Carboplatin Plus Pemetrexed Plus Atezolizumab Plus Bevacizumab in Chemotherapy and Immunotherapy-naïve Patients With Stage IV Non-squamous Non-small Cell Lung Cancer

Part of paid clinical trials in Chicago, Illinois.

Sponsor
Nasser Hanna
Study ID
NCT03713944
Phase
PHASE2
Status
Terminated

Conditions

  • NSCLC Stage IV
  • NSCLC, Recurrent

Eligibility Criteria

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

Interventions

  • Carboplatin — DRUG
    Carboplatin, AUC 5
  • Pemetrexed — DRUG
    Pemetrexed 500mg/m2
  • Atezolizumab — DRUG
    Atezolizumab 1200mg
  • Bevacizumab — DRUG
    Bevacizumab 15mg/kg

Study Details

This is a multicenter single arm phase II clinical trial. All eligible patients will receive: Carboplatin (AUC 5) i.v. day 1 plus pemetrexed (500 mg/m2) i.v. day 1 plus atezolizumab 1200 mg i.v. day 1 plus bevacizumab 15 mg/kg i.v. day 1 every 3 weeks for up to 4 cycles. Patients with non-PD after 4 cycles will be permitted to continue with maintenance therapy with pemetrexed plus atezolizumab plus bevacizumab every 3 weeks until the time of disease progression or intolerable toxicities.

Key Dates

Start date
Nov 15, 2018
Status verified
Feb 2023
Primary completion
Dec 16, 2021
Completion
Dec 16, 2021

Study Design

Enrollment
30 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Carboplatin, Pemetrexed, Atezolizumab plus Bevacizumab
    Carboplatin (AUC 5) i.v. day 1 plus pemetrexed (500 mg/m2) i.v. day 1 plus atezolizumab 1200 mg i.v. day 1 plus bevacizumab 15 mg/kg i.v. day 1 every 3 weeks for up to 4 cycles. Patients with non-PD after 4 cycles will be permitted to continue with maintenance therapy with pemetrexed plus atezolizumab plus bevacizumab every 3 weeks until the time of disease progression or intolerable toxicities.

Primary Outcome Measure

Progression Free Survival [ Time Frame: From C1D1 until progression or death up to maximum of 20 Months ]

Locations (7)

FacilityCityStateZIPSite coordinators
University of Illinois Cancer CenterChicagoIllinois60612-
Indiana Univeristy Melvin and Bren Simon Cancer CenterIndianapolisIndiana46202-
University of Iowa Hospitals and ClinicsIowa CityIowa52242-
Rutgers Cancer Institute of New JerseyNew BrunswickNew Jersey08903-
University of Virginia Health SystemCharlottesvilleVirginia22908-
University of WisconsinMadisonWisconsin53705-
ProHealth CareWaukeshaWisconsin53188-

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