At a glance
ClinicalIndex Comparison Record- ✓Age ≥18 years
- ✓Stage IV or recurrent NSCLC with activating alteration in EGFR, ALK, ROS1, or ERBB2
- ✓ECOG performance status 0 or 1
- ✓Expected survival ≥4 months
- ✕More than 6 prior lines of systemic therapy for NSCLC
- ✕Prior PD-1 or PD-L1 inhibitor treatment for metastatic NSCLC
- ✕Rapidly progressing tumors as judged by investigator
- ✕Active or prior autoimmune disease within past 2 years (with exceptions)
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
NCT05681780Phase 1RecruitingMonitorUpdated 3mo ago · Completion was 1mo agoClinical Trial of CD40L-augmented Tumor Infiltrating Lymphocytes (CD40L TIL) for Patients With Oncogene-Driven Advanced Non-Small Cell Lung Cancer (NSCLC)
In Brief
A Phase 1 clinical trial evaluating Tumor-infiltrating Lymphocytes (TIL), Nivolumab, and 4 other interventions for Non Small Cell Lung Cancer and 2 related conditions. Currently recruiting, targeting 20 participants across 1 site.
Signals
Detailed Summary
To determine the effect of a special preparation of cells, called tumor-infiltrating lymphocytes (TIL) stimulated with CD40L, when given with the drug nivolumab, for patients with EGFR, ALK, ROS1, or HER2-genomically altered lung cancer.
Study Details
Timeline
Interventions
Tumor harvest for TIL growth in the lab: A sample of the participant's tumor will be collected and sent to the lab for TIL growth. TIL will be prepared and cryopreserved.
Nivolumab (Opdivo®), 360 mg, IV infusion every 3 weeks prior to TIL infusion, and then after TIL infusion 480 mg ever 4 weeks for up to 12 months.
Cyclophosphamide will be administered on days -7 and -6.
Fludarabine will then be infused per institutional standard on Days -7 to -3.
On day 0, all patients will receive a dose infusion TIL cells.
Participants will receive IL-2 for up to 6 doses, based on participants tolerance and investigator judgement. This will be given after the infusion of the T-cells.