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NCT03645928 · ClinicalTrials.gov registry record · Phase 2
Study of Autologous Tumor Infiltrating Lymphocytes in Patients With Solid Tumors
A Phase 2 study of Non-Small Cell Lung Cancer and Metastatic Melanoma, sponsored by Iovance Biotherapeutics.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 245
- Enrollment target
- 20
- Study locations
NCT03645928: Recruiting Phase 2 study of Non-Small Cell Lung Cancer and Metastatic Melanoma, sponsored by Iovance Biotherapeutics.
NCT03645928 is a Phase 2 study of Non-Small Cell Lung Cancer and Metastatic Melanoma that is actively recruiting participants, run by Iovance Biotherapeutics. The registered enrollment target is 245 participants, below the 652-participant average among 454 other Non-Small Cell Lung Cancer trials with a reported enrollment target (62% lower). The trial reports 20 study locations across 12 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03645928, a Phase 2 study of Non-Small Cell Lung Cancer and Metastatic Melanoma, is actively recruiting participants, sponsored by Iovance Biotherapeutics.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 245 participants
- Enrollment target
- 20
- Study locations
Study Summary
A prospective, open-label, multi-cohort, non-randomized, multicenter Phase 2 study evaluating adoptive cell therapy (ACT) with TIL \[LN-144/LN-145 (lifileucel)\] in combination with immune checkpoint inhibitors or TIL \[LN-144/LN-145 (lifileucel) and LN-145-S1\] as a single agent therapy.
Primary Outcome
To evaluate the efficacy of autologous TIL in combination with ICIs in metastatic melanoma, HNSCC, and NSCLC patients and as a single therapy in metastatic melanoma and NSCLC patients as determined by objective response rate (ORR) using the Response Evaluation Criteria in Solid Tumors (RECIST 1.1) as assessed by Investigator
Conditions Studied
Interventions
- DRUG Pembrolizumab
- DRUG Ipilimumab
- BIOLOGICAL LN-145
- BIOLOGICAL Lifileucel
- BIOLOGICAL LN-145-S1
Study Locations (20)
California
- University of California, San Diego - La Jolla
- University of Southern California - Los Angeles
- University of California, Los Angeles - Los Angeles
Florida
- Mount Sinai Medical Center - Miami Beach
- Orlando Health Cancer Institute - Orlando
- Moffitt Cancer Center - Tampa
Michigan
- Karmanos Cancer Institute - Detroit
- Henry Ford Health System - Detroit
New Jersey
- MD Anderson at Cooper - Camden
- Morristown Medical Center - Morristown
New York
- Columbia University - New York
- Memorial Sloan Kettering Cancer Center - New York
Ohio
- University of Cincinnati - Cincinnati
- Ohio State University - Columbus
Colorado
- University of Colorado - Denver
Connecticut
- Yale University - New Haven
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 245 participants |
| Start Date | 2019-05-07 |
| Est. Completion | 2029-08-09 |
| Phase | Phase 2 |
What NCT03645928 shows while recruiting
NCT03645928 is an interventional study that assigns participants to a tested intervention. The registered 245 participants enrollment target is mid-sized for trials with a published cap, below the 652-participant average among 454 other Non-Small Cell Lung Cancer trials with a reported enrollment target (62% lower).
The record links to 3 conditions, with Non-Small Cell Lung Cancer appearing as the primary indexed condition, and to 5 interventions - of which Pembrolizumab is the first listed.
NCT03645928 names 20 study sites across 12 states, led by California, Florida, Michigan.
Frequently Asked Questions
What is clinical trial NCT03645928 about?
NCT03645928 is a clinical study titled "Study of Autologous Tumor Infiltrating Lymphocytes in Patients With Solid Tumors". A prospective, open-label, multi-cohort, non-randomized, multicenter Phase 2 study evaluating adoptive cell therapy (ACT) with TIL \[LN-144/LN-145 (lifileucel)\] in combination with immune checkpoint inhibitors or TIL \[LN-144/LN-145 (lifileucel) and LN-145-S1\] as a single agent therapy.
What is the current status of trial NCT03645928?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 245 participants. The study started on 2019-05-07. Estimated completion is 2029-08-09.
What conditions does trial NCT03645928 study?
This clinical trial studies the following conditions: Non-Small Cell Lung Cancer, Metastatic Melanoma, Squamous Cell Carcinoma of the Head and Neck.
What interventions are being tested in trial NCT03645928?
The interventions under investigation include: Pembrolizumab (DRUG), Ipilimumab (DRUG), LN-145 (BIOLOGICAL), Lifileucel (BIOLOGICAL), LN-145-S1 (BIOLOGICAL).
Who is sponsoring clinical trial NCT03645928?
This trial is sponsored by Iovance Biotherapeutics, which has 12 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03645928 being conducted?
This trial has 20 study locations across California, Colorado, Connecticut, District of Columbia, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Non-Small Cell Lung Cancer
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03645928's enrollment target sits among peer trials
245 149th of 454 higher than 306 of 454 other Non-Small Cell Lung Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Non-Small Cell Lung Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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