Status:
COMPLETED
To Evaluate the Efficacy and Safety of Anlotinib Combined With Furmonertinib Mesylate in Lung Cancer
Lead Sponsor:
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Conditions:
Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This Study is To Evaluate the Efficacy and Safety of Anlotinib Hydrochloride Capsule Combined with Furmonertinib Mesylate in First-line Treatment of Advanced no-squamous and No-small Cell Lung Cancer ...
Detailed Description
This Study is To Evaluate the Efficacy and Safety of Anlotinib Hydrochloride Capsule Combined with Furmonertinib Mesylate in First-line Treatment of Advanced No-squamous and No-small Cell Lung Cancer ...
Eligibility Criteria
Inclusion
- Locally advanced and/or metastatic NSCLC diagnosed histologically and/or cytologically;
- Age 18 and above; Eastern Cooperative Oncology Group Physical condition: 0\~1; The expected survival time is more than 3 months;
- The previous report confirmed the presence of an EGFR gene exon 19 deletion mutation or exon 21 L858R mutation, and the investigator verified that the report reflects the patient's current genetic status.
- There is at least one measurable lesion other than brain lesion defined by Response Evaluation Criteria In Solid Tumors 1.1 standard;
- The main organs are functioning well,Adequate laboratory indicators.
- 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;
- Patients voluntarily participated in this study, signed informed consent, and had good compliance.
Exclusion
- Prior history of targeted Epidermal Growth Factor Receptor therapy and anti-angiogenic drugs
- Received chemical or biological drugs after the diagnosis of advanced stage;
- 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 ;
- Within 2 weeks before the start of the study, patients were treated with Chinese medicines
- 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.
- Uncontrolled pleural effusion, pericardial effusion or ascites requiring repeated drainage ;
- Brain metastases with symptoms or symptom control time less than 2 weeks;
Key Trial Info
Start Date :
January 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 27 2023
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT04671303
Start Date
January 1 2021
End Date
July 27 2023
Last Update
May 11 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
cancer hospital Chinese academy of medical sciences
Beijing, Beijing Municipality, China, 100021