A Study of AL2846 Versus Zoledronic Acid in Subjects With Advanced Non-Small Cell Lung Cancer With Bone Metastasis

October 8, 2020 updated by: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Hongming Pan, Doctor
  • Phone Number: 0571-86006922
  • Email: shonco@sina.cn

Study Locations

  • China
    • Anhui
      • Hefei, Anhui, China, 230000
        • Recruiting
        • Anhui Chest Hospital
        • Principal Investigator:
          • Xuhong Min, Doctor
    • Henan
      • Zhengzhou, Henan, China, 450008
        • Recruiting
        • Henan Cancer Hospital
        • Principal Investigator:
          • Suxia Luo, Doctor
    • Jilin
      • Changchun, Jilin, China, 130031
        • Not yet recruiting
        • China-Japan Union Hospital of Jilin University
        • Contact:
        • Principal Investigator:
          • Yuansong Bai, Master
    • Liaoning
      • Jinzhou, Liaoning, China, 121001
        • Recruiting
        • Jinzhou Central Hospital
        • Contact:
        • Principal Investigator:
          • Wei Wang, Master
      • Shenyang, Liaoning, China, 110044
        • Recruiting
        • Shenyang Chest Hospital
        • Contact:
        • Principal Investigator:
          • Yinyin Li, Doctor
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310020
        • Recruiting
        • Sir Run Run Shaw Hospital (SRRSH)
        • Principal Investigator:
          • Hongming Pan, Doctor
        • Contact:
          • Hongming Pan, Doctor
          • Phone Number: 0571-86006922
          • Email: shonco@sina.cn
      • Jiaxing, Zhejiang, China, 314001
        • Not yet recruiting
        • The First hospital of Jiaxing
        • Contact:
        • Principal Investigator:
          • Xinmei Yang, Master
      • Quzhou, Zhejiang, China, 324000
        • Recruiting
        • Quzhou People's Hospital
        • Contact:
        • Principal Investigator:
          • Qinhong Zheng, Master

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: AL2846+An analog of zoledronic acid injection
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.
Drug: AL2846
AL2846 is a multi-target tyrosine kinase receptor inhibitor with obvious selective to c-met.
Active Comparator: An analog of AL2846+ zoledronic acid injection
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.
Drug: Zoledronic Acid Injection
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
up to 96 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall response rate (ORR)
Time Frame: up to 96 weeks
Percentage of participants achieving complete response (CR) and partial response (PR).
up to 96 weeks
Disease control rate（DCR）
Time Frame: up to 96 weeks
Percentage of participants achieving complete response (CR) and partial response (PR) and stable disease (SD).
up to 96 weeks
Overall survival (OS)
Time Frame: up to 96 weeks
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.
up to 96 weeks
Progression-free survival (PFS)
Time Frame: up to 96 weeks
PFS defined as the time from randomization until the first documented progressive disease (PD) or death from any cause, based on investigator.
up to 96 weeks
Duration of Response (DOR)
Time Frame: up to 96 weeks
The time when the participants first achieved complete or partial remission to disease progression.
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
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.
on 8 and 16 week
Biomarkers
Time Frame: up to 96 weeks
Relationship between drug efficacy and related biomarkers such as C-Met, FGFR, c-Kit, RET.
up to 96 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 24, 2020

Primary Completion (Anticipated)

May 1, 2021

Study Completion (Anticipated)

November 1, 2021

Study Registration Dates

First Submitted

March 25, 2020

First Submitted That Met QC Criteria

March 26, 2020

First Posted (Actual)

March 30, 2020

Study Record Updates

Last Update Posted (Actual)

October 12, 2020

Last Update Submitted That Met QC Criteria

October 8, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AL2846-II-01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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