NCT04614103Recruiting
Autologous LN-145 in Patients With Metastatic Non-Small-Cell Lung Cancer
Summary
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
Inclusion criteria
• 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. • LN-145 manufacture is allowed for patients who have residual resectable disease after completion of the platinum-based chemotherapy component of the front-line ICI and platinum-based chemotherapy combination and meet all eligibility criteria except documented disease progression. These patients must intend to receive TIL therapy after disease progression • Prior systemic therapy in the adjuvant or neoadjuvant setting, or as part of definitive chemoradiotherapy, will count as a line of therapy if the patient had disease progression during or within 12 months after the completion of such therapy. • At least 1 resectable lesion for TIL production and at least one remaining measurable lesion, as defined by RECIST v1.1 • Have adequate organ function • LVEF \> 45%, NYHA Class 1 • Have adequate pulmonary function • ECOG performance status of 0 or 1 • Patients of childbearing potential or those with partners of childbearing potential must be willing to practice an approved method of highly effective birth control during treatment and up to 12 months after all protocol-related therapy
Exclusion criteria
• 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 • Patients who are on systemic steroid therapy ≥ 10 mg/day of prednisone or equivalent. • Patients who have received a live or attenuated vaccination within 28 days prior to the start of treatment • Patients who have had another primary malignancy within the previous 3 years • Participation in another interventional clinical study within 21 days
Contacts
The trial team's contact details are shown on request.
See the official trial record- Status
- Recruiting
- Phase
- Phase 2
- Study type
- Interventional
- Countries
- Switzerland, France, Germany, Italy, United States, Australia, Canada, Netherlands, Singapore, South Korea, Spain, United Kingdom
- Sponsor
- Iovance Biotherapeutics, Inc.(Industry)
- Protocol no.
- IOV-LUN-202
- Conditions
- Metastatic Non Small Cell Lung Cancer
- Interventions
- Biological
Treatments studied
- LN-145
- LN-145
Locations · 65
- Lausanne, SwitzerlandCentre Hospitalier Universitaire Vaudois LausanneRecruiting at this site
- Marseille, FranceInstitut Paoli CalmettesRecruiting at this site
- Nantes, FranceCHU NantesRecruiting at this site
- Nice, FranceCHU NiceRecruiting at this site
- Pierre-Bénite, FranceCentre Hospitalier Lyon SudRecruiting at this site
- Poitiers, FranceCHRU de Poitiers La MiletrieRecruiting at this site
- Villejuif, FranceGustave Roussy Cancer CampusRecruiting at this site
- Berlin, GermanyCharite- Universitätsklinikum BerlinRecruiting at this site
- Dresden, GermanyUniversitätsklinikum Carl Gustav Carus, MK IRecruiting at this site
- Frankfurt, GermanyUniversitätsklinikum FrankfurtRecruiting at this site
- Mannheim, GermanyUniversitätsklinikum MannheimRecruiting at this site
- Florence, ItalyAzienda Ospedaliera Universitaria CareggiRecruiting at this site
- Pavia, ItalyFondazione IRCCS Policlinico San Matteo di PaviaRecruiting at this site
- Pesaro, ItalyAzienda Ospedaliera Ospedali Riuniti Marche NordRecruiting at this site
- Piemonte, ItalyIRCCS Fondazione del Piemonte per l'OncologiaRecruiting at this site
- Gilbert, United StatesBanner Health MD AndersonRecruiting at this site
- Tampa, United StatesH Lee Moffitt Cancer Center and Research InstituteRecruiting at this site
- Park Ridge, United StatesAdvocate Aurora HealthRecruiting at this site
- Louisville, United StatesUniversity of LouisvilleRecruiting at this site
- Detroit, United StatesKarmanos Cancer InstituteRecruiting at this site
- Minneapolis, United StatesUniversity of MinnesotaRecruiting at this site
- Omaha, United StatesUniversity of Nebraska Medical CenterRecruiting at this site
- Camden, United StatesMD Anderson CooperRecruiting at this site
- New York, United StatesNew York University Langone Medical CenterRecruiting at this site
- New York, United StatesMemorial Sloan Kettering Cancer CenterRecruiting at this site
- Chapel Hill, United StatesUniversity of North CarolinaRecruiting at this site
- Fargo, United StatesSanford Roger Maris Cancer CenterRecruiting at this site
- Cincinnati, United StatesUniversity of Cincinnati Medical CenterRecruiting at this site
- Columbus, United StatesOhio State University Comprehensive Cancer CenterRecruiting at this site
- Portland, United StatesOregon Health and Science UniversityRecruiting at this site
In total, worldwide, 65 of the 71 sites listed in the registry are recruiting; the other 6 are not currently recruiting.
Site status per the ClinicalTrials.gov registry (last update posted: June 26, 2026).
This status may have changed and says nothing about your eligibility: before taking any step, check with your oncologist or the site.
+ 35 more locations
Other identifiers
- 2020-003629-45 · EudraCT number
- 2024-510778-26-00 · CTIS number
See also
Other versions
These results are indicative and do not replace medical advice — discuss them with your doctor.