Clinical Trials List
Protocol NumberI3Y-MC-JPBX
NCT Number(ClinicalTrials.gov Identfier)NCT02450539
Completed
2015-09-30 - 2019-07-01
Phase II
Terminated4
ICD-9162.9
Malignant neoplasm of bronchus and lung, unspecified
A Randomized Phase 2 Study of Abemaciclib (LY2835219) versus Docetaxel in Patients with Stage IV Squamous Non-Small Cell Lung Cancer Previously Treated with Platinum-Based Chemotherapy
-
Trial Applicant
ELI LILLY AND COMPANY(TAIWAN), INC.
-
Sponsor
Eli Lilly and Company
-
Trial scale
Multi-Regional Multi-Center
-
Update
2026/02/01
Investigators and Locations
Co-Principal Investigator
- Chih-Yen Tu Division of Thoracic Medicine
- Chen Chia-Hung Division of Thoracic Medicine
- 陳鴻仁 Division of Thoracic Medicine
- 廖偉志 Division of Thoracic Medicine
The Actual Total Number of Participants Enrolled
0 Terminated
Co-Principal Investigator
- Wei-Pang Chung Division of Hematology & Oncology
- Yu-Min Yeh Division of Hematology & Oncology
- Wen-Pin Su Division of Hematology & Oncology
- Sin-Syue Li Division of Hematology & Oncology
- Shang-Yin Wu Division of Hematology & Oncology
The Actual Total Number of Participants Enrolled
0 Terminated
Audit
None
Co-Principal Investigator
- 陳焜結 Division of Thoracic Medicine
- JENG-SEN TSENG Division of Thoracic Medicine
- KUO-HSUAN HSU Division of Thoracic Medicine
- TSUNG -YING YANG Division of Thoracic Medicine
The Actual Total Number of Participants Enrolled
0 Terminated
Co-Principal Investigator
Audit
None
Co-Principal Investigator
- 廖唯昱 Division of General Internal Medicine
- 林育麟 Division of Hematology & Oncology
- 陳冠宇 Division of General Internal Medicine
- James Chih-Hsin Yang Division of Hematology & Oncology
- Chong-Jen Yu Division of General Internal Medicine
- 許嘉林 Division of General Internal Medicine
- 廖斌志 Division of Hematology & Oncology
- CHAO-CHI HO CHAO-CHI HO Division of General Internal Medicine
- Chia-Chi Lin Division of Hematology & Oncology
The Actual Total Number of Participants Enrolled
0 Terminated
Audit
None
Condition/Disease
Stage IV Squamous Non-Small Cell Lung Cancer
Objectives
The primary objective of this study is to compare treatment with abemaciclib versus docetaxel
therapy with respect to investigator-assessed progression-free survival (PFS) in patients with Stage IV squamous
cell carcinoma NSCLC who have relapsed after prior platinum-based therapy for advanced disease.
Test Drug
Abemaciclib (LY2835219)
Active Ingredient
Abemaciclib (LY2835219)
Dosage Form
capsule
Dosage
50/100
Endpoints
Criteria for Evaluation:
Efficacy:
Efficacy assessments include imaging studies/tumor assessments, according to RECIST v. 1.1, performed
every 6 weeks, and survival.
PFS
OS
Overall Response Rate
DCR
Time to worsening ECOG PS
Safety:
Safety will be evaluated based on recorded adverse events (AEs), physical examinations, vital sign
measurements, and clinical laboratory assessments. Adverse events and clinical lab values will be coded
using NCI CTCAE Version 4.0.
Health Outcomes:
Health outcomes will be assessed using standardized instruments, MDASI-LC and EQ-5D-5L.
Investigators will report resource utilization such as concomitant medications, transfusions, radiation
therapy, surgery, and treatment-related hospitalization days.
Pharmacokinetics:
The plasma concentrations of abemaciclib and its metabolites LSN2839567 and LSN3106726 will be
measured for patients receiving abemaciclib. Covariate effects (such as age, weight, sex, and plasma
protein levels) on the PK parameters of abemaciclib in plasma will also be investigated.
Biomarkers:
Whole blood, plasma, and tissue samples will be tested for biomarkers relevant to the cell cycle pathway,
abemaciclib, docetaxel, and/or the pathogenesis of lung cancer and to correlate these markers to clinical
outcomes
Efficacy:
Efficacy assessments include imaging studies/tumor assessments, according to RECIST v. 1.1, performed
every 6 weeks, and survival.
PFS
OS
Overall Response Rate
DCR
Time to worsening ECOG PS
Safety:
Safety will be evaluated based on recorded adverse events (AEs), physical examinations, vital sign
measurements, and clinical laboratory assessments. Adverse events and clinical lab values will be coded
using NCI CTCAE Version 4.0.
Health Outcomes:
Health outcomes will be assessed using standardized instruments, MDASI-LC and EQ-5D-5L.
Investigators will report resource utilization such as concomitant medications, transfusions, radiation
therapy, surgery, and treatment-related hospitalization days.
Pharmacokinetics:
The plasma concentrations of abemaciclib and its metabolites LSN2839567 and LSN3106726 will be
measured for patients receiving abemaciclib. Covariate effects (such as age, weight, sex, and plasma
protein levels) on the PK parameters of abemaciclib in plasma will also be investigated.
Biomarkers:
Whole blood, plasma, and tissue samples will be tested for biomarkers relevant to the cell cycle pathway,
abemaciclib, docetaxel, and/or the pathogenesis of lung cancer and to correlate these markers to clinical
outcomes
Inclution Criteria
Inclusion Criteria
Patients are eligible to be included in the study only if they meet all of the following criteria:
[1] have confirmed diagnosis of Stage IV NSCLC disease predominantly
squamous histology according to the American Joint Committee on Cancer on
Cancer Staging Handbook (Edge et al. 2009). Squamous NSCLC diagnosis
must be confirmed by histology or cytology local pathology report.
[2] have availability of adequate formalin-fixed paraffin-embedded (FFPE)
tumor-derived material (tumor blocks or 10 slides minimum) from a core
needle biopsy or surgery for analysis of biomarkers. This sample should be
the most recent available sample containing adequate material. Re-biopsy
after progression from prior therapy is not required.
[3] have progressed during or after platinum-based chemotherapy regimen for
advanced disease
Patients may have received one additional line of therapy only if an
immune checkpoint inhibitor was administered (for example, nivolumab).
This prior immunotherapy is allowed and does count as prior therapy. No
other anticancer agents (for example, chemotherapy, radiotherapy) are
permitted as prior therapy.
Patients with recurrent disease after adjuvant or neoadjuvant therapy or
patients who have received combined chemotherapy and radiation for
locally advanced disease are eligible, if:
a. The patient has progressed within 6 months after completion of
adjuvant or neoadjuvant platinum-based therapy (adjuvant therapy
will be considered the patient’s one and only prior first-line,
platinum-based chemotherapy). The time from completion of the
last cycle of adjuvant or neoadjuvant therapy to progression must
be less than 6 months. For radiotherapy for locally advanced
disease with curative intent with chemotherapy (platinum-based
therapy), the time of completion of chemotherapy or radiotherapy,
whichever finishes last, to progression must be less than 6 months
to count as a line of therapy.
May not have received docetaxel as monotherapy or in combination with
platinum therapy in first-line setting, or in the neoadjuvant/adjuvant setting
a. Prior paclitaxel therapy as monotherapy or in combination is
permitted (for example, single-agent neoadjuvant/adjuvant setting
or combination in first line).
[4] have a performance status (PS) of 0 to 1 on the Eastern Cooperative Oncology
Group (ECOG) scale (see Attachment 4)
[5] have the presence of measureable disease as defined by the Response
Evaluation Criteria In Solid Tumors RECIST 1.1 (Eisenhauer et al. 2009, see
Attachment 7)
[6] have discontinued all previous treatments for cancer (including chemotherapy,
radiotherapy, immunotherapy, and endocrine therapy) for at least 21 days for
myelosuppressive agents; or 14 days for nonmyelosuppressive agents prior to
receiving study drug, and recovered from the acute effects of therapy
(treatment-related toxicity resolved to baseline) except for residual alopecia
Radiation therapy: Prior radiotherapy to chest is permitted if completed
>3 weeks; and prior radiotherapy to the brain is permitted if completed
>4 weeks with assessment of stable disease. Patients must have recovered
from the acute toxic effects of the radiotherapy treatment prior to the first
dose of study treatment.
[7] have adequate organ function, including:
hematologic: absolute neutrophil count (ANC) 1.5 × 109/L, platelets
100 × 109/L, and hemoglobin 9 g/dL. Patients may receive erythrocyte
transfusions to achieve this hemoglobin level at the discretion of the
investigator. Initial study drug treatment must not begin earlier than the
day after the erythrocyte transfusion.
hepatic: bilirubin 1.5 times the upper limit of normal (ULN) and alanine
aminotransferase (ALT) and aspartate aminotransferase (AST) 3 times
ULN. For patients with hepatic metastases, ALT and AST equaling
≤5.0 times ULN are acceptable.
renal: Calculated creatinine clearance ≥50 ml/min (per the
Cockcroft-Gault formula or equivalent, see Attachment 5)
[8] are ≥ 18 years of age
[9] have agreed contraception methods as follows
[9a] are a man and agree to use a reliable medically approved method of birth
control (for example, intrauterine device [IUD], birth control pills, or
barrier method) and to not donate sperm during the study and for at least
3 months following the last dose of study drugs(s) or country
requirements, whichever is longer]
[9b] are women of child-bearing potential who test negative for pregnancy
within 14 days of start of study treatment and agree to use a reliable
medically approved method of birth control (for example, IUD, birth
control pills, or barrier method) during the study and for 3 months
following the last dose of the study drug(s) or country requirements,
whichever is longer
[10] have an estimated life expectancy of at least 12 weeks and in the judgment of
the investigator, will be able to complete at least 2 cycles of treatment
[11] have given written informed consent prior to any study-specific procedures
[12] are reliable and willing to make themselves available for the duration of the
study and are willing to follow study procedures
[13] are able to swallow capsules or tablets
Patients are eligible to be included in the study only if they meet all of the following criteria:
[1] have confirmed diagnosis of Stage IV NSCLC disease predominantly
squamous histology according to the American Joint Committee on Cancer on
Cancer Staging Handbook (Edge et al. 2009). Squamous NSCLC diagnosis
must be confirmed by histology or cytology local pathology report.
[2] have availability of adequate formalin-fixed paraffin-embedded (FFPE)
tumor-derived material (tumor blocks or 10 slides minimum) from a core
needle biopsy or surgery for analysis of biomarkers. This sample should be
the most recent available sample containing adequate material. Re-biopsy
after progression from prior therapy is not required.
[3] have progressed during or after platinum-based chemotherapy regimen for
advanced disease
Patients may have received one additional line of therapy only if an
immune checkpoint inhibitor was administered (for example, nivolumab).
This prior immunotherapy is allowed and does count as prior therapy. No
other anticancer agents (for example, chemotherapy, radiotherapy) are
permitted as prior therapy.
Patients with recurrent disease after adjuvant or neoadjuvant therapy or
patients who have received combined chemotherapy and radiation for
locally advanced disease are eligible, if:
a. The patient has progressed within 6 months after completion of
adjuvant or neoadjuvant platinum-based therapy (adjuvant therapy
will be considered the patient’s one and only prior first-line,
platinum-based chemotherapy). The time from completion of the
last cycle of adjuvant or neoadjuvant therapy to progression must
be less than 6 months. For radiotherapy for locally advanced
disease with curative intent with chemotherapy (platinum-based
therapy), the time of completion of chemotherapy or radiotherapy,
whichever finishes last, to progression must be less than 6 months
to count as a line of therapy.
May not have received docetaxel as monotherapy or in combination with
platinum therapy in first-line setting, or in the neoadjuvant/adjuvant setting
a. Prior paclitaxel therapy as monotherapy or in combination is
permitted (for example, single-agent neoadjuvant/adjuvant setting
or combination in first line).
[4] have a performance status (PS) of 0 to 1 on the Eastern Cooperative Oncology
Group (ECOG) scale (see Attachment 4)
[5] have the presence of measureable disease as defined by the Response
Evaluation Criteria In Solid Tumors RECIST 1.1 (Eisenhauer et al. 2009, see
Attachment 7)
[6] have discontinued all previous treatments for cancer (including chemotherapy,
radiotherapy, immunotherapy, and endocrine therapy) for at least 21 days for
myelosuppressive agents; or 14 days for nonmyelosuppressive agents prior to
receiving study drug, and recovered from the acute effects of therapy
(treatment-related toxicity resolved to baseline) except for residual alopecia
Radiation therapy: Prior radiotherapy to chest is permitted if completed
>3 weeks; and prior radiotherapy to the brain is permitted if completed
>4 weeks with assessment of stable disease. Patients must have recovered
from the acute toxic effects of the radiotherapy treatment prior to the first
dose of study treatment.
[7] have adequate organ function, including:
hematologic: absolute neutrophil count (ANC) 1.5 × 109/L, platelets
100 × 109/L, and hemoglobin 9 g/dL. Patients may receive erythrocyte
transfusions to achieve this hemoglobin level at the discretion of the
investigator. Initial study drug treatment must not begin earlier than the
day after the erythrocyte transfusion.
hepatic: bilirubin 1.5 times the upper limit of normal (ULN) and alanine
aminotransferase (ALT) and aspartate aminotransferase (AST) 3 times
ULN. For patients with hepatic metastases, ALT and AST equaling
≤5.0 times ULN are acceptable.
renal: Calculated creatinine clearance ≥50 ml/min (per the
Cockcroft-Gault formula or equivalent, see Attachment 5)
[8] are ≥ 18 years of age
[9] have agreed contraception methods as follows
[9a] are a man and agree to use a reliable medically approved method of birth
control (for example, intrauterine device [IUD], birth control pills, or
barrier method) and to not donate sperm during the study and for at least
3 months following the last dose of study drugs(s) or country
requirements, whichever is longer]
[9b] are women of child-bearing potential who test negative for pregnancy
within 14 days of start of study treatment and agree to use a reliable
medically approved method of birth control (for example, IUD, birth
control pills, or barrier method) during the study and for 3 months
following the last dose of the study drug(s) or country requirements,
whichever is longer
[10] have an estimated life expectancy of at least 12 weeks and in the judgment of
the investigator, will be able to complete at least 2 cycles of treatment
[11] have given written informed consent prior to any study-specific procedures
[12] are reliable and willing to make themselves available for the duration of the
study and are willing to follow study procedures
[13] are able to swallow capsules or tablets
Exclusion Criteria
Exclusion Criteria
Patients will be excluded from the study if they meet any of the following criteria:
[14] are currently receiving treatment in a clinical trial involving an investigational
product or non-approved use of a drug or device (other than the study
drug/device used in this study), or concurrently enrolled in any other type of
medical research judged not to be scientifically or medically compatible with
this study
[15] have known or suspected allergy to docetaxel or any of its components
[16] have received treatment with a drug that has not received regulatory approval
for any indication within 14 or 21 days of the initial dose of study drug of
nonmyelosuppressive or myelosuppressive agent, respectively
[17] have received prior treatment with any CDK 4 and 6 inhibitor (or participated
in any CDK 4and 6 inhibitor clinical trial for which treatment assignment is
still blinded)
[18] have had major surgery (excluding biopsy) < 28 days of the initial dose of
study drug and/or have not recovered from the acute effects of the surgery
[19] have a personal history within the last 12 months of any of the following
conditions: syncope of either unexplained or cardiovascular etiology,
ventricular tachycardia, ventricular fibrillation, or sudden cardiac arrest.
[20] have serious preexisting medical conditions that, in the judgment of the
investigator, would preclude participation in this study (for example, history
of major surgical resection involving the stomach or small bowel)
[21] have a history of any other cancer (except non-melanoma skin cancer or
carcinoma in-situ of the cervix), unless in complete remission with no therapy
for a minimum of 3 years
[22] have the presence of unstable central nervous system (CNS) metastasis:
History of CNS metastasis or stable CNS metastases are allowed (no
longer requiring active therapy such as steroid medications). Patients with
symptoms of CNS involvement or a history of CNS metastasis will have
brain scan during baseline procedures to document stability. Patients
having prior brain scan within 45 days of starting therapy and without
symptoms of CNS metastases (stable or unstable) do not need to repeat
scan at baseline (within 28 days of starting study treatment).
Steroidal treatment (if indicated) should be completed after cranial
irradiation (whole brain radiation therapy, focal radiation therapy, and
stereotactic radiosurgery)
Prior radiotherapy to the brain must be completed >4 weeks prior to
randomization with assessment of stable disease.
Prior surgical resection should be performed at least 28 days prior to
randomization. The patient may have no evidence of Grade ≥1 CNS
hemorrhage based on pretreatment magnetic resonance imaging (MRI) or
intravenous (IV) contrast computed tomography (CT) scan (performed
within 28 days before starting study treatment).
[23] have active bacterial, fungal, and/or known viral infection (for example,
human immunodeficiency virus [HIV] antibodies, hepatitis B surface antigen,
or hepatitis C antibodies). Screening for active infections is not required for
enrollment.
[24] females who are pregnant or lactating
Patients will be excluded from the study if they meet any of the following criteria:
[14] are currently receiving treatment in a clinical trial involving an investigational
product or non-approved use of a drug or device (other than the study
drug/device used in this study), or concurrently enrolled in any other type of
medical research judged not to be scientifically or medically compatible with
this study
[15] have known or suspected allergy to docetaxel or any of its components
[16] have received treatment with a drug that has not received regulatory approval
for any indication within 14 or 21 days of the initial dose of study drug of
nonmyelosuppressive or myelosuppressive agent, respectively
[17] have received prior treatment with any CDK 4 and 6 inhibitor (or participated
in any CDK 4and 6 inhibitor clinical trial for which treatment assignment is
still blinded)
[18] have had major surgery (excluding biopsy) < 28 days of the initial dose of
study drug and/or have not recovered from the acute effects of the surgery
[19] have a personal history within the last 12 months of any of the following
conditions: syncope of either unexplained or cardiovascular etiology,
ventricular tachycardia, ventricular fibrillation, or sudden cardiac arrest.
[20] have serious preexisting medical conditions that, in the judgment of the
investigator, would preclude participation in this study (for example, history
of major surgical resection involving the stomach or small bowel)
[21] have a history of any other cancer (except non-melanoma skin cancer or
carcinoma in-situ of the cervix), unless in complete remission with no therapy
for a minimum of 3 years
[22] have the presence of unstable central nervous system (CNS) metastasis:
History of CNS metastasis or stable CNS metastases are allowed (no
longer requiring active therapy such as steroid medications). Patients with
symptoms of CNS involvement or a history of CNS metastasis will have
brain scan during baseline procedures to document stability. Patients
having prior brain scan within 45 days of starting therapy and without
symptoms of CNS metastases (stable or unstable) do not need to repeat
scan at baseline (within 28 days of starting study treatment).
Steroidal treatment (if indicated) should be completed after cranial
irradiation (whole brain radiation therapy, focal radiation therapy, and
stereotactic radiosurgery)
Prior radiotherapy to the brain must be completed >4 weeks prior to
randomization with assessment of stable disease.
Prior surgical resection should be performed at least 28 days prior to
randomization. The patient may have no evidence of Grade ≥1 CNS
hemorrhage based on pretreatment magnetic resonance imaging (MRI) or
intravenous (IV) contrast computed tomography (CT) scan (performed
within 28 days before starting study treatment).
[23] have active bacterial, fungal, and/or known viral infection (for example,
human immunodeficiency virus [HIV] antibodies, hepatitis B surface antigen,
or hepatitis C antibodies). Screening for active infections is not required for
enrollment.
[24] females who are pregnant or lactating
The Estimated Number of Participants
-
Taiwan
7 participants
-
Global
193 participants
