Bone Metastatic Non-small Cell Lung CancerPhase 2NCT04325776
A Study of AL2846 Versus Zoledronic Acid in Subjects With Advanced Non-Small Cell Lung Cancer With Bone Metastasis
A Phase 2 study testing AL2846 and Zoledronic Acid Injection in people with Bone Metastatic Non-small Cell Lung Cancer, run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. at 8 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bone Metastatic Non-small Cell Lung Cancer
- What is being tested?
- AL2846 and Zoledronic Acid Injection
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 8 sitesChina
- Study dates
- 24 Sep 2020to Nov 2021
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
China8 sites, 8 recruiting
- Not yet recruiting
China-Japan Union Hospital Of Jilin University
Changchun, Jilin, 130031
Yuansong Bai, Master, baiyuansong@163.com
Yuansong Bai, Master
- Recruiting
Sir Run Run Shaw Hospital (SRRSH)
Hangzhou, Zhejiang, 310020
Hongming Pan, Doctor, 0571-86006922, shonco@sina.cn
Hongming Pan, Doctor
- Recruiting
Anhui Chest Hospital
Hefei, Anhui, 230000
Xuhong Min, Doctor, 1320722827@qq.com
Xuhong Min, Doctor
- Not yet recruiting
The First Hospital of Jiaxing
Jiaxing, Zhejiang, 314001
Xinmei Yang, Master, yangxinmei128@sina.com
Xinmei Yang, Master
- Recruiting
Jinzhou Central Hospital
Jinzhou, Liaoning, 121001
Wei Wang, Master, wangwei9628@126.com
Wei Wang, Master
- Recruiting
Quzhou People's Hospital
Quzhou, Zhejiang, 324000
Qinhong Zheng, Master, zqh180@126.com
Qinhong Zheng, Master
- Recruiting
Shenyang Chest Hospital
Shenyang, Liaoning, 110044
Yinyin Li, Doctor, 847226789@qq.com
Yinyin Li, Doctor
- Recruiting
Henan Cancer Hospital
Zhengzhou, Henan, 450008
Suxia Luo, Doctor, luosxrm@163.com
Suxia Luo, Doctor
About this study
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
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.
- Being tested
- AL2846, Zoledronic Acid Injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AL2846Drug
AL2846 is a multi-target tyrosine kinase receptor inhibitor with obvious selective to c-met.
Zoledronic Acid InjectionDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| AL2846+An analog of zoledronic acid injection | Experimental | 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. Receives: Drug: AL2846 |
| An analog of AL2846+ zoledronic acid injection | Active comparator | 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. Receives: Drug: Zoledronic Acid Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: up to 96 weeks
Secondary outcomes (7)
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.
Measured: up to 96 weeks
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.
Measured: up to 96 weeks
Overall response rate (ORR)
Percentage of participants achieving complete response (CR) and partial response (PR).
Measured: up to 96 weeks
Duration of Response (DOR)
The time when the participants first achieved complete or partial remission to disease progression.
Measured: up to 96 weeks
Disease control rate（DCR）
Percentage of participants achieving complete response (CR) and partial response (PR) and stable disease (SD).
Measured: up to 96 weeks
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.
Measured: on 8 and 16 week
Biomarkers
Relationship between drug efficacy and related biomarkers such as C-Met, FGFR, c-Kit, RET.
Measured: up to 96 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2020
- Study start24 Sep 2020
- Primary completionMay 2021 (estimated)
- Study completionNov 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bone Metastatic Non-small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04325776
- Sponsor's protocol ID
- AL2846-II-01
- Status last verified
- Mar 2020
- First submitted
- 25 Mar 2020
- Last updated
- 12 Oct 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04325776
- Acronym / sponsor ID
- AL2846-II-01
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 24 Sep 2020 (actual)
- Primary completion
- May 2021 (estimated)
- Study completion
- Nov 2021 (estimated)
- First posted
- 30 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AL2846+An analog of zoledronic acid injection | Experimental | Drug: AL2846AL2846 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+ zoledronic acid injection | Active comparator | Drug: Zoledronic Acid InjectionAn 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AL2846AL2846 is a multi-target tyrosine kinase receptor inhibitor with obvious selective to c-met. | Drug | AL2846+An analog of zoledronic acid injection |
| Zoledronic Acid InjectionZoledronic 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. | Drug | An analog of AL2846+ zoledronic acid injection |
Primary outcome
The time when the first bone-related event (SRE) occurred
Time frame: up to 96 weeks
The time from the randomization to the first occurrence of any meeting of bone-related event criteria.
7 secondary outcomes
Overall survival (OS)
Time frame: up to 96 weeks
Progression-free survival (PFS)
Time frame: up to 96 weeks
Overall response rate (ORR)
Time frame: up to 96 weeks
Duration of Response (DOR)
Time frame: up to 96 weeks
Disease control rate（DCR）
Time frame: up to 96 weeks
Effectiveness of improving average daily pain intensity on week 8 and 16 (Refer to Brief pain inventory (BPI) and the Verbal rating scale (VRS)
Time frame: on 8 and 16 week
Biomarkers
Time frame: up to 96 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing AL2846 and Zoledronic Acid Injection in people with Bone Metastatic Non-small Cell Lung Cancer, run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. at 8 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hongming Pan, Doctor (0571-86006922, shonco@sina.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The time when the first bone-related event (SRE) occurred (time frame: up to 96 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Oct 2020.