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RecruitingPhase 2NCT04614103

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

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Trial Parameters

ConditionMetastatic Non Small Cell Lung Cancer
SponsorIovance Biotherapeutics, Inc.
Study TypeINTERVENTIONAL
PhasePhase 2
Enrollment170
SexALL
Min Age18 Years
Max Age70 Years
Start Date2021-05-07
Completion2030-12
Interventions
LN-145LN-145

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Brief Summary

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 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

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