Table 4 Ongoing phase III trials for durvalumab in early-stage and advanced-stage lung cancer
Objectives | Identifier | Title | Intervention | Study design | Population | Primary endpoint | Secondary endpoint | Status | Primary completion |
|---|---|---|---|---|---|---|---|---|---|
Early-stage | NCT03703297 | A phase III, randomized, double-blind, placebo-controlled, multi-center, international study of durvalumab or durvalumab and tremelimumab as consolidation treatment for patients with stagei-iii limited disease small-cell lung cancer who have not progressed following concurrent chemoradiation therapy (ADRIATIC) | • Durvalumab+placebo • Durvalumab tremelimuab, placebo+placebo | Randomized parallel trial | Limited-stage SCLC without progression after definitive concurrent chemoradiation | PFS, OS | ORR, TTD/TTM, PFS2 | Recruiting | Jun 2021 |
NCT03800134 | A phase III, double-blind, placebo-controlled, multi-center international study of neoadjuvant/adjuvant durvalumab for the treatment of patients with resectable stages II and III non-small cell lung cancer (AEGEAN) | • Durvalumab+platinum-based chemotherapy • Placebo+platinum-based chemotherapy | Randomized parallel trial | Resectable stage IIA-IIIB NSCLC | MPR | pCR, OS, DFS | Recruiting | Jul 2020 | |
NCT03519971 | A phase III, randomized, placebo-controlled, double-blind, multi-center, international study of durvalumab given concurrently with platinum-based chemoradiation therapy in patients with locally advanced, unresectable non-small cell lung cancer (StageIII) (PACIFIC2) | • Durvalumab+platinum-based chemotherapy and radiation • Placebo+platinum-based chemotherapy and radiation | Randomized parallel trial | Unresectable locally advanced stage III NSCLC | PFS, ORR | OS, DOR, PFS2 | Recruiting | Sep 2020 | |
NCT02273375 | A phase III prospective double blind placebo controlled randomized study of adjuvant MEDI4736 in completely resected non-small cell lung cancer | • Durvalumab • Placebo | Randomized parallel trial | Stage IB (> 4 cm) to IIIA NSCLC after complete surgical resection | DFS | OS, LCSS | Recruiting | Jan 2023 | |
NCT03706690 | A phase III, randomized,double-blind,placebo-controlled,study of durvalumab as consolidation therapy in patients with locally advanced, unresectable NSCLC, who have not progressed following definitive, platinum-based chemoradiation therapy (PACIFIC5) | • Durvalumab • Placebo | Randomized parallel trial | Unresectable locally advanced stage III NSCLC | PFS | OS, ORR, DOR | Recruiting | Mar 2021 | |
Advanced-stage | NCT03164616 | A phase III, randomized, multi-center, open-label, comparative global study to determine the efficacy of durvalumab or durvalumab and tremelimumab in combination with platinum-based chemotherapy for first-line treatment in patients with metastatic non small-cell lung cancer (NSCLC) (POSEIDON) | • Durvalumab+tremelimumab • Durvalumab monotherapy+SoC • SoC chemotherapy alone | Randomized parallel trial | Untreated advanced NSCLC without activating EGFR mutation or ALK fusions | PFS, OS | ORR, DOR, PFS2 | Recruiting | Sep 2019 |
NCT03003962 | A phase III randomized, open-label, multi-center study of durvalumab (MEDI4736) versus standard of care (SoC) platinum-based chemotherapy as first line treatment in patients with PD-L1-high expression advanced non small-cell lung cancer | • Durvalumab • SoC chemotherapy | Randomized parallel trial | Untreated advanced PD-L1 positive NSCLC without EGFR mutation and ALK rearrangement | OS | ORR, DOR, PFS | Recruiting | Sep 2019 | |
NCT02453282 | A phase III randomized, open-label, multi-center, global study of MEDI4736 in combination with tremelimumab therapy or MEDI4736 monotherapy versus standard of careplatinum-based chemotherapy in first line treatment of patients with advanced or metastatic non small-cell lung cancer (MYSTIC) | • Durvalumab • Durvalumab+tremelimumab • SoC chemotherapy | Randomized parallel trial | Untreated advanced NSCLC without activating EGFR mutation or ALK fusions | OS, PFS | ORR | Active, not recruiting | Oct 2018 | |
NCT03043872 | A phase III, randomized, multicenter,open-label, comparative study to determine the efficacy of durvalumab or durvalumab and tremelimumab in combination with platinum-based chemotherapy for the first-line treatment in patients with extensive disease small-cell lung cancer (SCLC) (CASPIAN) | • Durvalumab+tremelimumab+EP • Durvalumab+EP • EP | Randomized parallel trial | Untreated extensive stage SCLC | OS, PFS | ORR, EORTC QLQ-C30 | Active, not recruiting | Sep 2019 | |
NCT02542293 | A phase III randomized, open-label, multi-center, global study of medi4736 in combination with tremelimumab therapy versus standard of care platinum-based chemotherapy in first-line treatment of patients with advanced or metastatic non small-cell lung cancer (NSCLC) | • Durvalumab+tremelimumab • SoC chemotherapy | Randomized parallel trial | Untreated advanced NSCLC without activating EGFR mutation or ALK fusions | OS | PFS, ORR, DOR | Active, not recruiting | Mar 2019 | |
NCT02352948 | A phase III, open label, randomized, multi-centre, international study of MEDI4736, given as monotherapy or in combination with tremelimumab determinedby PD-L1 expression versus standard of care in patients with locally advanced or metastatic non-small cell lung cancer (stage IIIB-IV) who have received at least two prior systemic treatment regimens including one platinum based chemotherapy regimen and do not have known EGFR activating mutations or ALK rearrangements (ARCTIC) | • Durvalumab • Durvalumab+tremelimumab • Tremelimumab • Vinorelbine/gemcitabine/erlotinib | Randomized parallel trial | Advanced NSCLC without EGFR mutations and ALK rearrangment after progression of chemotherapy and at least one prior regimens treatment | OS, PFS | ORR, DOR | Active, not recruiting | Feb 2018 |