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Clinical Trials List

Protocol NumberCA209-722
NCT Number(ClinicalTrials.gov Identfier)NCT02864251

2017-05-01 - 2023-10-30

Phase III

Terminated14

ICD-10C34

Malignant neoplasm of bronchus and lung

ICD-9162.9

Malignant neoplasm of bronchus and lung, unspecified

Open-Label, Randomized Trial of Nivolumab (BMS-936558) plus Pemetrexed/Platinum or Nivolumab plus Ipilimumab (BMS-734016) vs Pemetrexed plus Platinum in Stage IV or Recurrent Non-Small Cell Lung Cancer (NSCLC) Subjects with Epidermal Growth Factor Receptor (EGFR) Mutation, T790M Negative Who Failed 1L EGFR Tyrosine Kinase Inhibitor Therapy

  • Trial Applicant

    BRISTOL-MYERS SQUIBB (TAIWAN) LTD.

  • Sponsor

    Bristol-Myers Squibb Research and Development

  • Trial scale

    Multi-Regional Multi-Center

  • Update

    2025/08/20

Investigators and Locations

Principal Investigator Te-Chun Hsia Division of Thoracic Medicine
China Medical University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Terminated

Principal Investigator 林孟志 Division of Thoracic Medicine
Kaoshiung Chang Gung Memorial Hospital of the C.G.M.F.

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Terminated

Principal Investigator Gee-chen Chang Division of Thoracic Medicine
Taichung Veterans General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Terminated

Principal Investigator Wu-Chou Su Division of Hematology & Oncology
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Terminated

Audit

None

Principal Investigator Hsu-ching Huang 無
Taipei Veterans General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

13 Terminated

Audit

CRO

Principal Investigator 賴俊良 Division of Thoracic Medicine
Dalin Tzu Chi Hospital Buddhist Tzu Chi Medical Foundation

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Terminated

Principal Investigator 魏裕峰 Division of Thoracic Medicine
E-DA Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Terminated

Principal Investigator 曹朝榮 Division of Hematology & Oncology
Chi Mei Hospital, Liouying

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Terminated

Principal Investigator 簡志峰 Division of Thoracic Medicine
Tri-Service General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Terminated

Principal Investigator 吳健樑 Division of Thoracic Medicine
MacKay Memorial Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Terminated

Principal Investigator Te-Chun Hsia 未分科
China Medical University Hospital-Taipei

Co-Principal Investigator

Audit

None

Principal Investigator Cheng-Ta Yang Division of Thoracic Medicine
Linkou Chang Gung Medical Foundation

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

9 Terminated

Audit

None

Principal Investigator Inn-Wen Chong 未分科
Kaohsiung Municipal Gangshan Hospital

Co-Principal Investigator

Audit

CRO

Principal Investigator 夏和雄 Division of Hematology & Oncology
Taipei Medical University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

2 Terminated

Audit

None

Principal Investigator James Chih-Hsin Yang Division of Hematology & Oncology
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Terminated

Audit

None

Principal Investigator Inn-Wen Chong Division of Thoracic Medicine
Kaohsiung Medical Univeristy Chung-Ho Memorial Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Terminated

Condition/Disease

NSCLC

Objectives

To assess the PFS by blinded independent central review (BICR) of nivolumab plus pemetrexed/platinum compared to pemetrexed plus platinum in EGFR mutation positive (ie, G719X, L861Q, Del 19, and L858R),T790M negative metastatic or locally advanced NSCLC whose tumor has progressed on 1L EGFR TKI • To assess the PFS by BICR of nivolumab plus ipilimumab compared to pemetrexed plus platinum in EGFR mutation positive (ie, G719X, L861Q, Del 19, and L858R), T790M negative metastatic or locally advanced NSCLC that has progressed on 1L EGFR TKI

Test Drug

Nivolumab (BMS-936558),Ipilimumab (BMS-734016)

Active Ingredient

Ipilimumab
Nivolumab

Dosage Form

IV

Dosage

10 mg/ mL
5 mg/ mL

Endpoints

To assess the PFS by blinded independent central review (BICR) of nivolumab plus pemetrexed/platinum compared to pemetrexed plus platinum in EGFR mutation positive (ie, G719X, L861Q, Del 19, and L858R),T790M negative metastatic or locally advanced NSCLC whose tumor has progressed on 1L EGFR TKI
• To assess the PFS by BICR of nivolumab plus ipilimumab compared to pemetrexed plus platinum in EGFR mutation positive (ie, G719X, L861Q, Del 19, and L858R), T790M negative metastatic or locally advanced NSCLC that has progressed on 1L EGFR TKI

Inclution Criteria

a) Eastern Cooperative Group (ECOG) Performance Status 0-1
b) Subjects with histologically confirmed Stage IV or recurrent EGFR MT+ (ie, G719X, L861Q, Del 19, and L858R) NSCLC (per the 7th International Association for the Study of Lung Cancer classification) with disease progression on therapy with 1 prior EGFR TKI therapy consisting of erlotinib, afatinib or gefitinib
c) No evidence of exon 20 T790M mutation detected by tumor or cfDNA analysis obtained at progression on prior EGFR TKI therapy. T790M testing will be confirmed centrally using the cobas® EGFR Mutation Test v2 (US-IVD)
d) Measurable disease according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1)
i) Target lesions may be located in a previously irradiated field if there is documented (radiographic)disease progression in that site after the completion of radiation therapy.
e) No prior systemic therapy for advanced or metastatic NSCLC, except 1 prior line of first- or second-generation EGFR TKI. Prior adjuvant or neoadjuvant chemotherapy for early stage lung cancer is permitted as long as all toxicities have resolved or stabilized
i) Prior 1L EGFR TKI therapy must have been completed at least 2 weeks prior to randomization
f) Subjects must have sample available for PD-L1 IHC and exon 20 T790M testing performed by the central lab during the screening period

Exclusion Criteria

a) Subjects with known EGFR mutation, T790M positive, detected by tumor or cfDNA analysis
b) Subjects with known ALK translocations which are sensitive to available targeted inhibitor therapy are excluded. If tested, use of an FDA-approved test is strongly encouraged. Subjects with unknown or indeterminate ALK status may be enrolled.
c) As of Amendment 02, the criterion regarding CNS metastases was moved to the Inclusion Criteria.
d) Subjects with carcinomatous meningitis
e) As of Amendment 1, the criterion excluding known cMET amplification is no longer applicable.
f) Subjects with known SCLC transformation
g) Subjects who have progressed within 3 months of 1L EGFR TKI.

The Estimated Number of Participants

  • Taiwan

    96 participants

  • Global

    465 participants

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