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

Sponsor
Samsung Medical Center
Study ID
NCT03991403
Phase
PHASE3
Status
Unknown

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Atezolizumab(Tecentriq) — DRUG
    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
  • Pemetrexed — DRUG
    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
  • Bevacizumab — DRUG
    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
  • Carboplatin — DRUG
    Carboplatin(AUC 5 or 5.5 IV a); Over approximately 15-30 min
  • Paclitaxel — DRUG
    Paclitaxel(175 mg/m2 IV); Over 3 hours
  • Carboplatin or cisplatin — DRUG
    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

Study Details

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.

Key Dates

Start date
Aug 27, 2019
Status verified
Mar 2023
Primary completion
Mar 11, 2023
Completion
Mar 11, 2024

Study Design

Enrollment
228 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Atezolizumab group
  • Active Comparator: Control group

Primary Outcome Measure

progression-free survival, PFS [ Time Frame: 34month after the first patient is randomized ]

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