drugset / Trial / NCT02927301
A Study of Atezolizumab as Neoadjuvant and Adjuvant Therapy in Resectable Non-Small Cell Lung Cancer (NSCLC) - Lung Cancer Mutation Consortium (LCMC3)
NaSingle-groupOpen-labelTreatment
Summary
This study was designed to evaluate the safety and efficacy of neoadjuvant and adjuvant atezolizumab in participants with resectable Non-Small Cell Lung Cancer (NSCLC). Neoadjuvant therapy consisted of two 21-day cycles with atezolizumab. Following surgery, adjuvant therapy consisted of up to 12 months of atezolizumab in participants who demonstrate clinical benefit with neoadjuvant therapy. All participants who undergo surgery entered a surveillance period, which consisted of standardized blood sample collection and Chest CT Scans, for up to 2 years. All participants were monitored for disease recurrence and survival for up to 3 years after last dose of study drug.
Timeline
- Start
- 2017-04-20
- Primary completion
- 2020-05-07
- Completion
- 2023-09-05
Publications
- Dacic S, Travis WD, Giltnane JM, Kos F, Abel J, Hilz S, Fujimoto J, Sholl L, Ritter J, Khalil F, Liu Y, Taylor-Weiner A, Resnick M, Yu H, Hirsch FR, Bunn PA Jr, Carbone DP, Rusch V, Kwiatkowski DJ, Johnson BE, Lee JM, Hennek SR, Wapinski I, Nicholas A, Johnson A, Schulze K, Kris MG, Wistuba II. Artificial Intelligence-Powered Assessment of Pathologic Response to Neoadjuvant Atezolizumab in Patients With NSCLC: Results From the LCMC3 Study. J Thorac Oncol. 2024 May;19(5):719-731. doi: 10.1016/j.jtho.2023.12.010. Epub 2023 Dec 7.
- Chaft JE, Oezkan F, Kris MG, Bunn PA, Wistuba II, Kwiatkowski DJ, Owen DH, Tang Y, Johnson BE, Lee JM, Lozanski G, Pietrzak M, Seweryn M, Byun WY, Schulze K, Nicholas A, Johnson A, Grindheim J, Hilz S, Shames DS, Rivard C, Toloza E, Haura EB, McNamee CJ, Patterson GA, Waqar SN, Rusch VW, Carbone DP; LCMC study investigators. Neoadjuvant atezolizumab for resectable non-small cell lung cancer: an open-label, single-arm phase II trial. Nat Med. 2022 Oct;28(10):2155-2161. doi: 10.1038/s41591-022-01962-5. Epub 2022 Sep 12.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Atezolizumab | Monoclonal antibody | 1200 mg | Intravenous |