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

• ClinicalTrials.gov Identifier: NCT04671303
• Recruitment Status: Not yet recruiting
• First Posted: December 17, 2020
• Last Update Posted: December 17, 2020
• Sponsor: Chinese Academy of Medical Sciences
• Information provided by (Responsible Party): Shi Yuankai, Chinese Academy of Medical Sciences

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Lung Cancer	Drug: Anlotinib Hydrochloride Capsule Combined with Allitinib Tablets	Phase 2

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 36 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: This Study is To Evaluate the Efficacy and Safety of Anlotinib Hydrochloride Capsule Combined With Allitinib Tablets in First-line Treatment of Advanced No-small Cell Lung Cancer
• Estimated Study Start Date: January 1, 2021
• Estimated Primary Completion Date: September 30, 2021
• Estimated Study Completion Date: September 30, 2021

Arms and Interventions

Arm

Intervention/treatment

Experimental: 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.

Drug: 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.

Outcome Measures

Primary Outcome Measures :

1. Safety and Efficacy of drug therapy [ Time Frame: 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 :

1. The overall efficacy was assessed by the investigators [ Time Frame: up to 48 weeks ]
   Objective response rate (ORR) assessed by the investigators

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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.

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;

Contacts and Locations

Contacts

Contact: Yuankai S, Doctor; 010-87788268; medart@126.com

Sponsors and Collaborators

Chinese Academy of Medical Sciences

Investigators

• Principal Investigator: Yuankai S, Doctor; Chinese Academy of Medical Sciences and Peking Union Medical College

More Information

• Responsible Party: Shi Yuankai, Director, Chinese Academy of Medical Sciences
• ClinicalTrials.gov Identifier: NCT04671303
• Other Study ID Numbers: ALTN-AFTN-II-01
• First Posted: December 17, 2020
• Last Update Posted: December 17, 2020
• Last Verified: December 2020

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases