RecruitingPhase 2

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

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 70 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: Infusions

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "The cell transfer therapy used in this study involves patients receiving a non-myeloablative (NMA) lymphodepleting preparative regimen, followed by infusion of autologous TIL, then finally followed by the administration of IL-2."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This phase 2 study tests LN-145 in people with stage IV non-small-cell lung cancer that has spread to other parts of the body. It is for people who have had prior treatment and whose cancer does not have certain gene changes.

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

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Have confirmed stage IV non-small-cell lung cancer without EGFR, ALK, or ROS1 gene changes. People over 70 may join after discussion with the study’s medical monitor.
  • Scans must show cancer growth during or after first treatment with immune therapy and platinum-based chemotherapy, with or without bevacizumab. Only 1 prior treatment course is allowed if given together, or 2 if given separately.
  • If another gene change can be treated with an approved targeted drug, you must also have had that treatment.
  • LN-145 may be made before cancer grows if removable cancer remains after the chemotherapy part of first treatment. You must meet the other rules and plan to receive the cell treatment after cancer grows.
  • Earlier drug treatment given before or after surgery, or with radiation, counts as a prior treatment course if cancer grew during treatment or within 12 months afterward.
  • Have at least 1 tumor that can be removed to make the cell treatment, plus another tumor that can be measured.
  • Have good enough organ and lung function. Your heart must pump out more than 45% of its blood with each beat, with no limits on ordinary activity. You must be fully active or limited only in hard physical activity.
  • If you or your partner could become pregnant, agree to use approved, highly effective birth control during treatment and for 12 months after all study treatment.

Who can't join

  • Cancer has EGFR, ALK, or ROS1 gene changes.
  • Cancer has spread to the brain, causes symptoms, and has not been treated.
  • Had an organ transplant from a donor or cell therapy within the past 20 years.
  • Have a primary immune deficiency, a condition that weakens the body’s defenses.
  • Take steroid medicine that acts throughout the body at a dose equal to at least 10 mg of prednisone each day.
  • Received a vaccine containing live or weakened germs within 28 days before treatment starts.
  • Had another separate cancer within the past 3 years.
  • Took part in another study testing a treatment within 21 days.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: * 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 * 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 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

Study sites (27)

AZ

FL

IL

KY

MD

MI

MN

NC

ND

NE

NJ

NY

OH

OR

PA

SD

TN

VA

WA