Clinical Trials List
Protocol NumberD702KC00001
Active
2025-08-31 - 2028-08-31
Phase I/II
Recruiting3
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 Ib/II Open-Label, Multicentre Platform Study Evaluating Novel Combinations in Participants with Advanced or Metastatic Non-Small Cell Lung Cancer (ALTAIR)
-
Trial Applicant
PAREXEL INTERNATIONAL CO., LTD.
-
Sponsor
AstraZeneca AB
-
Trial scale
Multi-Regional Multi-Center
-
Update
2026/02/01
Investigators and Locations
Co-Principal Investigator
- 江振源 Division of Thoracic Medicine
- Yu-Tien Tzeng Division of Thoracic Medicine
- Tzu-Yao Liao Division of Thoracic Medicine
- 楊善堯 Division of Thoracic Medicine
- Chia-Lun Chang Division of Thoracic Medicine
- Chih-Hsin Lee Division of Thoracic Medicine
- Tzeon-jye Chiou Division of Thoracic Medicine
- Jer-Hwa Chang Division of Thoracic Medicine
- 石智元 Division of Thoracic Medicine
The Actual Total Number of Participants Enrolled
0 Recruiting
Principal Investigator
Chao-Hua Chiu
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Recruiting
Condition/Disease
Non-Small Cell Lung Cancer
Objectives
To assess the safety and tolerability
and determine RP2D of the
combination of novel anti-cancer
agents.
Test Drug
Injection
Active Ingredient
Rilvegostomig
AB248
ramucirumab
AB248
ramucirumab
Dosage Form
27C
27C
27C
27C
27C
Dosage
750 mg
10 mg
500 mg
10 mg
500 mg
Endpoints
Safety and tolerability will be evaluated in
terms of DLT (to determine the recommended
dose), AEs/SAEs, imAEs, AEs leading to
discontinuation, laboratory findings, ECGs,
vital signs, and physical examinations.
The estimates of interest are:
• Incidence of AEs/SAEs, imAEs, and AEs
leading to discontinuation
• Incidence of DLTs
• Mean changes from baseline in laboratory
parameters, vital signs, ECGs, and
physical examination.
The analysis will include participants in the
Safety Analysis Set. Participants will be
analysed according to the treatment they
receive.
The analysis of DLT will include participants
in the DLT evaluable population.
terms of DLT (to determine the recommended
dose), AEs/SAEs, imAEs, AEs leading to
discontinuation, laboratory findings, ECGs,
vital signs, and physical examinations.
The estimates of interest are:
• Incidence of AEs/SAEs, imAEs, and AEs
leading to discontinuation
• Incidence of DLTs
• Mean changes from baseline in laboratory
parameters, vital signs, ECGs, and
physical examination.
The analysis will include participants in the
Safety Analysis Set. Participants will be
analysed according to the treatment they
receive.
The analysis of DLT will include participants
in the DLT evaluable population.
Inclution Criteria
Participants are eligible to be included in the study only if all of the following criteria (and all
criteria from the relevant sub-study) apply. Where there are differences in stringency or cut-off
values, the specific sub-study criterion takes precedence.
Age
1 Participant must be ≥ 18 years of age at the time of signing the informed consent.
Type of Participant and Disease Characteristics
2 Participants with histologically or cytologically documented squamous or non-squamous
NSCLC.
3 With a current Stage IV mNSCLC (based on the American Joint Committee on Cancer
Edition 9) not amenable to curative treatment.
4 WHO/ECOG performance status of 0 or 1 at screening.
5 Provision of acceptable archival tumour tissue (or fresh tumour tissue biopsy if archival
tumour tissue is not available and if clinically feasible) is mandatory at screening.
Additional details are provided in Section 8.8.1.1 and/or the Laboratory Manual.
6 Measurable disease per RECIST 1.1 as defined by at least one lesion that can be
accurately measured at baseline as ≥ 10 mm at the longest diameter (except lymph nodes
which must have a short axis ≥ 15 mm) with CT or MRI, which is suitable for accurate
repeated measurements. Previously irradiated lesions or a lesion in the field of radiation
should not be used as target lesion unless the lesion(s) has/have demonstrated
unequivocal disease progression. Target lesions should not be used for the baseline
tumour biopsy, unless there are no other lesions suitable for biopsy and they fulfil
requirements outlined in Appendix G.
7 Minimum life expectancy of 12 weeks in the opinion of the investigator.
8 Adequate organ and marrow function as shown in Table 4.
criteria from the relevant sub-study) apply. Where there are differences in stringency or cut-off
values, the specific sub-study criterion takes precedence.
Age
1 Participant must be ≥ 18 years of age at the time of signing the informed consent.
Type of Participant and Disease Characteristics
2 Participants with histologically or cytologically documented squamous or non-squamous
NSCLC.
3 With a current Stage IV mNSCLC (based on the American Joint Committee on Cancer
Edition 9) not amenable to curative treatment.
4 WHO/ECOG performance status of 0 or 1 at screening.
5 Provision of acceptable archival tumour tissue (or fresh tumour tissue biopsy if archival
tumour tissue is not available and if clinically feasible) is mandatory at screening.
Additional details are provided in Section 8.8.1.1 and/or the Laboratory Manual.
6 Measurable disease per RECIST 1.1 as defined by at least one lesion that can be
accurately measured at baseline as ≥ 10 mm at the longest diameter (except lymph nodes
which must have a short axis ≥ 15 mm) with CT or MRI, which is suitable for accurate
repeated measurements. Previously irradiated lesions or a lesion in the field of radiation
should not be used as target lesion unless the lesion(s) has/have demonstrated
unequivocal disease progression. Target lesions should not be used for the baseline
tumour biopsy, unless there are no other lesions suitable for biopsy and they fulfil
requirements outlined in Appendix G.
7 Minimum life expectancy of 12 weeks in the opinion of the investigator.
8 Adequate organ and marrow function as shown in Table 4.
Exclusion Criteria
Participants are excluded from the study if any of the following criteria (and any criteria from
the relevant sub-study) apply. Where there are differences in stringency or cut-off values, the
specific sub-study criterion takes precedence.
Medical Conditions
1 Participants with either of the following are excluded:
(a) Sensitising EGFR mutations or ALK fusions (documented test result is mandatory for
participants with non-squamous histology). For participants with squamous
histology, mutation/fusion testing is mandatory only if participant is a never smoker
or in the presence of a mixed histology.
(b) Documented test result for any other known genomic alteration for which a targeted
therapy is approved in first line per local standard of care (eg, ROS1, NTRK fusions,
BRAF V600E mutation, etc).
2 As judged by the investigator, any severe or uncontrolled systemic diseases, including,
but not limited to, uncontrolled hypertension, and active bleeding diseases, ongoing or
active known infection; serious chronic gastrointestinal conditions associated with
diarrhoea (eg, active inflammatory bowel disease), active non-infectious skin disease
(including any grade rash, urticaria, dermatitis, ulceration, or psoriasis) requiring systemic
treatment, psychiatric illness/social situations, substance abuse, or significant cardiac
conditions which, in the investigator’s opinion, makes it undesirable for the participant to
participate in the study or that would jeopardise compliance with the protocol.
3 Has had a prior stem cell, bone marrow, allogenic tissue, or solid organ transplant.
4 Has an active autoimmune disease that has required systemic treatment in the past 2 years
(ie, with use of disease-modifying agents, corticosteroids, or immunosuppressive drugs).
Replacement therapy (eg, thyroxine, insulin, or physiologic corticosteroid replacement
therapy for adrenal or pituitary insufficiency) is not considered a form of systemic
treatment and is allowed.
5 History of clinically significant arrhythmia, cardiomyopathy of any aetiology;
symptomatic congestive heart failure (as defined by New York Heart Association
class ≥ 3), history of myocardial infarction within the past 6 months.
6 History of another primary malignancy except for malignancy treated with curative intent
with no known active disease ≥ 2 years before the first dose of study intervention and of
low potential risk for recurrence. Exceptions include adequately resected non-melanoma
skin cancer, localised non-invasive primary disease under surveillance and curatively
treated in situ disease.
7 Presence of small cell and neuroendocrine histology components.
8 Unresolved toxicities of Grade ≥ 2 (NCI CTCAE v5.0) from prior anti-cancer therapy
(excluding alopecia, vitiligo and endocrine disorders that are controlled with replacement
hormone therapy). Participants with chemotherapy induced Grade 2 neuropathy may be
eligible at discretion of the investigator and after consultation with the medical monitor or
delegate.
9 Spinal cord compression.
10 Symptomatic brain metastases.
Note: participants potentially are eligible if with known asymptomatic CNS lesions that
do not require local treatment according to principal investigator judgement, or
asymptomatic, adequately treated with stereotactic radiation therapy, craniotomy, gamma
knife therapy, or whole brain radiotherapy, with no subsequent evidence of CNS
progression (documented with MRI scans showing the absence of brain metastasis
progression after radiotherapeutic intervention). Participants must not require steroids or
anticonvulsants for at least 4 weeks prior to start of study intervention. A minimum of 2
weeks must have elapsed between the end of brain radiotherapy and study enrolment.
Participants must have recovered from the acute toxic effect of radiotherapy (eg, dizziness
and signs of increased intracranial pressure).
the relevant sub-study) apply. Where there are differences in stringency or cut-off values, the
specific sub-study criterion takes precedence.
Medical Conditions
1 Participants with either of the following are excluded:
(a) Sensitising EGFR mutations or ALK fusions (documented test result is mandatory for
participants with non-squamous histology). For participants with squamous
histology, mutation/fusion testing is mandatory only if participant is a never smoker
or in the presence of a mixed histology.
(b) Documented test result for any other known genomic alteration for which a targeted
therapy is approved in first line per local standard of care (eg, ROS1, NTRK fusions,
BRAF V600E mutation, etc).
2 As judged by the investigator, any severe or uncontrolled systemic diseases, including,
but not limited to, uncontrolled hypertension, and active bleeding diseases, ongoing or
active known infection; serious chronic gastrointestinal conditions associated with
diarrhoea (eg, active inflammatory bowel disease), active non-infectious skin disease
(including any grade rash, urticaria, dermatitis, ulceration, or psoriasis) requiring systemic
treatment, psychiatric illness/social situations, substance abuse, or significant cardiac
conditions which, in the investigator’s opinion, makes it undesirable for the participant to
participate in the study or that would jeopardise compliance with the protocol.
3 Has had a prior stem cell, bone marrow, allogenic tissue, or solid organ transplant.
4 Has an active autoimmune disease that has required systemic treatment in the past 2 years
(ie, with use of disease-modifying agents, corticosteroids, or immunosuppressive drugs).
Replacement therapy (eg, thyroxine, insulin, or physiologic corticosteroid replacement
therapy for adrenal or pituitary insufficiency) is not considered a form of systemic
treatment and is allowed.
5 History of clinically significant arrhythmia, cardiomyopathy of any aetiology;
symptomatic congestive heart failure (as defined by New York Heart Association
class ≥ 3), history of myocardial infarction within the past 6 months.
6 History of another primary malignancy except for malignancy treated with curative intent
with no known active disease ≥ 2 years before the first dose of study intervention and of
low potential risk for recurrence. Exceptions include adequately resected non-melanoma
skin cancer, localised non-invasive primary disease under surveillance and curatively
treated in situ disease.
7 Presence of small cell and neuroendocrine histology components.
8 Unresolved toxicities of Grade ≥ 2 (NCI CTCAE v5.0) from prior anti-cancer therapy
(excluding alopecia, vitiligo and endocrine disorders that are controlled with replacement
hormone therapy). Participants with chemotherapy induced Grade 2 neuropathy may be
eligible at discretion of the investigator and after consultation with the medical monitor or
delegate.
9 Spinal cord compression.
10 Symptomatic brain metastases.
Note: participants potentially are eligible if with known asymptomatic CNS lesions that
do not require local treatment according to principal investigator judgement, or
asymptomatic, adequately treated with stereotactic radiation therapy, craniotomy, gamma
knife therapy, or whole brain radiotherapy, with no subsequent evidence of CNS
progression (documented with MRI scans showing the absence of brain metastasis
progression after radiotherapeutic intervention). Participants must not require steroids or
anticonvulsants for at least 4 weeks prior to start of study intervention. A minimum of 2
weeks must have elapsed between the end of brain radiotherapy and study enrolment.
Participants must have recovered from the acute toxic effect of radiotherapy (eg, dizziness
and signs of increased intracranial pressure).
The Estimated Number of Participants
-
Taiwan
7 participants
-
Global
284 participants
