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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 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.

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

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 more

Side effects data

From 2022 Phase 2 trial • 64 Patients • NCT03083873
75%
Thrombocytopenia [4]
56%
Anaemia
56%
Hypophosphataemia
50%
Hypocalcaemia
44%
Hypotension
44%
Pyrexia
44%
Diarrhoea
44%
Hypomagnesaemia
44%
Chills
38%
Dyspnoea
31%
Leukopenia [1]
31%
Neutropenia [3]
31%
Febrile neutropenia
31%
Cough
31%
Hypokalaemia
25%
Constipation
25%
Dry mouth
25%
Hypoalbuminaemia
19%
Decreased appetite
19%
Hyponatraemia
19%
Hypoglycaemia
19%
Pneumonia
19%
Hypoxia
19%
Confusional state
19%
Fatigue
19%
Infusion related reaction
19%
Hypertension
13%
Back pain
13%
Arthralgia
13%
Vomiting
13%
Oedema
13%
Sinus tachycardia
13%
Pulmonary oedema
13%
Capillary leak syndrome
13%
Lymphopenia [2]
13%
Acute kidney injury
13%
Atrial fibrillation
13%
Rash
13%
Pollakiuria
13%
Respiratory failure
13%
Aspiration
13%
Oral pain
13%
Hypernatraemia
13%
Petechiae
13%
Tachypnoea
13%
Hypercalcaemia
13%
Embolism
6%
Haematuria
6%
Deep vein thrombosis
6%
Somnolence
6%
Alopecia
6%
Mucosal infection
6%
Dysgeusia
6%
Haematoma
6%
Haemoptysis
6%
Cheilitis
6%
Localised oedema
6%
Blood creatinine increased
6%
Weight increased
6%
Oedema peripheral
6%
Blood bilirubin increased
6%
Laryngeal oedema
6%
Incision site pain
6%
Face oedema
6%
Encephalopathy
6%
Tachycardia
6%
Dysuria
6%
Scrotal infection
6%
Headache
6%
Bladder pain
6%
Rhinitis allergic
6%
Decubitus ulcer
6%
Urine output decreased
6%
Acidosis
6%
Shock haemorrhagic
6%
Peripheral sensory neuropathy
6%
Disturbance in attention
6%
Soft tissue injury
6%
Supraventricular tachycardia
6%
Tachyarrhythmia
6%
Visual impairment
6%
Blood alkaline phosphatase increased
6%
Nausea
6%
Swelling face
6%
Cytokine release syndrome
6%
Septic shock
6%
International normalised ratio increased
6%
Hypermagnesaemia
6%
Rash maculo-papular
6%
Hyperkalaemia
6%
Skin ulcer
6%
Distributive shock
6%
Mouth haemorrhage
6%
Sepsis
6%
Multiple organ dysfunction syndrome
6%
Ventricular tachycardia
6%
Faeces discoloured
6%
Hypersensitivity
6%
Respiratory distress
6%
Flushing
6%
Malnutrition
6%
Mouth ulceration
6%
Tracheal haemorrhage
6%
Dysphagia
6%
Muscle tightness
6%
Neuropathy peripheral
6%
Lactic acidosis
6%
Dizziness
6%
Purpura
6%
Oral dysaesthesia
6%
Acute respiratory failure
6%
Oliguria
6%
Thrombocytopenia [2]
6%
Muscular weakness
6%
Epistaxis
6%
Rhinorrhoea
6%
Thrombocytosis
6%
Electrocardiogram QT prolonged
6%
Delirium
6%
Hypervolaemia
6%
Wound haemorrhage
6%
Alanine aminotransferase increased
6%
Weight decreased
6%
Insomnia
6%
Irritability
6%
Pleural effusion
6%
Metabolic syndrome
6%
Anxiety
6%
Malaise
6%
Micturition urgency
6%
Dysphonia
6%
Pallor
100%
80%
60%
40%
20%
0%
Study treatment Arm
Cohort 3
Cohort 1
Cohort 4
Cohort 2
Cohort 5

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
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

Non-Small Cell Lung Cancer Research Study Groups: Cohort 4, Retreatment Cohort, Cohort 1, Cohort 2, Cohort 3
~113 spots leftby Dec 2030
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