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

CTTQ

Status and phase: Unknown; Phase 2

Conditions: Bone Metastatic Non-small Cell Lung Cancer

Treatments: Drug: AL2846; Drug: Zoledronic Acid Injection

Study type: Interventional

Funder types: Industry

Identifiers

NCT04325776

AL2846-II-01

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

  6. 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.

  7. Imaging (CT or MRI) shows that tumor invades large blood vessels or the boundary with blood vessels is unclear.

  8. 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 design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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60 participants in 2 patient groups

AL2846+An analog of zoledronic acid injection

Experimental group

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.

Treatment:

Drug: AL2846

An analog of AL2846+ zoledronic acid injection

Active Comparator group

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.

Treatment:

Drug: Zoledronic Acid Injection