No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 – 70
Sex
Any
Trial phase
Phase 2
Study type
Interventional
Purpose
Treatment
Participants needed
170 (estimated)
Sponsor
Iovance Biotherapeutics, Inc. · Industry
Who this trial is looking for
This trial is looking for patients with advanced lung cancer who have not responded to initial treatments. Participants will receive a treatment called LN-145 to see how well it works.
Are You a Good Fit for This Trial?
You may be able to join if
I am over 70 years old.
I have been diagnosed with metastatic Stage IV lung cancer.
I have had disease progression after my first-line treatment.
I have at least one area of cancer that can be surgically removed.
I have adequate organ function.
I have a performance status of 0 or 1.
I am willing to use effective birth control during and after treatment.
You may not be able to join if
I have EGFR, ALK, or ROS1 mutations.
I have untreated brain metastases.
I have had an organ transplant or cell therapy in the past 20 years.
I have a primary immunodeficiency.
I take steroids at 10 mg/day or more.
I had a live vaccine within 28 days before starting treatment.
I have another cancer diagnosed within the last 3 years.
I participated in another clinical study within the last 21 days.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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
Trial Locations
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City
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Status
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 m…
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
Contacts
Iovance Biotherapeutics Study Team lungcelltherapy.com
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