Autologous 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 withthe Medical Monitor.

• Have historically or pathologically confirmed diagnosis of metastatic Stage IV NSCLCwithout EGFR, ALK, or ROS1 genomic alterations.

• For patients who have actionable mutations (other than EGFR, ALK, or ROS1 genomicalterations), 1 additional line of therapy with the appropriate health authorityapproved targeted therapy is required.

• Patients must have documented radiographic disease progression on or after thefirst-line therapy, including concurrent or sequential ICI and platinum-basedchemotherapy ± bevacizumab. No more than 1 prior line is allowed if ICI andplatinum-based chemotherapy were administered concurrently and no more than 2 priorlines are allowed for sequential administration of platinum-based chemotherapy andICI as 2 separate lines.

• LN-145 manufacture is allowed for patients who have residual resectable diseaseafter completion of the platinum-based chemotherapy component of the front-line ICIand platinum-based chemotherapy combination and meet all eligibility criteria exceptdocumented disease progression. These patients must intend to receive TIL therapyafter disease progression

• Prior systemic therapy in the adjuvant or neoadjuvant setting, or as part ofdefinitive chemoradiotherapy, will count as a line of therapy if the patient haddisease progression during or within 12 months after the completion of such therapy.

• At least 1 resectable lesion for TIL production and at least one remainingmeasurable 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 potentialmust be willing to practice an approved method of highly effective birth controlduring 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 thepast 20 years

• Patients who have any form of primary immunodeficiency

• Patients who are on systemic steroid therapy ≥ 10 mg/day of prednisone orequivalent.

• Patients who have received a live or attenuated vaccination within 28 days prior tothe start of treatment

• Patients who have had another primary malignancy within the previous 3 years

• Participation in another interventional clinical study within 21 days