NCT04073537

Brief Summary

Anlotinib hydrochloride is a multi-targeted receptor tyrosine kinase inhibitor that targets angiogenesis-related kinases such as VEGFR1/2/3, FGFR1/2/3, and other tumor-associated kinases involved in cell proliferation such as PDGFRα/β, c-Kit, and Ret have significant inhibitory activities.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
386

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Oct 2019

Typical duration for phase_3

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 26, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 29, 2019

Completed
2 months until next milestone

Study Start

First participant enrolled

October 31, 2019

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2021

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2022

Completed
Last Updated

August 29, 2019

Status Verified

August 1, 2019

Enrollment Period

1.8 years

First QC Date

August 26, 2019

Last Update Submit

August 27, 2019

Conditions

Squamous Non-small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

  • Progression Free Survival (PFS) evaluated by IRC

    PFS defined as the time from randomization until the first documented progressive disease (PD) or death from any cause; IRC defined as Independent Review Committee.

    up to 24 months

Secondary Outcomes (13)

  • Progression Free Survival (PFS) evaluated by investigator

    up to 24 months

  • Overall Survival (OS)

    up to 24 months

  • Overall Response Rate (ORR)

    up to 24 months

  • Disease Control Rate（DCR）

    up to 24 months

  • Duration of Overall Response (DOR)

    up to 24 months

  • +8 more secondary outcomes

Study Arms (2)

Experimental group

EXPERIMENTAL

Anlotinib hydrochloride capsules given orally in fasting conditions , once daily in 21-day cycle (14 days on treatment from Day 1-14, 7 days off treatment from Day 15-21) and paclitaxel 175mg/m2 D1 q3w, carboplatin AUC 5mg/mL/min D1 q3w.

Drug: AnlotinibDrug: PaclitaxelDrug: Carboplatin

Placebo group

PLACEBO COMPARATOR

Anlotinib hydrochloride placebo given orally in fasting conditions , once daily in 21-day cycle (14 days on treatment from Day 1-14, 7 days off treatment from Day 15-21) and paclitaxel 175mg/m\^2 D1 q3w, carboplatin AUC 5mg/mL/min D1 q3w.

Drug: PlacebosDrug: PaclitaxelDrug: Carboplatin

Interventions

AnlotinibDRUG

A multi-target receptor tyrosine kinase inhibitor.

Experimental group
PlacebosDRUG

Anlotinib blank analog capsule.

Placebo group
PaclitaxelDRUG

Paclitaxel 175 mg/m\^2 IV on Day 1 of each 21-day cycle.

Experimental groupPlacebo group
CarboplatinDRUG

Carboplatin area under the concentration curve (AUC) 5 milligrams per milliliter per minute (mg/mL/min) on Day 1 of each 21-day cycle.

Experimental groupPlacebo group

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Squamous non-small cell lung cancer.
  • A measurable lesion.
  • The disease progression occurs \>12 months after the end of the last treatment. 4.18-75 years old ; Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1; Life expectancy ≥ 3 months.
  • Adequate laboratory indicators. 6.No pregnant or breastfeeding women, and a negative pregnancy test. 7.Understood and signed an informed consent form.

You may not qualify if:

  • The tumor invades the large blood vessels.
  • Central type squamous non-small cell lung cancer.
  • EGFR/ALK gene mutation is positive.
  • Has used EGFR inhibitors and ALK inhibitors.
  • Has other malignant tumors within 5 years.
  • Has a variety of factors affecting oral medications.
  • Symptomatic brain metastasis.
  • Uncontrolled pleural effusion, pericardial effusion or ascites requiring repeated drainage.
  • Spinal cord compression.
  • Has received radiotherapy, chemotherapy, surgery less than 4 weeks before randomization.
  • Severe allergies to therapeutic medications.
  • Adverse events caused by previous treatment did not recover to grade 1.
  • Has received major surgical treatment within 4 weeks before randomization.
  • Arteriovenous thrombosis occurred within 6 months.
  • Has drug abuse history that unable to abstain from or mental disorders.
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Cancer Hospital Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, 100083, China

Location

The Fourth Hospital of Hebei Medical University

Shijiazhuang, Hebei, 50011, China

Location

MeSH Terms

Interventions

anlotinibPaclitaxelCarboplatin

Intervention Hierarchy (Ancestors)

TaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsDiterpenesTerpenesCoordination Complexes

Central Study Contacts

Yuankai Shi, Doctor

CONTACT

010-87788293syuankaipumc@126.com

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

August 26, 2019

First Posted

August 29, 2019

Study Start

October 31, 2019

Primary Completion

July 31, 2021

Study Completion

June 30, 2022

Last Updated

August 29, 2019

Record last verified: 2019-08

Locations

CN(2)