A Phase 2 Multicenter Study of Autologous Tumor Infiltrating Lymphocytes (LN-145) in Patients with Metastatic Non-Small-Cell Lung Cancer

Protocol # :
Metastatic Non Small Cell Lung Cancer
Disease Sites
Principal Investigator
Awad, Mark

Trial Description

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 Requirements

Inclusion Criteria:

- Patients who are over 70 years of age may be allowed to enroll after consultation with
the Medical Monitor.

- Have historically or pathologically confirmed diagnosis of metastatic Stage IV NSCLC
without EGFR, ALK, or ROS genomic alterations.

- For patients who have actionable mutations (other than EGFR, ALK, or ROS 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 ROS 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