Table 4 Ongoing clinical trials for avelumab in non-small cell lung cancer
From: Achievements and futures of immune checkpoint inhibitors in non-small cell lung cancer
NCT Number | Title | Phase | Interventions | Study design | Population | Primary endpoint | Secondary endpoint | Status | Primary completion |
|---|---|---|---|---|---|---|---|---|---|
NCT03050554 | Stereotactic body radiation therapy (SBRT) combined with avelumab (anti-PD-L1) for management of early stage non-small cell lung cancer (NSCLC) | I/II | Avelumab + SBRT | Single-arm trial | Stage I NSCLC with tumor(s) less than 5 cm in diameter or 250 cm3 in volume | Safety and tolerability, RFS | Locoregional control, OS | Active, not recruiting | 01-Oct-20 |
NCT02576574 | Avelumab in first-line non-small cell lung cancer (JAVELIN Lung 100) | III | Avelumab Pemetrexed Paclitaxel Gemcitabine Carboplatin Cisplatin | Randomized control trial | Metastatic or recurrent NSCLC without EGFR or ALK | PFS, OS | BOR, DOR, EQ-5D-5L | Active, not recruiting | 07-Jun-20 |
NCT03717155 | Study of avelumab and cetuximab plus gemcitabine and cisplatin in participants with squamous non-small cell lung cancer (NSCLC) | II | Avelumab + cetuximab + gemcitabine + cisplatin | Single-arm trial | Advanced lung squamous carcinoma without EGFR mutation, ALK rearrangementand brain metastasis | Best overall response | Occurrence of treatmentemergent adverse events, PFS, DOR | Recruiting | 25-Jan-21 |
NCT03472560 | A study of avelumab in combination with axitinib in non-small cell lung cancer (NSCLC) or urothelial cancer (Javelin Medley VEGF) | II | Avelumab + axitinib | Single-arm trial | Pretreated advanced NSCLC with no more than 2 prior lines and EGFR/ALK/ROS1 negative | ORR | TTR, DOR, PFS | Recruiting | 18-Sep-20 |
NCT02584634 | Study to evaluate safety, efficacy, pharmacokinetics and pharmacodynamics of avelumab in combination with either crizotinib or PF-06463922 In patients with NSCLC (Javelin Lung 101) | II | Avelumab Crizotinib | Non-randomized parallel trial | Advanced or metastatic NSCLC. ALK negative or positive | DLTs, ORR | PFS, DOR, TTR | Active, not recruiting | 15-Feb-19 |
NCT03317496 | Safety and efficacy study of avelumab plus chemotherapy with or without other anti-cancer immunotherapy agents in patients with advanced malignancies | II | Aveluma + pemetrexed/carboplatin Avelumab + gemcitabine/cisplatin | Non-randomized parallel trial | Untreated advanced non-squamous NSCLC without EGFR mutations or ALK rearrangement | DLT, ORR | PFS, DOR, TTR | Recruiting | 04-Sep-20 |
NCT03268057 | VX15/2503 in combination with avelumab in advanced non-small cell lung cancer | I/II | VX15/2503 + avelumab | Single-arm trial | No prior immunotherapy treated NSCLC | DLT, AEs | ORR, DOR, PFS | Recruiting | 01-May-20 |
NCT03270176 | A dose-finding study of the second mitochondrial activator of caspases (SMAC) mimetic debio 1143 when given in combination with avelumab to participants with advanced solid malignancies and to participants with advanced or metastatic non-small cell lung cancer (NSCLC) after platinum-based therapy | I | Debio 1143 + avelumab | Single-arm trial | NSCLC of stage IIIB or IV (7th IASLC) that has progressed after one line of platinum containing doublet chemotherapy | Maximum tolerated dose, ORR | SAEs, BOR, DOR, PFS, OS | Recruiting | 01-Sep-19 |
NCT03158883 | UCDCC#270: avelumab and stereotactic ablative radiotherapy in non-responding and progressing NSCLC patients | Early I | Avelumab Stereotactic ablative radiotherapy (SAR) | Non-randomized parallel trial | Immunotherapy pretreated advanced NSCLC without EGFR mutations or ALK rearrangement | Overall response rate | OS, PFS, DCR | Recruiting | 01-Jun-20 |
NCT03514719 | PD-L1 imaging in non small cell lung cancer’ (PINNACLE) | I | Avelumab | Single-arm trial | Stage IIIb/IV NSCLC or resectable stage Ia (≥ T1b tumor)—IIIa NSCLC | Tumor uptake of 89Zr-Avelumab | Correlation 89Zr-avelumab uptake in tumor lesions and PD-L1 expression | Recruiting | 31-Mar-22 |
NCT03637491 | A study of avelumab, binimetinib and talazoparib in patients with locally advanced or metastatic RAS-mutant solid tumors | II | Avelumab Binimetinib Talazoparib | Randomized control trial | Locally advanced (primary or recurrent) or metastatic solid tumors | DLT, ORR | TTR, OS, PFS | Recruiting | 01-May-22 |
NCT03409458 | A dose escalation and confirmation study of PT-112 in advanced solid tumors in combination with avelumab | I/II | PT-112 + avelumab | Single-arm trial | Metastatic or locally advanced disease | Recommended dose | DLTs, AEs, ORR, DCR, PFS | Recruiting | 01-Feb-20 |
NCT03386929 | Survival prolongation by rationale innovative genomics | I/II | Avelumab + axitinib + palbociclib | Single-arm trial | Locally advanced or metastatic NSCLC | DLT, RR, PFS, OS | Incidence of treatment-related and or biopsy-related serious adverse events | Recruiting | 01-Dec-21 |