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Report for Clinical Trial NCT03991403

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

Study of Atezolizumab in Combination With Carboplatin + Paclitaxel +Bevacizumab vs With Pemetrexed + Cisplatin or Carboplatin With Stage IV NON-SQUAMOUS NON-SMALL CELL LUNG CANCER With EGFR(+) or ALK(+)

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.

NCT03991403 Non-small Cell Lung Cancer
MeSH:Lung Neoplasms Carcinoma, Non-Small-Cell Lung
HPO:Neoplasm of the lung Non-small cell lung carcinoma

6 Interventions

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: