A Phase II Study of Carboplatin Plus Pemetrexed Plus Atezolizumab Plus Bevacizumab in Chemotherapy and Immunotherapy-naïve Patients With Stage IV Non-squamous Non-small Cell Lung Cancer: Big Ten Cancer Research Consortium BTCRC-LUN17-139
Investigating Treatment for Stage IV Non-Squamous NSCLC
Brief description of study.
The purpose of this study is to estimate the progression free survival (PFS) of the combination of Carboplatin plus Pemetrexed plus Atezolizumab plus Bevacizumab for patients with stage IV non-squamous NSCLC who are chemotherapy and immunotherapy naive.
Detailed description of study
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.
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: non-small cell lung cancer
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Age: 18 years - 100 years
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Gender: All
Inclusion Criteria
Histological or cytological confirmation of non-squamous NSCLC.
Patients who had disease progression greater than 1 year after completing prior adjuvant therapy for stage I - III are eligible as long as no systemic therapy was given for recurrence.
For a full list of participation criteria, please visit clinicaltrials.gov.
This study investigates the combination of several treatments for patients with stage IV non-squamous non-small cell lung cancer (NSCLC). The purpose is to understand how well these treatments work together to stop the cancer from growing or spreading. NSCLC is a type of lung cancer that does not include squamous cells, and the study is for patients who have not received chemotherapy or immunotherapy before.
Participants in this study will receive a combination of medications through an intravenous (i.v.) line. These include carboplatin, pemetrexed, atezolizumab, and bevacizumab, given every three weeks for up to four cycles. If the cancer does not progress after these cycles, patients may continue with a maintenance therapy that includes pemetrexed, atezolizumab, and bevacizumab until the cancer progresses or side effects become too severe.
- Who can participate: Adults with non-squamous non-small cell lung cancer (NSCLC) confirmed by tests can join. Patients must not have received chemotherapy or immunotherapy before and can have had disease progression more than a year after prior adjuvant therapy for earlier stages.
- Study details: Participants will be given a combination of investigational medications through an i.v. line every three weeks. If the cancer does not progress after four cycles, they may continue with maintenance therapy. A placebo, which is an inactive substance, is not used in this study.