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Clinical Trials Search at Vanderbilt-Ingram Cancer Center

A Neoadjuvant Study of Nivolumab Plus Ipilimumab or Nivolumab Plus Chemotherapy Versus Chemotherapy Alone in Early Stage Non-Small Cell Lung Cancer (NSCLC)

The purpose of this neoadjuvant study is to compare nivolumab plus chemotherapy and chemotherapy alone in terms of safety and effectiveness, and to describe nivolumab plus ipilimumab's safety and effectiveness in treating resectable NSCLC. This study has multiple primary endpoints. The first primary completion date of Pathological Complete Response is anticipated to be reached April 2020. The completion date for all primary outcome measures is expected May 2023.
Phase III
Chemotherapy - cytotoxic, Mol. targeted/Immunotherapy/Biologics
Cisplatin, Docetaxel (Taxotere), Gemcitabine, Ipilimumab, Nivolumab (BMS-936558), Pemetrexed, Vinorelbine
Horn, Leora
Vanderbilt University


18 Years
Inclusion Criteria:

Early stage IB-IIIA, operable non-small cell lung cancer, confirmed in tissue

Lung function capacity capable of tolerating the proposed lung surgery

Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1

Available tissue of primary lung tumor

Exclusion Criteria:

Presence of locally advanced, inoperable or metastatic disease

Participants with active, known or suspected autoimmune disease

Prior treatment with any drug that targets T cell co-stimulations pathways (such as checkpoint inhibitors)

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