Clinical Trials List
Protocol NumberCA224-1093
2024-10-01 - 2034-06-01
Phase III
Recruiting2
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 of Nivolumab + Relatlimab Fixed-dose Combination with Chemotherapy Versus Pembrolizumab with Chemotherapy as First-line Treatment for Participants with Non-squamous(NSQ), Stage IV or Recurrent Non-small Cell Lung Cancer and with Tumor Cell PD-L1 expression of 1% to 49%.
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Trial Applicant
BRISTOL-MYERS SQUIBB (TAIWAN) LTD.
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Sponsor
Bristol-Myers Squibb Company
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Trial scale
Multi-Regional Multi-Center
-
Update
2025/10/30
Investigators and Locations
Co-Principal Investigator
- Chi-Lu Chiang 無
- Yung-Hung Luo 無
- YEN-HAN TSENG 無
- 趙恒勝 無
- 廖映庭 無
The Actual Total Number of Participants Enrolled
0 Recruiting
Principal Investigator
kang-Yun LEE
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Recruiting
Condition/Disease
Non-squamous (NSQ), Stage IV or Recurrent Non-small Cell Lung Cancer and with Tumor Cell PD-L1 expression of 1% to 49%
Objectives
the main estimand is HR based on stratified Cox model;
P-value as per stratified log-rank test in OS as per treatment policy strategy in all randomized
participants assuming participants are not censored at the time of intercurrent events (starting a
subsequent therapy).
Test Drug
Relatlimab & Nivolumab Fixed Dose Vial (BMS-986213)
Active Ingredient
Relatlimab & Nivolumab Fixed Dose Vial
Dosage Form
Dosage
75mg nivolumab + 75mg relatlimab per mL
Endpoints
‧ OS
Inclution Criteria
1) Signed Written Informed Consent
a) Participants must have signed and dated an Institutional Review Board (IRB)/Independent
Ethics Committee (IEC)-approved written informed consent form (ICF) in accordance with
regulatory, local, and institutional guidelines. This ICF must be obtained before performing
any protocol-related procedures that are not part of normal patient care.
b) Participants must be willing and able to comply with scheduled visits, treatment schedule,
laboratory testing, and other requirements of the study.
2) Type of Participant and Target Disease Characteristics
a) Histologically confirmed Stage IV or recurrent NSCLC (as defined by the 8th International
Association for the Study of Lung Cancer Classification) of NSQ histology with no prior
systemic anti-cancer therapy (including targeted inhibitors for EGFR, ALK, ROS-1 BRAF-
1, RET and NTRK inhibitors) given as primary therapy for advanced or metastatic disease.
i) Tumor cell PD-L1 expression 1% to 49% as determined by a central laboratory result
from PD-L1 immunohistochemistry (IHC) conducted by central laboratory and then
provided to IRT must be reported during the screening period prior to randomization.
See Schedule of Activities (Section 2), Section 9.7.4.1, and laboratory manual for tissue
requirements.
ii) An FFPE tissue block containing enough tissue to cut 15 to 20 sections (preferred;
please see study Laboratory Manual for specific guidance) or a minimum of 15 to 20
unstained slides of tumor tissue from core biopsy, punch biopsy, excisional biopsy, or
surgical specimen obtained during screening or prior to enrollment (within 3 months of
enrollment if stored at 2-8oC or within 2 months of enrollment if stored at ambient
temperature and with no intervening systemic anti-cancer treatment between time of
acquisition and enrollment) must be sent to the central laboratory. Fine needle aspirates
or other cytology samples are not acceptable. Biopsies of bone lesions that do not have
a soft tissue component are also unacceptable for submission.
b) Prior definitive chemoradiation for locally advanced disease is permitted as long as the last
administration of chemotherapy or radiotherapy (which ever was given last) occurred at
least 6 months prior to enrollment. Participants with locally advanced disease with with no curative options) are eligible to enroll.
c) Prior adjuvant or neoadjuvant chemotherapy for early-stage lung cancer is permitted if
completed at least 6 months prior to initiating study treatment.
d) Participants should not have received any systemic anti-cancer therapy after the date that
the submitted tumor tissue was obtained.
e) No prior systemic anti-cancer treatment (including EGFR, ALK, BRAF ROS, RET, and
NTRK inhibitors) given as primary therapy for advanced or metastatic disease.
f) Prior palliative radiotherapy to non-central nervous system (CNS) lesions must have been
completed at least 2 weeks prior to treatment. Participants must have recovered (ie, Grade
≤ 1 or at baseline) from radiation-related toxicities prior to first study treatment.
g) Not Applicable as per Protocol Amendment 01.
h) Measurable disease by CT or MRI per RECIST v1.1 criteria (Appendix 7); radiographic
tumor assessment performed within 32 days prior to randomization.
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.
Note: If participant only has only 1 target lesion and it’s used for newly acquired biopsies, the
lesion can’t be used as RECIST 1.1 target lesion and participant should be excluded.
j) Eastern Cooperative Oncology Group (ECOG) PS of ≤ 1 at screening and confirmed prior
to randomization.
k) Participants must have a life expectancy of at least 3 months.
a) Participants must have signed and dated an Institutional Review Board (IRB)/Independent
Ethics Committee (IEC)-approved written informed consent form (ICF) in accordance with
regulatory, local, and institutional guidelines. This ICF must be obtained before performing
any protocol-related procedures that are not part of normal patient care.
b) Participants must be willing and able to comply with scheduled visits, treatment schedule,
laboratory testing, and other requirements of the study.
2) Type of Participant and Target Disease Characteristics
a) Histologically confirmed Stage IV or recurrent NSCLC (as defined by the 8th International
Association for the Study of Lung Cancer Classification) of NSQ histology with no prior
systemic anti-cancer therapy (including targeted inhibitors for EGFR, ALK, ROS-1 BRAF-
1, RET and NTRK inhibitors) given as primary therapy for advanced or metastatic disease.
i) Tumor cell PD-L1 expression 1% to 49% as determined by a central laboratory result
from PD-L1 immunohistochemistry (IHC) conducted by central laboratory and then
provided to IRT must be reported during the screening period prior to randomization.
See Schedule of Activities (Section 2), Section 9.7.4.1, and laboratory manual for tissue
requirements.
ii) An FFPE tissue block containing enough tissue to cut 15 to 20 sections (preferred;
please see study Laboratory Manual for specific guidance) or a minimum of 15 to 20
unstained slides of tumor tissue from core biopsy, punch biopsy, excisional biopsy, or
surgical specimen obtained during screening or prior to enrollment (within 3 months of
enrollment if stored at 2-8oC or within 2 months of enrollment if stored at ambient
temperature and with no intervening systemic anti-cancer treatment between time of
acquisition and enrollment) must be sent to the central laboratory. Fine needle aspirates
or other cytology samples are not acceptable. Biopsies of bone lesions that do not have
a soft tissue component are also unacceptable for submission.
b) Prior definitive chemoradiation for locally advanced disease is permitted as long as the last
administration of chemotherapy or radiotherapy (which ever was given last) occurred at
least 6 months prior to enrollment. Participants with locally advanced disease with with no curative options) are eligible to enroll.
c) Prior adjuvant or neoadjuvant chemotherapy for early-stage lung cancer is permitted if
completed at least 6 months prior to initiating study treatment.
d) Participants should not have received any systemic anti-cancer therapy after the date that
the submitted tumor tissue was obtained.
e) No prior systemic anti-cancer treatment (including EGFR, ALK, BRAF ROS, RET, and
NTRK inhibitors) given as primary therapy for advanced or metastatic disease.
f) Prior palliative radiotherapy to non-central nervous system (CNS) lesions must have been
completed at least 2 weeks prior to treatment. Participants must have recovered (ie, Grade
≤ 1 or at baseline) from radiation-related toxicities prior to first study treatment.
g) Not Applicable as per Protocol Amendment 01.
h) Measurable disease by CT or MRI per RECIST v1.1 criteria (Appendix 7); radiographic
tumor assessment performed within 32 days prior to randomization.
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.
Note: If participant only has only 1 target lesion and it’s used for newly acquired biopsies, the
lesion can’t be used as RECIST 1.1 target lesion and participant should be excluded.
j) Eastern Cooperative Oncology Group (ECOG) PS of ≤ 1 at screening and confirmed prior
to randomization.
k) Participants must have a life expectancy of at least 3 months.
Exclusion Criteria
1) Medical Conditions
a) Mutation Status:
i) EGFR mutations, ALK translocations, ROS-1 translocations and known BRAFV600E,
that are sensitive to available targeted inhibitor therapy; participants with a known
activating RET mutations and NTRK fusion gene alterations.
ii) Not applicable as per Protocol Amendment 01.
iii) Not applicable as per Protocol Amendment 01.
iv) Not applicable as per Protocol Amendment 01.
v) Not applicable as per Protocol Amendment 01.
NOTE: Use of an FDA-approved or local Health Authority approved test (tissue or blood) is
strongly encouraged.
b) Participants with untreated CNS metastases. Participants are eligible if CNS metastases are
asymptomatic and do not require immediate treatment or have been treated and participants
have neurologically returned to baseline (except for residual signs or symptoms related to
the CNS treatment). In addition, participants must have been either off corticosteroids or
on a stable or decreasing dose of ≤ 10 mg daily prednisone (or equivalent) for at least 2
weeks prior to randomization. Brain imaging performed within 32 days prior to
randomization must document radiographic stability of CNS lesions and should be
performed after completion of any CNS-directed therapy.
c) Participants with leptomeningeal metastases (carcinomatous meningitis).
d) Concurrent malignancy requiring treatment or history of prior malignancy active within
2 years prior to randomization (ie, participants with a history of prior malignancy are
eligible if treatment was completed at least 2 years before randomization and the patient
has no evidence of disease). The time requirement does not apply to participants who
underwent successful definitive resection of basal cell carcinoma of the skin, superficial
bladder cancer, squamous cell carcinoma of the skin, in situ cervical cancer, or other in situ
cancers.
a) Mutation Status:
i) EGFR mutations, ALK translocations, ROS-1 translocations and known BRAFV600E,
that are sensitive to available targeted inhibitor therapy; participants with a known
activating RET mutations and NTRK fusion gene alterations.
ii) Not applicable as per Protocol Amendment 01.
iii) Not applicable as per Protocol Amendment 01.
iv) Not applicable as per Protocol Amendment 01.
v) Not applicable as per Protocol Amendment 01.
NOTE: Use of an FDA-approved or local Health Authority approved test (tissue or blood) is
strongly encouraged.
b) Participants with untreated CNS metastases. Participants are eligible if CNS metastases are
asymptomatic and do not require immediate treatment or have been treated and participants
have neurologically returned to baseline (except for residual signs or symptoms related to
the CNS treatment). In addition, participants must have been either off corticosteroids or
on a stable or decreasing dose of ≤ 10 mg daily prednisone (or equivalent) for at least 2
weeks prior to randomization. Brain imaging performed within 32 days prior to
randomization must document radiographic stability of CNS lesions and should be
performed after completion of any CNS-directed therapy.
c) Participants with leptomeningeal metastases (carcinomatous meningitis).
d) Concurrent malignancy requiring treatment or history of prior malignancy active within
2 years prior to randomization (ie, participants with a history of prior malignancy are
eligible if treatment was completed at least 2 years before randomization and the patient
has no evidence of disease). The time requirement does not apply to participants who
underwent successful definitive resection of basal cell carcinoma of the skin, superficial
bladder cancer, squamous cell carcinoma of the skin, in situ cervical cancer, or other in situ
cancers.
The Estimated Number of Participants
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Taiwan
28 participants
-
Global
800 participants
