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

NCT04325776 | Unknown Phase 2

• 1 other identifier: AL2846-II-01
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 8

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.

Conditions

Bone Metastatic Non-small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

• 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.

  up to 96 weeks

Secondary Outcomes (7)

• Overall survival (OS)

  up to 96 weeks

• Progression-free survival (PFS)

  up to 96 weeks

• Overall response rate (ORR)

  up to 96 weeks

• Duration of Response (DOR)

  up to 96 weeks

• Disease control rate（DCR）

  up to 96 weeks

Study Arms (2)

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.

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.

Drug: Zoledronic Acid Injection

Interventions

AL2846 DRUG

AL2846 is a multi-target tyrosine kinase receptor inhibitor with obvious selective to c-met.

AL2846+An analog of zoledronic acid injection

Zoledronic Acid Injection DRUG

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.

An analog of AL2846+ zoledronic acid injection

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Histologically confirmed advanced non-small cell lung cancer with at least one bone metastatic lesion with bone destruction.
• Has received at least two systematic treatment regimens that failed or were unable to tolerate treatment.
• EGFR, ALK gene mutations are negative. 6.Adequate laboratory indicators. 7.No pregnant or breastfeeding women, and a negative pregnancy test.

You may not qualify if:

• 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.
• \. 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.
• \. Has received systemic radionuclide therapy or semi-extracorporeal radiation for bone metastases.
• \. 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.
• \. 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.
• \. Imaging (CT or MRI) shows that tumor invades large blood vessels or the boundary with blood vessels is unclear.
• \. 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.
• Uncontrolled pleural effusion, pericardial effusion, or ascites requiring repeated drainage.
• \. Has severe acute comorbidities before the first dose. 14. Has participated in other clinical trials within 4 weeks before the first dose.
• According to the investigators' judgment.

Sponsors & Collaborators

• Chia Tai Tianqing Pharmaceutical Group Co., Ltd.: lead

Study Sites (8)

Anhui Chest Hospital

Hefei, Anhui, 230000, China

RECRUITING

Henan Cancer Hospital

Zhengzhou, Henan, 450008, China

RECRUITING

China-Japan Union Hospital Of Jilin University

Changchun, Jilin, 130031, China

NOT YET RECRUITING

Jinzhou Central Hospital

Jinzhou, Liaoning, 121001, China

RECRUITING

Shenyang Chest Hospital

Shenyang, Liaoning, 110044, China

RECRUITING

Sir Run Run Shaw Hospital (SRRSH)

Hangzhou, Zhejiang, 310020, China

RECRUITING

The First Hospital of Jiaxing

Jiaxing, Zhejiang, 314001, China

NOT YET RECRUITING

Quzhou People's Hospital

Quzhou, Zhejiang, 324000, China

RECRUITING

MeSH Terms

Interventions

Zoledronic Acid

Intervention Hierarchy (Ancestors)

Diphosphonates; Organophosphonates; Organophosphorus Compounds; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Central Study Contacts

Hongming Pan, Doctor

CONTACT

0571-86006922; shonco@sina.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 25, 2020
• First Posted: March 30, 2020
• Study Start: September 24, 2020
• Primary Completion: May 1, 2021
• Study Completion: November 1, 2021
• Last Updated: October 12, 2020

Record last verified: 2020-03

Locations

CN (8)