Ongoing trials of intratumoural therapies for non-small cell lung cancer listed on ClinicalTrials.gov
| Therapy | Phase | Site | Tumour types | Key outcome(s) | ClinicalTrials.gov ID | Title |
| AdV-tk (aglatimagene besadenovec)+valacyclovir | I | Intratumoural bronchoscopic injection | NSCLC | Primary: Safety Secondary: Immunologic changes, PFS, OS | NCT03131037 | Intratumoural gene-mediated cytotoxic immunotherapy in patients with resectable NSCLC |
| CCL21 gene-modified dendritic cell with pembrolizumab | I | Bronchoscopic or CT-guided intratumoural injection | NSCLC | Primary: Maximum tolerated dose, objective response rate Secondary: Adverse events, PD-L1 expression | NCT03546361 | Intratumoural administration of CCL21 gene-modified dendritic cell with intravenous pembrolizumab for advanced NSCLC |
| Intratumoural G100 with atezolizumab and radiotherapy | II | Intratumoural bronchoscopic injection | NSCLC Pancreatic cancer Virus-associated tumours Melanoma Bladder cancer Triple-negative breast cancer | Primary: Response by RECIST 1.1 Secondary: Adverse events, tumour immune cells, blood cytokines, lymphocytes and kynurenine | NCT03915678 | Atezolizumab combined with intratumoural G100 And immunogenic radiotherapy in patients with advanced solid tumours (AGADIR) |
| Intratumoural ilixadencel with pembrolizumab | I/II | Intratumoural# | NSCLC Squamous cell carcinoma of head and neck Gastric adenocarcinoma | Primary: Adverse events, objective response rate Secondary: Objective response rate, CD8 T cell response by flow cytometry, overall survival, progression free survival | NCT03735290 | Study to evaluate the safety and effectiveness of ilIxadencel administered into tumours in combination with checkpoint inhibitor in patients with advanced cancer (ILIAD) |
| Oncolytic adenovirus (CAdVEC) and T cells (HER2-AdVST) | I | Intratumoural# | Lung cancer Bladder cancer Squamous cell carcinoma of head and neck Cancer of the salivary gland Breast cancer Gastric cancer Oesophageal cancer Colorectal cancer Pancreatic adenocarcinoma | Primary: Maximum tolerated dose Secondary: Response by RECIST 1.1, PFS, OS, adverse events | NCT03740256 | Binary oncolytic adenovirus in combination with HER2-specific chimeric antigen receptor modified cytotoxic T cells in advanced HER2 positive solid tumours (VISTA) |
| INT230-6 | I/II | Intratumoural# | Lung cancer Melanoma Head and neck cancer Lymphoma Breast cancer Pancreatic cancer Liver cancer Colon cancer Glioblastoma Bile duct cancer Ovarian cancer Sarcoma Squamous cell carcinoma | Primary: Adverse events Secondary: Efficacy, pharmacokinetics and pharmacodynamics | NCT03058289 | Phase 1/2 safety study of intratumourally dosed INT230-6 (IT-01) |
| Intratumoural ABBV-927 with or without ABBV-181 | I | Intratumoural# | NSCLC Squamous cell carcinoma of head and neck Advanced solid tumours | Primary: Maximum tolerated dose, pharmacokinetics and pharmacodynamics Secondary: Clinical benefit rate, objective response rate, PFS | NCT02988960 | Study of ABBV-927 and ABBV-181, an immunotherapy, in subjects with advanced solid tumours |
| Clostridium novyi-NT | I | Intratumoural# | Advanced solid tumours | Primary: Maximum tolerated dose Secondary: Response by RECIST 1.1 | NCT03435952 | Pembrolizumab with intratumoural injection of Clostridium novyi-NT |
NSCLC: non-small cell lung cancer; PFS: progression-free survival; OS: overall survival; RECIST: Response Evaluation Criteria In Solid Tumours. #: Method of intratumoural injection not specified or includes percutaneous injection.