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A Study of Neoadjuvant Chemotherapy Plus Nivolumab Versus Neoadjuvant Chemotherapy Plus Placebo, Followed by Surgical Removal and Adjuvant Treatment With Nivolumab or Placebo for Participants With Surgically Removable Early Stage Non-small Cell Lung Cancer

NCT04025879

Description:

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.

Related Conditions:
  • Non-Small Cell Lung Carcinoma
Recruiting Status:

Recruiting

Phase:

Phase 3

URL:

https://clinicaltrials.gov/show/NCT04025879

Trial Eligibility

Document

Title

  • Brief Title: A Study of Neoadjuvant Chemotherapy Plus Nivolumab Versus Neoadjuvant Chemotherapy Plus Placebo, Followed by Surgical Removal and Adjuvant Treatment With Nivolumab or Placebo for Participants With Surgically Removable Early Stage Non-small Cell Lung Cancer
  • Official Title: 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

Clinical Trial IDs

  • ORG STUDY ID: CA209-77T
  • SECONDARY ID: 2019-000262-38
  • NCT ID: NCT04025879

Conditions

  • Carcinoma, Non-Small-Cell Lung

Interventions

DrugSynonymsArms
NivolumabOpdivo, BMS936558Neoadj. Nivo+ Pt-based Doublet Chemo followed by Adj. Nivo
CarboplatinNeoadj. Nivo+ Pt-based Doublet Chemo followed by Adj. Nivo
CisplatinNeoadj. Nivo+ Pt-based Doublet Chemo followed by Adj. Nivo
PaclitaxelNeoadj. Nivo+ Pt-based Doublet Chemo followed by Adj. Nivo
PemetrexedNeoadj. Nivo+ Pt-based Doublet Chemo followed by Adj. Nivo
PlaceboNeoadj. Plac. + Pt-based Doublet Chemo followed by Adj.Plac.
DocetaxelNeoadj. Nivo+ Pt-based Doublet Chemo followed by Adj. Nivo

Purpose

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.

Trial Arms

NameTypeDescriptionInterventions
Neoadj. Nivo+ Pt-based Doublet Chemo followed by Adj. NivoExperimental
  • Nivolumab
  • Carboplatin
  • Cisplatin
  • Paclitaxel
  • Pemetrexed
  • Docetaxel
Neoadj. Plac. + Pt-based Doublet Chemo followed by Adj.Plac.Placebo Comparator
  • Carboplatin
  • Cisplatin
  • Paclitaxel
  • Pemetrexed
  • Placebo
  • Docetaxel

Eligibility Criteria

        For more information regarding Bristol-Myers Squibb Clinical Trial participation, please
        visit www.BMSStudyConnect.com

        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
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Event-Free Survival (EFS) as Assessed by Blinded Independent Central Review (BICR)
Time Frame:5 Years from randomization
Safety Issue:
Description:

Secondary Outcome Measures

Measure:Overall Survival (OS)
Time Frame:Up to 5 years from randomization
Safety Issue:
Description:
Measure:Pathologic Complete Response (pCR) Rate as Assessed by Blinded Independent Pathology Review (BIPR)
Time Frame:At the time of surgery, between week 12 to week 18
Safety Issue:
Description:
Measure:Major Pathological Response (MPR) Rate as Assessed by Blinded Independent Pathology Review
Time Frame:Up to 8 weeks following completion of neoadjuvant surgery, approximately study week 22
Safety Issue:
Description:
Measure:Incidence of Serious Adverse Events (SAEs)
Time Frame:Up to 80 weeks
Safety Issue:
Description:
Measure:Incidence of Adverse Events (AEs)
Time Frame:Up to 80 weeks
Safety Issue:
Description:

Details

Phase:Phase 3
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Bristol-Myers Squibb

Last Updated

August 25, 2021