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 is a prospective study to analyze the survival outcomes of different groups about lung cancer patients.
This study aims to analyze the survival outcomes of different groups about lung cancer patients. All the groups were assessed to the treatment decisions guided by molecular profiling and clinical judgment of principal investigators
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohorts 1 | Non-small cell lung cancer patients with EGFR mutations. Group A : Single EGFR Drive gene Mutations Group B :EGFR co-mutant with De novo MET alterations Group C :EGFR co-mutant with other genes including ALK , ROS , RET , BRAF .etc |
| |
| Cohorts 2 | Non-small cell lung cancer patients with ALK-fusion positive. |
| |
| Cohorts 3 | Non-small cell lung cancer patients with ROS-1-positive. |
| |
| Cohorts 4 | Non-small cell lung cancer patients with Other Rare Mutations. |
| |
| Cohorts 5 | Driver-negative lung cancer patients with ADC and SQC. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Treatment | Drug | Treatment decisions guided by molecular profiling and clinical judgment of principal investigators |
|
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free survival (PFS) | PFS defines as first dose to first documented disease progression assessed by investigator or death due to any cause. | Time from first subject dose to study completion, or up to 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival (OS) | To assess overall response rate according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 by investigator, define as the proportion of subjects who have a complete response (CR) or a partial response (PR) | Time from first subject dose to study completion, or up to 5 years |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Subjects who have received any of the following treatments must be excluded:
Presence of spinal cord compression or meningeal metastasis.
History of other malignant tumors within 2 years.
Adverse events (except alopecia of any degree) of CTCAE > grade 1 due to prior treatment (e.g., adjuvant chemotherapy, radiotherapy, etc.) prior to the first dose.
History of stroke or intracranial hemorrhage within 6 months prior to the first dose.
The presence of any severe or poorly controlled systemic disease, including poorly controlled hypertension and active bleeding in the judgment of the investigator.
Subjects with persistent or active infection, including but not limited to hepatitis B (HBV), hepatitis C (HCV), human immunodeficiency virus (HIV) and COVID-19 infection.
Heart-related diseases or abnormalities
Past history of interstitial lung disease, drug-induced interstitial lung disease, radiation pneumonitis requiring steroid therapy or interstitial lung disease with active clinical symptoms, immune pneumonia caused by immunotherapy.
Refractory nausea and vomiting, chronic gastrointestinal disease, difficulty swallowing drugs, or inability to adequately absorb drugs due to previous bowel resection.
Live vaccine was given 2 weeks before the first medication.
Women who are breastfeeding or pregnant.
Hypersensitivity to the test drug and the ingredients.
Other conditions assessed by the investigator to be unsuitable for participation in the study.
Not provided
Not provided
Not provided
lung cancer
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yongchang Zhang, MD | Contact | +8613873123436 | +8613873123436 | zhangyongchang@csu.edu.cn |
| Nong Z Yang, MD | Contact | +8613055193557 | +8613873123436 | yangnong0217@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Yongchang Zhang, MD | zhangyongchang@csu.edu.cn | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hunan Cancer Hospital | Recruiting | Changsha | Hunan | 410013 | 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 |
|---|---|
| D013812 | Therapeutics |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Tissue were obtained with the permission from patients.
| Adverse events (AEs) |
Number of participants with adverse events (AEs) according to CTCAE 5.0 |
| Time from first subject dose to study completion, or up to 5 years |
| D008171 |
| Lung Diseases |
| D012140 | Respiratory Tract Diseases |