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A study of Erlitinib in treating Patients with Advanced Lung Adenocarcinoma with EGFR Gene Mutation Phenotype detected by droplet digital PCR

A study of Erlitinib in treating Patients with Advanced Lung Adenocarcinoma with EGFR Gene Mutation Phenotype detected by droplet digital PCR

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR-DDD-17013131
Enrollment
Unknown
Registered
2017-10-27
Start date
2016-12-01
Completion date
Unknown
Last updated
2017-11-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lung cancer

Interventions

Gold Standard:1. Pathological diagnosis of lung cancer
2. Amplification refractory mutation system.

Sponsors

Fujian Province Cancer Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Histologically identified lung adenocarcinoma; 2. Aged 18 to 75 years old, life expectancy = 12 weeks; 3. According to TNM staging (IASLC 2009 version) identified as IV period; 4. No chemotherapy, targeting, biological or immunotherapy. The duration of prior radical surgery or radical radiotherapy must be more than 6 months from the first day of treatment, allowing adjuvant chemotherapy after radical surgery, but more than 6 months from the first day of treatment; 5. Measurable lesions according to RECIST 1.1 standard; 6. WHO physical status score (PS) 0-2 level; 7. Able to comply with research requirements and follow-up procedures, signed informed consent; 8. The total bilirubin (TB) = 1.5×10^9/L, (ALT) and aspartate aminotransferase (AST) = 2 times the normal upper limit; for liver metastases, ALT and AST = 5 times the normal upper limit, creatinine clearance = 50ml/min.;Inclusion criteria: 1. Histologically identified lung adenocarcinoma; 2. Aged 18 to 75 years old, life expectancy = 12 weeks; 3. According to TNM staging (IASLC 2009 version) identified as IV period; 4. No chemotherapy, targeting, biological or immunotherapy. The duration of prior radical surgery or radical radiotherapy must be more than 6 months from the first day of treatment, allowing adjuvant chemotherapy after radical surgery, but more than 6 months from the first day of treatment; 5. Measurable lesions according to RECIST 1.1 standard; 6. WHO physical status score (PS) 0-2 level; 7. Able to comply with research requirements and follow-up procedures, signed informed consent; 8. The total bilirubin (TB) = 1.5×10^9/L, (ALT) and aspartate aminotransferase (AST) = 2 times the normal upper limit; for liver metastases, ALT and AST = 5 times the normal upper limit, creatinine clearance = 50ml/min.;Inclusion criteria: 1. Histologically identified lung adenocarcinoma; 2. Aged 18 to 75 years old, life expectancy = 12 weeks; 3. According to TNM staging (IASLC 2009 version) identified as IV period; 4. No chemotherapy, targeting, biological or immunotherapy. The duration of prior radical surgery or radical radiotherapy must be more than 6 months from the first day of treatment, allowing adjuvant chemotherapy after radical surgery, but more than 6 months from the first day of treatment; 5. Measurable lesions according to RECIST 1.1 standard; 6. WHO physical status score (PS) 0-2 level; 7. Able to comply with research requirements and follow-up procedures, signed informed consent; 8. The total bilirubin (TB) = 1.5×10^9/L, (ALT) and aspartate aminotransferase (AST) = 2 times the normal upper limit; for liver metastases, ALT and AST = 5 times the normal upper limit, creatinine clearance = 50ml/min.;Inclusion criteria: 1. Histologically identified lung adenocarcinoma; 2. Aged 18 to 75 years old, life expectancy = 12 weeks; 3. According to TNM staging (IASLC 2009 version) identified as IV period; 4. No chemotherapy, targeting, biological or immunotherapy. The duration of prior radical surgery or radical radiotherapy must be more than 6 months from the first day of treatment, allowing adjuvant chemotherapy after radical surgery, but more than 6 months from the first day of treatment; 5. Measurable lesions according to RECIST 1.1 standard; 6. WHO physical status score (PS) 0-2 level; 7. Able to comply with research requirements and follow-up procedures, signed informed consent; 8. The total bilirubin (TB) = 1.5×10^9/L, (ALT) and aspartate aminotransferase (AST) = 2 times the normal upper limit; for liver metastases, ALT and AST = 5 times the normal upper limit, creatinine clearance = 50ml/min.;Inclusion criteria: 1. Histologically identified lung adenocarcinoma; 2. Aged 18 to 75 years old, life expectancy = 12 weeks; 3. According to TNM staging (IASLC 2009 version) identified as IV period; 4. No chemotherapy, targeting, biological or immunotherapy. The duration of prior radical surgery or radical radiotherapy must be more than 6 months from the first day of treatment, allowing adjuvant chemotherapy after radical surgery, but more than 6 months from the first day of treatment; 5. Measurable lesions according to RECIST 1.1 standard; 6. WHO physical status score (PS) 0-2 level; 7. Able to comply with research requirements and follow-up procedures, signed informed consent; 8. The total bilirubin (TB) = 1.5×10^9/L, (ALT) and aspartate aminotransferase (AST) = 2 times the normal upper limit; for liver metastases, ALT and AST = 5 times the normal upper limit, creatinine clearance = 50ml/min.

Exclusion criteria

Exclusion criteria: 1. Serious violation of the criteria for inclusion in the case; 2. no test records available for evaluation; 3. the loss of patients during follow-up; 4. independent of the disease changes or death occurred during treatment and follow-up which lead to can not continue to observe.;Exclusion criteria: 1. Serious violation of the criteria for inclusion in the case; 2. no test records available for evaluation; 3. the loss of patients during follow-up; 4. independent of the disease changes or death occurred during treatment and follow-up which lead to can not continue to observe.;Exclusion criteria: 1. Serious violation of the criteria for inclusion in the case; 2. no test records available for evaluation; 3. the loss of patients during follow-up; 4. independent of the disease changes or death occurred during treatment and follow-up which lead to can not continue to observe.;Exclusion criteria: 1. Serious violation of the criteria for inclusion in the case; 2. no test records available for evaluation; 3. the loss of patients during follow-up; 4. independent of the disease changes or death occurred during treatment and follow-up which lead to can not continue to observe.;Exclusion criteria: 1. Serious violation of the criteria for inclusion in the case; 2. no test records available for evaluation; 3. the loss of patients during follow-up; 4. independent of the disease changes or death occurred during treatment and follow-up which lead to can not continue to observe.

Design outcomes

Primary

MeasureTime frame
EGFR Gene Mutation Phenotype;EGFR Gene Mutation Phenotype;Accuracy;Sensitivity;Specificity;Positive predictive value;Negative predictive value;Objective remission rate;No progression-free survival;overall survival;

Countries

China

Contacts

Public ContactZhuang Wu;Zhuang Wu;Zhuang Wu;Zhuang Wu;Zhuang Wu ;;;;

Fujian Province Cancer Hospital;Fujian Province Cancer Hospital;Fujian Province Cancer Hospital;Fujian Province Cancer Hospital;Fujian Province Cancer Hospital

zhuangwu@medmail.com;zhuangwu@medmail.com;zhuangwu@medmail.com;zhuangwu@medmail.com;zhuangwu@medmail.com+86 13805900871;+86 13805900871;+86 13805900871;+86 13805900871;+86 13805900871

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 6, 2026