NCT03991403

Study of Atezolizumab Combination Carboplatin + Paclitaxel + Bevacizumab in EGRF Mutation or ALK Translocation NSCLC

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(+)

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 228 (actual)
• Sponsor: Samsung Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Non-small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	Atezolizumab(Tecentriq)	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
DRUG	Pemetrexed	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
DRUG	Bevacizumab	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
DRUG	Carboplatin	Carboplatin(AUC 5 or 5.5 IV a); Over approximately 15-30 min
DRUG	Paclitaxel	Paclitaxel(175 mg/m2 IV); Over 3 hours
DRUG	Carboplatin or cisplatin	Carboplatin(AUC 5.5 IV);Over approximately 30-60 minutes on Day 1 q3W or Cisplatin(75 mg/m²) ; Over 1-2 hours on Day 1 q3w

Timeline

• Start date: 2019-08-27
• Primary completion: 2023-03-11
• Completion: 2024-03-11
• First posted: 2019-06-19
• Last updated: 2023-04-03

Locations

1 site across 1 country: South Korea