SNPMiner Trials (Home Page)
Report for Clinical Trial NCT03991403
Developed by Shray Alag, 2020.
SNP Clinical Trial Gene
This randomized, Phase III, multicenter, open-label study designed to evaluate the efficacy
of Atezolizumab in combination with carboplatin, paclitaxel, bevacizumab compared with
treatment with pemetrexed, cisplatin in approximately 228 TKI(tyrosine kinase inhibitor) pre
treated patients with Stage IV non squamous non small cell lung cancer with activating EGFR
mutation or ALK translocation.
Name: Atezolizumab(Tecentriq)
Description: Atezolizumab(1200 mg IV);Over 60 (± 15) min (for the first infusion); 30 (± 10) min for subsequent infusions if tolerated Frequency: Day 1 of every 21 days Induction: Four or Six Cycles Maintenance : until PD
Type: Drug
Group Labels: 1 Atezolizumab group
Name: Pemetrexed
Description: Induction Period (Four or Six Cycles)
(1) Pemetrexed(500 mg/m2 IV); Over approximately10 minutes on Day 1 q3w
Maintenance Period (Until PD) Pemetrexed(500 mg/m2 IV); Over approximately10 minutes on Day 1 q3w
Type: Drug
Group Labels: 1 Control group
Name: Bevacizumab
Description: Bevacizumab(15 mg/kg IV);Over 90 (±15) min (for the first infusion); shortening to 60 (± 10) then 30 (± 10) min for subsequent infusions if tolerated
Type: Drug
Group Labels: 1 Atezolizumab group
Name: Carboplatin
Description: Carboplatin(AUC 6 IV a); Over approximately 15-30 min
Type: Drug
Group Labels: 1 Atezolizumab group
Name: Paclitaxel
Description: Paclitaxel(200 mg/m2 IV); Over 3 hours
Type: Drug
Group Labels: 1 Atezolizumab group
Name: Carboplatin or cisplatin
Description: Carboplatin(AUC 6 IV);Over approximately 30-60 minutes on Day 1 q3W or Cisplatin(75 mg/m²) ; Over 1-2 hours on Day 1 q3w
Type: Drug
Group Labels: 1 Control group
Primary Outcomes
Description: To evaluate the efficacy of atezolizumab + carboplatin + paclitaxel + bevacizumab as progression-free survival (PFS) according to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 (RECIST v1.1) in the following treatment:Atezolizumab + carboplatin + paclitaxel + bevacizumab versus Pemetrexed + carboplatin or cisplatin
Measure: progression-free survival, PFS
Time: through study completion, an average of 1 year
Secondary Outcomes
Measure: overall survival(OS) Time: through study completion, an average of 1 year
Measure: objective response rate(ORR) Time: through study completion, an average of 1 year
Measure: duration of response(DOR) Time: through study completion, an average of 1 year
Purpose: Treatment
Allocation: Randomized
Parallel Assignment
There is one SNP
SNPs
1 T790M
If the patients have identified T790M mutation after 1st or 2nd generation EGFR TKI
failure, the patient must be treated with the second line 3rd generation EGFR TKI
treatment, such as osimertinib, before the study participation. --- T790M ---
HPO Nodes
HPO: