Phase 3 Clinical Study of Chiauranib Capsule in Patients With Small-cell Lung Cancer

NCT04830813 | Completed Phase 3

• 1 other identifier: CAR302
• Study Type: interventional
• Target: 184
• Locations: 1 country
• Sites: 1

Brief Summary

Chiauranib , which simultaneously targets against VEGFR/Aurora B/CSF-1R, several key kinases involved in tumor angiogenesis, tumor cell mitosis, and chronic inflammatory microenvironment.

Conditions

Small Cell Lung Cancer

Outcome Measures

Primary Outcomes (2)

• PFS

  Progression-free survival

  From date of the first dose of study drug until the date of first documented progression or relapse or date of death from any cause, whichever came first, assessed up to 24 months

• OS

  Overall survival

  From date of the first dose of study drug until the date of death from any cause, assessed up to 24 months

Secondary Outcomes (4)

• ORR

  Up to a minimum 24 weeks after the last participant's first dose, or progression, or 75% subjects died

• DOR

  from the date of first documented objective response until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months

• DCR

  Up to a minimum 24 weeks after the last participant's first dose, or progression, or 75% subjects died

• percentage of AEs

  28 days after the last participant 's last medication or new anti-tumor therapy

Study Arms (2)

Chiauranib

EXPERIMENTAL

Patients take Chiauranib capsules 50mg, orally once daily, 21 days as a cycle until objective disease progression.

Drug: Chiauranib

Placebo

PLACEBO COMPARATOR

Participants received Chiauranib placebo capsule matching Chiauranib orally once daily until objective disease progression.

Drug: Placebo

Interventions

Chiauranib DRUG

Patients take Chiauranib capsules 50mg, orally once daily, 21 days as a cycle until objective disease progression.

Also known as: CS2164

Chiauranib

Placebo DRUG

Participants received Chiauranib placebo capsule matching Chiauranib orally once daily until objective disease progression.

Also known as: Simulation tablet of Chiauranib

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female, age ≥ 18 years and ≤75 years;
• Cytologically or histologically confirmed small cell lung cancer;
• Patients have received at least 2 different systemic chemotherapy regimens (contained platinum based regimen) , and progressed or relapsed
• At least one measurable lesion that can be accurately assessed ( RECIST1.1 criteria). If the only site of measurable disease is in a previously irradiated area, the patient must have documented progression of disease in this area.
• Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
• Laboratory criteria are as follows:
• Complete blood count: absolute neutrophil count (ANC) ≥1.5×10\^9/L ; platelets ≥75×10\^9/L; hemoglobin (Hb) ≥80g/L ;
• Biochemistry test: total bilirubin≤1.5×ULN; alanine aminotransferase (ALT) , aspartate aminotransferase(AST)≤2.5×ULN(ALT,AST≦5×ULN if liver involved); serum creatinine(cr)≤1.5×ULN;
• Coagulation test: International Normalized Ratio (INR) \< 1.5.
• Life expectancy of at least 3 months.
• All patients must have given signed, informed consent prior to registration on study.

You may not qualify if:

• Patients who known to brain metastases with neurological symptoms;
• Screening period imaging shows that the tumor has invaded the periphery of important blood vessels or the investigator judges that the tumor is likely to invade important blood vessels and cause hemorrhage during the trial
• Pleural fluid, ascites, pericardial effusion with clinical symptoms or need to be drained during the screening period
• Patients with second primary cancer, except: adequately treated basal cell or squamous cell skin cancer, curatively treated in-situ cancer of the cervix, unless received curative treatment and with documented evidence of no recurrence during the past five years
• Patients who have been used aurora kinase inhibitors, or VEGF/VEGFR inhibitors
• Patients have used any anti-cancer therapy, including adiotherapy, chemotherapy, immunotherapy, target therapy, and other anti-tumor treatments within 28 days before the first dose
• Patients have used experimental drugs or devices within 28 days before the first dose
• Patients received major surgical operations within 28 days before the first dose, or patients with serious non-healing wounds, ulcer or fracture at the time of screening
• With the exception of alopecia, any ongoing toxicities (\>CTCAE grade 1) caused by previous cancer therapy
• Patients with uncontrolled or significant cardiovascular disease, including:
• Grade II or higher Congestive heart failure, unstable angina pectoris, myocardial infarction (NYHA Classification) within 6 months prior to study entry; or arrhythmia requiring treatment, or Left Ventricular Ejection Fraction (LVEF) \< 50% during screening stage.
• Primary cardiomyopathy (dilated cardiomyopathy, hypertrophic cardiomyocyte, arrhythmogenic right ventricular cardiomyopathy, restrictive cardiomyopathy, et,al).
• History of significant QT interval prolongation, or Corrected QT Interval QTc≥450ms(male),QTc≥470ms（female）at screening.
• patient's treatment record of using at least 2 antihypertensive drugs at the same Within 14 days before the first dose, or uncontrolled hypertension (\> 140/90 mmHg) during the screening period.
• Obstructive atelectasis that requires chest radiotherapy or surgery during the screening period or CT or MRI of the chest during the screening period shows interstitial lung disease or pulmonary fibrosis or lung inflammation that requires treatment, or within 6 months before the first dose history of pneumonia requiring oral or intravenous steroid treatment

Sponsors & Collaborators

• Chipscreen Biosciences, Ltd.: lead

Study Sites (1)

Cancer Hospital, Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, 100000, China

Location

MeSH Terms

Conditions

Small Cell Lung Carcinoma

Interventions

chiauranib

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Yuankai Shi

  Cancer Hospital,Chinese Academy of Medical Sciences and Peking Union Medical College

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• 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 29, 2021
• First Posted: April 5, 2021
• Study Start: March 5, 2021
• Primary Completion: April 1, 2024
• Study Completion: April 1, 2024
• Last Updated: December 9, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)