lung cancer
Conditions
Interventions
EGFR-sensitive mutations without MLH1 V384D / TP53 Exon 8 / KRAS / PIK3CA mutation:EGFR-TKI and Pemetrexed (500mg/m2, day1, 21 day per cycle)
EGFR-sensitive mutations without MLH1 V384D / TP53 Exon 8 / KRAS / PIK3CA mutation:EGFR-TKI
EGFR-sensitive mutations with MLH1 V384D / TP53 Exon 8 / KRAS / PIK3CA mutation:EGFR-TKI and Pemetrexed (500mg/m2, day1, 21 day per cycle)
EGFR-sensitive mutations with MLH1 V384D / TP53 Exon 8 / KRAS / PIK3CA mutation:EGFR-TKI
Sponsors
The First People's Hospital of Foshan
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. The informed consent must be signed; 2. Adults aged 18 years or older; 3. histologically or cytologically confirmed lung adenocarcinoma; In the stage of AJCC TNM ( 8th edition), IIIb, IIIc and IV stages were diagnosed, and patients with NSCLC who were unable to undergo surgery and radiotherapy were not eligible for clinical staging; 5. according to RECIST 1.1, the patient has at least one measurable or assessable tumor lesion; 6. Patients with stable central nervous system (CNS) metastases or asymptomatic CNS metastases with successful local treatment may be enrolled. Allow stable CNS metastasis after treatment; The patient must remain stable=2 weeks after radiotherapy and stop glucocorticoid=1 week; 7.Prior palliative radiotherapy is permissible, but limited to the 25% of bone marrow, and may not include whole pelvic radiotherapy. Patients must recover from the toxic effects of treatment (except hair loss) before entering the study. Prior radiotherapy must be completed 1 month before the study. Radiotherapy should not be performed for the target lesions selected in this study unless it is proved that the selected target lesions have advanced in the field of radiation; 8. EGFR sensitive mutation positive, and EGFR T790M negative; 9. ALK/MET/ROS1/RET can drive gene negative; 10. The physical status score (ECoG) of the eastern oncology group was 0-1, and there was no sign of deterioration in the last 2 weeks; 11. Expected survival time > 12 weeks; 12. Clinical laboratory indicators meet the following criteria: Platelet 100*10^9/L; Absolute neutrophil count (ANC) 1.510^9/L; hemoglobin (Hgb) 90 G/L; Total bilirubin 1.5 times the upper limit of normal value ( ULN ); Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) 3 times ULN (5 times ULN) were allowed if there was liver metastasis; creatinine 1.5 times ULN or creatinine clearance 50 Ml / min; Mean corrected QT interval QTcF470 derived from 3 ECG (ECG) examinations at rest Msec; 13. Patient can swallow take oral medicine; 14. Except for alopecia and stable peripheral neurotoxicity below level-2, any clinical toxicity associated with prior treatment prior to induction must return to baseline or level-1; 15. For women: surgical sterilization, menopause, or during or after treatment is required Take effective contraception within a month; no pregnancy, no breast-feeding; postmenopausal women must have amenorrhea at least Twelve. Only a month can we think of childlessness. For men: surgical sterilization must be performed or during or after treatment. Take effective contraception within 3 months; 16. Patient compliance and geographic proximity can ensure adequate follow-up. Willing to provide blood samples for genetic testing at baseline and during disease progression.
Exclusion criteria
Exclusion criteria: 1. Patients with NSCLC who have received systemic treatment for metastatic disease; 2. Unwilling to provide tumor tissue / blood for genetic testing; 3. Previous interstitial lung disease, drug-induced interstitial lung disease, radiation pneumonitis requiring hormone therapy, or any clinically proven active interstitial lung disease; 4. Patients with other malignancies are still receiving treatment, or other malignancies that have recurred or are associated with other malignancies in the past five years, radical treatment of cervical cancer in situ, non-melanoma skin cancer, superficial bladder tumor (non-invasive tumor), or carcinoma in situ without recurrence 3 years after radical treatment, no relevant treatment can be considered into the group; 5. Any serious clinical problem that is beyond our control (such as severe mental, neurological, cardiovascular, respiratory and other systemic diseases); 6. The investigators assessed patients as unsuitable for the trial or poor patient compliance with the procedures, limitations, and requirements of the study; 7. The researcher considers any disease or condition that endangers the patient's safety or interferes with the study's assessment; 8. In the 120 days prior to the acquisition of the genetic test sample, the whole blood was infused without leukocytes; 9. Women with positive blood or urine pregnancy test results during lactation or screening follow-up; 10. Inability or unwillingness to take folic acid, vitamin B12 supplements, or dexamethasone; 11. Use any other anti-tumor treatment concurrently during the study period.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-Free-Survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival; | — |
Countries
China
Contacts
Public ContactWeineng Feng
Department of head, neck and chest oncology, The First People's Hospital of Foshan
Outcome results
None listed