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

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

Principal Investigator

Gilberto Lopes

Enrollment Status

Closed

Clinical Trial ID

Institutional Protocol # 20170923
National Clinical Trials Identifier NCT02998528

Clinical Trial Summary

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.


Phase

Phase 3


Funding Agency/Sponsor

Industrial


Disease

Thoracic Oncology


Enrollment Eligibility

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)
Other protocol defined inclusion/exclusion criteria apply


Contact Information

Phone Number +1 (305) 2434624
Get detailed information on ClinicalTrials.Gov

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