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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
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
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
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
  1. Avelumab showed a manageable safety profile and promising clinical activity in pretreated metastatic or recurrent NSCLC patients
  2. PFS progression-free survival, OS overall survival, ORR objective response rate, DLT dose-limiting toxicities, DOR duration of response, TTR time to response, BOR best overall response, TEAE treatment of adverse events