A Phase 3, Randomized, Double-blind Study of Neoadjuvant Chemotherapy Plus Nivolumab Versus Neoadjuvant Chemotherapy Plus Placebo, Followed by Surgical Resection and Adjuvant Treatment With Nivolumab or Placebo for Participants With Resectable Stage II-IIIB Non-small Cell Lung Cancer

  • End date
    Sep 30, 2024
  • participants needed
  • sponsor
    Bristol-Myers Squibb
Updated on 15 September 2022
brain metastases
cancer treatment
cancer chemotherapy
lung carcinoma


The main purpose of the study is to examine if periadjuvant (neoadjuvant, then adjuvant) immunotherapy will prolong event free survival in participants with early stage non-small cell lung cancer.

Condition Carcinoma, Non-Small-Cell Lung
Treatment cisplatin, docetaxel, carboplatin, Placebo, Paclitaxel, Pemetrexed, Nivolumab
Clinical Study IdentifierNCT04025879
SponsorBristol-Myers Squibb
Last Modified on15 September 2022


Yes No Not Sure

Inclusion Criteria

Participants with suspected or histologically confirmed Stage IIA (> 4 cm) to IIIB (T3N2) non-small cell lung carcinoma (NSCLC) with disease that is considered resectable
No brain metastasis
Treatment-naive for NSCLC (no prior systemic anti-cancer treatment)
Ability to provide surgical or biopsy tumor tissue for biomarkers
Eastern Cooperative Oncology Group (ECOG) Performance Status of ≤ 1

Exclusion Criteria

Participants with an active, known or suspected autoimmune disease
Any positive test for hepatitis B virus or hepatitis C virus or human immunodeficiency virus (HIV)
Any previous anti-cancer treatment including cytotoxic, IO treatment, targeted agents, or radiotherapy for NSCLC
Prior treatment with any anti-PD-1, anti-PD-L1, anti-PD-L2, or anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways
Other protocol-defined inclusion/exclusion criteria apply
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact



Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider


Browse trials for

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 



Reply by • Private

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note