2024
Phase II Trial of Afatinib in Patients With EGFR-Mutated Solid Tumors Excluding Lung Cancer: Results From NCI-MATCH ECOG-ACRIN Trial (EAY131) Subprotocol A
Gettinger S, Song Z, Reckamp K, Moscow J, Gray R, Wang V, McShane L, Rubinstein L, Patton D, Williams P, Hamilton S, Kong X, Tricoli J, Conley B, Arteaga C, Harris L, O'Dwyer P, Chen A, Flaherty K. Phase II Trial of Afatinib in Patients With EGFR-Mutated Solid Tumors Excluding Lung Cancer: Results From NCI-MATCH ECOG-ACRIN Trial (EAY131) Subprotocol A. JCO Precision Oncology 2024, 8: e2300725. PMID: 38986051, DOI: 10.1200/po.23.00725.Peer-Reviewed Original ResearchConceptsProgression-free survivalTyrosine kinase inhibitorsEGFR tyrosine kinase inhibitorsNCI-MATCHLung cancerGlioblastoma multiformeOverall survivalAdvanced non-small cell lung cancerNational Cancer Institute-Molecular AnalysisNon-small cell lung cancerEnd pointsTumor genomic testingTrial primary end pointPhase 2 trialPhase II trialSecondary end pointsPrimary end pointCell lung cancerCohort of patientsMedian OSStable diseaseAdenosquamous carcinomaProtocol therapyPartial responseArm A
2023
First-Line Treatment of Driver-Negative Non–Small Cell Lung Cancer
Kim S, Gettinger S. First-Line Treatment of Driver-Negative Non–Small Cell Lung Cancer. Hematology/Oncology Clinics Of North America 2023, 37: 557-573. PMID: 37150586, DOI: 10.1016/j.hoc.2023.02.008.Peer-Reviewed Original ResearchConceptsNon-small cell lung cancerCell lung cancerLung cancerAdvanced non-small cell lung cancerFirst-line settingFirst-line treatmentStandard of careCombination immunotherapyImmunotherapy monotherapyPD-L1Immunotherapy responseLine treatmentSmoking statusTreatment choiceTrial dataCancerImmunotherapyRegimensCliniciansTreatmentChemoimmunotherapyMonotherapyCare
2021
458 First phase 2 results of autologous tumor-infiltrating lymphocyte (TIL; LN-145) monotherapy in patients with advanced, immune checkpoint inhibitor-treated, non-small cell lung cancer (NSCLC)
Schoenfeld A, Lee S, Paz-Ares L, Doger B, Gettinger S, Haefliger S, Orcurto A, Sukari A, Papa S, Rodriguez Moreno J, Finckenstein F, Jagasia M, Fiaz R, Sulur G, Chen G, Gontcharova V, He K. 458 First phase 2 results of autologous tumor-infiltrating lymphocyte (TIL; LN-145) monotherapy in patients with advanced, immune checkpoint inhibitor-treated, non-small cell lung cancer (NSCLC). 2021, a486-a487. DOI: 10.1136/jitc-2021-sitc2021.458.Peer-Reviewed Original ResearchNon-small cell lung cancerImmune checkpoint inhibitorsAdvanced non-small cell lung cancerDurable responsesPrior linesSystemic therapyMetastatic non-small cell lung cancerFirst-line immune checkpoint inhibitorsPrior immune checkpoint inhibitorsT cell receptor repertoireExpected safety profileExploratory biomarker analysisPhase 2 multicenterObjective response rateOpen-label studyComplete metabolic responsePD-L1 expressionMajority of patientsCell lung cancerTCR repertoire analysisOncogene-directed therapyBest percentage changeInstitutional review boardWarrants further investigationInformed consent formImmune Therapy: What Can We Learn From Acquired Resistance?
Grant M, Politi K, Gettinger S. Immune Therapy: What Can We Learn From Acquired Resistance? Current Cancer Research 2021, 75-114. DOI: 10.1007/978-3-030-74028-3_5.ChaptersNon-small cell lung cancerAdvanced non-small cell lung cancerDeath-1 pathway inhibitorsPD-1 axis inhibitorsInitial tumor regressionCell lung cancerImmune checkpoint pathwaysIFN-γ signalingMediators of resistanceDisease stabilitySystemic progressionMost patientsLocal therapyClinical criteriaLung cancerTumor regressionTumor typesDisease sitesPathway inhibitorAcquired ResistancePresentation defectPatientsTranslational workProgressionEpigenetic changesNivolumab Plus Ipilimumab vs Nivolumab for Previously Treated Patients With Stage IV Squamous Cell Lung Cancer
Gettinger SN, Redman MW, Bazhenova L, Hirsch FR, Mack PC, Schwartz LH, Bradley JD, Stinchcombe TE, Leighl NB, Ramalingam SS, Tavernier SS, Yu H, Unger JM, Minichiello K, Highleyman L, Papadimitrakopoulou VA, Kelly K, Gandara DR, Herbst RS. Nivolumab Plus Ipilimumab vs Nivolumab for Previously Treated Patients With Stage IV Squamous Cell Lung Cancer. JAMA Oncology 2021, 7: 1368-1377. PMID: 34264316, PMCID: PMC8283667, DOI: 10.1001/jamaoncol.2021.2209.Peer-Reviewed Original ResearchConceptsNon-small cell lung cancerInvestigator-assessed progression-free survivalNivolumab/ipilimumabPlatinum-based chemotherapyCell lung cancerOverall survivalIpilimumab groupLung cancerClinical trialsDisease progressionStage IV squamous cell lung cancerAdvanced non-small cell lung cancerHigher treatment-related adverse eventsTreatment-related adverse eventsSquamous cell lung cancerNational Clinical Trials NetworkStandard platinum-based chemotherapyEnd pointAddition of ipilimumabIntolerable toxic effectsNivolumab Plus IpilimumabMedian response durationPrimary end pointSecondary end pointsProgression-free survival
2020
Biomarkers Associated with Beneficial PD-1 Checkpoint Blockade in Non–Small Cell Lung Cancer (NSCLC) Identified Using High-Plex Digital Spatial Profiling
Zugazagoitia J, Gupta S, Liu Y, Fuhrman K, Gettinger S, Herbst RS, Schalper KA, Rimm DL. Biomarkers Associated with Beneficial PD-1 Checkpoint Blockade in Non–Small Cell Lung Cancer (NSCLC) Identified Using High-Plex Digital Spatial Profiling. Clinical Cancer Research 2020, 26: 4360-4368. PMID: 32253229, PMCID: PMC7442721, DOI: 10.1158/1078-0432.ccr-20-0175.Peer-Reviewed Original ResearchConceptsNon-small cell lung cancerPD-1 checkpoint blockadeCell lung cancerCheckpoint blockadeLung cancerAdvanced non-small cell lung cancerUnivariate unadjusted analysisProgression-free survivalImmune cell countsMinority of patientsRobust predictive biomarkersBiomarkers of responseLarge independent cohortsSpatial profiling technologyDigital spatial profilingDigital spatial profiling (DSP) technologyOverall survivalClinical outcomesImmune predictorsHigher CD56NSCLC casesPredictive biomarkersUnadjusted analysesImmune parametersTissue microarrayPhase 1 Trial of Pembrolizumab Administered Concurrently With Chemoradiotherapy for Locally Advanced Non–Small Cell Lung Cancer
Jabbour SK, Berman AT, Decker RH, Lin Y, Feigenberg SJ, Gettinger SN, Aggarwal C, Langer CJ, Simone CB, Bradley JD, Aisner J, Malhotra J. Phase 1 Trial of Pembrolizumab Administered Concurrently With Chemoradiotherapy for Locally Advanced Non–Small Cell Lung Cancer. JAMA Oncology 2020, 6: 848-855. PMID: 32077891, PMCID: PMC7042914, DOI: 10.1001/jamaoncol.2019.6731.Peer-Reviewed Original ResearchMeSH KeywordsAgedAged, 80 and overAntibodies, Monoclonal, HumanizedAntineoplastic Agents, ImmunologicalCarboplatinCarcinoma, Non-Small-Cell LungChemoradiotherapyFemaleHumansImmune Checkpoint InhibitorsLung NeoplasmsMaleMiddle AgedNeoplasm StagingPaclitaxelProgrammed Cell Death 1 ReceptorTreatment OutcomeConceptsNon-small cell lung cancerProgression-free survivalStage III non-small cell lung cancerMedian progression-free survivalDose of pembrolizumabSafety expansion cohortPD-1 inhibitionCell lung cancerExpansion cohortLung cancerDay 29Eastern Cooperative Oncology Group performance status 0Advanced non-small cell lung cancerDay 1Cell death 1 (PD-1) inhibitionDeath ligand 1 (PD-L1) inhibitionDose-limiting toxic effectDeath-1 (PD-1) inhibitionDoses of pembrolizumabGrade 5 pneumonitisLeast grade 4Performance status 0PD-1 inhibitorsPhase 1 trialLeast grade 3
2019
O.02 Long-term Survival Outcomes with Nivolumab (NIVO) in Pts with Previously Treated Advanced Non-Small Cell Lung Cancer (NSCLC): Impact of Early Disease Control and Response
Brahmer J, Horn L, Hossein B, Ramalingam S, Pluzanski A, Burgio M, Garassino M, Chow L, Gettinger S, Crino L, Planchard D, Butts C, Drilon A, Wojcik-Tomaszewska J, Otterson G, Agrawal S, Li A, Penrod J, Antonia S, Bautista Y. O.02 Long-term Survival Outcomes with Nivolumab (NIVO) in Pts with Previously Treated Advanced Non-Small Cell Lung Cancer (NSCLC): Impact of Early Disease Control and Response. Journal Of Thoracic Oncology 2019, 14: s1152-s1153. DOI: 10.1016/j.jtho.2019.09.089.Peer-Reviewed Original ResearchExpression Analysis and Significance of PD-1, LAG-3, and TIM-3 in Human Non–Small Cell Lung Cancer Using Spatially Resolved and Multiparametric Single-Cell Analysis
Datar I, Sanmamed MF, Wang J, Henick BS, Choi J, Badri T, Dong W, Mani N, Toki M, Mejías L, Lozano MD, Perez-Gracia JL, Velcheti V, Hellmann MD, Gainor JF, McEachern K, Jenkins D, Syrigos K, Politi K, Gettinger S, Rimm DL, Herbst RS, Melero I, Chen L, Schalper KA. Expression Analysis and Significance of PD-1, LAG-3, and TIM-3 in Human Non–Small Cell Lung Cancer Using Spatially Resolved and Multiparametric Single-Cell Analysis. Clinical Cancer Research 2019, 25: 4663-4673. PMID: 31053602, PMCID: PMC7444693, DOI: 10.1158/1078-0432.ccr-18-4142.Peer-Reviewed Original ResearchMeSH KeywordsAntigens, CDBiomarkers, TumorCarcinoma, Non-Small-Cell LungGene Expression Regulation, NeoplasticHepatitis A Virus Cellular Receptor 2HumansLung NeoplasmsLymphocyte ActivationLymphocyte Activation Gene 3 ProteinLymphocytes, Tumor-InfiltratingPrognosisProgrammed Cell Death 1 ReceptorRetrospective StudiesSingle-Cell AnalysisSurvival RateConceptsNon-small cell lung cancerHuman non-small cell lung cancerTumor-infiltrating lymphocytesAdvanced non-small cell lung cancerTim-3PD-1Cell lung cancerLAG-3Lung cancerPD-1 axis blockadeShorter progression-free survivalBaseline samplesTim-3 protein expressionMajor clinicopathologic variablesMultiplexed quantitative immunofluorescencePD-1 expressionProgression-free survivalTim-3 expressionLAG-3 expressionT-cell phenotypeTumor mutational burdenImmune inhibitory receptorsImmune evasion pathwaysTIM-3 proteinMass cytometry analysis
2018
Five-Year Follow-Up of Nivolumab in Previously Treated Advanced Non-Small-Cell Lung Cancer: Results From the CA209-003 Study.
Gettinger S, Horn L, Jackman D, Spigel D, Antonia S, Hellmann M, Powderly J, Heist R, Sequist LV, Smith DC, Leming P, Geese WJ, Yoon D, Li A, Brahmer J. Five-Year Follow-Up of Nivolumab in Previously Treated Advanced Non-Small-Cell Lung Cancer: Results From the CA209-003 Study. Journal Of Clinical Oncology 2018, 36: 1675-1684. PMID: 29570421, DOI: 10.1200/jco.2017.77.0412.Peer-Reviewed Original ResearchConceptsLigand 1 expressionOverall survivalAdvanced NSCLCProgressive diseaseOS ratesLung cancerAdvanced non-small cell lung cancerNon-small cell lung cancerLong-term OSPhase III studyProportion of patientsResponse Evaluation CriteriaKaplan-Meier methodLong-term survivorsCell lung cancerEarly phase INivolumab 1Nivolumab treatmentStable diseaseNonsquamous NSCLCAdverse eventsDurable responsesFirst doseFormer smokersIII studyClinical Features and Management of Acquired Resistance to PD-1 Axis Inhibitors in 26 Patients With Advanced Non–Small Cell Lung Cancer
Gettinger SN, Wurtz A, Goldberg SB, Rimm D, Schalper K, Kaech S, Kavathas P, Chiang A, Lilenbaum R, Zelterman D, Politi K, Herbst R. Clinical Features and Management of Acquired Resistance to PD-1 Axis Inhibitors in 26 Patients With Advanced Non–Small Cell Lung Cancer. Journal Of Thoracic Oncology 2018, 13: 831-839. PMID: 29578107, PMCID: PMC6485248, DOI: 10.1016/j.jtho.2018.03.008.Peer-Reviewed Original ResearchConceptsPD-1 axis inhibitorsNon-small cell lung cancerAdvanced non-small cell lung cancerCell lung cancerInhibitor therapyLocal therapyLymph nodesLung cancerSurvival rateSolid Tumors v1.1Response Evaluation CriteriaSite of diseaseProgression of diseaseProgressive diseaseClinical patternLN metastasisSuch patientsClinical featuresMedian timeRadiographic featuresTumor regressionProlonged benefitPatientsTherapyResponse criteria
2017
P3.07-012 Nivolumab Versus Docetaxel in Patients With Previously Treated Advanced Non-Small Cell Lung Cancer and Liver Metastases
Crinò L, Horn L, Felip E, Frontera O, Burgio M, Waterhouse D, Blumenschein G, Barlesi F, Garassino M, Holgado E, Antonia S, Spigel D, Gainor J, Gettinger S, Geese W, Li A, Healey D, Ready N. P3.07-012 Nivolumab Versus Docetaxel in Patients With Previously Treated Advanced Non-Small Cell Lung Cancer and Liver Metastases. Journal Of Thoracic Oncology 2017, 12: s2302. DOI: 10.1016/j.jtho.2017.09.1703.Peer-Reviewed Original ResearchAdvanced non-small cell lung cancerNon-small cell lung cancerCell lung cancerLiver metastasesLung cancerPatientsDocetaxelMetastasisCancer1301PD Three-year follow-up from CheckMate 017/057: Nivolumab versus docetaxel in patients with previously treated advanced non-small cell lung cancer (NSCLC)
Font E, Gettinger S, Burgio M, Antonia S, Holgado E, Spigel D, Arrieta O, Gomez M, Frontera O, Brahmer J, Chow L, Crinò L, Butts C, Coudert B, Horn L, Steins M, Geese W, Li A, Healey D, Vokes E. 1301PD Three-year follow-up from CheckMate 017/057: Nivolumab versus docetaxel in patients with previously treated advanced non-small cell lung cancer (NSCLC). Annals Of Oncology 2017, 28: v462. DOI: 10.1093/annonc/mdx380.004.Peer-Reviewed Original ResearchNon-small cell lung cancerAdvanced non-small cell lung cancerCell lung cancerLung cancerThree yearsNivolumabPatientsDocetaxelCancerPhase II Trial of Atezolizumab As First-Line or Subsequent Therapy for Patients With Programmed Death-Ligand 1–Selected Advanced Non–Small-Cell Lung Cancer (BIRCH)
Peters S, Gettinger S, Johnson ML, Jänne PA, Garassino MC, Christoph D, Toh CK, Rizvi NA, Chaft JE, Carcereny Costa E, Patel JD, Chow LQM, Koczywas M, Ho C, Früh M, van den Heuvel M, Rothenstein J, Reck M, Paz-Ares L, Shepherd FA, Kurata T, Li Z, Qiu J, Kowanetz M, Mocci S, Shankar G, Sandler A, Felip E. Phase II Trial of Atezolizumab As First-Line or Subsequent Therapy for Patients With Programmed Death-Ligand 1–Selected Advanced Non–Small-Cell Lung Cancer (BIRCH). Journal Of Clinical Oncology 2017, 35: jco.2016.71.947. PMID: 28609226, PMCID: PMC5562171, DOI: 10.1200/jco.2016.71.9476.Peer-Reviewed Original ResearchConceptsMedian overall survivalOverall survivalImmune cellsPD-L1Tumor cellsLung cancerAdvanced non-small cell lung cancerNon-small cell lung cancerTumor-infiltrating immune cellsEnd pointEfficacy of atezolizumabEfficacy-evaluable patientsMethods Eligible patientsObjective response ratePrimary end pointSecondary end pointsLines of therapyPD-L1 expressionPD-L1 statusPhase II trialProgression-free survivalDeath ligand 1Cell lung cancerKRAS mutation statusAtezolizumab monotherapyAtezolizumab (atezo) plus platinum-based chemotherapy (chemo) in non-small cell lung cancer (NSCLC): Update from a phase Ib study.
Liu S, Camidge D, Gettinger S, Giaccone G, Heist R, Hodi F, Ready N, Zhang W, Wallin J, Funke R, Waterkamp D, Foster P, Iizuka K, Powderly J. Atezolizumab (atezo) plus platinum-based chemotherapy (chemo) in non-small cell lung cancer (NSCLC): Update from a phase Ib study. Journal Of Clinical Oncology 2017, 35: 9092-9092. DOI: 10.1200/jco.2017.35.15_suppl.9092.Peer-Reviewed Original ResearchNon-small cell lung cancerOverall response rateAdverse eventsAnti-programmed death ligand 1 antibodyAdvanced non-small cell lung cancerMetastatic non-small cell lung cancerCommon treatment-related grade 3Terms of ORRConfirmed overall response rateGrade 5 adverse eventsStandard first-line therapyTreatment-related grade 3Death ligand 1 antibodyPhase Ib studyTumor antigen releaseFirst-line therapyPhase III studyPlatinum-based chemotherapyCell lung cancerActionable gene alterationsMulti-arm studiesMultiple tumor typesMedian PFSNSCLC ptsPrior chemo84O Atezolizumab as first-line (1L) therapy for advanced non-small cell lung cancer (NSCLC) in PD-L1–selected patients: Efficacy data from the BIRCH trial
Peters S, Costa E, Garassino M, Christoph D, Kurata T, Chaft J, Johnson M, Mocci S, Gettinger S, Felip E. 84O Atezolizumab as first-line (1L) therapy for advanced non-small cell lung cancer (NSCLC) in PD-L1–selected patients: Efficacy data from the BIRCH trial. Annals Of Oncology 2017, 28: ii29-ii30. DOI: 10.1093/annonc/mdx091.004.Peer-Reviewed Original ResearchNon-small cell lung cancerAdvanced non-small cell lung cancerFirst-line therapyCell lung cancerPD-L1Lung cancerEfficacy dataAtezolizumabPatientsTherapyCancerTrials
2016
The BATTLE-2 Study: A Biomarker-Integrated Targeted Therapy Study in Previously Treated Patients With Advanced Non–Small-Cell Lung Cancer
Papadimitrakopoulou V, Lee JJ, Wistuba II, Tsao AS, Fossella FV, Kalhor N, Gupta S, Byers LA, Izzo JG, Gettinger SN, Goldberg SB, Tang X, Miller VA, Skoulidis F, Gibbons DL, Shen L, Wei C, Diao L, Peng SA, Wang J, Tam AL, Coombes KR, Koo JS, Mauro DJ, Rubin EH, Heymach JV, Hong WK, Herbst RS. The BATTLE-2 Study: A Biomarker-Integrated Targeted Therapy Study in Previously Treated Patients With Advanced Non–Small-Cell Lung Cancer. Journal Of Clinical Oncology 2016, 34: 3638-3647. PMID: 27480147, PMCID: PMC5065110, DOI: 10.1200/jco.2015.66.0084.Peer-Reviewed Original ResearchDisease control rateKRAS wild-type patientsMedian overall survivalProgression-free survivalWild-type patientsArm 1Overall survivalKRAS statusArm 3Lung cancerAdvanced non-small cell lung cancerNon-small cell lung cancerBiomarker-driven treatment strategiesLung Cancer Elimination (BATTLE) trialMedian progression-free survivalImproved progression-free survivalBiomarker-Integrated ApproachesReal-time biopsyPrimary end pointCell lung cancerPrior therapyUmbrella studyAdvanced NSCLCControl rateMesenchymal tumorsNivolumab in Combination With Platinum‐Based Doublet Chemotherapy for First-Line Treatment of Advanced Non–Small-Cell Lung Cancer
Rizvi NA, Hellmann MD, Brahmer JR, Juergens RA, Borghaei H, Gettinger S, Chow LQ, Gerber DE, Laurie SA, Goldman JW, Shepherd FA, Chen AC, Shen Y, Nathan FE, Harbison CT, Antonia S. Nivolumab in Combination With Platinum‐Based Doublet Chemotherapy for First-Line Treatment of Advanced Non–Small-Cell Lung Cancer. Journal Of Clinical Oncology 2016, 34: 2969-2979. PMID: 27354481, PMCID: PMC5569693, DOI: 10.1200/jco.2016.66.9861.Peer-Reviewed Original ResearchMeSH KeywordsAgedAntibodies, MonoclonalAntineoplastic Combined Chemotherapy ProtocolsB7-H1 AntigenCarboplatinCarcinoma, Non-Small-Cell LungCisplatinCohort StudiesDeoxycytidineDisease-Free SurvivalDose-Response Relationship, DrugErbB ReceptorsFemaleGemcitabineHumansLung NeoplasmsMaleMiddle AgedNivolumabPemetrexedProto-Oncogene Proteins p21(ras)Survival RateConceptsPlatinum-based doublet chemotherapyTreatment-related adverse eventsProgression-free survival ratesDeath ligand 1 (PD-L1) expressionObjective response ratePercent of patientsLigand 1 expressionAdverse eventsPaclitaxel-carboplatinDoublet chemotherapyOverall survivalOS ratesLung cancerDeath-1 immune checkpoint inhibitor antibodyAdvanced non-small cell lung cancerResponse rateSurvival rateNon-small cell lung cancerImmune checkpoint inhibitor antibodyCheckpoint inhibitor antibodyEfficacy of nivolumabPaclitaxel-carboplatin groupDose-limiting toxicityCurrent standard therapyWeeks of treatmentNivolumab Monotherapy for First-Line Treatment of Advanced Non–Small-Cell Lung Cancer
Gettinger S, Rizvi NA, Chow LQ, Borghaei H, Brahmer J, Ready N, Gerber DE, Shepherd FA, Antonia S, Goldman JW, Juergens RA, Laurie SA, Nathan FE, Shen Y, Harbison CT, Hellmann MD. Nivolumab Monotherapy for First-Line Treatment of Advanced Non–Small-Cell Lung Cancer. Journal Of Clinical Oncology 2016, 34: 2980-2987. PMID: 27354485, PMCID: PMC5569692, DOI: 10.1200/jco.2016.66.9929.Peer-Reviewed Original ResearchConceptsTreatment-related adverse eventsObjective response ratePD-ligand 1 (PD-L1) expressionAdverse eventsOverall survivalNivolumab monotherapyAdvanced NSCLCLung cancerGrade 3Death-1 immune checkpoint inhibitor antibodyAdvanced non-small cell lung cancerGrade treatment-related adverse eventsNon-small cell lung cancerImmune checkpoint inhibitor antibodyProgression-free survival ratesCheckpoint inhibitor antibodyExploratory end pointsFirst tumor assessmentFirst-line monotherapyOngoing complete responseTolerable safety profileMedian overall survivalGrade 3 rashOnly grade 3Cell lung cancer
2015
3096 First-line monotherapy with nivolumab (NIVO) in advanced non-small cell lung cancer (NSCLC): Safety, efficacy, and biomarker analyses
Gettinger S, Hellmann M, Shepherd F, Antonia S, Brahmer J, Chow L, Goldman J, Juergens R, Borghaei H, Ready N, Gerber D, Nathan F, Shen Y, Harbison C, Rizvi N. 3096 First-line monotherapy with nivolumab (NIVO) in advanced non-small cell lung cancer (NSCLC): Safety, efficacy, and biomarker analyses. European Journal Of Cancer 2015, 51: s632. DOI: 10.1016/s0959-8049(16)31737-3.Peer-Reviewed Original ResearchNon-small cell lung cancerAdvanced non-small cell lung cancerFirst-line monotherapyCell lung cancerLung cancerNivolumabBiomarker analysisMonotherapyCancer