Status:
UNKNOWN
Efficacy and Safety of the Combination of Anlotinib and JS001 in EGFR-TKI Resistant T790M-Negative NSCLC
Lead Sponsor:
Baodong Qin
Conditions:
NSCLC Stage IV
EGFR T790M-negative
Eligibility:
All Genders
18-75 years
Brief Summary
This study is designed to evaluate the efficacy and safety of the combination of Anlotinb and JS001 in EGFR-TKI resistant T790M-negative NSCLC patients.
Detailed Description
All EGFR mutation NSCLC patients with EGFR-TKIs eventually develop acquired resistance and in 40%-50% of these the resistance mechanism is based on the EGFR T790M mutation who could receive Osimertini...
Eligibility Criteria
Inclusion
- Adult patients \>=18 years of age
- Inoperable locally advanced, recurrent, and/or metastatic NSCLC patients with EGFR sensitive mutation
- EGFR-TKI resistent
- EGFR T790M negative
- Expected survival ≥ 3 month;
- ECOG / PS score: 0-2;
- the main organ function to meet the following criteria: HB ≥ 90g / L, ANC ≥ 1.5 × 109 / L, PLT ≥ 80 × 109 / L,BIL \<1.5 times the upper limit of normal (ULN); Liver ALT and AST \<2.5 × ULN and if liver metastases, ALT and AST \<5 × ULN; Serum Cr ≤ 1 × ULN, endogenous creatinine clearance ≥50ml/min
Exclusion
- EGFR-T790M positive
- with druggable gene alteration;
- Patient can not comply with research program requirements or follow-up;
Key Trial Info
Start Date :
September 1 2019
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
September 30 2021
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT04116918
Start Date
September 1 2019
End Date
September 30 2021
Last Update
October 7 2019
Active Locations (1)
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1
Shanghai Changzheng Hospital
Shanghai, China