Anlotinib, EGFR T790M-negative, JS001, NSCLC Stage IV
Conditions
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 Osimertinib. Several alternative mechanisms of escape from EGFR-TKIs have been detected in NSCLC patients without the T790M, such as Met application, BRAF mutation, PIK3CA mutation, etc, who could receive the combination of EGFR-TKI with comparable target drug. Given the lack of targeted therapy for the majority of T790M-negative patients, platinum-doublet chemotherapy remains the standard of care with low effectiveness. In the present study, we aimed to evaluate the efficacy and safety of the combination of Anlotinb and JS001 in EGFR-TKI resistant T790M-negative NSCLC patients.
Interventions
None listed
Sponsors
Baodong Qin
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Months to 75 Years
Healthy volunteers
No
Inclusion criteria
* 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 criteria
* EGFR-T790M positive * with druggable gene alteration; * Patient can not comply with research program requirements or follow-up;
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression-Free Survival (PFS) | Evaluation of tumor burden based on RECIST criteria until first documented progress through study completion, an average of 2 months | Time from treatment beginning until disease progression |
| Objective Response Rate | Evaluation of tumor burden based on RECIST criteria through study completion, an average of 2 months | Proportion of patients with reduction in tumor burden of a predefined amount, including complete remission and partial remission. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall Survival | From date of treatment beginning until the date of death from any cause, through study completion, an average of 1 months | Time from treatment beginning until death from any cause |
| Adverse Effect | Through study completion, an average of 1 months | Incidence of Treatment-related adverse Events |
Countries
China
Outcome results
None listed