Anlotinib Plus Pemetrexed or Pemetrexed for Previously Untreated Elderly (>=70) or PS=2 Non-squamous NSCLC

Advanced Non-squamous NSCLC Clinical Trial

Official title:

A Study to Evaluate the Efficacy and Safety of Anlotinib Plus Pemetrexed as the 1-line Treatment of Patients With Platinum Intolerant Advanced Non-squamous NSCLC, With Pemetrexed Control.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03768037
• Other study ID #: CTONG1801
• Status: Recruiting
• Phase: Phase 4
• Start date: November 26, 2018
• Est. completion date: November 26, 2020

Study information

• Verified date: November 2018
• Source: Guangdong Association of Clinical Trials
• Contact: Xiaoqing Liu
• Phone: 86-010-89509324
• Email: liuxiaoqing[@]csco.org.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Evaluate the efficacy and safety of Anlotinib plus Pemetrexed as the 1-line treatment of patients with Platinum intolerant advanced non-squamous NSCLC, with Pemetrexed control.

Description:

Anlotinib (AL3818) is a kind of innovative medicines approved by State Food and Drug Administration（SFDA:2011L00661） which was researched by Jiangsu Chia-tai Tianqing Pharmaceutical Co., Ltd. Anlotinib is a kinase inhibitor of receptor tyrosine with multi-targets, especially for VEGFR1、VEGFR2、VEGFR3、FGFR1/2/3、PDGFRa/β c-Kit and MET.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 106
• Est. completion date: November 26, 2020
• Est. primary completion date: November 26, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 120 Years

Eligibility

Inclusion Criteria:

• =70 years old and ECOG PS=0-2 or =18 years old and ECOG PS=2

• Diagnosed with advanced or recurrent non-squamous NSCLC (phase IIIB/IV) through pathology, with measurable nidus(using RECIST 1.1)

• No prior systemic treatment for non-squamous NSCLC

• Negative in EGFR&ALK&ROS1

• Main organs function is normal

Exclusion Criteria:

• Have any habitus or medical history of hemorrhage, however severe it is; the patients who have non healing wounds, ulcer or fracture after any events with hemorrhage or bleeding

• Symptoms of brain metastases cannot be controlled and treated within less than 21 days

• Have participated in other clinical trials of anti-tumor medicine within 4 weeks

• Get any severe diseases or the ones that cannot be controlled

Related Conditions & MeSH terms

• Advanced Non-squamous NSCLC

Intervention

Drug:
• Anlotinib plus Pemetrexed
Anlotinib p.o, qd and it should be continued until disease progress or unacceptable toxic effects. Pemetrexed 500 mg/m2 every 21 days for 4-6 cycles or unacceptable toxic effects
• Pemetrexed
Pemetrexed 500 mg/m2 every 21 days for 4-6 cycles or unacceptable toxic effects

Locations

Country	Name	City	State
China	Beijing Chest Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Guangdong Association of Clinical Trials

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of patients alive and progression free at 6 months (APF6)	the number (%) of patients who are alive and progression free per RECIST 1.1 at 6 months after randomization per Kaplan-Meier estimate of progression free survival at 6 months.	Estimated to be from baseline up to 2 years
Secondary	Progression Free Survival(PFS)	the time from randomization until the date of objective disease progression (RECIST 1.1) or death (by any cause in the absence of progression)	Estimated to be from baseline up to 2 years
Secondary	Overall Survival(OS)	the time from randomization to death from any cause	Estimated to be from baseline up to 2 years
Secondary	Disease Control Rate(DCR)	the total proportion of patients who demonstrate a response(complete responses + partial responses + stable disease ) to treatment	Estimated to be from baseline up to 2 years
Secondary	Objective Response Rate(ORR)	the total proportion of patients who demonstrate a response(complete responses + partial responses) to treatment	Estimated to be from baseline up to 2 years