Table 3 Details of ongoing clinical trials for avelumab in early-stage and advanced-stage lung cancer
Objectives | Identifier | Title | Phase | Intervention | Study design | Population | Primary endpoint | Secondary endpoint | Status | Primary completion |
|---|---|---|---|---|---|---|---|---|---|---|
Early-stage | NCT03050554 | Phase I/II study of the safety, tolerability, and efficacy of stereotactic body radiation therapy (SBRT) combined with concurrent and adjuvant avelumab for definitive 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 | Recruiting | Oct 2020 |
Advanced-stage | NCT02576574 | A Phase III, open-label, multicenter trial of avelumab (MSB0010718C) versus platinum-based doublet as a first line treatment of recurrent or stage IV PD-L1+non-small cell lung cancer | III | Avelumab | Randomized control trial | Metastatic or recurrent NSCLC without EGFR or ALK | PFS, OS | Best overall response, DOR, EQ-5D-5L | Active, not recruiting | 2019 Oct |
NCT03472560 | A phase II, open-label study to evaluate safety and clinical activity of avelumab in combination with axitinib in patients with advanced or metastatic previously treated non-small cell lung cancer or treatment naive cisplatin-ineligble 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 | Sep 2020 | |
NCT03717155 | A phase IIa, single-arm, multicenter study to investigate the clinical activity and safety of avelumab in combination with cetuximab plus gemcitabine and cisplatinin participants with advanced squamous non-small-cell lung cancer | II | Avelumab+cetuximab+gemcitabine+cisplatin | Single-arm trial | Advanced lung squamous carcinoma without EGFR mutation, ALK rearrangementand brain metastasis | Best overall response | Occurrence of treatment-emergent adverse events, PFS, DOR | Recruiting | Jan 2021 | |
NCT03568097 | Phased avelumab combined with chemotherapy as first-line treatment for patients with advanced small-cell lung cancer (SCLC) | II | Avelumab+cisplatin (carboplatin)+etoposide | Single-arm trial | Treatment-naive advanced SCLC with untreated stable brain metastasis | 1-year PFS | OS, best overall response, ORR | Recruiting | Nov 2020 | |
NCT02584634 | A phase 1B/2, open-label, dose-finding study to evaluate safety, efficacy, pharmacokinetics and pharmacodynamics of avelumab in combination with either crizotinib or PF-06463922 in patients with advanced or metastatic non-small cell lung cancer | II | Group A: avelumab+crizotinib; group B: avelumab+PF-06463922 | Non-randomized trial | Pretreated advanced NSCLC without ALK rearrangement for group A and unlimited prior lines with ALK positive for group B | DLT, overall response rate | DCR, OS | Active, not recruiting | Feb 2019 | |
NCT03268057 | Phase 1b/study of 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 | May 2020 | |
NCT03317496 | A multicenter, open-label, phase 1B/2 study to evaluate safety and efficacy of avelumab in combination with chemotherapy with or without other anti-cancer immunotherapies as first-line treatment in patients with advanced malignancies | II | Avelumab+pemetrexed/carboplatin | Non-randomized parallel trial | Untreated advanced non-squamous NSCLC without EGFR mutations or ALK rearrangement | DLT, ORR | PFS, DOR, TTR | Recruiting | Oct 2020 | |
NCT03158883 | A pilot study of avelumab and stereotactic ablative radiotherapy in non-responding and progressing NSCLC patients previously treated with a PD-1 inhibitor | I | Avelumab+Stereotactic ablative radiotherapy | Non-randomized parallel trial | Immunotherapy pre-treated advanced NSCLC without EGFR mutations or ALK rearrangement | Overall response rate | OS, PFS, DCR | Recruiting | Jun 2020 | |
NCT02554812 | A phase 1B/2, open-label study to evaluate safety, clinical activity, pharmacokinetics and pharmacodynamics of avelumab in combination with other cancer immunotherapies in patients with advanced maligancies | II | Avelumab+Utomilumab | Randomized parallel trial | Advanced NSCLC without EGFR mutation or ALK/ROS1 rearrangement regardless of prior lines treatment | DLT, ORR | TTR, DOR, PFS | Recruiting | Dec 2020 |