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Small Cell Lung CancerPhase 3NCT04830813

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

A Phase 3 study testing Chiauranib in people with Small Cell Lung Cancer, run by Chipscreen Biosciences, Ltd. at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Small Cell Lung Cancer
What is being tested?
Chiauranib
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
184 participants
Where
1 siteChina
Study dates
5 Mar 2021to 1 Apr 2024
Phase
Phase 3
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 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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:
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  • 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.

Who cannot join

  • 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
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  • 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
  • Patients with factors that could affect oral medication (such as dysphagia，chronic diarrhea, intestinal obstruction, After small bowel resection,etc), or undergone gastrectomy, or history of gastrointestinal perforation
  • Proteinuria positive(≥1g/24h)
  • Active bleeding within 2 months before the first dose, or anticoagulant drugs are being taken during the screening period, or the investigator judges that there is a high risk of bleeding during the screening period
  • History of deep vein thrombosis or pulmonary embolism within 6 months before the first dose
  • Active infections that require systemic treatment (oral, intravenous infusion) during the screening period
  • Screening for HIV antibody positive
  • Screening test for hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) positive with virus replication, hepatitis C antibody (HCV-Ab) positive with virus replication
  • Any mental or cognitive disorder, that would impair the ability to understand the informed consent document, or the compliance of study
  • Candidates with drug and alcohol abuse
  • Women of childbearing potential not willing to use and utilize an adequate method of contraception (such as intrauterine device, contraceptive and condom) throughout treatment and for at least 12 weeks after the last dose; pregnant or breastfeeding women; the result of urine pregnancy test was positive at screening; Man participants not willing to use and utilize an adequate method of contraception throughout treatment.
  • Any other condition which is inappropriate for the study according to investigators' judgment.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Cancer Hospital, Chinese Academy of Medical Sciences

    Beijing, Beijing Municipality, 100000

Other trials in China

About this study

Official title: A Randomized, Double-blind, Placebo-controlled, Multicenter Phase 3 Clinical Study of Chiauranib Capsule in Patients With Progressed or Relapsed Small-cell Lung Cancer After 2 Lines Chemotherapy (CHIS)

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

Read the detailed description

Chiauranib is a novel orally active multi-target inhibitor that simultaneously inhibits the angiogenesis-related kinases (VEGFR2, VEGFR1, VEGFR3, PDGFRa and c-Kit), mitosis-related kinase Aurora B and chronic inflammationrelated kinase CSF-1R in a high potency manner with the IC50 at a single-digit nanomolar range. In particular, Chiauranib showed very high selectivity in the kinase inhibition profile with little activity on off-target non-receptor kinases, proteins, GPCR and ion channels, indicative of a better drug safety profile in terms of clinical relevance.

In July 2017, the sponsor initiated a phase Ib/II trial (CAR105). As of October 9, 2020, a total of 42 subjects entered the safety analysis and 41 subjects entered the efficacy analysis. The results of the phased trial analysis show the preliminary efficacy of this product in the treatment of SCLC at ≥3 lines.

This clinical trial is studying the efficacy and safety of chiauranib works in treating patients with relapsed or refractory small cell lung cancer, in the meantime, exploreing the latent biomarkers accompany with chiauranib, as well as the relevancy of which and clinical benefit.

Being tested
Chiauranib, Placebo
Medical subject headings
Small Cell Lung Carcinoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ChiauranibDrug

    Also called CS2164

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

  • PlaceboDrug

    Also called Simulation tablet of Chiauranib

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

Study groups in NCT04830813
Study groupRoleWhat they receive
ChiauranibExperimentalPatients take Chiauranib capsules 50mg, orally once daily, 21 days as a cycle until objective disease progression.
Receives: Drug: Chiauranib
PlaceboPlacebo comparatorParticipants received Chiauranib placebo capsule matching Chiauranib orally once daily until objective disease progression.
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. PFS

    Progression-free survival

    Measured: 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

  2. OS

    Overall survival

    Measured: 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)

  1. ORR

    Objective reponse rate

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

  2. DOR

    Duration of response

    Measured: 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

  3. DCR

    Disease-control rate

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

  4. percentage of AEs

    Safety

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Apr 2021
  2. Study start5 Mar 2021
  3. Primary completion1 Apr 2024
  4. Study completion1 Apr 2024

Resources

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
184 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04830813
Sponsor's protocol ID
CAR302
Status last verified
Nov 2024
First submitted
29 Mar 2021
Last updated
9 Dec 2024
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Chiauranib in people with Small Cell Lung Cancer, run by Chipscreen Biosciences, Ltd. at 1 site 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 11 inclusion and 26 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: finished, as of the sponsor's last update on 9 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

PFS (time frame: 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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04830813.

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 9 Dec 2024.

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