A Multi-center, One-arm Clinical Study of Anlotinib Combined With Icotinib as the First-line Treatment in Patients With EGFR Mutation-positive Advanced NSCLC. The Trial Aims to Evaluate the Efficacy and Safety of This Treatment.

Tianjin Medical University Cancer Institute and Hospital5 sites in 1 country60 target enrollmentDecember 1, 2018

ConditionsNon Small Cell Lung Cancer

InterventionsAnlotinib Plus Icotinib

DrugsAnlotinib Plus Icotinib

Overview

Phase: Phase 2
Intervention: Anlotinib Plus Icotinib
Conditions: Non Small Cell Lung Cancer
Sponsor: Tianjin Medical University Cancer Institute and Hospital
Enrollment: 60
Locations: 5
Primary Endpoint: PFS（Progress free survival）
Status: Completed
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

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

Detailed Description

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.

Registry

clinicaltrials.gov

Start Date

December 1, 2018

End Date

January 1, 2021

Last Updated

5 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Tianjin Medical University Cancer Institute and Hospital

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Signed and dated informed consent
•18-75years，ECOG PS：0-2，Life expectancy of more than 3 months，with measurable lesion ( RECIST1.1)
•Histologically or cytologically confirmed, locally advanced and/or metastatic IIIB, IIIC or IV non-squamous NSCLC or recurrent non-squamous NSCLC（according to the 8th Edition of the AJCC Staging system）with EGFR 19 del and/or 21 L858R gene mutation
•Has not received chemotherapy or other targeted therapies；For recurrent disease, adjuvant chemotherapy, neoadjuvant chemotherapy or neoadjuvant chemotherapy plus adjuvant chemotherapy may be accepted, but recurrence occurs after ≥6 months from stopping treatment.
•≥1 target lesion that has not received radiotherapy in the past 3 months and can be accurately measured in at least 1 direction；Previously received radiation therapy, but the radiotherapy area must be \<25% of the bone marrow area, and radiation therapy must have closed for at least≥4 weeks at the time of enrollment;
•Main organs function is normal
•Patients of brain metastases with asymptomatic or mild symptoms can be enrolled
•The woman patients of childbearing age must agree to take contraceptive methods during the research and within another 8 weeks after treatment. Pregnancy test (blood serum test or urine) should be done within 7 days before the research and the result should be negative.The man patients who must agree to take contraceptive methods during the research and within another 8 weeks after treatment.

Exclusion Criteria

•Squamous cell carcinoma (including adenosquamous carcinoma); Small Cell Lung Cancer (including small cell cancer and other kinds of cancer mixed with non-small cell cancer)
•ALK-positive NSCLC
•Central Lung tumors that Imaging (CT or MRI) shows tumor lesions invade local large blood vessels; or with significant pulmonary cavum or necrotizing
•Patients with obvious brain metastases, cancerous meningitis, spinal cord compression, or with brain or pia mater disease. (patient with brain metastases who have completed treatment 14 days before and the symptoms are stable can be Enrolled, also should have no cerebral hemorrhage symptoms confirmed by brain MRI, CT or venography evaluation
•The patient is participating in other clinical studies or Participated in other anti-tumor drug clinical trials within 4 weeks before enrollment
•With other active malignancies that require simultaneous treatment
•Has a history of malignant tumors. Except for patients with cutaneous basal cell carcinoma, superficial bladder cancer, cutaneous squamous cell carcinoma or orthotopic cervical cancer who have undergone curative treatment and have no disease recurrence within 5 years after the start of treatment
•Patients with adverse reactions derived from previous therapies (excluding hair loss), which is over level 1 in CTC AE (4.0)
•abnormal blood coagulation (INR\>1.5 or PT \> ULN + 4s or APTT \> 1.5 ULN), with bleeding tendency or receiving thrombolytic or anticoagulant therapy
•renal insufficiency: urinary protein ≥ ++, or 24-hour urine protein ≥ 1.0g;

Arms & Interventions

Anlotinib Plus Icotinib

Anlotinib 12 mg once a day from day 1 to 14 of a 21-day cycle. Icotinib 125mg p.o, tid. It should be continued until disease progress or toxicity cannot be tolerated or patients withdraw consent.

Intervention: Anlotinib Plus Icotinib

Outcomes

Primary Outcomes

PFS（Progress free survival）

Time Frame: each 42 days up to PD or death (up to 24 months)

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"

Secondary Outcomes

OS（Overall Survival）(From enrollment until death (up to 24 months))
ORR（Objective Response Rate）(each 42 days up to intolerance the toxicity or PD (up to 24 months))
DCR（Disease Control Rate）(each 42 days up to intolerance the toxicity or PD (up to 24 months))
Adverse Events(Until 30 day safety follow-up visit)