RecruitingMetastatic Non Small Cell Lung Cancer

Autologous LN-145 in Patients With Metastatic Non-Small-Cell Lung Cancer

Eligible age

18–70 yrs

Accepts

All genders

Locations

25 states

Healthy volunteers

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About this study

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

Sponsor: Iovance Biotherapeutics, Inc.

You may qualify if…

✓ 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

You may not qualify if…

✕ 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