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
Most of the lung cancer patients treated in hospitals in China are in advanced stage, accounting for more than 2/3 of all lung cancer patients, and some of the patients have a poor performence status.At present, most of the patients included in clinical trials are patients with good PS score, and the NCCN guidelines for advanced lung cancer patients with poor performence status recommend the best supportive care.Therefore, the investigator wanted to explore the efficacy and safety of Almonertinib in lung cancer patients with poor performance status.
Most of the lung cancer patients treated in hospitals in China are in advanced stage, accounting for more than 2/3 of all lung cancer patients, and some of the patients have a poor performence status.In recent years, systemic treatments with good efficacy and low toxicity, such as gene-targeted therapy, anti-angiogenic therapy and immunotherapy, have largely replaced single chemotherapy, and have great potential to benefit from existing treatments for poor PS scores of advanced lung cancer patients can adopt more aggressive treatment strategies.At present, most of the patients included in clinical trials are patients with good PS score, and the NCCN guidelines for advanced lung cancer patients with poor performence status recommend the best supportive care.Therefore,the investigator wanted to explore the efficacy and safety of Almonertinib in lung cancer patients with poor performance status.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Almonertinib | Experimental | Almonertinib, 110 mg, po, QD; 28 days every cycle |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Almonertinib | Drug | Almonertinib Mesilate Tablets |
|
| Measure | Description | Time Frame |
|---|---|---|
| ORR | Objective Response Rate | 24 months |
| Time of PS score change from 2~4 to 1 | Time of performance status score change from 2~4 to 1 | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| PFS | Median progression-free survival | 24 months |
| OS | Median overall survival | from baseline until death due to any cause, up to a maximum of approximately 4years |
| Measure | Description | Time Frame |
|---|---|---|
| Safety: Dose-limiting toxicities | Any level 3 or greater toxicity | from the screening period to 28 days after treatment completion |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zhou Chengzhi, MD | Contact | 13560351186 | doctorzcz@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Zhou Chengzhi, MD | The First Affiliated Hospital of Guangzhou Medical University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zhou Chengzhi | Recruiting | Guangzhou | Guangdong | 510120 | China |
no plan
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 |
|---|---|
| C000718108 | aumolertinib |
Not provided
Not provided
Not provided
Single Group Assignment Almonertinib monotherapy
Not provided
Not provided
Not provided
Not provided
| DCR | Disease control rate | 24 months |
| D008171 |
| Lung Diseases |
| D012140 | Respiratory Tract Diseases |