Advanced Non-squamous NSCLC
Conditions
Brief 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.
Detailed 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.
Interventions
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
DRUGPemetrexed
Pemetrexed 500 mg/m2 every 21 days for 4-6 cycles or unacceptable toxic effects
Sponsors
Guangdong Association of Clinical Trials
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 120 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of patients alive and progression free at 6 months (APF6) | Estimated to be from baseline up to 2 years | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Progression Free Survival(PFS) | Estimated to be from baseline up to 2 years | the time from randomization until the date of objective disease progression (RECIST 1.1) or death (by any cause in the absence of progression) |
| Overall Survival(OS) | Estimated to be from baseline up to 2 years | the time from randomization to death from any cause |
| Disease Control Rate(DCR) | Estimated to be from baseline up to 2 years | the total proportion of patients who demonstrate a response(complete responses + partial responses + stable disease ) to treatment |
| Objective Response Rate(ORR) | Estimated to be from baseline up to 2 years | the total proportion of patients who demonstrate a response(complete responses + partial responses) to treatment |
Countries
China
Contacts
Primary ContactXiaoqing Liu
Backup ContactShucai Zhang
Outcome results
None listed