iquid biopsy-based risk stratification and intensification of treatment In EGFR mutant advanced NSCLC

All India Institute of Medical Sciences0 个研究点目标入组 0 人开始时间: 待定最近更新: 2022年5月30日

试验速览

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•1.Age 18- 65yrs
•2.Eastern Cooperative Oncology Group (ECOG) performance status 0-2
•3.Treatment naÃ¯ve plasma EGFR mutant positive NSCLC for exon 19, 21 or 18 (adenocarcinoma/not otherwise specified)
•4.Being considered for EGFR TKI as first line treatment
•5.Stage IV and IIIB or C non squamous NSCLC not amenable to radical radiotherapy/ chemoradiation
•6. Adequate organ function, including the following:
•i) Adequate bone marrow reserve: absolute neutrophil (segmented and bands) counts (ANC) >= 1.5X109 /L, Platelets >=100X109 /L
•ii) Hepatic: bilirubin <= 1.5 times the upper limit of normal(xULN), Alanine aminotransferase (ALT) & aspartate aminotransferase (AST) <= 3.0 times the ULN if no demonstrable liver metastases (AST, ALT <= 5 XULN is acceptable if liver has tumor involvement). Serum Creatinine <= 1.5 times the ULN or Creatinine Clearance >= 60 ml/min.
•7.No h/o ILD at baseline
•8.Willingness to comply with all study requirements, including treatment, timing and/or nature of required assessments

•1.Poor PS (3 or 4)
•2.Pre-existing Interstitial lung disease documented by CT at baseline
•3.Symptomatic brain metastasis (treated, asymptomatic brain metastasis would be allowed)
•4.Pregnant and lactating women
•5.Not able to take oral medicines
•6.History or presence of any other malignancy
•7.Past medical history of interstitial lung disease, drug induced interstitial disease, radiation pneumonitis which required steroid treatment or any evidence of clinically active interstitial lung disease.
•8. Life expectancy of <= 12 weeks
•9. Concomitant use of phenytoin, carbamazepine, rifampicin, barbiturates

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