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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04025879
Recruitment Status : Recruiting
First Posted : July 19, 2019
Last Update Posted : October 30, 2020
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

Brief Summary:
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 or disease Intervention/treatment Phase
Carcinoma, Non-Small-Cell Lung Biological: Nivolumab Drug: Carboplatin Drug: Cisplatin Drug: Paclitaxel Drug: Pemetrexed Drug: Placebo Drug: Docetaxel Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 452 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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
Actual Study Start Date : September 16, 2019
Estimated Primary Completion Date : December 10, 2023
Estimated Study Completion Date : September 30, 2024

Resource links provided by the National Library of Medicine

Drug Information available for: Nivolumab

Arm Intervention/treatment
Experimental: Neoadj. Nivo+ Pt-based Doublet Chemo followed by Adj. Nivo Biological: Nivolumab
Specified dose on specified days
Other Name: Opdivo, BMS936558

Drug: Carboplatin
Specified dose on specified days

Drug: Cisplatin
Specified dose on specified days

Drug: Paclitaxel
Specified dose on specified days

Drug: Pemetrexed
Specified dose on specified days

Drug: Docetaxel
Specified dose on specified days

Placebo Comparator: Neoadj. Plac. + Pt-based Doublet Chemo followed by Adj.Plac. Drug: Carboplatin
Specified dose on specified days

Drug: Cisplatin
Specified dose on specified days

Drug: Paclitaxel
Specified dose on specified days

Drug: Pemetrexed
Specified dose on specified days

Drug: Placebo
Specified dose on specified days

Drug: Docetaxel
Specified dose on specified days




Primary Outcome Measures :
  1. Event-Free Survival (EFS) as Assessed by Blinded Independent Central Review (BICR) [ Time Frame: 5 Years from randomization ]

Secondary Outcome Measures :
  1. Overall Survival (OS) [ Time Frame: Up to 5 years from randomization ]
  2. 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 ]
  3. 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 ]
  4. Incidence of Serious Adverse Events (SAEs) [ Time Frame: Up to 80 weeks ]
  5. Incidence of Adverse Events (AEs) [ Time Frame: Up to 80 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04025879


Contacts
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Contact: Recruiting sites have contact information. Please contact the sites directly. If there is no contact information, please email: Clinical.Trials@bms.com
Contact: First line of the email MUST contain NCT# and Site #.

Locations
Show Show 122 study locations
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
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Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
Additional Information:
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Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT04025879    
Other Study ID Numbers: CA209-77T
2019-000262-38 ( EudraCT Number )
First Posted: July 19, 2019    Key Record Dates
Last Update Posted: October 30, 2020
Last Verified: October 2020

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Carcinoma, Non-Small-Cell Lung
Carcinoma, Bronchogenic
Bronchial Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Paclitaxel
Docetaxel
Cisplatin
Carboplatin
Nivolumab
Pemetrexed
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Immunological
Enzyme Inhibitors
Folic Acid Antagonists
Nucleic Acid Synthesis Inhibitors