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

Guangdong Association of Clinical Trials

Status and phase: Unknown; Phase 4

Conditions: Advanced Non-squamous NSCLC

Treatments: Drug: Anlotinib plus Pemetrexed; Drug: Pemetrexed

Study type: Interventional

Funder types: Other

Identifiers

NCT03768037

CTONG1801

Details and patient eligibility

About

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.

Full 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.

Enrollment: 106 estimated patients

Sex: All

Ages: 18 to 120 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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106 participants in 2 patient groups

Anlotinib plus Pemetrexed

Experimental group

Description:

Anlotinib plus Pemetrexed

Treatment:

Drug: Anlotinib plus Pemetrexed

Pemetrexed

Other group

Description:

Pemetrexed

Treatment:

Drug: Pemetrexed