Table 2.
Current trials without results.
| Identifier, phase | Disease | Intervention | Primary outcomes | Estimated completion date |
|---|---|---|---|---|
| NCT02599454a I | Medically/surgically inoperable I NSCLC | Atez + SBRT | Maximum tolerated dose | November 2019 |
| NCT02994576a (PRINCEPS) II | IB, II, or IIIA (non N2) NSCLC | Atez as neoadjuvant therapy | Rate of patients without major toxicities or morbidities | May 2021 |
| NCT03102242b II | unresectable or inoperable IIIA/B NSCLC | Atez as neoadjuvant therapy, with CRT, and as adjuvant therapy | DCR after 12 weeks induction | Mar 2020 |
| NCT02927301a II | IB, II, or IIIA NSCLC | Atez as neoadjuvant and adjuvant therapy | Major pathologic response based on surgical resection* | July 2023 |
| NCT02848651a (B-F1RST) II | IIIB-IVB NSCLC | Atez monotherapy | INV-assessed ORR per modified RECIST v1.1; PFS per RECIST v1.1 by circulating blood-based tumor biomarkers | June 2020 |
| NCT02409342a (IMpower110) III | PDL-1 positive, IV non-squamous or squamous NSCLC | Atez vs. chemotherapy | OS | August 2020 |
| NCT02409355c IMpower111) III | PDL-1 positive, IV squamous NSCLC | Atezo vs. chemotherapy | INV-assessed PFS per RECIST v1.1 | September 2017 |
| NCT02367781c (IMpower130) III | IV non-squamous NSCLC | (Atez + chemotherapy) vs. chemotherapy | INV-assessed PFS per RECIST v1.1 (ITT and PDL-1-selected population); OS (ITT and PDL-1-selected population) | October 2018 |
| NCT02367794c (IMpower131) III | IV squamous NSCLC | (Atez + chemotherapy) vs. chemotherapy | INV-assessed PFS per RECIST v1.1 (ITT and TGE population); OS (ITT population) | February 2023 |
| NCT02657434a (IMpower132) III | IV non-squamous NSCLC | (Atez + chemotherapy) vs. chemotherapy | INV-assessed PFS per RECIST v1.1; OS | November 2019 |
Currently recruiting participants.
Not yet open for recruiting participants.
Not currently recruiting participants.
Hellman et al., 2014. Atez, atezolizumab; AEs, adverse events; CRT, chemoradiotherapy; DCR, disease control rate; DLT, dose-limiting toxicities; IC1/2/3, tumor-infiltrating immune cells with minimum 1% PDL-1 expression; IC2/3, tumor-infiltrating immune cells with minimum 5% PDL-1 expression; INV, investigator; IRF, independent review facility; ITT, intent-to-treat; NSCLC, non-small cell lung cancer; ORR, objective response rate; OS, overall survival; PFS, progression-free survival; RECIST, Response Evaluation Criteria in Solid Tumors; SBRT, stereotactic ablative radiotherapy; TC1/2/3, tumor cells with minimum 1% PDL-1 expression; TC2/3, tumor cells with minimum 5% PDL-1 expression; TGE, tumor gene expression.