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New treatment option for Metastatic Non Small Cell Lung Cancer
Official title Autologous LN-145 in Patients With Metastatic Non-Small-Cell Lung Cancer
ClinicalTrials.gov ID: NCT04614103
What this study is testing
What is LN-145?
LN-145 is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for metastatic non small cell lung cancer.
Also referred to as TIL, Autologous Tumor Infiltrating Lymphocytes.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 70
You may be able to join 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...
- Patients must have documented radiographic disease progression on or after the first-line therapy, including concurrent or sequential ICI and...
- LN-145 manufacture is allowed for patients who have residual resectable disease after completion of the platinum-based chemotherapy component of the...
You likely can't join 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
See the full eligibility 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...
- 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...
- 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...
- 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...
- 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 treatment clinical study within 21 days
The study team makes the final eligibility decision.
Where it's taking place
- Gilbert, Arizona, United States
- Miami, Florida, United States
- Tampa, Florida, United States
- Chicago, Illinois, United States
- Park Ridge, Illinois, United States
- Louisville, Kentucky, United States
- Baltimore, Maryland, United States
- Detroit, Michigan, United States
- Minneapolis, Minnesota, United States
- Omaha, Nebraska, United States
- Camden, New Jersey, United States
- New York, New York, United States
- Chapel Hill, North Carolina, United States
- Winston-Salem, North Carolina, United States
- Fargo, North Dakota, United States
- Cincinnati, Ohio, United States
- Columbus, Ohio, United States
- Portland, Oregon, United States
- Natrona Heights, Pennsylvania, United States
- Sioux Falls, South Dakota, United States
+ 42 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Gilbert, Arizona, United States; Miami, Florida, United States; Tampa, Florida, United States; Chicago, Illinois, United States; Park Ridge, Illinois, United States; Louisville, Kentucky, United States and 56 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.