Autologous LN-145 in Patients With Metastatic Non-Small-Cell Lung Cancer
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-70
SponsorIovance Biotherapeutics, Inc.
About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
LN-145
Biological/VaccineA 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-145
Biological/VaccineA 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.
Treatment groups
170 Participants
are divided into 5 treatment groupsGroup A: Cohort 1Experimental treatment 1 intervention
Group B: Cohort 2Experimental treatment 1 intervention
Group C: Cohort 3Experimental treatment 1 intervention
Group D: Cohort 4Experimental treatment 1 intervention
Group E: Retreatment CohortExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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
Time frame
Up to 60 monthsSecondary outcomes
1
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
Time frame
Up to 60 months2
Complete Response Rate
To evaluate efficacy parameters such as Complete Response Rate (CRR) per RECIST v1.1
Time frame
Up to 60 months3
Duration of Response
To evaluate efficacy parameters such as Duration of Response (DOR) rate per RECIST v1.1
Time frame
Up to 60 months4
Disease Control Rate
To evaluate efficacy parameters such as Disease Control Rate (DCR) per RECIST v1.1
Time frame
Up to 60 monthsSponsors and contacts
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Source ClinicalTrials.gov