Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Immune System Diseases

Carcinoma, Non-Small-Cell Lung

Lung Neoplasms

Hypersensitivity

Carcinoma

Carcinoma, Bronchogenic

Bronchial Neoplasms

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Anlotinib 12 mg once a day from day 1 to 14 of a 21-day cycle.

Anlotinib

Icotinib：125 mg/tablet，three times a day，fasting or serving with food. It should be continued until disease progression or intolerable toxicity or patients withdraw of consent.

Icotinib

Dingzhi Huang, M.D.

Evaluate the efficacy and safety of Anlotinib plus Icotinib as the first-line treatment in patients with sensitive EGFR concomitant mutations advanced non-small cell lung cancer

Anlotinib Hydrochloride is a kind of innovative medicines approved by State Food and Drug Administration（CFDA:2011L00661） which was developed 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.

Study of Anlotinib Combined With Icotinib as the First-line Treatment in Patients With EGFR Concomitant Mutation NSCLC

Phase III Study Comparing Anlotinib Plus Icotinib to Icotinib in Patients With Untreated Non-squmous NSCLC Harboring EGFR Concomitant Mutations

The PFS time is defined as time from enrollment to locoregional or systemic recurrence, second malignancy or death due to any cause; censored observations will be the last date of : "death", "last tumor assessment", "last follow up date" or "last date in drug log"

OS was defined as time from date of enrollment to date of death due to any cause. For participants still alive at the time of analysis, OS time was censored on last date that participants were known to be alive.

To evaluate the effectiveness of Anlotinib Hydrochloric Capsule Plus Icotinib Hydrochloric Tablet by enhanced CT/MRI scan every two cycles. Objective Response Rate (ORR) is defined as participants who had complete response (CR) or partial response(PR) divided by the total number of patients.

To evaluate the effectiveness of Anlotinib Hydrochloric Capsule Plus Icotinib Hydrochloric Tablet by enhanced CT/MRI scan every two cycles. Disease Control Rate (DCR) defined as the percentage of participants with Disease Control best overall response (complete response, partial response or stable disease).

Number of Participants with Adverse Events as a Measure of Safety and Tolerability

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Study of Anlotinib Combined With Icotinib as the First-line Treatment in Patients With EGFR Concomitant Mutation NSCLC	NCT04797806	Non Small Cell ...	Anlotinib Icotinib	18 Years - 75 Years	Tianjin Medical University Cancer Institute and Hospital
Study of Anlotinib Combined With Icotinib as the First-line Treatment in Patients With EGFR Concomitant Mutation NSCLC	NCT04797806	Non Small Cell ...	Anlotinib Icotinib	18 Years - 75 Years	Tianjin Medical University Cancer Institute and Hospital

Spots Global Cancer Trial Database for sensitive egfr mutations and concomitant orthers