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# Clinical Hold on Iovance Lung Cancer Trial
- URL: https://www.fdaweb.com/clinical-hold-on-iovance-lung-cancer-trial/
- Published: 2024-01-02T12:00:00.000Z
- Updated: 2026-09-14T14:18:55.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5156057

FDA has placed a clinical hold on Iovance Biotherapeutics’ IOV-LUN-202 clinical trial, which is assessing LN-145 tumor infiltrating lymphocyte (TIL) therapy in non-small cell lung cancer (NSCLC), in response to a recently reported Grade 5 (fatal) serious adverse event potentially related to the non-myeloablative lymphodepletion pre-conditioning regimen. The trial is investigating LN-145 in patients who have progressed on or after chemotherapy and anti-PD-1 therapy for advanced (unresectable or metastatic) NSCLC without EGFR, ROS or ALK genomic mutations and had received at least one line of an FDA-approved targeted therapy if indicated by other actionable tumor mutations.

Iovance says it will pause enrollment in the LN-145 TIL treatment regimen for new patients in IOV-LUN-202 during the clinical hold. “Patients previously treated with LN-145 in the IOV-LUN-202 trial will continue to be monitored and followed according to the trial protocol,” it explains. “Patients who have already undergone tumor resection will continue to receive the LN-145 TIL treatment regimen with additional precautions and risk mitigations.”

The company says the clinical hold for IOV-LUN-202 has no impact on any other Iovance clinical trials and is independent of the agency’s ongoing priority review of a BLA for lifileucel in advanced melanoma. The BLA remains on track toward a user fee review action target date of 2/24, it adds.