This phase II, umbrella trial study directed by next generation sequencing (NGS) works in Chinese patients with advanced stage NSCLC who never received any anti-tumor treatment. The purpose of this study is to evaluate efficacy of targeted therapies or immunotherapy to NSCLC patients whose tumor harbors a genomic variant known to be a drug target or to predict sensitivity to a drug.
PRIMARY OBJECTIVES: I. To evaluate the anti-tumor efficacy of targeted agents or checkpiont inhibitors in advanced stage NSCLC with genomic alteration. SECONDARY OBJECTIVES: I. To evaluate the clinical efficacy of targeted agents or checkpiont inhibitors in advanced stage NSCLC with genomic alteration. II. To evaluate safty and tolerence of targeted agents or checkpiont inhibitors in advanced stage NSCLC with genomic alteration.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
400
300mg orally (PO) twice daily (BID) on day 1-28.
40mg orally once a day, 28 days as one cycle.
250mg PO QD on days 1-28. 28 days as one cycle.
Guangdong Lung Cancer Institute, Guangdong Provincial People's Hospital, Guangdong Academy of Medical Sciences, School of Medicine, South China University of Technology
Guangzhou, Guangdong, China
RECRUITINGResponse rate (RR)
RECIST version 1.1
Time frame: 24 months
Progression-free survival (PFS)
RECIST version 1.1
Time frame: 24 months
Overall survival (OS)
Overall Survival is defined as the time from first dose to death due to any cause. Through the follow-up within 30 days after study completion or termination of the last subject, death and date of death will be checked for subject alive during treatment period
Time frame: 48 months
Disease control rate(DCR)
RECIST version 1.1
Time frame: 24 months
Duration of response (DOR)
RECIST version 1.1
Time frame: 24 months
Toxicity (number of patients with treatment-related AE as assessed by CTCAE v4.03)
number of patients with treatment-related AE as assessed by CTCAE v4.03
Time frame: 24 months
Health-Related Quality of Life (HRQOL)
EORTC-LC13
Time frame: 24 months
To explore the mechanism of drug resistance in the treatment of specific gene mutation
Time frame: 24 months
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225mg PO QD on days 1-28. 28 days as one cycle.
30mg orally twice weekly, 28 days as one cycle.
400mg PO QD on days 1-28. 28 days as one cycle.
200mg PO BID on days 1-28. 28 days as one cycle.
60mg PO QD/40mg PO BID on days 1-28. 28 days as one cycle.
400mg, iv gtt. on day 1,8,15. 21 days as one cycle.
500mg/m\^2, iv gtt. Q3W. 21 days as one cycle.
75mg/m\^2, iv gtt. Q3W on day1. 21 days as one cycle.
200mg iv gtt. Q3W on day1. 21 days as one cycle.
1g/m\^2 iv gtt. on day1,8. 21 days as one cycle.
1.25g/m\^2 iv gtt. on day1,8. 21 days as one cycle.
AUC5 iv gtt. Q3W on day1. 21 days as one cycle.