Table 2.

Selected clinical trials using TILs

Reference	Study type	Patients	Treatment	Source	Dose-administered	IL2 / FC	Efficacy	Toxicity
Kradin, 1989 [68]	Phase II	8 NSCLC, 13 melanoma, 7 renal cell carcinomas	TILs	Autologous, tumor biopsy samples	10*10	IL2	5 PR (melanoma and renal cell carcinoma), 10 SD, 13 PD	Correlated with IL-2 dose: fever, local rash and superficial thrombophlebitis, nausea, weight gain, supraventricular tachycardia, rise in bilirubin and creatinine
Ratto, 1996 [69]	Randomized controlled trial	113 NSCLC, stage II–IIIB, post-surgery	RT ± Cisplatin Vinblastine ± TILs	Autologous, resected tumor tissue	4–70 × 10*9	IL2	mOS 22.4 m in the TIL group vs 14.1 m in the control group	Correlated with IL-2 dose: fever, chills, nausea
Chesney, 2019 [70]	Phase II, ongoing	135 advanced melanomas, HNSCC or NSCLC	TILs (Lifileucel) ± Pembrolizumab or Nivolumab + Ipilimumab	Autologous, resected tumor tissue		IL2 + FC	No published result yet	No published result yet
Massarelli, 2021 [71]	Phase II, ongoing	95 NSCLC, stage III–IV, pre-treated	TILs	Autologous, resected tumor tissue		IL2 + FC	No published result yet	No published result yet
Creelan, 2021 [72]	Phase I	20 NSCLC, stage IV—16 received TILs	Nivolumab, then TILs if PD	Autologous, resected metastases	4.3–175 × 10*9	IL2 + FC	2 CR after 1.5 years, 11 reductions in tumor burden	Grade 4 cytopenia and in 1 patient pulmonary oedema

HNSCC head and neck squamous cell cancer, RT radiotherapy, FC fludarabine and cyclophosphamide, PR partial response, SD stable disease, PD progressive disease, mOS median overall survival