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

Qualifiers

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

Treatments tested in this trial

  • LN-145
  • LN-145

Treatment groups

170 Participants
are divided into 5 treatment groups

Sponsors and collaborators