Non Small Cell Lung Cancer Clinical Trial
Official title:
A Two-arm (Phase 2) Exploratory Study of Nivolumab Monotherapy or in Combination With Nab-paclitaxel and Carboplatin in Early Stage NSCLC in China
Nivolumab (BMS-936558) is a fully human, IgG4 (kappa) isotype mAb that binds PD-1 on
activated immune cells and disrupts engagement of the receptor with its ligands PD-L1 (B7
H1/CD274) and PD-L2 (B7-DC/CD273), thereby abrogating inhibitory signals and augmenting the
host antitumor response. In early clinical trials, nivolumab has demonstrated activity in
several tumor types, including melanoma, renal cell carcinoma (RCC), and non-small cell lung
cancer (NSCLC).
Nivolumab is in clinical development for the treatment of patients with NSCLC, RCC, melanoma,
squamous cell carcinoma of the head and neck (SCCHN) and other tumors (eg, glioblastoma
multiforme, mesothelioma, small cell lung cancer, gastric).
Nivolumab is approved in the United States (US), European Union, and other countries for the
treatment of patients with unresectable or metastatic melanoma, advanced NSCLC with
progression on or after platinum-based chemotherapy, advanced RCC whose disease progressed on
an antiangiogenic therapy, classical Hodgkin lymphoma that has relapsed or progressed after
autologous hematopoietic stem cell transplantation and post-transplantation brentuximab
vedotin treatment, and recurrent or metastatic squamous cell carcinoma of the head and neck
with disease progression on or after a platinum-based therapy.
The proposed study will evaluate the efficacy and safety of preoperative administration of
Nivolumab or Nivolumab combined with nab-paclitaxel and carboplatin in neoadjuvant setting
and administration of Nivolumab in adjuvant setting in patients with high-risk resectable
NSCLC, and will facilitate a comprehensive exploratory characterization of the tumor immune
microenvironment and circulating immune cells in these patients. Data obtained in this study
will provide valuable information for planning further prospective clinical trials of
anti-PD-1 and other immunotherapies in NSCLC, both in the peri-operative and advanced disease
setting. Ultimately, it is highly desirable to discover prospective biomarkers of response
and toxicity to allow patients with NSCLC who are most likely to derive benefit to receive
anti-PD-1 treatment, and conversely to minimize the risk of toxicity and ineffective
treatment for patients who are unlikely to benefit.
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