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Clinical Trials List

Protocol NumberCA209-73L
NCT Number(ClinicalTrials.gov Identfier)NCT04026412
Completed

2020-04-01 - 2025-11-26

Phase III

Not yet recruiting1

Recruiting6

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, Open Label Study to Compare Nivolumab Plus Concurrent Chemoradiotherapy (CCRT) Followed by Nivolumab Plus Ipilimumab or Nivolumab Plus CCRT Followed by Nivolumab vs CCRT Followed by Durvalumab in Previously Untreated, Locally Advanced Non-small Cell Lung Cancer (LA NSCLC)

  • Trial Applicant

    BRISTOL-MYERS SQUIBB (TAIWAN) LTD.

  • Sponsor

    Bristol-Myers Squibb

  • Trial scale

    Multi-Regional Multi-Center

  • Update

    2026/02/01

Investigators and Locations

Principal Investigator Chao-Hua Chiu Division of Hematology & Oncology
Taipei Veterans General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator CHIN-CHOU WANG 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 Not yet recruiting

Principal Investigator kang-Yun LEE Division of Thoracic Medicine
Taipei Medical University-Shuang Ho Hospital,Ministry of Health and Welfare

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 蘇健 Division of Thoracic Medicine
MacKay Memorial Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator JIN-YUAN SHIH Division of General Internal Medicine
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Chien-Chung Lin Division of Thoracic Medicine
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator
Taichung Veterans General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Condition/Disease

Previously Untreated, Locally Advanced Non-small Cell Lung Cancer

Objectives

The primary purpose of the study is to compare the effectiveness of nivolumab plus concurrent chemoradiotherapy (CCRT) followed by nivolumab plus ipilimumab (Arm A) vs CCRT followed by durvalumab (Arm C) in participants with untreated Locally Advanced Non-small Cell Lung Cancer (LA NSCLC)

Test Drug

OPDIVO (nivolumab) Injection 10mg/mL
OPDIVO (nivolumab) Injection 10mg/mL
YERVOY (ipilimumab) Injection 5mg/mL
YERVOY (ipilimumab) Injection 5mg/mL

Active Ingredient

Nivolumab
Nivolumab
Ipilimumab
Ipilimumab

Dosage Form

Injection
Injection
Injection
Injection

Dosage

10mg/ml
10mg/ml
5mg/ml
5mg/ml

Endpoints

Primary Outcome Measures :
Progression-free survival (PFS) by RECIST 1.1 per Blinded Independent Central Review (BICR) for Arm A and Arm C [ Time Frame: Up to 5 years ]
Overall Survival (OS) for Arm A and Arm C [ Time Frame: Up to 5 years ]

Inclution 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
2) Participant and Target Disease Characteristics
a) ECOG performance status ≤1 (See Appendix 5)
b) Locally advanced stage IIIA, IIIB, or IIIC (T1-2 N2-3 M0, T3 N1-3 M0, or T4 N0-3 M0)
histologically-confirmed NSCLC, according to 8th TNM classification
36, that is amenable to definitive CCRT. Participants who are not planned for potential curative surgical
resection are eligible.
i) Overt cT4 disease, including encasement of the large vessels defined by > 50 % of the
circumference OR
ii) Nodal status N2 or N3 must be proven (by biopsy in at least one N2 or N3 node, via
EBUS, mediastinoscopy or thoracoscopy) OR
iii) Nodal status N1 must be proven (by biopsy in at least one N1 node, via EBUS,
mediastinoscopy or thoracoscopy) for T3 disease
c) Newly diagnosed and treatment-naïve, with no prior local or systemic anticancer therapy
given as primary therapy for locally advanced disease
d) Measurable disease per RECIST 1.1 criteria
e) All participants must have tissue submitted to a central laboratory during screening. Either
a formalin-fixed, paraffin-embedded (FFPE) tissue block or a minimum of 15 unstained
tumor tissue sections, obtained within 3 months prior to enrollment, with an associated
pathology report, must be submitted to the central laboratory for inclusion. If less than 15
slides are available, BMS must be contacted to discuss the inclusion of the patient. Biopsy
should be excisional, core needle or surgical specimen. Fine needle aspiration is
unacceptable for submission. The central laboratory must provide IRT with PD-L1 status
prior to randomization.
3) Age and Reproductive Status
a) Males and females, ≥18 years of age
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) Women of childbearing potential (WOCBP) must agree to follow instructions for
method(s) of contraception for the duration of treatment with study treatment and for 5
months post-treatment completion. Women should use an adequate method(s) of
contraception as indicated in Appendix 4
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
treatment(s) and 7 months post-treatment completion. In addition, male participants must
be willing to refrain from sperm donation during this time.
4) 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.
6.1.2 Inclusion Criteria for Maintenance Treatment
5) For entry into maintenance therapy, the following criteria MUST be met:
a) Eastern Cooperative Oncology Group (ECOG) performance status ≤1 (Appendix 5).
b) No evidence of progressive disease during or after CCRT
c) No current or prior use of immunosuppressive medication within 14 days before the first
dose of maintenance immunotherapy, with the exceptions of intranasal and inhaled
corticosteroids or systemic corticosteroids at physiological doses, which are not to exceed
10 mg/day of daily prednisone equivalent. Systemic steroid administration required as
prophylaxis against or to manage toxicities arising from CCRT is allowed
d) Any toxicity from CCRT should resolve to Grade 1 or baseline (except for Grade 2 fatigue
or alopecia). Participants with irreversible toxicity that is not reasonably expected to be
exacerbated by study drug may be included (eg, hearing loss) after consultation with the
BMS medical monitor
e) Participants in Arm A and Arm B that received nivolumab should NOT meet
discontinuation criteria for immunotherapy

Exclusion Criteria

1) Medical Conditions
a) Any condition including medical, emotional, psychiatric, or logistical that, in the opinion
of the Investigator, would preclude the patient from adhering to the protocol or would
increase the risk associated with study participation or study drug administration or interfere with the interpretation of safety results (eg, a condition associated with diarrhea
or acute diverticulitis)
b) Active infection requiring systemic therapy within 14 days prior to randomization
c) Prior malignancy active within the previous 3 years except for locally curable cancers that
have been apparently cured, such as basal or squamous cell skin cancer, superficial bladder
cancer, or carcinoma in situ of the prostate, cervix, or breast
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 start 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) Prior treatment with an 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
g) Presence of pleural/pericardial effusion on CT scan and/or X-ray, unless it is not
cytologically positive nor exudative via pleuracentesis. Effusions that are too small to be
tapped safely are acceptable
h) 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).
i) Known ALK translocation and/or ROS1 rearrangement
j) Clinical evidence of hearing loss
k) ≥ Grade 2 peripheral neuropathy
l) History of organ or tissue transplant that requires systemic use of immune suppressive
agents
m) 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.
2) Prior/Concomitant Therapy
3) Physical and Laboratory Test Findings
4) Allergies and Adverse Drug Reaction
a) History of allergy or hypersensitivity to study drug components
b) History of severe hypersensitivity reaction to any monoclonal antibody
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 Bristol-Myers Squibb approval is required
b) Participants who are compulsorily detained for treatment of either a psychiatric or physical
(eg, infectious disease) illness

Exclusion Criteria for Maintenance
6) For entry into maintenance therapy, any of the following criteria MUST NOT be met:
a) Any condition including medical, emotional, psychiatric, or logistical that, in the opinion
of the Investigator, would preclude the patient from adhering to the protocol or would
increase the risk associated with study participation or study drug administration or
interfere with the interpretation of safety results
7) Physical and Laboratory Test Findings

The Estimated Number of Participants

  • Taiwan

    6 participants

  • Global

    1400 participants

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