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An Investigational Immuno-therapy Study of Nivolumab Given After Surgery in Non-Small Cell Lung Cancer (NSCLC) Participants With Minimal Residual Disease

NCT03770299

Description:

The purpose of this study is to determine if nivolumab added to the standard of care therapy (SOC) given after surgery is more effective than SOC alone in prolonging disease free survival in NSCLC participants with minimal residual disease detected after surgery.

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

Not yet recruiting

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: An Investigational Immuno-therapy Study of Nivolumab Given After Surgery in Non-Small Cell Lung Cancer (NSCLC) Participants With Minimal Residual Disease
  • Official Title: A Phase 2 Multi-Center Randomized Trial to Assess Early Intervention With Adjuvant Nivolumab in Non-Small Cell Lung Cancer Participants With ctDNA-detected Minimal Residual Disease After Surgical Resection

Clinical Trial IDs

  • ORG STUDY ID: CA209-9TN
  • SECONDARY ID: 2018-003719-23
  • NCT ID: NCT03770299

Conditions

  • Non-Small Cell Lung Cancer
  • Non-Small-Cell Lung Carcinoma
  • Circulating Tumor DNA

Interventions

DrugSynonymsArms
NivolumabArm A
VinorelbineArm A
GemcitabineArm A
DocetaxelArm A
PemetrexedArm A
CisplatinArm A
CarboplatinArm A
PaclitaxelArm A

Purpose

The purpose of this study is to determine if nivolumab added to the standard of care therapy (SOC) given after surgery is more effective than SOC alone in prolonging disease free survival in NSCLC participants with minimal residual disease detected after surgery.

Trial Arms

NameTypeDescriptionInterventions
Arm AExperimentalNivolumab + SOC (chemotherapy in eligible participants or observation)
  • Nivolumab
  • Vinorelbine
  • Gemcitabine
  • Docetaxel
  • Pemetrexed
  • Cisplatin
  • Carboplatin
  • Paclitaxel
Arm BActive ComparatorSOC (chemotherapy in eligible participants or observation)
  • Vinorelbine
  • Gemcitabine
  • Docetaxel
  • Pemetrexed
  • Cisplatin
  • Carboplatin
  • Paclitaxel

Eligibility Criteria

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

        Inclusion Criteria prior to Surgery:

          -  Suspected or histologically confirmed Stage IIA to IIIB NSCLC with disease that is
             considered resectable

          -  Must be deemed eligible for complete resection and must agree to undergo standard of
             care surgery for complete resection of NSCLC

          -  Treatment naive (no previous systemic treatment)

        Inclusion Criteria prior to Treatment Randomization:

          -  Must have undergone complete surgical resection of their Stage IIA to IIIB NSCLC

          -  Must have adequately recovered from surgery at the time of randomization

          -  Minimal residual disease (MRD) positive results as detected by ctDNA

        Exclusion Criteria prior to Surgery:

          -  Participants with known EGFR mutations which are sensitive to available targeted
             inhibitor therapy (Prior to treatment randomization in select sites)

          -  Active, known or suspected autoimmune disease

          -  Participants with a condition requiring systemic treatment with either corticosteroids
             (> 10 mg daily prednisone equivalent) or other immunosuppressive medications within 14
             days of randomization

        Exclusion Criteria prior to Treatment Randomization:

          -  Must continue to meet Exclusion Criteria prior to Surgery

          -  Must have no evidence of metastatic disease after surgery

          -  Received a live/attenuated vaccine within 30 days of first treatment

        Other protocol defined inclusion/exclusion criteria could apply
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Disease-free survival (DFS)
Time Frame:Approximately 24 months
Safety Issue:
Description:

Secondary Outcome Measures

Measure:Circulating tumor DNA (ctDNA) response rate
Time Frame:Approximately 36 months
Safety Issue:
Description:
Measure:ctDNA duration of response (DOR)
Time Frame:Approximately 36 months
Safety Issue:
Description:
Measure:ctDNA time to response (TTR)
Time Frame:Approximately 36 months
Safety Issue:
Description:
Measure:Incidence of adverse events (AEs)
Time Frame:Approximately 36 months
Safety Issue:
Description:
Measure:Incidence of serious adverse events (SAEs)
Time Frame:Approximately 36 months
Safety Issue:
Description:

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Not yet recruiting
Lead Sponsor:Bristol-Myers Squibb

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