Clinical Trials List
Protocol NumberCA209-77T
NCT Number(ClinicalTrials.gov Identfier)NCT04025879
Active
2020-01-01 - 2026-12-31
Phase III
Recruiting4
ICD-10C34.90
Malignant neoplasm of unspecified part of unspecified bronchus or lung
ICD-10C34.91
Malignant neoplasm of unspecified part of right bronchus or lung
ICD-10C34.92
Malignant neoplasm of unspecified part of left bronchus or lung
ICD-10C7A.090
Malignant carcinoid tumor of the bronchus and lung
ICD-10Z51.12
Encounter for antineoplastic immunotherapy
ICD-9162.9
Malignant neoplasm of bronchus and lung, unspecified
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
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Trial Applicant
BRISTOL-MYERS SQUIBB (TAIWAN) LTD.
-
Sponsor
Bristol-Myers Squibb
-
Trial scale
Multi-Regional Multi-Center
-
Update
2026/02/01
Investigators and Locations
Co-Principal Investigator
- YEN-HAN TSENG Division of General Internal Medicine
- Ching-Shan Luo Division of General Internal Medicine
- Shiou-Fu Lin Division of General Internal Medicine
- Po-Hao Feng Division of General Internal Medicine
- Tzu-Tao Chen Division of General Internal Medicine
- Kuang-Tai Kuo Division of General Internal Medicine
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- Chia-Chi Lin Division of General Internal Medicine
- Jih-Hsiang Lee Division of General Internal Medicine
- 陳冠宇 Division of General Internal Medicine
- 吳尚俊 Division of General Internal Medicine
- 許嘉林 Division of General Internal Medicine
- 謝明書 Division of General Internal Medicine
- Chong-Jen Yu Division of General Internal Medicine
- 廖斌志 Division of General Internal Medicine
- 廖唯昱 Division of General Internal Medicine
- JIN-SHING CHEN Division of General Internal Medicine
- 黃彥霖 Division of General Internal Medicine
- Hsao-Hsun Hsu Division of General Internal Medicine
- CHAO-CHI HO CHAO-CHI HO Division of General Internal Medicine
- 徐偉勛 Division of General Internal Medicine
- SHUENN-WEN KUO Division of General Internal Medicine
- Mong-Wei Lin Division of General Internal Medicine
- James Chih-Hsin Yang Division of General Internal Medicine
- 林宗哲 Division of General Internal Medicine
- 蔡子修 Division of General Internal Medicine
- 楊景堯 Division of General Internal Medicine
- 張逸良 Division of General Internal Medicine
- YEN-TING LIN Division of General Internal Medicine
The Actual Total Number of Participants Enrolled
0 Recruiting
Principal Investigator
Co-Principal Investigator
- 李玫萱 Division of Thoracic Medicine
- Jen-Yu Hung Division of Thoracic Medicine
- Jui-Ying Lee Division of Thoracic Medicine
- Inn-Wen Chong Division of Thoracic Medicine
- Chih-Jen Yang Division of Thoracic Medicine
- Ying-Ming Tsai Tsai Division of Thoracic Medicine
The Actual Total Number of Participants Enrolled
0 Recruiting
Condition/Disease
RESECTION NSCLC
Objectives
Primary
To compare the event-free survival (EFS) by blinded independent central review (BICR) in Arm A vs Arm B participants
Test Drug
OPDIVO (nivolumab) Injection 10mg/mLOPDIVO (nivolumab) Injection 10mg/mL
Active Ingredient
OPDIVO (nivolumab) Injection 10mg/mLOPDIVO (nivolumab) Injection 10mg/mL
Dosage Form
Solution for Injection
Solution for Injection
Solution for Injection
Dosage
10mg/mL
10mg/mL
10mg/mL
Endpoints
-Primary:
To compare the event-free survival (EFS) by blinded independent central review
(BICR) in Arm A vs Arm B participants. EFS is defined as the length of time from randomization
to any of the following events: progression of disease or worsening of disease precluding surgery,
progression or recurrence of disease after surgery, or death due to any cause.
Progression/recurrence will be assessed by BICR per RECIST 1.1. Participants who do not
undergo surgery for reason other than progression will be considered to have an event at RECIST
1.1 progression or death.
To compare the event-free survival (EFS) by blinded independent central review
(BICR) in Arm A vs Arm B participants. EFS is defined as the length of time from randomization
to any of the following events: progression of disease or worsening of disease precluding surgery,
progression or recurrence of disease after surgery, or death due to any cause.
Progression/recurrence will be assessed by BICR per RECIST 1.1. Participants who do not
undergo surgery for reason other than progression will be considered to have an event at RECIST
1.1 progression or death.
Inclution Criteria
Inclusion Criteria
1) Signed Written Informed Consent
a) Participants must have signed and dated an IRB/IEC approved written informed consent
form in accordance with regulatory and institutional guidelines. This must be obtained before the performance of any protocol related procedures that are not part of normal
participant care.
b) Participants must be willing and able to comply with scheduled visits, treatment schedule,
and laboratory testing. tumor biopsies, and other requirements of the study.
2) Type of Participant and Target Disease Characteristics
a) Participants with suspected or histologically confirmed Stage IIA ( 4 cm) to IIIB (T3N2)
NSCLC (per the American Joint Committee on Cancer (AJCC) Cancer Staging Manual
8th Edition22) with disease that is considered resectable
b) No brain metastasis
c) Participant must be deemed eligible for complete resection and must agree to undergo
standard of care surgery for complete resection of NSCLC after neoadjuvant therapy
d) Treatment-naive (no prior systemic anti-cancer treatment)
e) Ability to provide surgical or biopsy tumor tissue for biomarkers (eg, whole exome
sequencing, PD-L1 testing, etc) See Section 9.8.
f) Eastern Cooperative Oncology Group (ECOG) Performance Status 1
3) Age and Reproductive Status
a) Males and Females, 18 years
b) Women of childbearing potential (WOCBP) must have a negative serum or urine
pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 24 hours
prior to the start of study treatment.
c) Women must not be breastfeeding
d) WOCBP must agree to follow instructions for method(s) of contraception (Appendix 4) for
the duration of treatment with study treatments and after the last dose of study treatment
(ie, 30 days [duration of ovulatory cycle] plus the time required for the study drug to
undergo approximately 5 half-lives. WOCBP must agree to follow instructions for
method(s) of contraception for 5 months after the last dose of study treatment.
e) Males who are sexually active with WOCBP must agree to follow instructions for
method(s) of contraception (Appendix 4) for the duration of treatment with study
treatments and after the last dose of study treatment (ie, 90 days [duration of sperm
turnover] plus the time required for the study drug to undergo approximately 5 half-lives).
Males who are sexually active with WOCBP must agree to follow instructions for
method(s) of contraception for 7 months after the last dose of study treatment. In addition,
male participants must be willing to refrain from sperm donation during this time.
f) Azoospermic males are exempt from contraceptive requirements. WOCBP who are
continuously not heterosexually active are also exempt from contraceptive requirements,
and still must undergo pregnancy testing as described in this section.
Investigators shall counsel WOCBP, and male participants who are sexually active with WOCBP,
on the importance of pregnancy prevention and the implications of an unexpected pregnancy.
Investigators shall advise on the use of highly effective methods of contraception, (Appendix 4)
which have a failure rate of < 1% when used consistently and correctly.
1) Signed Written Informed Consent
a) Participants must have signed and dated an IRB/IEC approved written informed consent
form in accordance with regulatory and institutional guidelines. This must be obtained before the performance of any protocol related procedures that are not part of normal
participant care.
b) Participants must be willing and able to comply with scheduled visits, treatment schedule,
and laboratory testing. tumor biopsies, and other requirements of the study.
2) Type of Participant and Target Disease Characteristics
a) Participants with suspected or histologically confirmed Stage IIA ( 4 cm) to IIIB (T3N2)
NSCLC (per the American Joint Committee on Cancer (AJCC) Cancer Staging Manual
8th Edition22) with disease that is considered resectable
b) No brain metastasis
c) Participant must be deemed eligible for complete resection and must agree to undergo
standard of care surgery for complete resection of NSCLC after neoadjuvant therapy
d) Treatment-naive (no prior systemic anti-cancer treatment)
e) Ability to provide surgical or biopsy tumor tissue for biomarkers (eg, whole exome
sequencing, PD-L1 testing, etc) See Section 9.8.
f) Eastern Cooperative Oncology Group (ECOG) Performance Status 1
3) Age and Reproductive Status
a) Males and Females, 18 years
b) Women of childbearing potential (WOCBP) must have a negative serum or urine
pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 24 hours
prior to the start of study treatment.
c) Women must not be breastfeeding
d) WOCBP must agree to follow instructions for method(s) of contraception (Appendix 4) for
the duration of treatment with study treatments and after the last dose of study treatment
(ie, 30 days [duration of ovulatory cycle] plus the time required for the study drug to
undergo approximately 5 half-lives. WOCBP must agree to follow instructions for
method(s) of contraception for 5 months after the last dose of study treatment.
e) Males who are sexually active with WOCBP must agree to follow instructions for
method(s) of contraception (Appendix 4) for the duration of treatment with study
treatments and after the last dose of study treatment (ie, 90 days [duration of sperm
turnover] plus the time required for the study drug to undergo approximately 5 half-lives).
Males who are sexually active with WOCBP must agree to follow instructions for
method(s) of contraception for 7 months after the last dose of study treatment. In addition,
male participants must be willing to refrain from sperm donation during this time.
f) Azoospermic males are exempt from contraceptive requirements. WOCBP who are
continuously not heterosexually active are also exempt from contraceptive requirements,
and still must undergo pregnancy testing as described in this section.
Investigators shall counsel WOCBP, and male participants who are sexually active with WOCBP,
on the importance of pregnancy prevention and the implications of an unexpected pregnancy.
Investigators shall advise on the use of highly effective methods of contraception, (Appendix 4)
which have a failure rate of < 1% when used consistently and correctly.
Exclusion Criteria
Exclusion Criteria
1) Medical Conditions
a) Participants with EGFR mutation regardless of mutation type are excluded. Non-squamous
tumor with unknown EGFR mutation status must be tested for EGFR mutation (PCR based
test should be used).
b) Participants with known ALK mutations
c) Participants with Grade ≥ 2 peripheral neuropathy
d) Participants with an active, known or suspected autoimmune disease. Participants with
type I diabetes mellitus, hypothyroidism only requiring hormone replacement, skin
disorders (such as vitiligo, psoriasis, or alopecia) not requiring systemic treatment, or
conditions not expected to recur in the absence of an external trigger are permitted to enroll.
e) Participants with a condition requiring systemic treatment with either corticosteroids
(> 10 mg daily prednisone equivalent) or other immunosuppressive medications within
14 days of randomization. Inhaled or topical steroids, and adrenal replacement steroid
doses > 10 mg daily prednisone equivalent, are permitted in the absence of active
autoimmune disease.
f) Participants with interstitial lung disease or active, non-infectious pneumonitis
(symptomatic and/or requiring treatment) that may interfere with the detection or
management of suspected drug-related pulmonary toxicity.
g) Participants with previous malignancies (except non-melanoma skin cancers, and in situ
cancers such as the following: bladder, gastric, colon, cervical/dysplasia, melanoma, or
breast) are excluded unless a complete remission was achieved at least 2 years prior to first
treatment and no additional therapy is required or anticipated to be required during the
study period.
h) Known history of positive test for human immunodeficiency virus (HIV) or known
acquired immunodeficiency syndrome (AIDS). NOTE: Testing for HIV must be performed
at sites where mandated locally.
i) Known medical condition that, in the investigator’s opinion, would increase the risk
associated with study participation or study drug administration or interfere with the
interpretation of safety results.
j) Participants with serious or uncontrolled medical disorders.
2) Prior/Concomitant Therapy
a) Any previous anti-cancer treatment including cytotoxic, IO treatment, targeted agents, or
radiotherapy
b) Treatment with botanical preparations (eg, herbal supplements or traditional Chinese
medicines) intended for general health support or to treat the disease under study within
2 weeks prior to randomization/treatment.
c) Participants who have received a live/attenuated vaccine within 30 days of randomization
3) Physical and Laboratory Test Findings
a) WBC < 2000/μL
b) Neutrophils < 1500/μL
c) Platelets < 100 x 103/μL
d) Hemoglobin < 9.0 g/dL
e) Serum creatinine >1.5 x ULN or calculated creatinine clearance < 40 mL/min (using the
Cockcroft-Gault formula)
f) AST/ALT: > 3.0 x ULN
g) Total bilirubin >1.5 x ULN (except participants with Gilbert Syndrome who must have a
total bilirubin level of < 3.0x ULN)
h) Any positive test result for hepatitis B virus or hepatitis C virus indicating presence of
virus, eg, Hepatitis B surface antigen (HBsAg, Australia antigen) positive, or Hepatitis C
antibody (anti-HCV) positive (except if HCV-RNA negative).
4) Allergies and Adverse Drug Reaction
a) History of allergy or hypersensitivity to platinum-containing compounds (if deemed
chemotherapy eligible) or study drug components
5) Other Exclusion Criteria
a) Prisoners or participants who are involuntarily incarcerated. (Note: under certain specific
circumstances a person who has been imprisoned may be included or permitted to continue
as a participant. Strict conditions apply and BMS approval is required.)
b) Participants who are compulsorily detained for treatment of either a psychiatric or physical
(eg, infectious disease) illness
Eligibility criteria for this study have been carefully considered to ensure the safety of the study
participants and that the results of the study can be used. It is imperative that participants fully
meet all eligibility criteria.
1) Medical Conditions
a) Participants with EGFR mutation regardless of mutation type are excluded. Non-squamous
tumor with unknown EGFR mutation status must be tested for EGFR mutation (PCR based
test should be used).
b) Participants with known ALK mutations
c) Participants with Grade ≥ 2 peripheral neuropathy
d) Participants with an active, known or suspected autoimmune disease. Participants with
type I diabetes mellitus, hypothyroidism only requiring hormone replacement, skin
disorders (such as vitiligo, psoriasis, or alopecia) not requiring systemic treatment, or
conditions not expected to recur in the absence of an external trigger are permitted to enroll.
e) Participants with a condition requiring systemic treatment with either corticosteroids
(> 10 mg daily prednisone equivalent) or other immunosuppressive medications within
14 days of randomization. Inhaled or topical steroids, and adrenal replacement steroid
doses > 10 mg daily prednisone equivalent, are permitted in the absence of active
autoimmune disease.
f) Participants with interstitial lung disease or active, non-infectious pneumonitis
(symptomatic and/or requiring treatment) that may interfere with the detection or
management of suspected drug-related pulmonary toxicity.
g) Participants with previous malignancies (except non-melanoma skin cancers, and in situ
cancers such as the following: bladder, gastric, colon, cervical/dysplasia, melanoma, or
breast) are excluded unless a complete remission was achieved at least 2 years prior to first
treatment and no additional therapy is required or anticipated to be required during the
study period.
h) Known history of positive test for human immunodeficiency virus (HIV) or known
acquired immunodeficiency syndrome (AIDS). NOTE: Testing for HIV must be performed
at sites where mandated locally.
i) Known medical condition that, in the investigator’s opinion, would increase the risk
associated with study participation or study drug administration or interfere with the
interpretation of safety results.
j) Participants with serious or uncontrolled medical disorders.
2) Prior/Concomitant Therapy
a) Any previous anti-cancer treatment including cytotoxic, IO treatment, targeted agents, or
radiotherapy
b) Treatment with botanical preparations (eg, herbal supplements or traditional Chinese
medicines) intended for general health support or to treat the disease under study within
2 weeks prior to randomization/treatment.
c) Participants who have received a live/attenuated vaccine within 30 days of randomization
3) Physical and Laboratory Test Findings
a) WBC < 2000/μL
b) Neutrophils < 1500/μL
c) Platelets < 100 x 103/μL
d) Hemoglobin < 9.0 g/dL
e) Serum creatinine >1.5 x ULN or calculated creatinine clearance < 40 mL/min (using the
Cockcroft-Gault formula)
f) AST/ALT: > 3.0 x ULN
g) Total bilirubin >1.5 x ULN (except participants with Gilbert Syndrome who must have a
total bilirubin level of < 3.0x ULN)
h) Any positive test result for hepatitis B virus or hepatitis C virus indicating presence of
virus, eg, Hepatitis B surface antigen (HBsAg, Australia antigen) positive, or Hepatitis C
antibody (anti-HCV) positive (except if HCV-RNA negative).
4) Allergies and Adverse Drug Reaction
a) History of allergy or hypersensitivity to platinum-containing compounds (if deemed
chemotherapy eligible) or study drug components
5) Other Exclusion Criteria
a) Prisoners or participants who are involuntarily incarcerated. (Note: under certain specific
circumstances a person who has been imprisoned may be included or permitted to continue
as a participant. Strict conditions apply and BMS approval is required.)
b) Participants who are compulsorily detained for treatment of either a psychiatric or physical
(eg, infectious disease) illness
Eligibility criteria for this study have been carefully considered to ensure the safety of the study
participants and that the results of the study can be used. It is imperative that participants fully
meet all eligibility criteria.
The Estimated Number of Participants
-
Taiwan
8 participants
-
Global
452 participants
