A Two-arm (Phase 2) Exploratory Study of Nivolumab Monotherapy or in Combination With Nab-paclitaxel and Carboplatin in Early Stage NSCLC in China

A Two-arm (Phase 2) Exploratory Study of Nivolumab Monotherapy or in Combination With Nab-paclitaxel and Carboplatin in Early Stage NSCLC in China

Publication date: Jul 11, 2019

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.

Concepts Keywords
Adjuvant Checkpoint inhibitors protocol
Antiangiogenic Chemotherapy
Autoimmune Transplantation
Autologous Checkpoint inhibitor
Biomarkers Non-small-cell lung carcinoma
Brentuximab Vedotin Nivolumab
Carboplatin Lung cancer
Carcinoma Breakthrough therapy
CD274 Antineoplastic drugs
Chemotherapy Monoclonal antibodies
China Bristol-Myers Squibb
Clinical Trials Cancer treatments
Cooperative Group Clinical medicine
European Union Chemotherapy
Glioblastoma Multiforme Immunotherapies
Guangdong Lung surgery
Hematopoietic Unresectable metastatic melanoma
IgG4 Lung Tumor
Immunotherapies Activity tumor
Isotype Characterization tumor
Lung Cancer
Renal Carcinoma
Squamous Carcinoma


Type Source Name
disease DOID Hodgkin lymphoma
disease MESH Hodgkin lymphoma
drug DRUGBANK Platinum
pathway BSID Small cell lung cancer
disease MESH small cell lung cancer
disease MESH mesothelioma
disease DOID glioblastoma multiforme
disease MESH glioblastoma multiforme
disease DOID squamous cell carcinoma of the head and neck
disease MESH squamous cell carcinoma of the head and neck
disease MESH development
pathway BSID Non-small cell lung cancer
disease MESH non-small cell lung cancer
pathway BSID Renal cell carcinoma
disease DOID renal cell carcinoma
disease MESH renal cell carcinoma
pathway BSID Melanoma
disease DOID melanoma
disease MESH melanoma
disease MESH tumor
drug DRUGBANK Nivolumab
drug DRUGBANK Paclitaxel
drug DRUGBANK Carboplatin
disease DOID NSCLC
disease MESH disease progression
drug DRUGBANK Brentuximab vedotin
disease MESH autoimmune disease
disease DOID autoimmune disease


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