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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) (CheckMate 816)
EU CTIS ID: 2022-501360-18-00
What this study is testing
-To compare the event-free survival (EFS) by blinded independent central review (BICR) in participants receiving nivolumab plus platinum doublet chemotherapy vs participants receiving platinum doublet chemotherapy in operable stage IB (>= 4 cm), II, or resectable IIIA (N2) NSCLC. -To compare the pathologic complete response (pCR) rate in participants receiving nivolumab plus platinum doublet chemotherapy vs participants receiving platinum doublet chemotherapy in operable stage IB (>= 4cm), II, or resectable IIIA (N2) NSCLC
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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.
You likely can't join if
- 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).
The study team makes the final eligibility decision.
Where it's taking place
- United States
- Argentina
- Korea, Republic of
- Japan
- South Africa
- China
- Canada
- Brazil
- Taiwan
- Turkey
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include United States; Argentina; Korea, Republic of; Japan; South Africa; China and 4 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.