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Clinical Trials/NCT04073537
NCT04073537UnknownPhase 3

A Randomized, Double-Blind, Multicenter, Phase Ⅲ Study of Anlotinib Hydrochloride Capsule Combined With Chemotherapy Versus Placebo Combined With Chemotherapy in Subjects With Squamous Non-small Cell Lung Cancer

Chia Tai Tianqing Pharmaceutical Group Co., Ltd.2 sites in 1 country386 target enrollmentStarted: October 31, 2019Last updated:
Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 3
Enrollment
386
Locations
2
Primary Endpoint
Progression Free Survival (PFS) evaluated by IRC

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to 75 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • 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.
  • 5.Adequate laboratory indicators. 6.No pregnant or breastfeeding women, and a negative pregnancy test. 7.Understood and signed an informed consent form.

Exclusion Criteria

  • 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
  • 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.
  • Has severe or uncontrolled disease.
  • Participated in other clinical trials within 4 weeks.
  • According to the investigators' judgement.

Arms & Interventions

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.

Intervention: Anlotinib (Drug)

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.

Intervention: Paclitaxel (Drug)

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.

Intervention: Carboplatin (Drug)

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.

Intervention: Placebos (Drug)

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.

Intervention: Paclitaxel (Drug)

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.

Intervention: Carboplatin (Drug)

Outcomes

Primary Outcomes

Progression Free Survival (PFS) evaluated by IRC

Time Frame: up to 24 months

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.

Secondary Outcomes

  • PFS rate at month 6(up to 6 months)
  • PFS rate at month 12(up to 12 months)
  • OS rate at month 12(up to 12 months)
  • OS rate at month 18(up to 18 months)
  • Adverse Event (AE)(up to 24 months)
  • Duration of Overall Response (DOR)(up to 24 months)
  • 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)
  • OS rate at month 6(up to 6 months)
  • Serious Adverse Event (SAE)(up to 24 months)
  • Abnormal laboratory test index(up to 24 months)

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (2)

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