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 — DRUGCarboplatin, AUC 5
- Pemetrexed — DRUGPemetrexed 500mg/m2
- Atezolizumab — DRUGAtezolizumab 1200mg
- Bevacizumab — DRUGBevacizumab 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 BevacizumabCarboplatin (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)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| University of Illinois Cancer Center | Chicago | Illinois | 60612 | - |
| Indiana Univeristy Melvin and Bren Simon Cancer Center | Indianapolis | Indiana | 46202 | - |
| University of Iowa Hospitals and Clinics | Iowa City | Iowa | 52242 | - |
| Rutgers Cancer Institute of New Jersey | New Brunswick | New Jersey | 08903 | - |
| University of Virginia Health System | Charlottesville | Virginia | 22908 | - |
| University of Wisconsin | Madison | Wisconsin | 53705 | - |
| ProHealth Care | Waukesha | Wisconsin | 53188 | - |
Find similar trials in Chicago, IL
By research site
University of Illinois Cancer Center· Chicago, ILIndiana Univeristy Melvin and Bren Simon Cancer Center· Indianapolis, INUniversity of Iowa Hospitals and Clinics· Iowa City, IARutgers Cancer Institute of New Jersey· New Brunswick, NJUniversity of Virginia Health System· Charlottesville, VAUniversity of Wisconsin· Madison, WI
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