計劃書編號D5162C00052
試驗執行中
2023-07-01 - 2027-11-30
Phase II
尚未開始8
召募中2
ICD-10C33
氣管惡性腫瘤
ICD-10Z51.12
來院接受抗腫瘤免疫療法
ICD-9162.0
氣管惡性腫瘤
一項第II期、開放性、單組、多中心的試驗評估Osimertinib搭配Amivantamab作為第一線治療用於表皮生長因子受體突變陽性、局部晚期或轉移性非小細胞肺癌參與者的安全性和療效(OSTARA)
-
試驗申請者
百瑞精鼎國際股份有限公司
-
試驗委託 / 贊助單位名稱
百瑞精鼎國際股份有限公司
-
臨床試驗規模
多國多中心
-
更新日期
2026/02/01
試驗主持人及試驗醫院
實際收案人數
0 尚未開始
實際收案人數
0 尚未開始
實際收案人數
0 尚未開始
實際收案人數
0 尚未開始
實際收案人數
0 尚未開始
實際收案人數
0 召募中
適應症
表皮生長因子受體突變陽性、局部晚期或轉移性非小細胞肺癌
試驗目的
主要目標：
•評估osimertinib加上amivantamab用於患有EGFR突變陽性、局部晚期或轉移性NSCLC之參與者的安全性及耐受性。
•藉由評估患有EGFR突變陽性、局部晚期或轉移性NSCLC之參與者的PFS，證實osimertinib加上amivantamab的療效。
次要目標：
•進一步評估osimertinib加上amivantamab用於患有EGFR突變陽性、局部晚期或轉移性NSCLC之參與者的安全性及耐受性。
•藉由評估ORR、DoR、OS，進一步評估osimertinib加上amivantamab用於患有EGFR突變陽性、局部晚期或轉移性NSCLC之參與者的療效。
藥品名稱
膜衣錠
注射液
注射液
主成份
Osimertinib
Amivantamab
Amivantamab
劑型
116
279
279
劑量
-
評估指標
將依據AE、SAE、導致劑量調整之AE以及導致劑量中止之AE，評估安全性及耐受性。
PFS的定義為從第一劑試驗介入治療的日期開始，直到由當地試驗單位的試驗主持人根據RECIST 1.1評估為疾病惡化為止，或由於任何原因死亡為止所經過的時間。這項分析將涵蓋所有已接受藥物劑量的參與者。將涵蓋所有事件，不論參與者是否退出治療、接受另一項抗癌療法，或在RECIST 1.1評估之前發生臨床惡化。不過，如果參與者在連續2次以上錯過回診後立即惡化或死亡，則該名參與者的惡化時間將設限在2次錯過回診之前的最後一次可評量之評估的時間。所關注的測量項目為PFS的中位數。
PFS的定義為從第一劑試驗介入治療的日期開始，直到由當地試驗單位的試驗主持人根據RECIST 1.1評估為疾病惡化為止，或由於任何原因死亡為止所經過的時間。這項分析將涵蓋所有已接受藥物劑量的參與者。將涵蓋所有事件，不論參與者是否退出治療、接受另一項抗癌療法，或在RECIST 1.1評估之前發生臨床惡化。不過，如果參與者在連續2次以上錯過回診後立即惡化或死亡，則該名參與者的惡化時間將設限在2次錯過回診之前的最後一次可評量之評估的時間。所關注的測量項目為PFS的中位數。
主要納入條件
Age
1 Participant must be at least 18 years of age or the legal age of consent in the jurisdiction
in which the study is taking place, at the time of signing the ICF.
Type of Participant and Disease Characteristics
2 Histologically or cytologically documented non-squamous NSCLC. NSCLC of mixed
histology is allowed.
3 Newly diagnosed locally advanced (clinical stage IIIB, IIIC) or metastatic NSCLC
(clinical stage IVA or IVB) or recurrent non-squamous NSCLC (per Version 8 of the
IASLC Staging Manual in Thoracic Oncology), not amenable to curative surgery or
radiotherapy (Appendix F).
4 WHO PS of 0 to 1 with no deterioration over the previous 2 weeks prior to enrolment.
5 Minimum life expectancy ＞ 12 weeks at Day 1.
6 Confirmation by the locally accredited laboratory that the tumour harbours one of the 2
common EGFRm known to be associated with EGFR-TKI sensitivity (Ex19del, L858R),
either alone or in combination with other EGFR mutations including de novo T790M
(refer to Section 8.1.4).
7 At least 1 lesion that can be accurately measured at baseline as ≥10 mm in the longest
diameter (except lymph nodes, which must have a short axis of ≥15 mm) with CT or MRI
and that is suitable for accurate repeated measurements.
8 Adequate organ and bone marrow function as follows:
Haemoglobin ≥ 9.0 g/dL
Absolute neutrophil count ≥ 1.5 × 109 /L
Platelet count ≥100 × 109 /L
Total bilirubin ≤1.5 × the ULN; or ≤3 × ULN in the presence of documented
Gilbert’s syndrome (unconjugated hyperbilirubinaemia) or liver metastases
ALT and AST ≤2.5 × ULN; for participants with hepatic metastases, ALT, and AST
≤5×ULN
Creatinine ＞1.5 × ULN concurrent with creatinine clearance ＜ 50 mL/min (measured
or calculated by Cockcroft or Gault equation); confirmation of creatinine clearance is
only required when creatinine is ＞1.5 × ULN.
9 Mandatory provision of a baseline plasma sample and an unstained tumour tissue sample.
Sex and Contraceptive/Barrier Requirements
10 Male or female
Contraceptive use by males or females should be consistent with local regulations regarding
the methods of contraception for those participating in clinical studies (see Appendix G for
further details).
(a) Male participants:
Use of barrier contraception from screening and throughout the study, until at least
4 months after the last dose of osimertinib and 6 months after the last dose of
amivantamab. Participants should refrain from donating sperm from the start of
dosing until 4 months after the last dose of osimertinib and 6 months after the last
dose of amivantamab.
(b) Female participants:
Females not of child-bearing potential, see Appendix G for definition; must fulfil one
of the following criteria at screening:
Post-menopausal defined as more than 50 years of age and amenorrhoeic for at least
12 months following cessation of all exogenous hormonal treatments.
Females under 50 years old would be considered as post-menopausal if they have
been amenorrhoeic for 12 months or more following cessation of exogenous
hormonal treatments and have luteinizing hormone and follicle-stimulating hormone
levels in the post-menopausal range for the institution.
Documentation of irreversible surgical sterilisation by hysterectomy, bilateral
oophorectomy or bilateral salpingectomy but not tubal ligation.
Females receiving HRT and whose menopausal status is in doubt will be required to
use one of the contraception methods outlined for FOCBP if they wish to continue
using HRT during the study. Otherwise, HRT must be discontinued to allow
confirmation of post-menopausal status prior to study screening; see Appendix G for
further details.
FOCBP must use one highly effective form of contraception from screening
throughout study and until at least 6 weeks after the last dose of osimertinib and
3 months after the last dose of amivantamab (Appendix G).
All FOCBP must have a negative serum or urine pregnancy test result prior to start of
dosing.
Informed Consent
11 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 CSP.
12 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, as allowed by local regulations (see Appendix D 2).
Other Inclusion Criteria
13 All races, gender and ethnic groups are eligible for this study.Age
1 Participant must be at least 18 years of age or the legal age of consent in the jurisdiction
in which the study is taking place, at the time of signing the ICF.
Type of Participant and Disease Characteristics
2 Histologically or cytologically documented non-squamous NSCLC. NSCLC of mixed
histology is allowed.
3 Newly diagnosed locally advanced (clinical stage IIIB, IIIC) or metastatic NSCLC
(clinical stage IVA or IVB) or recurrent non-squamous NSCLC (per Version 8 of the
IASLC Staging Manual in Thoracic Oncology), not amenable to curative surgery or
radiotherapy (Appendix F).
4 WHO PS of 0 to 1 with no deterioration over the previous 2 weeks prior to enrolment.
5 Minimum life expectancy ＞ 12 weeks at Day 1.
6 Confirmation by the locally accredited laboratory that the tumour harbours one of the 2
common EGFRm known to be associated with EGFR-TKI sensitivity (Ex19del, L858R),
either alone or in combination with other EGFR mutations including de novo T790M
(refer to Section 8.1.4).
7 At least 1 lesion that can be accurately measured at baseline as ≥10 mm in the longest
diameter (except lymph nodes, which must have a short axis of ≥15 mm) with CT or MRI
and that is suitable for accurate repeated measurements.
8 Adequate organ and bone marrow function as follows:
Haemoglobin ≥ 9.0 g/dL
Absolute neutrophil count ≥ 1.5 × 109 /L
Platelet count ≥100 × 109 /L
Total bilirubin ≤1.5 × the ULN; or ≤3 × ULN in the presence of documented
Gilbert’s syndrome (unconjugated hyperbilirubinaemia) or liver metastases
ALT and AST ≤2.5 × ULN; for participants with hepatic metastases, ALT, and AST
≤5×ULN
Creatinine ＞1.5 × ULN concurrent with creatinine clearance ＜ 50 mL/min (measured
or calculated by Cockcroft or Gault equation); confirmation of creatinine clearance is
only required when creatinine is ＞1.5 × ULN.
9 Mandatory provision of a baseline plasma sample and an unstained tumour tissue sample.
Sex and Contraceptive/Barrier Requirements
10 Male or female
Contraceptive use by males or females should be consistent with local regulations regarding
the methods of contraception for those participating in clinical studies (see Appendix G for
further details).
(a) Male participants:
Use of barrier contraception from screening and throughout the study, until at least
4 months after the last dose of osimertinib and 6 months after the last dose of
amivantamab. Participants should refrain from donating sperm from the start of
dosing until 4 months after the last dose of osimertinib and 6 months after the last
dose of amivantamab.
(b) Female participants:
Females not of child-bearing potential, see Appendix G for definition; must fulfil one
of the following criteria at screening:
Post-menopausal defined as more than 50 years of age and amenorrhoeic for at least
12 months following cessation of all exogenous hormonal treatments.
Females under 50 years old would be considered as post-menopausal if they have
been amenorrhoeic for 12 months or more following cessation of exogenous
hormonal treatments and have luteinizing hormone and follicle-stimulating hormone
levels in the post-menopausal range for the institution.
Documentation of irreversible surgical sterilisation by hysterectomy, bilateral
oophorectomy or bilateral salpingectomy but not tubal ligation.
Females receiving HRT and whose menopausal status is in doubt will be required to
use one of the contraception methods outlined for FOCBP if they wish to continue
using HRT during the study. Otherwise, HRT must be discontinued to allow
confirmation of post-menopausal status prior to study screening; see Appendix G for
further details.
FOCBP must use one highly effective form of contraception from screening
throughout study and until at least 6 weeks after the last dose of osimertinib and
3 months after the last dose of amivantamab (Appendix G).
All FOCBP must have a negative serum or urine pregnancy test result prior to start of
dosing.
Informed Consent
11 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 CSP.
12 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, as allowed by local regulations (see Appendix D 2).
Other Inclusion Criteria
13 All races, gender and ethnic groups are eligible for this study.
1 Participant must be at least 18 years of age or the legal age of consent in the jurisdiction
in which the study is taking place, at the time of signing the ICF.
Type of Participant and Disease Characteristics
2 Histologically or cytologically documented non-squamous NSCLC. NSCLC of mixed
histology is allowed.
3 Newly diagnosed locally advanced (clinical stage IIIB, IIIC) or metastatic NSCLC
(clinical stage IVA or IVB) or recurrent non-squamous NSCLC (per Version 8 of the
IASLC Staging Manual in Thoracic Oncology), not amenable to curative surgery or
radiotherapy (Appendix F).
4 WHO PS of 0 to 1 with no deterioration over the previous 2 weeks prior to enrolment.
5 Minimum life expectancy ＞ 12 weeks at Day 1.
6 Confirmation by the locally accredited laboratory that the tumour harbours one of the 2
common EGFRm known to be associated with EGFR-TKI sensitivity (Ex19del, L858R),
either alone or in combination with other EGFR mutations including de novo T790M
(refer to Section 8.1.4).
7 At least 1 lesion that can be accurately measured at baseline as ≥10 mm in the longest
diameter (except lymph nodes, which must have a short axis of ≥15 mm) with CT or MRI
and that is suitable for accurate repeated measurements.
8 Adequate organ and bone marrow function as follows:
Haemoglobin ≥ 9.0 g/dL
Absolute neutrophil count ≥ 1.5 × 109 /L
Platelet count ≥100 × 109 /L
Total bilirubin ≤1.5 × the ULN; or ≤3 × ULN in the presence of documented
Gilbert’s syndrome (unconjugated hyperbilirubinaemia) or liver metastases
ALT and AST ≤2.5 × ULN; for participants with hepatic metastases, ALT, and AST
≤5×ULN
Creatinine ＞1.5 × ULN concurrent with creatinine clearance ＜ 50 mL/min (measured
or calculated by Cockcroft or Gault equation); confirmation of creatinine clearance is
only required when creatinine is ＞1.5 × ULN.
9 Mandatory provision of a baseline plasma sample and an unstained tumour tissue sample.
Sex and Contraceptive/Barrier Requirements
10 Male or female
Contraceptive use by males or females should be consistent with local regulations regarding
the methods of contraception for those participating in clinical studies (see Appendix G for
further details).
(a) Male participants:
Use of barrier contraception from screening and throughout the study, until at least
4 months after the last dose of osimertinib and 6 months after the last dose of
amivantamab. Participants should refrain from donating sperm from the start of
dosing until 4 months after the last dose of osimertinib and 6 months after the last
dose of amivantamab.
(b) Female participants:
Females not of child-bearing potential, see Appendix G for definition; must fulfil one
of the following criteria at screening:
Post-menopausal defined as more than 50 years of age and amenorrhoeic for at least
12 months following cessation of all exogenous hormonal treatments.
Females under 50 years old would be considered as post-menopausal if they have
been amenorrhoeic for 12 months or more following cessation of exogenous
hormonal treatments and have luteinizing hormone and follicle-stimulating hormone
levels in the post-menopausal range for the institution.
Documentation of irreversible surgical sterilisation by hysterectomy, bilateral
oophorectomy or bilateral salpingectomy but not tubal ligation.
Females receiving HRT and whose menopausal status is in doubt will be required to
use one of the contraception methods outlined for FOCBP if they wish to continue
using HRT during the study. Otherwise, HRT must be discontinued to allow
confirmation of post-menopausal status prior to study screening; see Appendix G for
further details.
FOCBP must use one highly effective form of contraception from screening
throughout study and until at least 6 weeks after the last dose of osimertinib and
3 months after the last dose of amivantamab (Appendix G).
All FOCBP must have a negative serum or urine pregnancy test result prior to start of
dosing.
Informed Consent
11 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 CSP.
12 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, as allowed by local regulations (see Appendix D 2).
Other Inclusion Criteria
13 All races, gender and ethnic groups are eligible for this study.Age
1 Participant must be at least 18 years of age or the legal age of consent in the jurisdiction
in which the study is taking place, at the time of signing the ICF.
Type of Participant and Disease Characteristics
2 Histologically or cytologically documented non-squamous NSCLC. NSCLC of mixed
histology is allowed.
3 Newly diagnosed locally advanced (clinical stage IIIB, IIIC) or metastatic NSCLC
(clinical stage IVA or IVB) or recurrent non-squamous NSCLC (per Version 8 of the
IASLC Staging Manual in Thoracic Oncology), not amenable to curative surgery or
radiotherapy (Appendix F).
4 WHO PS of 0 to 1 with no deterioration over the previous 2 weeks prior to enrolment.
5 Minimum life expectancy ＞ 12 weeks at Day 1.
6 Confirmation by the locally accredited laboratory that the tumour harbours one of the 2
common EGFRm known to be associated with EGFR-TKI sensitivity (Ex19del, L858R),
either alone or in combination with other EGFR mutations including de novo T790M
(refer to Section 8.1.4).
7 At least 1 lesion that can be accurately measured at baseline as ≥10 mm in the longest
diameter (except lymph nodes, which must have a short axis of ≥15 mm) with CT or MRI
and that is suitable for accurate repeated measurements.
8 Adequate organ and bone marrow function as follows:
Haemoglobin ≥ 9.0 g/dL
Absolute neutrophil count ≥ 1.5 × 109 /L
Platelet count ≥100 × 109 /L
Total bilirubin ≤1.5 × the ULN; or ≤3 × ULN in the presence of documented
Gilbert’s syndrome (unconjugated hyperbilirubinaemia) or liver metastases
ALT and AST ≤2.5 × ULN; for participants with hepatic metastases, ALT, and AST
≤5×ULN
Creatinine ＞1.5 × ULN concurrent with creatinine clearance ＜ 50 mL/min (measured
or calculated by Cockcroft or Gault equation); confirmation of creatinine clearance is
only required when creatinine is ＞1.5 × ULN.
9 Mandatory provision of a baseline plasma sample and an unstained tumour tissue sample.
Sex and Contraceptive/Barrier Requirements
10 Male or female
Contraceptive use by males or females should be consistent with local regulations regarding
the methods of contraception for those participating in clinical studies (see Appendix G for
further details).
(a) Male participants:
Use of barrier contraception from screening and throughout the study, until at least
4 months after the last dose of osimertinib and 6 months after the last dose of
amivantamab. Participants should refrain from donating sperm from the start of
dosing until 4 months after the last dose of osimertinib and 6 months after the last
dose of amivantamab.
(b) Female participants:
Females not of child-bearing potential, see Appendix G for definition; must fulfil one
of the following criteria at screening:
Post-menopausal defined as more than 50 years of age and amenorrhoeic for at least
12 months following cessation of all exogenous hormonal treatments.
Females under 50 years old would be considered as post-menopausal if they have
been amenorrhoeic for 12 months or more following cessation of exogenous
hormonal treatments and have luteinizing hormone and follicle-stimulating hormone
levels in the post-menopausal range for the institution.
Documentation of irreversible surgical sterilisation by hysterectomy, bilateral
oophorectomy or bilateral salpingectomy but not tubal ligation.
Females receiving HRT and whose menopausal status is in doubt will be required to
use one of the contraception methods outlined for FOCBP if they wish to continue
using HRT during the study. Otherwise, HRT must be discontinued to allow
confirmation of post-menopausal status prior to study screening; see Appendix G for
further details.
FOCBP must use one highly effective form of contraception from screening
throughout study and until at least 6 weeks after the last dose of osimertinib and
3 months after the last dose of amivantamab (Appendix G).
All FOCBP must have a negative serum or urine pregnancy test result prior to start of
dosing.
Informed Consent
11 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 CSP.
12 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, as allowed by local regulations (see Appendix D 2).
Other Inclusion Criteria
13 All races, gender and ethnic groups are eligible for this study.
主要排除條件
Age
1 Participant must be at least 18 years of age or the legal age of consent in the jurisdiction
in which the study is taking place, at the time of signing the ICF.
Type of Participant and Disease Characteristics
2 Histologically or cytologically documented non-squamous NSCLC. NSCLC of mixed
histology is allowed.
3 Newly diagnosed locally advanced (clinical stage IIIB, IIIC) or metastatic NSCLC
(clinical stage IVA or IVB) or recurrent non-squamous NSCLC (per Version 8 of the
IASLC Staging Manual in Thoracic Oncology), not amenable to curative surgery or
radiotherapy (Appendix F).
4 WHO PS of 0 to 1 with no deterioration over the previous 2 weeks prior to enrolment.
5 Minimum life expectancy ＞ 12 weeks at Day 1.
6 Confirmation by the locally accredited laboratory that the tumour harbours one of the 2
common EGFRm known to be associated with EGFR-TKI sensitivity (Ex19del, L858R),
either alone or in combination with other EGFR mutations including de novo T790M
(refer to Section 8.1.4).
7 At least 1 lesion that can be accurately measured at baseline as ≥10 mm in the longest
diameter (except lymph nodes, which must have a short axis of ≥15 mm) with CT or MRI
and that is suitable for accurate repeated measurements.
8 Adequate organ and bone marrow function as follows:
Haemoglobin ≥ 9.0 g/dL
Absolute neutrophil count ≥ 1.5 × 109 /L
Platelet count ≥100 × 109 /L
Total bilirubin ≤1.5 × the ULN; or ≤3 × ULN in the presence of documented
Gilbert’s syndrome (unconjugated hyperbilirubinaemia) or liver metastases
ALT and AST ≤2.5 × ULN; for participants with hepatic metastases, ALT, and AST
≤5×ULN
Creatinine ＞1.5 × ULN concurrent with creatinine clearance ＜ 50 mL/min (measured
or calculated by Cockcroft or Gault equation); confirmation of creatinine clearance is
only required when creatinine is ＞1.5 × ULN.
9 Mandatory provision of a baseline plasma sample and an unstained tumour tissue sample.
Sex and Contraceptive/Barrier Requirements
10 Male or female
Contraceptive use by males or females should be consistent with local regulations regarding
the methods of contraception for those participating in clinical studies (see Appendix G for
further details).
(a) Male participants:
Use of barrier contraception from screening and throughout the study, until at least
4 months after the last dose of osimertinib and 6 months after the last dose of
amivantamab. Participants should refrain from donating sperm from the start of
dosing until 4 months after the last dose of osimertinib and 6 months after the last
dose of amivantamab.
(b) Female participants:
Females not of child-bearing potential, see Appendix G for definition; must fulfil one
of the following criteria at screening:
Post-menopausal defined as more than 50 years of age and amenorrhoeic for at least
12 months following cessation of all exogenous hormonal treatments.
Females under 50 years old would be considered as post-menopausal if they have
been amenorrhoeic for 12 months or more following cessation of exogenous
hormonal treatments and have luteinizing hormone and follicle-stimulating hormone
levels in the post-menopausal range for the institution.
Documentation of irreversible surgical sterilisation by hysterectomy, bilateral
oophorectomy or bilateral salpingectomy but not tubal ligation.
Females receiving HRT and whose menopausal status is in doubt will be required to
use one of the contraception methods outlined for FOCBP if they wish to continue
using HRT during the study. Otherwise, HRT must be discontinued to allow
confirmation of post-menopausal status prior to study screening; see Appendix G for
further details.
FOCBP must use one highly effective form of contraception from screening
throughout study and until at least 6 weeks after the last dose of osimertinib and
3 months after the last dose of amivantamab (Appendix G).
All FOCBP must have a negative serum or urine pregnancy test result prior to start of
dosing.
Informed Consent
11 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 CSP.
12 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, as allowed by local regulations (see Appendix D 2).
Other Inclusion Criteria
13 All races, gender and ethnic groups are eligible for this study.Age
1 Participant must be at least 18 years of age or the legal age of consent in the jurisdiction
in which the study is taking place, at the time of signing the ICF.
Type of Participant and Disease Characteristics
2 Histologically or cytologically documented non-squamous NSCLC. NSCLC of mixed
histology is allowed.
3 Newly diagnosed locally advanced (clinical stage IIIB, IIIC) or metastatic NSCLC
(clinical stage IVA or IVB) or recurrent non-squamous NSCLC (per Version 8 of the
IASLC Staging Manual in Thoracic Oncology), not amenable to curative surgery or
radiotherapy (Appendix F).
4 WHO PS of 0 to 1 with no deterioration over the previous 2 weeks prior to enrolment.
5 Minimum life expectancy ＞ 12 weeks at Day 1.
6 Confirmation by the locally accredited laboratory that the tumour harbours one of the 2
common EGFRm known to be associated with EGFR-TKI sensitivity (Ex19del, L858R),
either alone or in combination with other EGFR mutations including de novo T790M
(refer to Section 8.1.4).
7 At least 1 lesion that can be accurately measured at baseline as ≥10 mm in the longest
diameter (except lymph nodes, which must have a short axis of ≥15 mm) with CT or MRI
and that is suitable for accurate repeated measurements.
8 Adequate organ and bone marrow function as follows:
Haemoglobin ≥ 9.0 g/dL
Absolute neutrophil count ≥ 1.5 × 109 /L
Platelet count ≥100 × 109 /L
Total bilirubin ≤1.5 × the ULN; or ≤3 × ULN in the presence of documented
Gilbert’s syndrome (unconjugated hyperbilirubinaemia) or liver metastases
ALT and AST ≤2.5 × ULN; for participants with hepatic metastases, ALT, and AST
≤5×ULN
Creatinine ＞1.5 × ULN concurrent with creatinine clearance ＜ 50 mL/min (measured
or calculated by Cockcroft or Gault equation); confirmation of creatinine clearance is
only required when creatinine is ＞1.5 × ULN.
9 Mandatory provision of a baseline plasma sample and an unstained tumour tissue sample.
Sex and Contraceptive/Barrier Requirements
10 Male or female
Contraceptive use by males or females should be consistent with local regulations regarding
the methods of contraception for those participating in clinical studies (see Appendix G for
further details).
(a) Male participants:
Use of barrier contraception from screening and throughout the study, until at least
4 months after the last dose of osimertinib and 6 months after the last dose of
amivantamab. Participants should refrain from donating sperm from the start of
dosing until 4 months after the last dose of osimertinib and 6 months after the last
dose of amivantamab.
(b) Female participants:
Females not of child-bearing potential, see Appendix G for definition; must fulfil one
of the following criteria at screening:
Post-menopausal defined as more than 50 years of age and amenorrhoeic for at least
12 months following cessation of all exogenous hormonal treatments.
Females under 50 years old would be considered as post-menopausal if they have
been amenorrhoeic for 12 months or more following cessation of exogenous
hormonal treatments and have luteinizing hormone and follicle-stimulating hormone
levels in the post-menopausal range for the institution.
Documentation of irreversible surgical sterilisation by hysterectomy, bilateral
oophorectomy or bilateral salpingectomy but not tubal ligation.
Females receiving HRT and whose menopausal status is in doubt will be required to
use one of the contraception methods outlined for FOCBP if they wish to continue
using HRT during the study. Otherwise, HRT must be discontinued to allow
confirmation of post-menopausal status prior to study screening; see Appendix G for
further details.
FOCBP must use one highly effective form of contraception from screening
throughout study and until at least 6 weeks after the last dose of osimertinib and
3 months after the last dose of amivantamab (Appendix G).
All FOCBP must have a negative serum or urine pregnancy test result prior to start of
dosing.
Informed Consent
11 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 CSP.
12 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, as allowed by local regulations (see Appendix D 2).
Other Inclusion Criteria
13 All races, gender and ethnic groups are eligible for this study.
1 Participant must be at least 18 years of age or the legal age of consent in the jurisdiction
in which the study is taking place, at the time of signing the ICF.
Type of Participant and Disease Characteristics
2 Histologically or cytologically documented non-squamous NSCLC. NSCLC of mixed
histology is allowed.
3 Newly diagnosed locally advanced (clinical stage IIIB, IIIC) or metastatic NSCLC
(clinical stage IVA or IVB) or recurrent non-squamous NSCLC (per Version 8 of the
IASLC Staging Manual in Thoracic Oncology), not amenable to curative surgery or
radiotherapy (Appendix F).
4 WHO PS of 0 to 1 with no deterioration over the previous 2 weeks prior to enrolment.
5 Minimum life expectancy ＞ 12 weeks at Day 1.
6 Confirmation by the locally accredited laboratory that the tumour harbours one of the 2
common EGFRm known to be associated with EGFR-TKI sensitivity (Ex19del, L858R),
either alone or in combination with other EGFR mutations including de novo T790M
(refer to Section 8.1.4).
7 At least 1 lesion that can be accurately measured at baseline as ≥10 mm in the longest
diameter (except lymph nodes, which must have a short axis of ≥15 mm) with CT or MRI
and that is suitable for accurate repeated measurements.
8 Adequate organ and bone marrow function as follows:
Haemoglobin ≥ 9.0 g/dL
Absolute neutrophil count ≥ 1.5 × 109 /L
Platelet count ≥100 × 109 /L
Total bilirubin ≤1.5 × the ULN; or ≤3 × ULN in the presence of documented
Gilbert’s syndrome (unconjugated hyperbilirubinaemia) or liver metastases
ALT and AST ≤2.5 × ULN; for participants with hepatic metastases, ALT, and AST
≤5×ULN
Creatinine ＞1.5 × ULN concurrent with creatinine clearance ＜ 50 mL/min (measured
or calculated by Cockcroft or Gault equation); confirmation of creatinine clearance is
only required when creatinine is ＞1.5 × ULN.
9 Mandatory provision of a baseline plasma sample and an unstained tumour tissue sample.
Sex and Contraceptive/Barrier Requirements
10 Male or female
Contraceptive use by males or females should be consistent with local regulations regarding
the methods of contraception for those participating in clinical studies (see Appendix G for
further details).
(a) Male participants:
Use of barrier contraception from screening and throughout the study, until at least
4 months after the last dose of osimertinib and 6 months after the last dose of
amivantamab. Participants should refrain from donating sperm from the start of
dosing until 4 months after the last dose of osimertinib and 6 months after the last
dose of amivantamab.
(b) Female participants:
Females not of child-bearing potential, see Appendix G for definition; must fulfil one
of the following criteria at screening:
Post-menopausal defined as more than 50 years of age and amenorrhoeic for at least
12 months following cessation of all exogenous hormonal treatments.
Females under 50 years old would be considered as post-menopausal if they have
been amenorrhoeic for 12 months or more following cessation of exogenous
hormonal treatments and have luteinizing hormone and follicle-stimulating hormone
levels in the post-menopausal range for the institution.
Documentation of irreversible surgical sterilisation by hysterectomy, bilateral
oophorectomy or bilateral salpingectomy but not tubal ligation.
Females receiving HRT and whose menopausal status is in doubt will be required to
use one of the contraception methods outlined for FOCBP if they wish to continue
using HRT during the study. Otherwise, HRT must be discontinued to allow
confirmation of post-menopausal status prior to study screening; see Appendix G for
further details.
FOCBP must use one highly effective form of contraception from screening
throughout study and until at least 6 weeks after the last dose of osimertinib and
3 months after the last dose of amivantamab (Appendix G).
All FOCBP must have a negative serum or urine pregnancy test result prior to start of
dosing.
Informed Consent
11 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 CSP.
12 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, as allowed by local regulations (see Appendix D 2).
Other Inclusion Criteria
13 All races, gender and ethnic groups are eligible for this study.Age
1 Participant must be at least 18 years of age or the legal age of consent in the jurisdiction
in which the study is taking place, at the time of signing the ICF.
Type of Participant and Disease Characteristics
2 Histologically or cytologically documented non-squamous NSCLC. NSCLC of mixed
histology is allowed.
3 Newly diagnosed locally advanced (clinical stage IIIB, IIIC) or metastatic NSCLC
(clinical stage IVA or IVB) or recurrent non-squamous NSCLC (per Version 8 of the
IASLC Staging Manual in Thoracic Oncology), not amenable to curative surgery or
radiotherapy (Appendix F).
4 WHO PS of 0 to 1 with no deterioration over the previous 2 weeks prior to enrolment.
5 Minimum life expectancy ＞ 12 weeks at Day 1.
6 Confirmation by the locally accredited laboratory that the tumour harbours one of the 2
common EGFRm known to be associated with EGFR-TKI sensitivity (Ex19del, L858R),
either alone or in combination with other EGFR mutations including de novo T790M
(refer to Section 8.1.4).
7 At least 1 lesion that can be accurately measured at baseline as ≥10 mm in the longest
diameter (except lymph nodes, which must have a short axis of ≥15 mm) with CT or MRI
and that is suitable for accurate repeated measurements.
8 Adequate organ and bone marrow function as follows:
Haemoglobin ≥ 9.0 g/dL
Absolute neutrophil count ≥ 1.5 × 109 /L
Platelet count ≥100 × 109 /L
Total bilirubin ≤1.5 × the ULN; or ≤3 × ULN in the presence of documented
Gilbert’s syndrome (unconjugated hyperbilirubinaemia) or liver metastases
ALT and AST ≤2.5 × ULN; for participants with hepatic metastases, ALT, and AST
≤5×ULN
Creatinine ＞1.5 × ULN concurrent with creatinine clearance ＜ 50 mL/min (measured
or calculated by Cockcroft or Gault equation); confirmation of creatinine clearance is
only required when creatinine is ＞1.5 × ULN.
9 Mandatory provision of a baseline plasma sample and an unstained tumour tissue sample.
Sex and Contraceptive/Barrier Requirements
10 Male or female
Contraceptive use by males or females should be consistent with local regulations regarding
the methods of contraception for those participating in clinical studies (see Appendix G for
further details).
(a) Male participants:
Use of barrier contraception from screening and throughout the study, until at least
4 months after the last dose of osimertinib and 6 months after the last dose of
amivantamab. Participants should refrain from donating sperm from the start of
dosing until 4 months after the last dose of osimertinib and 6 months after the last
dose of amivantamab.
(b) Female participants:
Females not of child-bearing potential, see Appendix G for definition; must fulfil one
of the following criteria at screening:
Post-menopausal defined as more than 50 years of age and amenorrhoeic for at least
12 months following cessation of all exogenous hormonal treatments.
Females under 50 years old would be considered as post-menopausal if they have
been amenorrhoeic for 12 months or more following cessation of exogenous
hormonal treatments and have luteinizing hormone and follicle-stimulating hormone
levels in the post-menopausal range for the institution.
Documentation of irreversible surgical sterilisation by hysterectomy, bilateral
oophorectomy or bilateral salpingectomy but not tubal ligation.
Females receiving HRT and whose menopausal status is in doubt will be required to
use one of the contraception methods outlined for FOCBP if they wish to continue
using HRT during the study. Otherwise, HRT must be discontinued to allow
confirmation of post-menopausal status prior to study screening; see Appendix G for
further details.
FOCBP must use one highly effective form of contraception from screening
throughout study and until at least 6 weeks after the last dose of osimertinib and
3 months after the last dose of amivantamab (Appendix G).
All FOCBP must have a negative serum or urine pregnancy test result prior to start of
dosing.
Informed Consent
11 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 CSP.
12 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, as allowed by local regulations (see Appendix D 2).
Other Inclusion Criteria
13 All races, gender and ethnic groups are eligible for this study.
試驗計畫預計收納受試者人數
-
台灣人數
14 人
-
全球人數
80 人
