First-line Treatment of Participants With Stage IV Squamous Non-Small Cell Lung Cancer With Necitumumab and Gemcitabine-Cisplatin
Summary
The research study is testing the investigational drug necitumumab (IMC-11F8) in the treatment of advanced non-small cell lung cancer. The aim of this study is to determine if necitumumab, given together with a standard chemotherapy combination consisting of cisplatin and gemcitabine will be more effective in improving participant disease than the standard chemotherapy combination alone.
Timeline
- Start
- 2010-01-07
- Primary completion
- 2013-06-17
- Completion
- 2024-05-30
Outcome
Met primary endpoint
registry analysis (unspecified test); Necitumumab + Gemcitabine + Cisplatin vs Gemcitabine + Cisplatin; p = 0.0120; Hazard Ratio (HR) 0.842 (95% CI 0.736 to 0.962); Log Rank NCT00981058 ↗
paper Overall survival was significantly longer in the necitumumab plus gemcitabine and cisplatin group than in the gemcitabine and cisplatin alone group PMID 26045340 ↗
release “SQUIRE, a recently completed Phase III study, met its primary endpoint, finding that patients with stage IV metastatic squamous non-small cell lung cancer” lilly.com ↗
Publications
- Yuan M, Su S, Ding H, Yang Y, Gupta M, Xu XS. Multitask learning of longitudinal circulating biomarkers and clinical outcomes: identification of optimal machine-learning and deep-learning models. BMC Med Inform Decis Mak. 2026 Jun 30. doi: 10.1186/s12911-026-03671-2. Online ahead of print.
- Ciuleanu T, Socinski MA, Obasaju C, Luft AV, Szczesna A, Szafranski W, Ramlau R, Balint B, Molinier O, Depenbrock H, Nanda S, Paz-Ares L, Thatcher N. Efficacy and Safety of Necitumumab Continuation Therapy in the Phase III SQUIRE Study of Patients With Stage IV Squamous Non-Small-Cell Lung Cancer. Clin Lung Cancer. 2018 Mar;19(2):130-138.e2. doi: 10.1016/j.cllc.2017.10.004. Epub 2017 Oct 13.
- Paz-Ares L, Socinski MA, Shahidi J, Hozak RR, Soldatenkova V, Kurek R, Varella-Garcia M, Thatcher N, Hirsch FR. Correlation of EGFR-expression with safety and efficacy outcomes in SQUIRE: a randomized, multicenter, open-label, phase III study of gemcitabine-cisplatin plus necitumumab versus gemcitabine-cisplatin alone in the first-line treatment of patients with stage IV squamous non-small-cell lung cancer. Ann Oncol. 2016 Aug;27(8):1573-9. doi: 10.1093/annonc/mdw214. Epub 2016 May 20.
- Reck M, Socinski MA, Luft A, Szczesna A, Dediu M, Ramlau R, Losonczy G, Molinier O, Schumann C, Gralla RJ, Bonomi P, Brown J, Soldatenkova V, Chouaki N, Obasaju C, Peterson P, Thatcher N. The Effect of Necitumumab in Combination with Gemcitabine plus Cisplatin on Tolerability and on Quality of Life: Results from the Phase 3 SQUIRE Trial. J Thorac Oncol. 2016 Jun;11(6):808-18. doi: 10.1016/j.jtho.2016.03.002. Epub 2016 Mar 12.
- Thatcher N, Hirsch FR, Luft AV, Szczesna A, Ciuleanu TE, Dediu M, Ramlau R, Galiulin RK, Balint B, Losonczy G, Kazarnowicz A, Park K, Schumann C, Reck M, Depenbrock H, Nanda S, Kruljac-Letunic A, Kurek R, Paz-Ares L, Socinski MA; SQUIRE Investigators. Necitumumab plus gemcitabine and cisplatin versus gemcitabine and cisplatin alone as first-line therapy in patients with stage IV squamous non-small-cell lung cancer (SQUIRE): an open-label, randomised, controlled phase 3 trial. Lancet Oncol. 2015 Jul;16(7):763-74. doi: 10.1016/S1470-2045(15)00021-2. Epub 2015 Jun 1.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Necitumumab | Monoclonal antibody | 800 mg | Intravenous |
| Background | Cisplatin | Other / unclassified | 75 mg/m2 | Intravenous |
| Background | Gemcitabine | Small molecule | 1250 mg/m2 | Intravenous |