Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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 with Epidermal Growth Factor Receptor Mutation.
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 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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Anlotinib Hydrochloride Capsule Combined with Furmonertinib Mesylate | Experimental | Anlotinib Hydrochloride Capsule: Oral on an empty stomach, once a day, 1 capsule each time, orally for 2 consecutive weeks, stop for 1 week Furmonertinib Mesylate:The dose of Furmonertinib 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Anlotinib Hydrochloride Capsule Combined with Furmonertinib Mesylate | Drug | Anlotinib Hydrochloride Capsule: Oral on an empty stomach, once a day, 1 capsule each time, orally for 2 consecutive weeks, stop for 1 week Furmonertinib Mesylate:The dose of Furmonertinib 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Safety and Efficacy of drug therapy | 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; | up to 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| The overall efficacy was assessed by the investigators | Objective response rate (ORR) assessed by the investigators | up to 48 weeks |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Yuankai SHI, Doctor | Chinese Academy of Medical Sciences and Peking Union Medical College | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| cancer hospital Chinese academy of medical sciences | Beijing | Beijing Municipality | 100021 | China |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
Not provided
Not provided
| ID | Term |
|---|---|
| C000705711 | aflutinib |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| D008171 |
| Lung Diseases |
| D012140 | Respiratory Tract Diseases |