Back to resultsA Study of AL2846 Versus Zoledronic Acid in Subjects With Advanced Non-Small Cell Lung Cancer With Bone Metastasis
Primary Purpose
Bone Metastatic Non-small Cell Lung Cancer
Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
AL2846
Zoledronic Acid Injection
Sponsored by
About this trial
This is an interventional treatment trial for Bone Metastatic Non-small Cell Lung Cancer
Eligibility Criteria
Inclusion Criteria:
1.Understood and signed an informed consent form. 2.18 years and older; Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1; Life expectancy ≥ 3 months.
3.Histologically confirmed advanced non-small cell lung cancer with at least one bone metastatic lesion with bone destruction.
4.Has received at least two systematic treatment regimens that failed or were unable to tolerate treatment.
5.EGFR, ALK gene mutations are negative. 6.Adequate laboratory indicators. 7.No pregnant or breastfeeding women, and a negative pregnancy test.
Exclusion Criteria:
1.Small cell lung cancer. 2. Diagnosed and/or treated additional malignancy within 5 years with the exception of cured cervical carcinoma in situ and non-melanoma skin cancer.
3. Has received radiotherapy, chemotherapy and surgery before and less than 4 weeks from the first administration and less than 5 half-lives of oral targeted drugs after the completion of treatment.
4. Has received systemic radionuclide therapy or semi-extracorporeal radiation for bone metastases.
5. Has known to be allergic to the study drug or any of its excipients. 6. Has symptomatic brain metastases, spinal cord compression, and cancerous meningitis within 8 weeks,or brain or pia mater disease confirmed by CT or MRI examination before the first dose.
7. Has adverse events caused by previous therapy that did not recover to ≤ grade 1, with the exception of alopecia or ≥ grade 2 neurotoxicity caused by Oxaliplatin.
8. Imaging (CT or MRI) shows that tumor invades large blood vessels or the boundary with blood vessels is unclear.
9. Has spinal cord compression or mandibular osteonecrosis. 10.Has multiple factors that affect oral medications. 11.Has gastroduodenal ulcer, ulcerative colitis, intestinal obstruction and other gastrointestinal diseases or other conditions judged by the investigator that may cause gastrointestinal bleeding or perforation.
12.Uncontrolled pleural effusion, pericardial effusion, or ascites requiring repeated drainage.
13. Has severe acute comorbidities before the first dose. 14. Has participated in other clinical trials within 4 weeks before the first dose.
15.According to the investigators' judgment.
Sites / Locations
- Anhui Chest HospitalRecruiting
- Henan Cancer HospitalRecruiting
- China-Japan Union Hospital Of Jilin University
- Jinzhou Central HospitalRecruiting
- Shenyang Chest HospitalRecruiting
- Sir Run Run Shaw Hospital (SRRSH)Recruiting
- The First Hospital of Jiaxing
- Quzhou People's HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
AL2846+An analog of zoledronic acid injection
An analog of AL2846+ zoledronic acid injection
Arm Description
AL2846 capsules 150 mg given orally, once daily in 28-day cycle, an analog of zoledronic acid injection (5ml:0mg) administered intravenously (IV) on Day 1 of each 28-day cycle.
An analog of AL2846 capsules 0 mg given orally, once daily in 28-day cycle, zoledronic acid injection (5ml:4mg) administered intravenously (IV) on Day 1 of each 28-day cycle.
Outcomes
Primary Outcome Measures
The time when the first bone-related event (SRE) occurred
The time from the randomization to the first occurrence of any meeting of bone-related event criteria.
Secondary Outcome Measures
Overall survival (OS)
OS defined as the time from randomization to death from any cause. Participants who do not die at the end of the extended follow-up period, or were lost to follow-up during the study, were censored at the last date they were known to be alive.
Progression-free survival (PFS)
PFS defined as the time from randomization until the first documented progressive disease (PD) or death from any cause, based on investigator.
Overall response rate (ORR)
Percentage of participants achieving complete response (CR) and partial response (PR).
Duration of Response (DOR)
The time when the participants first achieved complete or partial remission to disease progression.
Disease control rate（DCR）
Percentage of participants achieving complete response (CR) and partial response (PR) and stable disease (SD).
Effectiveness of improving average daily pain intensity on week 8 and 16 (Refer to Brief pain inventory (BPI) and the Verbal rating scale (VRS)
Referring to Brief pain inventory (BPI) and Verbal rating scale (VRS), the percentage of improvement in the average intensity of pain confirmed at week 8 and week 16 compared to the previous average intensity.
Biomarkers
Relationship between drug efficacy and related biomarkers such as C-Met, FGFR, c-Kit, RET.
Full Information
NCT ID
NCT04325776
First Posted
March 25, 2020
Last Updated
October 8, 2020
Sponsor
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT04325776
Brief Title
A Study of AL2846 Versus Zoledronic Acid in Subjects With Advanced Non-Small Cell Lung Cancer With Bone Metastasis
Official Title
A Randomized, Double-blind and Imitation, Parallel-control, Multicenter Phase II Study of AL2846 Versus Zoledronic Acid in Subjects With Advanced Non-small Cell Lung Cancer (NSCLC) With Bone Metastasis
Study Type
Interventional
2. Study Status
Record Verification Date
March 2020
Overall Recruitment Status
Unknown status
Study Start Date
September 24, 2020 (Actual)
Primary Completion Date
May 2021 (Anticipated)
Study Completion Date
November 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
AL2846 is a multi-target tyrosine kinase receptor inhibitor with obvious selective to c-met, suggesting that its anti-tumor effect mainly inhibits the activation of key downstream oncogenic pathways by inhibiting expression of c-met, tumor angiogenesis and tumor cell migration.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bone Metastatic Non-small Cell Lung Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
AL2846+An analog of zoledronic acid injection
Arm Type
Experimental
Arm Description
AL2846 capsules 150 mg given orally, once daily in 28-day cycle, an analog of zoledronic acid injection (5ml:0mg) administered intravenously (IV) on Day 1 of each 28-day cycle.
Arm Title
An analog of AL2846+ zoledronic acid injection
Arm Type
Active Comparator
Arm Description
An analog of AL2846 capsules 0 mg given orally, once daily in 28-day cycle, zoledronic acid injection (5ml:4mg) administered intravenously (IV) on Day 1 of each 28-day cycle.
Intervention Type
Drug
Intervention Name(s)
AL2846
Intervention Description
AL2846 is a multi-target tyrosine kinase receptor inhibitor with obvious selective to c-met.
Intervention Type
Drug
Intervention Name(s)
Zoledronic Acid Injection
Intervention Description
Zoledronic acid is a bisphosphonate drug that has a strong inhibition of bone resorption and a potential to promote bone formation, and can be used for bone metastasis caused by malignant tumors.
Primary Outcome Measure Information:
Title
The time when the first bone-related event (SRE) occurred
Description
The time from the randomization to the first occurrence of any meeting of bone-related event criteria.
Time Frame
up to 96 weeks
Secondary Outcome Measure Information:
Title
Overall survival (OS)
Description
OS defined as the time from randomization to death from any cause. Participants who do not die at the end of the extended follow-up period, or were lost to follow-up during the study, were censored at the last date they were known to be alive.
Time Frame
up to 96 weeks
Title
Progression-free survival (PFS)
Description
PFS defined as the time from randomization until the first documented progressive disease (PD) or death from any cause, based on investigator.
Time Frame
up to 96 weeks
Title
Overall response rate (ORR)
Description
Percentage of participants achieving complete response (CR) and partial response (PR).
Time Frame
up to 96 weeks
Title
Duration of Response (DOR)
Description
The time when the participants first achieved complete or partial remission to disease progression.
Time Frame
up to 96 weeks
Title
Disease control rate（DCR）
Description
Percentage of participants achieving complete response (CR) and partial response (PR) and stable disease (SD).
Time Frame
up to 96 weeks
Title
Effectiveness of improving average daily pain intensity on week 8 and 16 (Refer to Brief pain inventory (BPI) and the Verbal rating scale (VRS)
Description
Referring to Brief pain inventory (BPI) and Verbal rating scale (VRS), the percentage of improvement in the average intensity of pain confirmed at week 8 and week 16 compared to the previous average intensity.
Time Frame
on 8 and 16 week
Title
Biomarkers
Description
Relationship between drug efficacy and related biomarkers such as C-Met, FGFR, c-Kit, RET.
Time Frame
up to 96 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
1.Understood and signed an informed consent form. 2.18 years and older; Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1; Life expectancy ≥ 3 months.
3.Histologically confirmed advanced non-small cell lung cancer with at least one bone metastatic lesion with bone destruction.
4.Has received at least two systematic treatment regimens that failed or were unable to tolerate treatment.
5.EGFR, ALK gene mutations are negative. 6.Adequate laboratory indicators. 7.No pregnant or breastfeeding women, and a negative pregnancy test.
Exclusion Criteria:
1.Small cell lung cancer. 2. Diagnosed and/or treated additional malignancy within 5 years with the exception of cured cervical carcinoma in situ and non-melanoma skin cancer.
3. Has received radiotherapy, chemotherapy and surgery before and less than 4 weeks from the first administration and less than 5 half-lives of oral targeted drugs after the completion of treatment.
4. Has received systemic radionuclide therapy or semi-extracorporeal radiation for bone metastases.
5. Has known to be allergic to the study drug or any of its excipients. 6. Has symptomatic brain metastases, spinal cord compression, and cancerous meningitis within 8 weeks,or brain or pia mater disease confirmed by CT or MRI examination before the first dose.
7. Has adverse events caused by previous therapy that did not recover to ≤ grade 1, with the exception of alopecia or ≥ grade 2 neurotoxicity caused by Oxaliplatin.
8. Imaging (CT or MRI) shows that tumor invades large blood vessels or the boundary with blood vessels is unclear.
9. Has spinal cord compression or mandibular osteonecrosis. 10.Has multiple factors that affect oral medications. 11.Has gastroduodenal ulcer, ulcerative colitis, intestinal obstruction and other gastrointestinal diseases or other conditions judged by the investigator that may cause gastrointestinal bleeding or perforation.
12.Uncontrolled pleural effusion, pericardial effusion, or ascites requiring repeated drainage.
13. Has severe acute comorbidities before the first dose. 14. Has participated in other clinical trials within 4 weeks before the first dose.
15.According to the investigators' judgment.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hongming Pan, Doctor
Phone
0571-86006922
Email
shonco@sina.cn
Facility Information:
Facility Name
Anhui Chest Hospital
City
Hefei
State/Province
Anhui
ZIP/Postal Code
230000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xuhong Min, Doctor
Email
1320722827@qq.com
First Name & Middle Initial & Last Name & Degree
Xuhong Min, Doctor
Facility Name
Henan Cancer Hospital
City
Zhengzhou
State/Province
Henan
ZIP/Postal Code
450008
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Suxia Luo, Doctor
Email
luosxrm@163.com
First Name & Middle Initial & Last Name & Degree
Suxia Luo, Doctor
Facility Name
China-Japan Union Hospital Of Jilin University
City
Changchun
State/Province
Jilin
ZIP/Postal Code
130031
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yuansong Bai, Master
Email
baiyuansong@163.com
First Name & Middle Initial & Last Name & Degree
Yuansong Bai, Master
Facility Name
Jinzhou Central Hospital
City
Jinzhou
State/Province
Liaoning
ZIP/Postal Code
121001
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wei Wang, Master
Email
wangwei9628@126.com
First Name & Middle Initial & Last Name & Degree
Wei Wang, Master
Facility Name
Shenyang Chest Hospital
City
Shenyang
State/Province
Liaoning
ZIP/Postal Code
110044
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yinyin Li, Doctor
Email
847226789@qq.com
First Name & Middle Initial & Last Name & Degree
Yinyin Li, Doctor
Facility Name
Sir Run Run Shaw Hospital (SRRSH)
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310020
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hongming Pan, Doctor
Phone
0571-86006922
Email
shonco@sina.cn
First Name & Middle Initial & Last Name & Degree
Hongming Pan, Doctor
Facility Name
The First Hospital of Jiaxing
City
Jiaxing
State/Province
Zhejiang
ZIP/Postal Code
314001
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xinmei Yang, Master
Email
yangxinmei128@sina.com
First Name & Middle Initial & Last Name & Degree
Xinmei Yang, Master
Facility Name
Quzhou People's Hospital
City
Quzhou
State/Province
Zhejiang
ZIP/Postal Code
324000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Qinhong Zheng, Master
Email
zqh180@126.com
First Name & Middle Initial & Last Name & Degree
Qinhong Zheng, Master
12. IPD Sharing Statement
Learn more about this trial
A Study of AL2846 Versus Zoledronic Acid in Subjects With Advanced Non-Small Cell Lung Cancer With Bone Metastasis
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