Clinical Trials List
Protocol NumberCA244-0010
Active
2025-10-01 - 2028-12-31
Phase II/III
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
IZABRIGHT-Lung01: A Randomized, Open-label, Phase 2/3 Study of Izalontamab Brengitecan (BMS-986507) versus Platinum-based Chemotherapy in Patients with EGFR-mutated Non-small Cell Lung Cancer and Disease Progression on EGFR Tyrosine Kinase Inhibitor Therapy
-
Trial Applicant
BRISTOL-MYERS SQUIBB (TAIWAN) LTD.
-
Sponsor
Bristol-Myers Squibb Company
-
Trial scale
Multi-Regional Multi-Center
-
Update
2026/02/01
Investigators and Locations
Principal Investigator
Chao-Hua Chiu
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- Seu-Chun Yang 無
- 林建佑 無
- 蔡政軒 無
- Chun-Hui Lee 無
- Chian-Wei Chen 無
- Po-Lan Su 無
- Shang-Yin Wu 無
- Chin-Wei Kuo 無
- Yi-Ting Yen 無
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- Chia-Chi Lin 無
- 楊景堯 無
- Chong-Jen Yu 無
- 張立群 無
- James Chih-Hsin Yang 無
- 于鎧綸 無
- 徐偉勛 無
- 廖斌志 無
- 吳尚俊 無
- 陳冠宇 無
- 廖唯昱 無
- Jih-Hsiang Lee 無
- 黃俊凱 無
- 錢穎群 無
- 黃得瑞 無
- CHAO-CHI HO CHAO-CHI HO 無
- 許嘉林 無
- 蔡子修 無
- YEN-TING LIN 無
- 黃信端 無
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- Chia-I Shen 無
- 趙恒勝 無
- Yuh-Min Chen 無
- 蕭慈慧 無
- Chi-Lu Chiang 無
- 廖映庭 無
- Hsu-ching Huang 無
The Actual Total Number of Participants Enrolled
0 Recruiting
Condition/Disease
EGFR-mutated Non-small Cell Lung Cancer
Objectives
To determine the RP3D for iza-bren to advance
to Stage 2 (Phase 3) of the study
Test Drug
powder
Active Ingredient
BMS-986507
Dosage Form
048
Dosage
120 mg/Vial
Endpoints
RP3D determined based on the totality of safety,
tolerability, efficacy, and PK/pharmacodynamic
data
tolerability, efficacy, and PK/pharmacodynamic
data
Inclution Criteria
Participants are eligible to be included in the study only if all of the following criteria apply:
Signed Written Informed Consent
1) Participants [or their legally acceptable representative (see APPENDIX 1)] must have signed
and dated an IRB/IEC-approved written 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.
Note:Participants must agree to comply with the requirements and restrictions listed in the IC
and in this protocol.
Type of Participant and Target Disease Characteristics
2) Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 1.
3) Histologically or cytologically confirmed diagnosis of non-squamous NSCLC, not amenable
to treatment in curative intent.
4) Evidence of documented EGFR TKI-sensitizing deletion mutation according to local test in
EGFR exon 19 (ex19del) or leucin-arginine substitution point mutation in EGFR exon 21
(ex21L858R) at or after the time of disease diagnosis and prior to initiation of an EGFR-TKI.
Note: EGFR mutational status can be based on either liquid biopsy or tissue biopsy.
5) Measurable disease as defined by RECIST v1.1 with at least 1 measurable extra-cranial lesion.
Note: Lesions that have been treated with external beam radiotherapy or loco-regional
therapies such as radiofrequency ablation must show evidence of disease progression based
on RECIST v1.1 to be deemed a target lesion.
Note: If there is only 1 measurable lesion, and a core-needle biopsy is done (instead of
excisional), the lesion may be used as a measurable lesion, and baseline imaging should be
performed at least 14 days after. The lesion must not have been previously treated with surgery
or radiotherapy.
6) Mandatory pretreatment fresh tissue or FFPE tumor tissue block (strongly preferred) from a
biopsy obtained after progressive disease on a 3rd-generation EGFR-TKI-based therapy must
be submitted to central laboratory no later than 4 weeks after randomization. If an FFPE block
is unavailable, a minimum of 20* unstained slides sectioned within 3 months prior to
submission might also be acceptable. If none of these options is available, archival tissue
collected from the last biopsy performed might be accepted after consultation with the
Medical Monitor. *If despite best efforts, a minimum of 20 slides is not obtainable,
submission of fewer slides may be acceptable in some circumstances following discussion
with the Medical Monitor. See Table 2-1 & Table 2-3 for additional details.
Note: For participants in China, refer to APPENDIX 8.
7) Radiographically documented disease progression on a 3rd-generation EGFR-TKI-based
mono- or combination therapy as the most recent line of therapy in 1 of the following
adjuvant, locally advanced, or metastatic treatment settings:
a) Progression of disease on a 3rd-generation EGFR-TKI monotherapy as the first treatment
for locally advanced or metastatic disease.
b) Progression of disease on a 3rd-generation EGFR-TKI monotherapy as the second
treatment for locally advanced or metastatic disease after no more than one prior line of
therapy with a first/second generation EGFR-TKI.
c) Progression of disease on osimertinib in combination with platinum-pemetrexed as the
first treatment for locally advanced or metastatic disease, with a platinum- and
pemetrexed-free interval ≥ 12 months.
d) Progression of disease on amivantamab+lazertinib (including progression of disease on
lazertinib monotherapy after discontinuation of amivantamab) as the first treatment for
locally advanced or metastatic disease.
e) Progression of disease on osimertinib maintenance monotherapy following concurrent or
sequential chemoradiotherapy for unresectable Stage III disease and a platinum-free
interval ≥ 12 months from completing the platinum part of chemoradiotherapy.
f) Progression of disease on adjuvant osimertinib monotherapy for completely resected stage
IB-IIIA disease. Note: Investigators should evaluate participants with very limited disease
progression in the adjuvant setting for local ablative treatment options prior enrolment
into this study.
g) Progression of disease on adjuvant osimertinib after a prior sequence of neoadjuvant
osimertinib and complete resection of stage IB-IIIA disease. Note: Participants
progressing on neoadjuvant osimertinib with prior complete resection are ineligible.
Note: Criterion 7f also applies regarding evaluation of local therapy.
8) Prior neoadjuvant or adjuvant PBC is permitted as long as the interval between completion of
PBC and randomization is ≥ 12 months.
9) Participant is eligible to receive a platinum-based regimen (either cisplatin or carboplatin) in
combination with pemetrexed.
10) Any toxicity from prior antineoplastic therapy has returned to baseline or Grade ≤ 1 defined
by NCI-CTCAE v5.0 (except for asymptomatic laboratory abnormalities or toxicity that the
investigator determined to have no safety risk, for example, alopecia).
Age of Participant
11) Participant must be ≥ 18 years of age, or local age of majority in the jurisdiction of the study
site, at the time of signing the ICF.
Signed Written Informed Consent
1) Participants [or their legally acceptable representative (see APPENDIX 1)] must have signed
and dated an IRB/IEC-approved written 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.
Note:Participants must agree to comply with the requirements and restrictions listed in the IC
and in this protocol.
Type of Participant and Target Disease Characteristics
2) Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 1.
3) Histologically or cytologically confirmed diagnosis of non-squamous NSCLC, not amenable
to treatment in curative intent.
4) Evidence of documented EGFR TKI-sensitizing deletion mutation according to local test in
EGFR exon 19 (ex19del) or leucin-arginine substitution point mutation in EGFR exon 21
(ex21L858R) at or after the time of disease diagnosis and prior to initiation of an EGFR-TKI.
Note: EGFR mutational status can be based on either liquid biopsy or tissue biopsy.
5) Measurable disease as defined by RECIST v1.1 with at least 1 measurable extra-cranial lesion.
Note: Lesions that have been treated with external beam radiotherapy or loco-regional
therapies such as radiofrequency ablation must show evidence of disease progression based
on RECIST v1.1 to be deemed a target lesion.
Note: If there is only 1 measurable lesion, and a core-needle biopsy is done (instead of
excisional), the lesion may be used as a measurable lesion, and baseline imaging should be
performed at least 14 days after. The lesion must not have been previously treated with surgery
or radiotherapy.
6) Mandatory pretreatment fresh tissue or FFPE tumor tissue block (strongly preferred) from a
biopsy obtained after progressive disease on a 3rd-generation EGFR-TKI-based therapy must
be submitted to central laboratory no later than 4 weeks after randomization. If an FFPE block
is unavailable, a minimum of 20* unstained slides sectioned within 3 months prior to
submission might also be acceptable. If none of these options is available, archival tissue
collected from the last biopsy performed might be accepted after consultation with the
Medical Monitor. *If despite best efforts, a minimum of 20 slides is not obtainable,
submission of fewer slides may be acceptable in some circumstances following discussion
with the Medical Monitor. See Table 2-1 & Table 2-3 for additional details.
Note: For participants in China, refer to APPENDIX 8.
7) Radiographically documented disease progression on a 3rd-generation EGFR-TKI-based
mono- or combination therapy as the most recent line of therapy in 1 of the following
adjuvant, locally advanced, or metastatic treatment settings:
a) Progression of disease on a 3rd-generation EGFR-TKI monotherapy as the first treatment
for locally advanced or metastatic disease.
b) Progression of disease on a 3rd-generation EGFR-TKI monotherapy as the second
treatment for locally advanced or metastatic disease after no more than one prior line of
therapy with a first/second generation EGFR-TKI.
c) Progression of disease on osimertinib in combination with platinum-pemetrexed as the
first treatment for locally advanced or metastatic disease, with a platinum- and
pemetrexed-free interval ≥ 12 months.
d) Progression of disease on amivantamab+lazertinib (including progression of disease on
lazertinib monotherapy after discontinuation of amivantamab) as the first treatment for
locally advanced or metastatic disease.
e) Progression of disease on osimertinib maintenance monotherapy following concurrent or
sequential chemoradiotherapy for unresectable Stage III disease and a platinum-free
interval ≥ 12 months from completing the platinum part of chemoradiotherapy.
f) Progression of disease on adjuvant osimertinib monotherapy for completely resected stage
IB-IIIA disease. Note: Investigators should evaluate participants with very limited disease
progression in the adjuvant setting for local ablative treatment options prior enrolment
into this study.
g) Progression of disease on adjuvant osimertinib after a prior sequence of neoadjuvant
osimertinib and complete resection of stage IB-IIIA disease. Note: Participants
progressing on neoadjuvant osimertinib with prior complete resection are ineligible.
Note: Criterion 7f also applies regarding evaluation of local therapy.
8) Prior neoadjuvant or adjuvant PBC is permitted as long as the interval between completion of
PBC and randomization is ≥ 12 months.
9) Participant is eligible to receive a platinum-based regimen (either cisplatin or carboplatin) in
combination with pemetrexed.
10) Any toxicity from prior antineoplastic therapy has returned to baseline or Grade ≤ 1 defined
by NCI-CTCAE v5.0 (except for asymptomatic laboratory abnormalities or toxicity that the
investigator determined to have no safety risk, for example, alopecia).
Age of Participant
11) Participant must be ≥ 18 years of age, or local age of majority in the jurisdiction of the study
site, at the time of signing the ICF.
Exclusion Criteria
Participants are excluded from the study if any of the following criteria apply:
Oncologic Medical Conditions
1) Mixed SCLC and NSCLC histology.
2) Any evidence or suspicion of SCLC transformation (Note: Exclusion of SCLC transformation
by tumor biopsy at screening is not mandated).
3) Participants with untreated CNS metastases.
Note: Participants can enroll if CNS metastases have been definitively treated, are stable, do
not require immediate re-treatment, and participants have neurologically returned to baseline
(except for residual signs or symptoms related to the CNS treatment).
Note: Participants must have discontinued corticosteroids or be on a stable/decreasing dose
of ≤ 10 mg prednisone (or equivalent) daily for at least 2 weeks before starting treatment.
Note: Baseline imaging required at screening must be performed 28 days after treatment for
CNS metastases is completed. Imaging must demonstrate stable CNS metastases.
4) Leptomeningeal metastases or spinal cord compression.
5) Previously documented EGFR exon 20 insertion mutations as primary EGFR mutation.
6) Participants treated with platinum+pemetrexed+osimertinib as first-line therapy for advanced
disease and having disease progression on osimertinib monotherapy with a platinum- and
pemetrexed-free interval of ≤ 12 months.
7) Concurrent malignancy (present during screening) requiring treatment or history of prior
malignancy active within 2 years prior to treatment assignment (ie, participants with a history
of prior malignancy are eligible if treatment was completed at least 2 years before treatment
assignment and the participant has no evidence of disease). Participants with history of prior
early-stage cancer including basal/squamous cell skin cancer or non-invasive or in situ cancers
that have undergone definitive treatment at any time are also eligible if the condition would
not confound study results.
Systemic Medical Conditions
8) History of severe heart disease including, but not limited to, any of the following:
a) History of clinically significant heart disease (eg, cardiomyopathy, congestive heart
failure with New York Heart Association functional classification II to IV, or significant
pericardial effusion) within the past 6 months.
b) Myocardial infarction, uncontrolled angina or stroke/transient ischemic attack within the
past 6 months.
c) QTcF prolongation ≥ 450 msec for males and ≥ 470 msec for females, except for right
bundle branch block.
9) Unstable thrombotic events such as deep vein thrombosis, arterial thrombosis, and pulmonary
embolism within 2 months prior to screening that requires therapeutic intervention; except for
infusion set-related thrombosis. Participants with prior VTE events requiring anticoagulation
are eligible given they are on a stable anticoagulant dose and have not experienced major
bleeding events. Catheter-associated thrombosis (Port-A-Cath, central lines, peripherally-
inserted central lines) is also allowed.
10) Participants with known coagulation disorders, including but not limited to hemophilia, von
Willebrand disease, or any other coagulopathies that may affect blood clotting.
11) Participants with known hematologic conditions that may affect bone marrow reserve,
including but not limited to myelodysplastic syndrome, unexplained anemia, unexplained
thrombocytopenia, or a history of immune thrombocytopenia.
12) Prior history of clinically significant bleeding, or perforation of the gastrointestinal tract
within 6 months prior to randomization.
13) Participants with advanced / clinically significant lung disease (eg, poorly controlled COPD
or asthma, restrictive lung disease, or pulmonary hypertension) within 6 months prior to
randomization or any history of interstitial lung disease (ILD) or pneumonitis requiring
treatment with steroids (≥ Grade 2), or who have current or suspected ILD or pneumonitis.
14) Any other serious or uncontrolled medical disorder, active infection, physical exam finding,
laboratory finding, altered mental status, or psychiatric condition that, in the opinion of the
investigator, would limit a participant's ability to comply with the study requirements,
substantially increase risk to the participant, or impact the interpretability of study results.
Oncologic Medical Conditions
1) Mixed SCLC and NSCLC histology.
2) Any evidence or suspicion of SCLC transformation (Note: Exclusion of SCLC transformation
by tumor biopsy at screening is not mandated).
3) Participants with untreated CNS metastases.
Note: Participants can enroll if CNS metastases have been definitively treated, are stable, do
not require immediate re-treatment, and participants have neurologically returned to baseline
(except for residual signs or symptoms related to the CNS treatment).
Note: Participants must have discontinued corticosteroids or be on a stable/decreasing dose
of ≤ 10 mg prednisone (or equivalent) daily for at least 2 weeks before starting treatment.
Note: Baseline imaging required at screening must be performed 28 days after treatment for
CNS metastases is completed. Imaging must demonstrate stable CNS metastases.
4) Leptomeningeal metastases or spinal cord compression.
5) Previously documented EGFR exon 20 insertion mutations as primary EGFR mutation.
6) Participants treated with platinum+pemetrexed+osimertinib as first-line therapy for advanced
disease and having disease progression on osimertinib monotherapy with a platinum- and
pemetrexed-free interval of ≤ 12 months.
7) Concurrent malignancy (present during screening) requiring treatment or history of prior
malignancy active within 2 years prior to treatment assignment (ie, participants with a history
of prior malignancy are eligible if treatment was completed at least 2 years before treatment
assignment and the participant has no evidence of disease). Participants with history of prior
early-stage cancer including basal/squamous cell skin cancer or non-invasive or in situ cancers
that have undergone definitive treatment at any time are also eligible if the condition would
not confound study results.
Systemic Medical Conditions
8) History of severe heart disease including, but not limited to, any of the following:
a) History of clinically significant heart disease (eg, cardiomyopathy, congestive heart
failure with New York Heart Association functional classification II to IV, or significant
pericardial effusion) within the past 6 months.
b) Myocardial infarction, uncontrolled angina or stroke/transient ischemic attack within the
past 6 months.
c) QTcF prolongation ≥ 450 msec for males and ≥ 470 msec for females, except for right
bundle branch block.
9) Unstable thrombotic events such as deep vein thrombosis, arterial thrombosis, and pulmonary
embolism within 2 months prior to screening that requires therapeutic intervention; except for
infusion set-related thrombosis. Participants with prior VTE events requiring anticoagulation
are eligible given they are on a stable anticoagulant dose and have not experienced major
bleeding events. Catheter-associated thrombosis (Port-A-Cath, central lines, peripherally-
inserted central lines) is also allowed.
10) Participants with known coagulation disorders, including but not limited to hemophilia, von
Willebrand disease, or any other coagulopathies that may affect blood clotting.
11) Participants with known hematologic conditions that may affect bone marrow reserve,
including but not limited to myelodysplastic syndrome, unexplained anemia, unexplained
thrombocytopenia, or a history of immune thrombocytopenia.
12) Prior history of clinically significant bleeding, or perforation of the gastrointestinal tract
within 6 months prior to randomization.
13) Participants with advanced / clinically significant lung disease (eg, poorly controlled COPD
or asthma, restrictive lung disease, or pulmonary hypertension) within 6 months prior to
randomization or any history of interstitial lung disease (ILD) or pneumonitis requiring
treatment with steroids (≥ Grade 2), or who have current or suspected ILD or pneumonitis.
14) Any other serious or uncontrolled medical disorder, active infection, physical exam finding,
laboratory finding, altered mental status, or psychiatric condition that, in the opinion of the
investigator, would limit a participant's ability to comply with the study requirements,
substantially increase risk to the participant, or impact the interpretability of study results.
The Estimated Number of Participants
-
Taiwan
37 participants
-
Global
917 participants
