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

Squamous Non-small Cell Lung Cancer Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04073537
• Other study ID #: ALTN-03-III-02
• Status: Not yet recruiting
• Phase: Phase 3
• Start date: October 31, 2019
• Est. completion date: June 30, 2022

Study information

• Verified date: August 2019
• Source: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
• Contact: Yuankai Shi, Doctor
• Phone: 010-87788293
• Email: syuankaipumc[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 386
• Est. completion date: June 30, 2022
• Est. primary completion date: July 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Squamous Non-small Cell Lung Cancer

Intervention

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

Locations

Country	Name	City	State
China	Cancer Hospital Chinese Academy of Medical Sciences	Beijing	Beijing
China	The Fourth Hospital of Hebei Medical University	Shijiazhuang	Hebei

Sponsors (1)

Lead Sponsor	Collaborator
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Progression Free Survival (PFS) evaluated by investigator	PFS defined as the time from randomization until the first documented progressive disease (PD) or death from any cause.	up to 24 months
Secondary	Overall Survival (OS)	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.	up to 24 months
Secondary	Overall Response Rate (ORR)	Percentage of participants achieving complete response (CR) and partial response (PR).	up to 24 months
Secondary	Disease Control Rate(DCR)	Percentage of participants achieving complete response (CR) and partial response (PR) and stable disease (SD).	up to 24 months
Secondary	Duration of Overall Response (DOR)	The time when the patient first achieved complete or partial remission to disease progression.	up to 24 months
Secondary	PFS rate at month 6	The percentage of PFS at month 6.	up to 6 months
Secondary	PFS rate at month 12	The percentage of PFS at month 12.	up to 12 months
Secondary	OS rate at month 6	The percentage of OS at month 6.	up to 6 months
Secondary	OS rate at month 12	The percentage of OS at month 12.	up to 12 months
Secondary	OS rate at month 18	The percentage of OS at month 18.	up to 18 months
Secondary	Adverse Event (AE)	Safety data	up to 24 months
Secondary	Serious Adverse Event (SAE)	Safety data	up to 24 months
Secondary	Abnormal laboratory test index	Safety data	up to 24 months