Comparing 5 approaches for metastatic non small cell lung cancer

Inclusion

• +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.
• +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 controlControl groupThe group a new treatment is measured against.Read more → during treatment and up to 12 months after all protocolProtocolThe detailed plan a study must follow.Read more →-related therapy
• +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 criteriaEligibility criteriaThe full list of requirements for taking part in a study.Read more → except documented disease progression. These patients must intend to receive TIL therapy after disease progression