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Study record managers: refer to the Data Element Definitions if submitting registration or information. 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.
Study record managers: refer to the Data Element Definitions if submitting registration or information. To centrally test resected non-small cell lung cancer NSCLC for genetic mutations to facilitate accrual to randomized adjuvant studies. To obtain clinically annotated tumor tissue and patient-matched non-malignant deoxyribonucleic acid DNA from peripheral blood, as well as detailed epidemiologic and clinical follow-up data, to allow clinically annotated advanced genomic analyses in concert with the National Cancer Institute NCI Center for Cancer Genomics CCG.
To characterize the natural history of molecularly characterized NSCLC to allow subsequent development of targeted therapies against genotype-defined subpopulations in the adjuvant and recurrent settings.
To cross-validate local genotyping assays for epidermal growth factor receptor EGFR and anaplastic lymphoma receptor tyrosine kinase ALK with a central reference standard. To study the genomic evolution of lung cancers by comparing genomic characteristics at resection and at recurrence. To understand reasons behind lack of enrollment to adjuvant targeted therapy studies for potentially eligible patients. Patients that have had surgery prior to pre-registration will submit samples from the surgery for testing.
A Patients are randomized to 1 of 4 treatment arms.
Testing the timing of pembrolizumab alone or with chemotherapy as first line treatment and maintenance in non-small cell lung cancer
Treatment repeats every 21 days for up to 2 years in the absence of disease progression or unacceptable toxicity. E Patients are randomized to 1 of 2 treatment arms. EA Patients are randomized to 1 of 2 treatment arms.
Cycles repeat every 4 weeks for up to 1 year in the absence of disease progression or unacceptable toxicity. Treatment repeats every 21 days for 4 cycles in the absence of disease progression or unacceptable toxicity. Treatment repeats every 21 days for 17 cycles in the absence of disease progression or unacceptable toxicity. Treatment repeats every 21 days for 13 cycles in the absence of disease progression or unacceptable toxicity. After completion of study, patients that are not enrolled on either A, E, EA, or A are followed up every 6 months for 5 years.
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Last Update Posted : July 27, See Contacts and Locations. Study Description.
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Studying the genes in a patient's tumor cells may help doctors select the best treatment for patients that have certain genetic changes. Show detailed description. Hide detailed description. Detailed Description:. ARM B: Patients undergo observation.
A Patients are randomized to 1 of 3 arms. MedlinePlus related topics: Genetic Testing. FDA Resources. Arms and Interventions. Patients receive placebo PO QD on days Unblinded patients receive erlotinib hydrochloride PO QD on days Patients including patients ly randomized to placebo undergo observation at least every 6 months for 2 years.
Patients receive nivolumab IV over 30 minutes on day 1. Patients are followed serially with imaging for 1 year. Outcome Measures. Primary Outcome Measures : Central clinical genotyping to facilitate accrual to the adjuvant Intergroup studies, E and A [ Time Frame: Up to 4 years ] Central clinical genotyping to facilitate accrual to the adjuvant Intergroup studies, E and A, will be measured by the rate of accrual.
Research grade formalin-fixed, paraffin-embedded tissue collection for Center for CCG analysis, will be measured by adequate specimens collected per month.
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For each locally used assay, agreement will be defined as the proportion of patients deemed mutant or wild-type by local and central assessment divided by the of evaluable patients, where an evaluable patient is one who has a local assessment result and has submitted tissue for central assessment. Other Outcome Measures: Spectrum of new mutations identified at recurrence [ Time Frame: Up to 5 years ] Genomic analysis will be performed on tissue collected at time of recurrence and compared to baseline genomics.
New mutations in key oncogenes and tumor suppressor genes phosphatidylinositol-4,5-bisphosphate 3-kinase, catalytic subunit alpha and phosphatase and tensin homolog, etc will be quantified. Concern with randomization, or not needing further therapy versus those who become otherwise ineligible due to recurrent disease or missing the enrollment window will be catalogued.
The levels of cfDNA stratified by the timing of collection will be correlated with clinical outcomes of overall survival and disease-free survival using Kaplan-Meier approach as well as exploratory Cox proportional Hazards models adjusted for baseline smoking, patient, and tumor characteristics as well as treatment information.
Eligibility Criteria. 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. Not Applicable. Study Type :. Interventional Clinical Trial. Estimated Enrollment :. Actual Study Start Date :.
Estimated Primary Completion Date :. Active Comparator: A Arm D observation Patients including patients ly randomized to placebo undergo observation at least every 6 months for 2 years. OncologyResearchSupport providence. Principal Investigator: Alison K. Contact: Site Public Contact Veronica. Stevenson foundationhealth. Principal Investigator: Nicholas DiBella. Contact: Site Public Contact Principal Investigator: Mohammed Salhab.
Contact: Site Public Contact research sncrf. Principal Investigator: John A. Principal Investigator: Richard L. Principal Investigator: Dennis A. Contact: Site Public Contact aselegue .
Principal Investigator: Linda L. Principal Investigator: Jay W. Contact: Site Public Contact clinicaltrials sfmc-gi. Contact: Site Public Contact Emily.
Genetic testing in screening patients with stage ib-iiia non-small cell lung cancer that has been or will be removed by surgery (the alchemist screening trial)
Carvell bmhcc. Principal Investigator: Edward T. Contact: Site Public Contact clinical. Principal Investigator: Eric C. Contact: Site Public Contact Kpoct kp. Principal Investigator: Tatjana Kolevska. Contact: Site Public Contact research dignityhealth.
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Contact: Site Public Contact bernicl sutterhealth. Principal Investigator: Edmund W. Contact: Site Public Contact Najee. Boucher providence. Principal Investigator: Shahzad Siddique. Principal Investigator: Uzair B. Principal Investigator: Gigi Q. Contact: Site Public Contact becomingapatient coh. Principal Investigator: Marianna Koczywas.