To Evaluate the Efficacy and Safety of Anlotinib Combined With Allitinib in Lung Cancer

Phase 2

• Conditions: Lung Cancer
• Interventions: Drug: Anlotinib Hydrochloride Capsule Combined with Allitinib Tablets

• Registration Number: NCT04671303
• Lead Sponsor: Chinese Academy of Medical Sciences

Brief Summary

This Study is To Evaluate the Efficacy and Safety of Anlotinib Hydrochloride Capsule Combined with Allitinib Tablets in First-line Treatment of Advanced no-squamous and No-small Cell Lung Cancer with Epidermal Growth Factor Receptor Mutation.

Detailed Description

This Study is To Evaluate the Efficacy and Safety of Anlotinib Hydrochloride Capsule Combined with Allitinib Tablets in First-line Treatment of Advanced No-squamous and No-small Cell Lung Cancer with Epidermal Growth Factor Receptor Mutation.

This study is a single arm, phase II study, including 18 to 36 subjects; Common Terminology Criteria for Adverse Events 5.0 standard was used to evaluate adverse events of drugs, and Response Evaluation Criteria In Solid Tumors 1.1 was used to evaluated efficacy.

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study First Submitted: 2020-11-30
• Status Verified: 2020-12
• Study First Submitted QC: 2020-12-11
• Last Update Submitted: 2020-12-11
• Study First Posted: 2020-12-17
• Last Update Posted: 2020-12-17
• Study Start: 2021-01-01
• Primary Completion: 2021-09-30
• Study Completion: 2021-09-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 36

Inclusion Criteria

1. Locally advanced and/or metastatic NSCLC diagnosed histologically and/or cytologically;

2. Age 18 and above; Eastern Cooperative Oncology Group Physical condition: 0~1; The expected survival time is more than 3 months;

3. Patients must present with a previously reported exon deletion mutation of Epidermal Growth Factor Receptor 19 .

   The investigator confirmed that the report could reflect the patient's current genetic status.

4. There is at least one measurable lesion other than brain lesion defined by Response Evaluation Criteria In Solid Tumors 1.1 standard;

5. The main organs are functioning well,Adequate laboratory indicators.

6. Women of childbearing age should agree to use contraceptives during the study period and for a period of six months after the study; Negative serum or urine pregnancy test within 7 days prior to study inclusion, and must be non-lactating; Male patients should agree to use contraception during the study period and for six months after the end of the study period;

7. Patients voluntarily participated in this study, signed informed consent, and had good compliance.

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Exclusion Criteria

1. Prior history of targeted Epidermal Growth Factor Receptor therapy and anti-angiogenic drugs
2. Received chemical or biological drugs after the diagnosis of advanced stage;
3. Subjects had undergone surgery , radiation therapy or other anticancer therapies within 4 weeks prior to the commencement of study treatment; Subjects who have previously received local radiation therapy may be enrolled if the following conditions are met: more than 4 weeks after the end of radiation therapy ;
4. Within 2 weeks before the start of the study, patients were treated with Chinese medicines
5. Imaging shows that the tumor has invaded the periphery of important blood vessels or the investigator has determined that the tumor is very likely to invade important blood vessels and cause fatal bleeding during the follow-up study.
6. Uncontrolled pleural effusion, pericardial effusion or ascites requiring repeated drainage ;
7. Brain metastases with symptoms or symptom control time less than 2 weeks;

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Anlotinib Hydrochloride Capsule Combined with Allitinib Tablets	Anlotinib Hydrochloride Capsule Combined with Allitinib Tablets	Anlotinib Hydrochloride Capsule: Oral on an empty stomach, once a day, 1 capsule each time, orally for 2 consecutive weeks, stop for 1 week Allitinib Tablets：The dose of allitinib mesylate is 80 mg once a day, 2 tablets each time, taken orally on an empty stomach before breakfast. Take medicine continuously for 3 weeks (21 days) for 1 cycle.

Primary Outcome Measures

Name	Time	Method
Safety and Efficacy of drug therapy	up to 4 weeks	The probability and severity of first cycle adverse events (AE) and serious adverse events (SAE) (based on Common Terminology Criteria for Adverse Events 5.0) and abnormal laboratory test indicators;

Secondary Outcome Measures

Name	Time	Method
The overall efficacy was assessed by the investigators	up to 48 weeks	Objective response rate (ORR) assessed by the investigators