age?
"According to the criteria listed, those participating in this trial must be 18 years of age or older and under 70."
Answered by AI
How many healthcare establishments are currently implementing this trial?
"This ground-breaking trial is accepting patients from Seattle Cancer Care Alliance in Seattle, Washington, University of Oklahoma in Oklahoma City, Oklahoma and Rush University Medical Center in Chicago Illinois. Additionally, 40 other sites are participating."
Answered by AI
What safety measures should be taken with regards to LN-145?
"Considering the Phase 2 status of LN-145, our team at Power assigned it a safety ranking of two as there is evidence to suggest that this medication has some level of protection against adverse effects but no data proving its efficacy."
Answered by AI
How many participants are presently undergoing this clinical investigation?
"Affirmative. Clinicaltrials.gov contains records which indicate that this medical trial is currently recruiting participants; the initial posting was on May 7th 2021, with an update being made on October 20th 2022. The research team is seeking 95 individuals across 40 distinct sites."
Answered by AI
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