Clinical Trials List
Protocol NumberD967YC00001
Active
2020-11-01 - 2027-06-30
Phase I
Recruiting8
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 Multicenter, Open-label Dose-escalation Study to Evaluate the Safety and Tolerability of Trastuzumab Deruxtecan (T-DXd) and Durvalumab in Combination with Cisplatin, Carboplatin or Pemetrexed in First-line Treatment of Patients with Advanced or Metastatic Non-squamous Non-small Cell Lung Cancer (NSCLC) and Human Epidermal Growth Factor Receptor 2 Overexpression (HER2+) (DESTINY-Lung03)
-
Trial Applicant
-
Sponsor
AstraZeneca
-
Trial scale
Multi-Regional Multi-Center
-
Update
2026/02/01
Investigators and Locations
Co-Principal Investigator
- Chi-Lu Chiang 無
- 蕭慈慧 無
- Heng-Sheng Chao 未分科
- Chia-I Shen 無
- YEN-HAN TSENG 無
- Yuh-Min Chen 無
- 趙恒勝 無
- Hsu-ching Huang 無
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- 柯皓文 無
- Shih-Hong Li 無
- Chih-Hung Chen 無
- Chih-Hung Chen 未分科
- 枋岳甫 無
- Wen-Cheng Chang 無
- Chih-Liang Wang 無
- Ping-Chih Hsu 無
- 張境夫 無
- Chien-Ying Liu 無
- Chih-Hsi Kuo 無
- 吳教恩 無
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- Yu-Min Yeh 無
- Po-Lan Su 無
- Wu-Chou Su 無
- Jui-Hung Tsai 無
- Shang-Yin Wu 無
- Chien-Chung Lin 無
- Wen-Pin Su 無
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- 徐偉勛 無
- CHAO-CHI HO CHAO-CHI HO 無
- 楊景堯 無
- 朱筱桑 無
- Chia-Chi Lin 無
- Chong-Jen Yu 無
- 廖唯昱 無
- 吳尚俊 無
- Hsin-Yu Liu 無
- 廖斌志 無
- 陳冠宇 無
- 蔡子修 無
- YEN-TING LIN 無
- Jih-Hsiang Lee 無
- JIN-YUAN SHIH 無
- 許嘉林 無
The Actual Total Number of Participants Enrolled
0 Recruiting
Condition/Disease
Metastatic Non-squamous Non-small Cell Lung Cancer (NSCLC)
Objectives
Primary:
To assess the safety and tolerability (and to
determine the RP2D) of T-DXd plus
durvalumab in combination with cisplatin,
carboplatin, or pemetrexed.
Secondary:
To assess the preliminary antitumor activity of
T-DXd monotherapy (Part 1 only); T-DXd with
durvalumab (Part 2 only); and T-DXd plus
durvalumab in combination with cisplatin,
carboplatin, or pemetrexed (Parts 1 and 2).
To assess the safety and tolerability of T-DXd
monotherapy (Part 1) and T-DXd plus
durvalumab (Part 2).
To assess the PK of T-DXd, total anti-HER2
antibody, and MAAA-1181 in all arms.
To assess the PK of durvalumab.
To investigate the immunogenicity of T-DXd
and durvalumab.
Test Drug
ENHERTUR
Active Ingredient
Trastuzumab deruxtecan (DS-8201a、T-DXd或AZD4552)
Durvalumab
Durvalumab
Dosage Form
Injection
Dosage
100 mg/vial
50mg/mL
50mg/mL
Endpoints
Primary:
Frequency of AEs (including SAEs), AESIs,
DLTs, and changes from baseline in laboratory
parameters, vital signs, and ECG results.
Secondary:
Endpoints assessed by investigator per
RECIST v1.1:
Confirmed ORR
DoR
DCRa
PFS b
OS b
Frequency of AEs (including SAEs), AESIs, and
changes from baseline in laboratory parameters,
vital signs, and ECG results.
Serum concentration of T-DXd, total anti-HER2
antibody, and MAAA-1181 in all arms.
Serum concentration of durvalumab in study
arms including T-DXd in combination with
durvalumab.
Presence of ADAs for T-DXd and durvalumab.
Frequency of AEs (including SAEs), AESIs,
DLTs, and changes from baseline in laboratory
parameters, vital signs, and ECG results.
Secondary:
Endpoints assessed by investigator per
RECIST v1.1:
Confirmed ORR
DoR
DCRa
PFS b
OS b
Frequency of AEs (including SAEs), AESIs, and
changes from baseline in laboratory parameters,
vital signs, and ECG results.
Serum concentration of T-DXd, total anti-HER2
antibody, and MAAA-1181 in all arms.
Serum concentration of durvalumab in study
arms including T-DXd in combination with
durvalumab.
Presence of ADAs for T-DXd and durvalumab.
Inclution Criteria
Informed Consent
1 Capable of giving signed informed consent as described in Appendix A, which includes
compliance with the requirements and restrictions listed in the ICF and in this protocol.
2 Provision of signed and dated written Optional Genetic Research Information informed
consent prior to collection of samples for optional genetic research that supports the
Genomic Initiative (see Appendix D).
3 Provision of signed and dated written ICF prior to any mandatory study-specific
procedures, sampling, or analyses.
Age
4 Male and female patients must be at least 18 years of age at the time of signing the ICF.
Other age restrictions may apply as per local regulations.
Type of Patient and Disease Characteristics
5 Histologically documented Stage III locally advanced and unresectable non-squamous
mNSCLC not amenable to curative surgery or radiation (according to Version 8 of the
IASLC Staging Manual in Thoracic Oncology) and/or Stage IV NSCLC.
6
(a) Part 1 (dose-escalation combinations and T-DXd monotherapy): Patients with
therapy-targetable alterations are allowed.
(b) Part 2 (dose-expansion): Tumors that lack activating EGFR mutations (eg, exon 19
deletion or exon 21 L858R mutation) or EML4-ALK fusion. If routinely tested for
according to local standard or guidelines as a therapy-targetable alterations with
available therapy, patients must also have tumors that lack other targetable
alterations.
7
(a) Part 1 (dose-escalation combinations and T-DXd monotherapy): Progression on or
after either one or 2 lines of therapy which is required to have included prior
appropriate targeted therapy for patients with therapy-targetable alterations.
(b) Part 2 (dose-expansion): Treatment-naïve for locally advanced or mNSCLC. Prior
adjuvant, neo-adjuvant therapies are permitted if progression has occurred
> 12 months from the end of last therapy.
8 HER2+ (IHC 3+ or 2+) status as determined by central review of tumor tissue.
9 At least 1 measurable lesion by RECIST v1.1.
10 WHO / ECOG performance status of 0 or 1.
11 All patients must provide an existing FFPE tumor sample for tissue-based IHC staining to
centrally determine HER2 expression and other correlatives. The mandatory FFPE tumor
sample should be obtained at the time of diagnosis of metastatic or locally advanced
unresectable disease. Specimens with limited tumor content and cytology samples are
inadequate for defining tumor HER2 status. Additional details on sample requirements
are provided in Section 8.6.
12 Adequate organ and bone marrow function within 14 days before treatment assignment,
13 LVEF ≥ 50% within 28 days before treatment assignment.
14 Need adequate treatment washout period before assignment/enrolment
15 Must have a life expectancy of at least 12 weeks.
Reproduction
16 Evidence of post-menopausal status or negative serum pregnancy test for females of
childbearing potential who are sexually active with a non-sterilized male partner.
(a) For women of childbearing potential, a negative result for serum pregnancy test (test
must have a sensitivity of at least 25 mIU/mL) must be available at the screening visit
and urine β-HCG pregnancy test prior to each administration of study intervention.
(b) Women of childbearing potential are defined as those who are not surgically sterile
(ie, underwent bilateral salpingectomy, bilateral oophorectomy, or complete
hysterectomy) or post-menopausal. Women will be considered post-menopausal if
they have been amenorrheic for 12 months without an alternative medical cause.
17 Female patients of childbearing potential who are sexually active with a non-sterilized
male partner must use at least 1 highly effective method of contraception (Table 9) from
the time of screening and must agree to continue using such precautions for 7 months
after the last dose of study intervention or the duration of time for the marketed products
used in this study according to the respective SmPCs, whichever is longer. Not all
methods of contraception are highly effective (see Appendix L for complete list of highly
effective birth control methods). Female patients must refrain from egg cell donation and
breastfeeding while on study and for 7 months after the last dose of study intervention.
Complete heterosexual abstinence for the duration of the study and drug washout period
is an acceptable contraceptive method if it is in line with the patient’s usual lifestyle
(consideration must be made to the duration of the clinical trial); however, periodic or
occasional abstinence, the rhythm method, and the withdrawal method are not acceptable
methods of contraception.
18 Non-sterilized male patients who are sexually active with a female partner of childbearing
potential must use a condom with spermicide from screening to 4 months after the final
dose of study intervention, or the duration of time for the marketed products used in this
study according to the respective SmPCs, whichever is longer (see Appendix L).
Complete heterosexual abstinence for the duration of the study and drug washout period
is an acceptable contraceptive method if it is in line with the patient’s usual lifestyle
(consideration must be made to the duration of the clinical trial); however, periodic or
occasional abstinence, the rhythm method, and the withdrawal method are not acceptable
methods of contraception. It is strongly recommended for the female partners of a male
patient to also use at least 1 highly effective method of contraception throughout this
period, as described in Table 9. In addition, male patients should refrain from fathering a
child or donating sperm during the study and for 4 months after the last dose of study
intervention, or the duration of time for the marketed products used in this study
according to the respective SmPCs, whichever is longer. Preservation of sperm should be
considered prior to enrollment in this study.
19 Female patients must not donate, or retrieve for their own use, ova from the time of
Screening and throughout the study treatment period, and for at least 7 months after the
final study drug administration, or the duration of time for the marketed products used in
this study according to the respective SmPCs, whichever is longer.
1 Capable of giving signed informed consent as described in Appendix A, which includes
compliance with the requirements and restrictions listed in the ICF and in this protocol.
2 Provision of signed and dated written Optional Genetic Research Information informed
consent prior to collection of samples for optional genetic research that supports the
Genomic Initiative (see Appendix D).
3 Provision of signed and dated written ICF prior to any mandatory study-specific
procedures, sampling, or analyses.
Age
4 Male and female patients must be at least 18 years of age at the time of signing the ICF.
Other age restrictions may apply as per local regulations.
Type of Patient and Disease Characteristics
5 Histologically documented Stage III locally advanced and unresectable non-squamous
mNSCLC not amenable to curative surgery or radiation (according to Version 8 of the
IASLC Staging Manual in Thoracic Oncology) and/or Stage IV NSCLC.
6
(a) Part 1 (dose-escalation combinations and T-DXd monotherapy): Patients with
therapy-targetable alterations are allowed.
(b) Part 2 (dose-expansion): Tumors that lack activating EGFR mutations (eg, exon 19
deletion or exon 21 L858R mutation) or EML4-ALK fusion. If routinely tested for
according to local standard or guidelines as a therapy-targetable alterations with
available therapy, patients must also have tumors that lack other targetable
alterations.
7
(a) Part 1 (dose-escalation combinations and T-DXd monotherapy): Progression on or
after either one or 2 lines of therapy which is required to have included prior
appropriate targeted therapy for patients with therapy-targetable alterations.
(b) Part 2 (dose-expansion): Treatment-naïve for locally advanced or mNSCLC. Prior
adjuvant, neo-adjuvant therapies are permitted if progression has occurred
> 12 months from the end of last therapy.
8 HER2+ (IHC 3+ or 2+) status as determined by central review of tumor tissue.
9 At least 1 measurable lesion by RECIST v1.1.
10 WHO / ECOG performance status of 0 or 1.
11 All patients must provide an existing FFPE tumor sample for tissue-based IHC staining to
centrally determine HER2 expression and other correlatives. The mandatory FFPE tumor
sample should be obtained at the time of diagnosis of metastatic or locally advanced
unresectable disease. Specimens with limited tumor content and cytology samples are
inadequate for defining tumor HER2 status. Additional details on sample requirements
are provided in Section 8.6.
12 Adequate organ and bone marrow function within 14 days before treatment assignment,
13 LVEF ≥ 50% within 28 days before treatment assignment.
14 Need adequate treatment washout period before assignment/enrolment
15 Must have a life expectancy of at least 12 weeks.
Reproduction
16 Evidence of post-menopausal status or negative serum pregnancy test for females of
childbearing potential who are sexually active with a non-sterilized male partner.
(a) For women of childbearing potential, a negative result for serum pregnancy test (test
must have a sensitivity of at least 25 mIU/mL) must be available at the screening visit
and urine β-HCG pregnancy test prior to each administration of study intervention.
(b) Women of childbearing potential are defined as those who are not surgically sterile
(ie, underwent bilateral salpingectomy, bilateral oophorectomy, or complete
hysterectomy) or post-menopausal. Women will be considered post-menopausal if
they have been amenorrheic for 12 months without an alternative medical cause.
17 Female patients of childbearing potential who are sexually active with a non-sterilized
male partner must use at least 1 highly effective method of contraception (Table 9) from
the time of screening and must agree to continue using such precautions for 7 months
after the last dose of study intervention or the duration of time for the marketed products
used in this study according to the respective SmPCs, whichever is longer. Not all
methods of contraception are highly effective (see Appendix L for complete list of highly
effective birth control methods). Female patients must refrain from egg cell donation and
breastfeeding while on study and for 7 months after the last dose of study intervention.
Complete heterosexual abstinence for the duration of the study and drug washout period
is an acceptable contraceptive method if it is in line with the patient’s usual lifestyle
(consideration must be made to the duration of the clinical trial); however, periodic or
occasional abstinence, the rhythm method, and the withdrawal method are not acceptable
methods of contraception.
18 Non-sterilized male patients who are sexually active with a female partner of childbearing
potential must use a condom with spermicide from screening to 4 months after the final
dose of study intervention, or the duration of time for the marketed products used in this
study according to the respective SmPCs, whichever is longer (see Appendix L).
Complete heterosexual abstinence for the duration of the study and drug washout period
is an acceptable contraceptive method if it is in line with the patient’s usual lifestyle
(consideration must be made to the duration of the clinical trial); however, periodic or
occasional abstinence, the rhythm method, and the withdrawal method are not acceptable
methods of contraception. It is strongly recommended for the female partners of a male
patient to also use at least 1 highly effective method of contraception throughout this
period, as described in Table 9. In addition, male patients should refrain from fathering a
child or donating sperm during the study and for 4 months after the last dose of study
intervention, or the duration of time for the marketed products used in this study
according to the respective SmPCs, whichever is longer. Preservation of sperm should be
considered prior to enrollment in this study.
19 Female patients must not donate, or retrieve for their own use, ova from the time of
Screening and throughout the study treatment period, and for at least 7 months after the
final study drug administration, or the duration of time for the marketed products used in
this study according to the respective SmPCs, whichever is longer.
Exclusion Criteria
Medical Conditions
1 Known HER2 activating mutation.
2 Mixed small-cell lung cancer, squamous NSCLC and sarcomatoid histology variant
NSCLC.
3 Patients with a medical history of myocardial infarction within 6 months before treatment
assignment, symptomatic CHF (New York Heart Association Class II to IV), clinically
important cardiac arrhythmias, or a recent (< 6 months) CV event including stroke.
Patients with troponin levels above ULN at screening (as defined by the manufacturer),
and without any myocardial related symptoms, should have a cardiologic consultation
before treatment assignment to rule out myocardial infarction.
4 QTcF prolongation to > 470 msec (females) or > 450 msec (males) based on average of
the screening triplicate 12-lead ECG.
5 Has a history of (non-infectious) ILD/pneumonitis that required steroids, has current
ILD/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out by imaging at
screening.
6 A pleural effusion, ascites or pericardial effusion that requires drainage, peritoneal shunt,
or CART.
7 Uncontrolled intercurrent illness, including but not limited to ongoing or active infection,
uncontrolled hypertension, serious chronic gastrointestinal conditions associated with
diarrhea, or psychiatric illness/social situations that would limit compliance with study
requirement, substantially increase risk of incurring AEs, or compromise the ability of the
patient to give written informed consent.
8 Lung criteria:
Lung-specific intercurrent clinically significant illnesses including, but not limited to, any
underlying pulmonary disorder (eg, pulmonary emboli within 3 months of study
enrollment, severe asthma, severe COPD, restrictive lung disease, pleural effusion etc.)
Any autoimmune, connective tissue or inflammatory disorders (eg, rheumatoid arthritis,
Sjogren's syndrome, sarcoidosis etc.) where this is documented, or a suspicion of
pulmonary involvement at the time of screening. Full details of the disorder should be
recorded in the eCRF for patients who are included in the study.
Prior pneumonectomy (complete)
9 Uncontrolled infection requiring IV antibiotics, antivirals, or antifungals
10 Active primary immunodeficiency, known HIV infection, or active hepatitis B or C
infection. Patients positive for HCV antibody are eligible only if polymerase chain
reaction is negative for HCV RNA. Patients should be tested for HIV prior to treatment
assignment if required by local regulations or IRB/EC.
11 Active or prior documented autoimmune or inflammatory disorders (including
inflammatory bowel disease [eg, colitis or Crohn’s disease], diverticulitis [with the
exception of diverticulosis], systemic lupus erythematosus, sarcoidosis syndrome,
Wegener syndrome [granulomatosis with polyangiitis], Graves’ disease, and rheumatoid
arthritis, hypophysis, uveitis, etc.). The following are exceptions to this criterion:
Patients with vitiligo or alopecia
Patients with hypothyroidism (eg, following Hashimoto syndrome) stable on
hormone replacement
Patients with any chronic skin condition that does not require systemic therapy
Patients without active disease in the last 5 years, who may also be included but only
after consultation with the study physician
Patients with celiac disease controlled by diet alone
12 Active infection including tuberculosis (clinical evaluation that includes clinical history,
physical examination, and radiographic findings, and tuberculosis testing in line with
local practice).
13 Has spinal cord compression or clinically active central nervous system metastases,
defined as untreated and symptomatic, or requiring therapy with corticosteroids or
anticonvulsants to control associated symptoms. Patients with clinically inactive brain
metastases may be included in the study. Patients with treated brain metastases that are no
longer symptomatic and who require no treatment with corticosteroids or anticonvulsants
may be included in the study if they have recovered from the acute toxic effect of
radiotherapy. A minimum of 2 weeks must have elapsed between the end of whole brain
radiotherapy and treatment assignment.
14 History of allogenic organ transplant.
15 History of leptomeningeal carcinomatosis.
Prior/Concomitant Therapy
16 Receipt of live, attenuated vaccine within 30 days prior to the first dose of T-DXd. Note:
Patients, if assigned treatment, should not receive live vaccine during the study and up to
30 days after the last dose of study intervention.
17 Current or prior use of immunosuppressive medication within 14 days before first dose of
durvalumab-containing investigational therapy. The following are exceptions to this
criterion:
Intra-nasal, inhaled, topical steroids, or local steroid injections (eg, intra-articular
injection)
Systemic corticosteroids at physiologic doses not to exceed 10mg/day of prednisone
or its equivalent
Steroids as premedication for hypersensitivity reactions (eg, CT scan premedication,
cytotoxic chemotherapy premedication)
18 Prior radiation therapy for localized Stage 3 unresectable NSCLC. Exceptions are:
palliative radiation to brain, with associated criteria for stability or lack of symptoms,
palliative radiation to painful bony lesions (this must comprise less than 30% of the bone
marrow) and palliative stereotactic radiation therapy to chest providing the washout
period of ≥ 4 weeks (palliative stereotactic radiation therapy to the chest and ≥ 2 weeks in
other areas) as in inclusion #14).
19 Has a concomitant medical condition that would increase the risk of toxicity in the
opinion of the investigator.
20 Known allergy or hypersensitivity to study treatment, other monoclonal antibodies, or any
study drug excipients.
21 Is unable or unwilling to take folic acid or vitamin B12 supplementation.
22 Multiple primary malignancies within 3 years, except for malignancy treated with
curative intent and not known active disease ≥ 5 years before the first dose of the study
intervention and of low potential risk for recurrence, adequately treated/resected
non-melanoma skin cancer or lentigo malignant without evidence of disease,
curatively/adequate treated in-situ disease without evidence of disease, and/or other solid
tumors curatively treated.
23 Patients participating in a concurrent interventional study and/or previously treated with
T-DXd.
24 Unresolved toxicities from previous anticancer therapy, defined as toxicities (other than
alopecia) not yet resolved to Grade ≤ 1 or baseline OR prior discontinuation of planned
study therapy (cisplatin, carboplatin, pemetrexed or PD-1/PD-L1 targeting antibody) due
to toxicity.
Other Exclusions
25 Involvement in the planning and/or conduct of the study (applies to both AstraZeneca
staff and/or staff at the study site).
26 Judgment by the investigator that the patient should not participate in the study if the
patient is unlikely to comply with study procedures, restrictions and requirements.
27 Currently pregnant (confirmed with positive pregnancy test) or breast-feeding.
1 Known HER2 activating mutation.
2 Mixed small-cell lung cancer, squamous NSCLC and sarcomatoid histology variant
NSCLC.
3 Patients with a medical history of myocardial infarction within 6 months before treatment
assignment, symptomatic CHF (New York Heart Association Class II to IV), clinically
important cardiac arrhythmias, or a recent (< 6 months) CV event including stroke.
Patients with troponin levels above ULN at screening (as defined by the manufacturer),
and without any myocardial related symptoms, should have a cardiologic consultation
before treatment assignment to rule out myocardial infarction.
4 QTcF prolongation to > 470 msec (females) or > 450 msec (males) based on average of
the screening triplicate 12-lead ECG.
5 Has a history of (non-infectious) ILD/pneumonitis that required steroids, has current
ILD/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out by imaging at
screening.
6 A pleural effusion, ascites or pericardial effusion that requires drainage, peritoneal shunt,
or CART.
7 Uncontrolled intercurrent illness, including but not limited to ongoing or active infection,
uncontrolled hypertension, serious chronic gastrointestinal conditions associated with
diarrhea, or psychiatric illness/social situations that would limit compliance with study
requirement, substantially increase risk of incurring AEs, or compromise the ability of the
patient to give written informed consent.
8 Lung criteria:
Lung-specific intercurrent clinically significant illnesses including, but not limited to, any
underlying pulmonary disorder (eg, pulmonary emboli within 3 months of study
enrollment, severe asthma, severe COPD, restrictive lung disease, pleural effusion etc.)
Any autoimmune, connective tissue or inflammatory disorders (eg, rheumatoid arthritis,
Sjogren's syndrome, sarcoidosis etc.) where this is documented, or a suspicion of
pulmonary involvement at the time of screening. Full details of the disorder should be
recorded in the eCRF for patients who are included in the study.
Prior pneumonectomy (complete)
9 Uncontrolled infection requiring IV antibiotics, antivirals, or antifungals
10 Active primary immunodeficiency, known HIV infection, or active hepatitis B or C
infection. Patients positive for HCV antibody are eligible only if polymerase chain
reaction is negative for HCV RNA. Patients should be tested for HIV prior to treatment
assignment if required by local regulations or IRB/EC.
11 Active or prior documented autoimmune or inflammatory disorders (including
inflammatory bowel disease [eg, colitis or Crohn’s disease], diverticulitis [with the
exception of diverticulosis], systemic lupus erythematosus, sarcoidosis syndrome,
Wegener syndrome [granulomatosis with polyangiitis], Graves’ disease, and rheumatoid
arthritis, hypophysis, uveitis, etc.). The following are exceptions to this criterion:
Patients with vitiligo or alopecia
Patients with hypothyroidism (eg, following Hashimoto syndrome) stable on
hormone replacement
Patients with any chronic skin condition that does not require systemic therapy
Patients without active disease in the last 5 years, who may also be included but only
after consultation with the study physician
Patients with celiac disease controlled by diet alone
12 Active infection including tuberculosis (clinical evaluation that includes clinical history,
physical examination, and radiographic findings, and tuberculosis testing in line with
local practice).
13 Has spinal cord compression or clinically active central nervous system metastases,
defined as untreated and symptomatic, or requiring therapy with corticosteroids or
anticonvulsants to control associated symptoms. Patients with clinically inactive brain
metastases may be included in the study. Patients with treated brain metastases that are no
longer symptomatic and who require no treatment with corticosteroids or anticonvulsants
may be included in the study if they have recovered from the acute toxic effect of
radiotherapy. A minimum of 2 weeks must have elapsed between the end of whole brain
radiotherapy and treatment assignment.
14 History of allogenic organ transplant.
15 History of leptomeningeal carcinomatosis.
Prior/Concomitant Therapy
16 Receipt of live, attenuated vaccine within 30 days prior to the first dose of T-DXd. Note:
Patients, if assigned treatment, should not receive live vaccine during the study and up to
30 days after the last dose of study intervention.
17 Current or prior use of immunosuppressive medication within 14 days before first dose of
durvalumab-containing investigational therapy. The following are exceptions to this
criterion:
Intra-nasal, inhaled, topical steroids, or local steroid injections (eg, intra-articular
injection)
Systemic corticosteroids at physiologic doses not to exceed 10mg/day of prednisone
or its equivalent
Steroids as premedication for hypersensitivity reactions (eg, CT scan premedication,
cytotoxic chemotherapy premedication)
18 Prior radiation therapy for localized Stage 3 unresectable NSCLC. Exceptions are:
palliative radiation to brain, with associated criteria for stability or lack of symptoms,
palliative radiation to painful bony lesions (this must comprise less than 30% of the bone
marrow) and palliative stereotactic radiation therapy to chest providing the washout
period of ≥ 4 weeks (palliative stereotactic radiation therapy to the chest and ≥ 2 weeks in
other areas) as in inclusion #14).
19 Has a concomitant medical condition that would increase the risk of toxicity in the
opinion of the investigator.
20 Known allergy or hypersensitivity to study treatment, other monoclonal antibodies, or any
study drug excipients.
21 Is unable or unwilling to take folic acid or vitamin B12 supplementation.
22 Multiple primary malignancies within 3 years, except for malignancy treated with
curative intent and not known active disease ≥ 5 years before the first dose of the study
intervention and of low potential risk for recurrence, adequately treated/resected
non-melanoma skin cancer or lentigo malignant without evidence of disease,
curatively/adequate treated in-situ disease without evidence of disease, and/or other solid
tumors curatively treated.
23 Patients participating in a concurrent interventional study and/or previously treated with
T-DXd.
24 Unresolved toxicities from previous anticancer therapy, defined as toxicities (other than
alopecia) not yet resolved to Grade ≤ 1 or baseline OR prior discontinuation of planned
study therapy (cisplatin, carboplatin, pemetrexed or PD-1/PD-L1 targeting antibody) due
to toxicity.
Other Exclusions
25 Involvement in the planning and/or conduct of the study (applies to both AstraZeneca
staff and/or staff at the study site).
26 Judgment by the investigator that the patient should not participate in the study if the
patient is unlikely to comply with study procedures, restrictions and requirements.
27 Currently pregnant (confirmed with positive pregnancy test) or breast-feeding.
The Estimated Number of Participants
-
Taiwan
80 participants
-
Global
1200 participants
