Study of Anlotinib Hydrochloride Capsule Combined With Chemotherapy in Subjects With Squamous Non-small Cell Lung Cancer

NCT04073537 — Phase 3, Unknown, 386 participants, Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

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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

RegistryNCT04073537
StatusUnknown
PhasePhase 3
Study typeInterventional; randomized, parallel, masking: quadruple, treatment
Enrollment386 (Estimated)
SponsorChia Tai Tianqing Pharmaceutical Group Co., Ltd. (Industry)
ConditionsSquamous Non-small Cell Lung Cancer
InterventionsAnlotinib, Placebos, Paclitaxel, Carboplatin (Drug)
Datesstart 2019-10-31 (estimated), primary completion 2021-07-31 (estimated), completion 2022-06-30 (estimated), first posted 2019-08-29, last updated 2019-08-29
Locations2 sites in China

Related Papers Related Patents Related Grants Related Experts
All trials for Squamous Non-small Cell Lung Cancer All trials of Anlotinib All trials of Placebos

-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.

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+Arms and interventions

ArmTypeInterventionsDescription
Experimental groupExperimentalDrug: Anlotinib; Drug: Paclitaxel; Drug: CarboplatinAnlotinib 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.
Placebo groupPlacebo comparatorDrug: Placebos; Drug: Paclitaxel; Drug: CarboplatinAnlotinib 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.
  • Anlotinib (Drug): A multi-target receptor tyrosine kinase inhibitor.
  • Placebos (Drug): Anlotinib blank analog capsule.
  • Paclitaxel (Drug): Paclitaxel 175 mg/m\^2 IV on Day 1 of each 21-day cycle.
  • Carboplatin (Drug): Carboplatin area under the concentration curve (AUC) 5 milligrams per milliliter per minute (mg/mL/min) on Day 1 of each 21-day cycle.

+Outcome measures

Primary outcomes

  • Progression Free Survival (PFS) evaluated by IRC [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

  • Progression Free Survival (PFS) evaluated by investigator [up to 24 months]: PFS defined as the time from randomization until the first documented progressive disease (PD) or death from any cause.
  • Overall Survival (OS) [up to 24 months]: OS defined as the time from randomization to death from any cause. Participants who do not die at the end of the extended follow-up period, or were lost to follow-up during the study, were censored at the last date they were known to be alive.
  • Overall Response Rate (ORR) [up to 24 months]: Percentage of participants achieving complete response (CR) and partial response (PR).
  • Disease Control Rate(DCR) [up to 24 months]: Percentage of participants achieving complete response (CR) and partial response (PR) and stable disease (SD).
  • Duration of Overall Response (DOR) [up to 24 months]: The time when the patient first achieved complete or partial remission to disease progression.
  • PFS rate at month 6 [up to 6 months]: The percentage of PFS at month 6.
  • PFS rate at month 12 [up to 12 months]: The percentage of PFS at month 12.
  • OS rate at month 6 [up to 6 months]: The percentage of OS at month 6.
  • OS rate at month 12 [up to 12 months]: The percentage of OS at month 12.
  • OS rate at month 18 [up to 18 months]: The percentage of OS at month 18.
  • Adverse Event (AE) [up to 24 months]: Safety data
  • Serious Adverse Event (SAE) [up to 24 months]: Safety data
  • Abnormal laboratory test index [up to 24 months]: Safety data

+Eligibility

Sex: All, ages: 18 Years to 75 Years

Inclusion Criteria:

1. Squamous non-small cell lung cancer.
2. A measurable lesion.
3. 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:

1. The tumor invades the large blood vessels.
2. Central type squamous non-small cell lung cancer.
3. EGFR/ALK gene mutation is positive.
4. Has used EGFR inhibitors and ALK inhibitors.
5. Has other malignant tumors within 5 years.
6. Has a variety of factors affecting oral medications.
7. Symptomatic brain metastasis.
8. Uncontrolled pleural effusion, pericardial effusion or ascites requiring repeated drainage.
9. Spinal cord compression.
10. Has received radiotherapy, chemotherapy, surgery less than 4 weeks before randomization.
11. Severe allergies to therapeutic medications.
12. Adverse events caused by previous treatment did not recover to grade 1.
13. Has received major surgical treatment within 4 weeks before randomization.
14. Arteriovenous thrombosis occurred within 6 months.
15. Has drug abuse history that unable to abstain from or mental disorders.
16. Has severe or uncontrolled disease.
17. Participated in other clinical trials within 4 weeks.
18. According to the investigators' judgement.

+Locations (2)

FacilityCityCountryStatus
Cancer Hospital Chinese Academy of Medical SciencesBeijing, Beijing MunicipalityChina
The Fourth Hospital of Hebei Medical UniversityShijiazhuang, HebeiChina