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Study record managers: refer to the Data Element Definitions if submitting registration or information.

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To compare outcomes between Arms A and B. To collect and bank tissue and blood for future research studies, including potential development of a prognostic and predictive ature for MK pembrolizumab in combination with chemotherapy versus MK pembrolizumab alone. Cycles repeat every 21 days for up to 2 years in the absence of disease progression or unacceptable toxicity.

Within 6 weeks of disease progression, patients receive pemetrexed IV over 10 minutes and carboplatin IV over 30 minutes on day 1. Treatment repeats every 21 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity. Patients then may receive pemetrexed IV over 10 minutes on day 1. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Within 6 weeks of disease progression, patients receive pembrolizumab IV over 30 minutes, pemetrexed IV over 10 minutes, and carboplatin IV over 30 minutes on day 1. Patients then receive pembrolizumab IV over 30 minutes and pemetrexed IV over 10 minutes on day 1. Cycles repeat every 21 days for up to 2 years for pembrolizumab in the absence of disease progression or unacceptable toxicity and until to disease progression for pemetrexed.

After completion of study treatment, patients are followed up for 5 years. Secondary Outcome Measures : Progression-free survival PFS [ Time Frame: From randomization to documented disease progression or death from any cause, assessed up to 5 years post treatment ] PFS distributions will be estimated using the Kaplan-Meier method.

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Toxicity rates between arms in the overall population will be compared using Fisher's exact tests with a one-sided type I error rate of 1. Talk with your doctor and family members or friends about deciding to a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies. Patients must have measurable or non-measurable disease.

The presence of malignant pleural fluid alone is sufficient to satisfy this eligibility criterion. Baseline imaging assessments and measurements used to evaluate all measurable or non-measurable sites of disease must be done within 4 weeks prior to study registration. Patients with treated brain metastases are eligible if follow-up brain imaging after central nervous system CNS -directed therapy shows no evidence of progression. CNS progression counts as progression and patients must move on to the next phase after CNS treatment.

Patients with asymptomatic new at screening or progressive brain metastases active brain metastases at screening or leptomeningeal disease are eligible if the treating physician determines that immediate CNS specific treatment is not required and is unlikely to be required during the first cycle of therapy. Women must not be pregnant or breast-feeding due to potential harm to the fetus or infant from cytotoxic chemotherapy and the unknown risk of MK pembrolizumab. Patients must also not expect to conceive or father children from the time of registration, while on study treatment, and until at least days after the last dose of study treatment.

Hide glossary Glossary Study record managers: refer to the Data Element Definitions if submitting registration or information. Search for terms x. Save this study. Warning You have reached the maximum of saved studies Listing a study does not mean it has been evaluated by the U. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Last Update Posted : July 9, See Contacts and Locations.

Study Description. This phase III trial studies whether pembrolizumab alone as a first-line treatment, followed by pemetrexed and carboplatin with or without pembrolizumab after disease progression is superior to induction with pembrolizumab, pemetrexed and carboplatin followed by pembrolizumab and pemetrexed maintenance in treating patients with stage IV non-squamous non-small cell lung cancer.

Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Drugs used in chemotherapy, such as pemetrexed and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading.

It is not yet known whether giving first-line pembrolizumab followed by pemetrexed and carboplatin with or without pembrolizumab works better in treating patients with non-squamous non-small cell cancer. Detailed Description:. FDA Resources. Arms and Interventions. Patients receive pembrolizumab IV over 30 minutes on day 1. Patients receive pembrolizumab IV over 30 minutes, pemetrexed IV over 10 minutes, and carboplatin IV over 30 minutes on day 1.

Outcome Measures. Eligibility Criteria. Information from the National Library of Medicine Choosing to participate in a study is an important personal decision. The assay must have been performed by a Clinical Laboratory Improvement Act CLIA or equivalent certified laboratory Patients must have measurable or non-measurable disease.

Baseline imaging assessments and measurements used to evaluate all measurable or non-measurable sites of disease must be done within 4 weeks prior to study registration NOTE: If patient receives pemetrexed, follow institutional guidelines to drain fluids Patients must have an Eastern Cooperative Oncology Group ECOG performance status of 0 to 1 Patients must NOT have received the following: Ladies want real sex MI Marlette 48453 systemic chemotherapy or immunotherapy for advanced metastatic NSCLC.

Patients treated with any prior checkpoint inhibitors for metastatic lung cancer are ineligible. Chemotherapy for non-metastatic disease e.

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Local therapy, e. Registration prior to treatment during the 14 days is allowed. Palliative radiation must be to non-target lesions Methotrexate MTX given in low doses for non-malignant conditions with last dose at least 14 days prior to date of registration will be allowed.

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Other low dose chemotherapeutics for non-malignant conditions will be considered, but review by the study chair is required Patients with known EGFR mutations except exon 20 insertionBRAF mutations V or ALK or ROS1 translocations that can be treated with oral tyrosine kinase inhibitors are excluded Patients with treated brain metastases are eligible if follow-up brain imaging after central nervous system CNS -directed therapy shows no evidence of progression.

Crohn's disease, malabsorption, etc.

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Patients must not have history of auto-immune condition requiring ongoing or intermittent systemic treatment in the Ladies want real sex MI Marlette 48453 2 years i. Replacement therapy e. To be eligible for this trial, patients should be class 2B or better Patients must not have any other concomitant serious illness or organ system dysfunction that in the opinion of the investigator would either compromise patient safety or interfere with the evaluation of the safety of the study drug Patients must not receive any other investigational agents during the course of therapy Women must not be pregnant or breast-feeding due to potential harm to the fetus or infant from cytotoxic chemotherapy and the unknown risk of MK pembrolizumab.

Patients must also not expect to conceive or father children from the time of registration, while on study treatment, and until at least days after the last dose of study treatment All females of childbearing potential must have a blood test or urine study within 72 hours prior to registration to rule out pregnancy A female of childbearing potential is any woman, regardless of sexual orientation or whether they have undergone tubal ligation, who meets the following criteria: has achieved menarche at some point; has not undergone a hysterectomy or bilateral oophorectomy; or has not been naturally postmenopausal amenorrhea following cancer therapy does not rule out childbearing potential for at least 24 consecutive months i.

Seasonal flu vaccines that do not contain live virus are permitted Human immunodeficiency virus HIV -infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial For patients with evidence of chronic hepatitis B virus HBV infection, the HBV viral load must be undetectable or on suppressive therapy, if indicated.

Patients with a history of hepatitis C virus HCV infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load. Contacts and Locations. Information from the National Library of Medicine To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor. Please refer to this study by its ClinicalTrials. The safety and scientific validity of this study is the responsibility of the study sponsor and investigators.

Phase 3. Study Type :.

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Interventional Clinical Trial. Estimated Enrollment :. Actual Study Start Date :. Estimated Primary Completion Date :. Estimated Study Completion Date :. Experimental: Arm A pembrolizumab, pemetrexed, carboplatin Patients receive pembrolizumab IV over 30 minutes on day 1.

Experimental: Arm B pembrolizumab, pemetrexed, carboplatin Patients receive pembrolizumab IV over 30 minutes on day 1. Active Comparator: Arm C pembrolizumab, pembrolizumab, carboplatin Patients receive pembrolizumab IV over 30 minutes, pemetrexed IV over 10 minutes, and carboplatin IV over 30 minutes on day 1. OncologyResearchSupport providence. Principal Investigator: Alison K. Contact: Site Public Contact Veronica. Stevenson foundationhealth. Principal Investigator: Nicholas DiBella.

Contact: Site Public Contact research sncrf. Principal Investigator: John A. Contact: Site Public Contact Principal Investigator: Richard L. Principal Investigator: Linda L. Contact: Site Public Contact aselegue. Principal Investigator: Jay W. Contact: Site Public Contact clinicaltrials sfmc-gi. Contact: Site Public Contact Emily. Carvell bmhcc. Principal Investigator: Philip E.

Contact: Site Public Contact clinical. Principal Investigator: Eric C. Contact: Site Public Contact Kpoct kp. Principal Investigator: Jennifer M. Contact: Site Public Contact research dignityhealth. Contact: Site Public Contact bernicl sutterhealth.

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