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

• Status: Not yet recruiting
• Trial end date: 2021-09-30
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Chinese Academy of Medical Sciences

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;