Clinical trial NCT04073537: Study of Anlotinib Hydrochloride Capsule Combined With Chemotherapy in Subjects With Squamous Non-small Cell Lung Cancer
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Squamous Non-small Cell Lung Cancer
Lead sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2019-08-29
Enrollment: 386
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Progression Free Survival (PFS) evaluated by IRC
timeFrame: up to 24 months
Secondary outcomes:
measure: Progression Free Survival (PFS) evaluated by investigator
timeFrame: up to 24 months
measure: Overall Survival (OS)
timeFrame: up to 24 months
measure: Overall Response Rate (ORR)
timeFrame: up to 24 months
measure: Disease Control Rate（DCR）
timeFrame: up to 24 months
measure: Duration of Overall Response (DOR)
timeFrame: up to 24 months
measure: PFS rate at month 6
timeFrame: up to 6 months
measure: PFS rate at month 12
timeFrame: up to 12 months
measure: OS rate at month 6
timeFrame: up to 6 months
measure: OS rate at month 12
timeFrame: up to 12 months
measure: OS rate at month 18
timeFrame: up to 18 months
measure: Adverse Event (AE)
timeFrame: up to 24 months
measure: Serious Adverse Event (SAE)
timeFrame: up to 24 months
measure: Abnormal laboratory test index
timeFrame: up to 24 months
Other outcomes:
Locations:
city: Beijing
country: China
facility: Cancer Hospital Chinese Academy of Medical Sciences
state: Beijing
city: Shijiazhuang
country: China
facility: The Fourth Hospital of Hebei Medical University
state: Hebei
Study officials:
References: