2025
Randomized Phase II Study to Assess the Role of Single-Agent Nivolumab to Maintain Remission in Acute Myeloid Leukemia
Pyzer A, Dillon L, Sharon E, Karrison T, Zha Y, Fulton N, Gui G, Andrew G, Streicher H, Sweet K, Yaghmour G, Liu J, Jonas B, Schimmer A, Grant S, Zeidan A, Hildebrandt G, Lowrey C, Mattison R, Palmisiano N, Salhotra A, Tzachanis D, Baer M, Lin T, Patel P, Chen H, Stadler W, Odenike O, Larson R, Gajewski T, Hourigan C, Stock W, Liu H. Randomized Phase II Study to Assess the Role of Single-Agent Nivolumab to Maintain Remission in Acute Myeloid Leukemia. Blood Advances 2025 PMID: 39928953, DOI: 10.1182/bloodadvances.2024015176.Peer-Reviewed Original ResearchRandomized phase II studyProgression-free survivalPhase II studyNivolumab armAdverse eventsObservation armOverall survivalII studyMedian duration of follow-upProgression-free survival curvesDuration of follow-upEfficacy of nivolumabIncomplete hematologic recoverySingle-agent nivolumabEvaluation of adverse eventsAcute myeloid leukemiaIncreased AEsAML chemotherapyMedian OSNivolumab administrationNivolumab maintenanceHematologic recoveryDisease relapseOpen-labelMedian duration
2024
Thirty-day outcomes from the Disrupt PAD BTK II study of the Shockwave Intravascular Lithotripsy System for treatment of calcified below-the-knee peripheral arterial disease
Chandra V, Lansky A, Sayfo S, Shammas N, Soukas P, Park J, Siah M, Babaev A, Shields R, West N, Armstrong E. Thirty-day outcomes from the Disrupt PAD BTK II study of the Shockwave Intravascular Lithotripsy System for treatment of calcified below-the-knee peripheral arterial disease. Journal Of Vascular Surgery 2024, 81: 710-719.e2. PMID: 39536842, DOI: 10.1016/j.jvs.2024.11.003.Peer-Reviewed Original ResearchPost-operative deathsII studyPercutaneous transluminal angioplastyProcedural successBTK lesionsResidual stenosisFollow-upIntravascular lithotripsyIndex limbCore labRutherford category 3Treated target lesionsUltrasound core laboratoryInterventional clinical studyAngiographic core labThirty-day outcomesMinimal adverse eventsTarget lesion lengthSevere lesion calcificationIVL systemAdverse limb eventsOptimal standard of careStandard of carePeripheral arterial diseaseVascuQol scoresA Phase II Study of Atezolizumab, Pertuzumab, and High-Dose Trastuzumab for Central Nervous System Metastases in Patients with HER2-Positive Breast Cancer
Giordano A, Kumthekar P, Jin Q, Kurt B, Ren S, Li T, Leone J, Mittendorf E, Pereslete A, Sharp L, Davis R, DiLullo M, Tayob N, Mayer E, Winer E, Tolaney S, Lin N. A Phase II Study of Atezolizumab, Pertuzumab, and High-Dose Trastuzumab for Central Nervous System Metastases in Patients with HER2-Positive Breast Cancer. Clinical Cancer Research 2024, 30: of1-of10. PMID: 39226397, PMCID: PMC11528201, DOI: 10.1158/1078-0432.ccr-24-1161.Peer-Reviewed Original ResearchHER2-positive breast cancer brain metastasesBreast cancer brain metastasesClinical benefit rateCancer brain metastasesCentral nervous systemCNS responseBrain metastasesOverall response rateOverall survivalAny-grade adverse eventsEffective systemic therapy optionsNeuro-Oncology Brain MetastasesHER2-positive breast cancerIntracranial partial responseSystemic therapy optionsPhase II studyPhase II trialCNS ORRRANO-BMDose delaysPartial responseII studyPrimary endpointHigh-doseBenefit rate1622P A phase II study of the first-in-class oral innate immune activator BXCL701 with pembrolizumab in patients with metastatic castration-resistant prostate cancer (mCRPC): Long-term follow-up
Aggarwal R, Tagawa S, Monk P, Zhu X, Jones R, Linch M, Costin D, de Bono J, Karsh L, Petrylak D, Borderies P, Deshpande R, O'Neill V, Zhang J. 1622P A phase II study of the first-in-class oral innate immune activator BXCL701 with pembrolizumab in patients with metastatic castration-resistant prostate cancer (mCRPC): Long-term follow-up. Annals Of Oncology 2024, 35: s979. DOI: 10.1016/j.annonc.2024.08.1703.Peer-Reviewed Original ResearchTROPHY-U-01 Cohort 2: A Phase II Study of Sacituzumab Govitecan in Cisplatin-Ineligible Patients With Metastatic Urothelial Cancer Progressing After Previous Checkpoint Inhibitor Therapy
Petrylak D, Tagawa S, Jain R, Bupathi M, Balar A, Kalebasty A, George S, Palmbos P, Nordquist L, Davis N, Ramamurthy C, Sternberg C, Loriot Y, Agarwal N, Park C, Tonelli J, Vance M, Zhou H, Grivas P, Petrylak D, Tagawa S, Jain R, Bupathi M, Balar A, Kalebasty A, George S, Palmbos P, Nordquist L, Davis N, Ramamurthy C, Sternberg C, Agarwal N, Park C, Tonelli J, Vance M, Zhou H, Grivas P, Loriot Y. TROPHY-U-01 Cohort 2: A Phase II Study of Sacituzumab Govitecan in Cisplatin-Ineligible Patients With Metastatic Urothelial Cancer Progressing After Previous Checkpoint Inhibitor Therapy. Journal Of Clinical Oncology 2024, 42: 3410-3420. PMID: 39186707, PMCID: PMC11458109, DOI: 10.1200/jco.23.01720.Peer-Reviewed Original ResearchConceptsMetastatic urothelial cancerClinical benefit rateProgression-free survivalDuration of responseCisplatin-ineligible patientsCheckpoint inhibitor therapyPhase II studyCheckpoint inhibitorsSacituzumab govitecanCohort 2Central reviewOpen-label phase II studyPlatinum (Pt)-based chemotherapyMedian duration of responseMedian progression-free survivalTreatment-emergent adverse eventsMedian overall survivalSN-38 payloadUrothelial cancer progressionSecondary end pointsAntibody-drug conjugatesCisplatin-ineligibleInhibitor therapyOverall survivalII studySacituzumab Govitecan Demonstrates Efficacy across Tumor Trop-2 Expression Levels in Patients with Advanced Urothelial Cancer.
Loriot Y, Balar A, Petrylak D, Kalebasty A, Grivas P, Fléchon A, Jain R, Swami U, Bupathi M, Barthélémy P, Beuzeboc P, Palmbos P, Kyriakopoulos C, Pouessel D, Sternberg C, Tonelli J, Sierecki M, Zavodovskaya M, Elboudwarej E, Diehl L, Jürgensmeier J, Tagawa S. Sacituzumab Govitecan Demonstrates Efficacy across Tumor Trop-2 Expression Levels in Patients with Advanced Urothelial Cancer. Clinical Cancer Research 2024, 30: 3179-3188. PMID: 39086310, DOI: 10.1158/1078-0432.ccr-23-3924.Peer-Reviewed Original ResearchConceptsTrop-2 expressionTrop-2Positive tumor cellsUrothelial cancerMetastatic UCSacituzumab govitecanTumor cellsTumor samplesOpen-label phase II studyTrophoblast cell surface antigen 2Human trophoblast cell-surface antigen 2Advanced urothelial cancerSN-38 payloadPhase II studyC1-3Archival tumor samplesExpression levelsCohorts 1 to 3Surface antigen 2Antibody drug conjugatesOS benefitII studyExamined tumorsH-scoreMembrane expressionNeratinib and ado-trastuzumab emtansine for pretreated and untreated human epidermal growth factor receptor 2 (HER2)-positive breast cancer brain metastases: Translational Breast Cancer Research Consortium trial 022 ☆
Freedman R, Heiling H, Li T, Trapani D, Tayob N, Smith K, Davis R, Pereslete A, DeMeo M, Cotter C, Chen W, Parsons H, Santa-Maria C, Van Poznak C, Moy B, Brufsky A, Melisko M, O’Sullivan C, Ashai N, Rauf Y, Nangia J, Burns R, Savoie J, Wolff A, Winer E, Rimawi M, Krop I, Lin N. Neratinib and ado-trastuzumab emtansine for pretreated and untreated human epidermal growth factor receptor 2 (HER2)-positive breast cancer brain metastases: Translational Breast Cancer Research Consortium trial 022 ☆. Annals Of Oncology 2024, 35: 993-1002. PMID: 38977064, DOI: 10.1016/j.annonc.2024.07.245.Peer-Reviewed Original ResearchHER2-positive breast cancer brain metastasesBreast cancer brain metastasesT-DM1Ado-trastuzumab emtansineCentral nervous systemOverall survivalCNS objective response rateEfficacy of neratinibT-DM1 exposureObjective response rateCancer brain metastasesPhase II studyMedian OSRANO-BMBrain MetastasesSlow accrualIntracranial activityII studyPrimary endpointPreclinical dataCohort 4Response assessmentTreatment optionsNeratinibPatientsA Phase II Trial of the WEE1 Inhibitor Adavosertib in SETD2-Altered Advanced Solid Tumor Malignancies (NCI 10170)
Maldonado E, Rathmell W, Shapiro G, Takebe N, Rodon J, Mahalingam D, Trikalinos N, Kalebasty A, Parikh M, Boerner S, Balido C, Krings G, Burns T, Bergsland E, Munster P, Ashworth A, LoRusso P, Aggarwal R. A Phase II Trial of the WEE1 Inhibitor Adavosertib in SETD2-Altered Advanced Solid Tumor Malignancies (NCI 10170). Cancer Research Communications 2024, 4: 1793-1801. PMID: 38920407, PMCID: PMC11264598, DOI: 10.1158/2767-9764.crc-24-0213.Peer-Reviewed Original ResearchSolid tumor malignanciesStable diseaseTumor malignancyAdverse eventsDepth of tumor responseLoss of H3K36me3Median duration of treatmentAdvanced solid tumor malignanciesClear cell renal cell carcinomaMinor tumor regressionsProlonged stable diseaseArchival tumor tissuePhase II studyCell renal cell carcinomaPhase II trialRenal cell carcinomaDuration of treatmentArchival tissue samplesSimon's two-stageTumor responseTumor regressionII trialMedian durationII studySETD2 mutationsKROCUS: A phase II study investigating the efficacy and safety of fulzerasib (GFH925) in combination with cetuximab in patients with previously untreated advanced KRAS G12C mutated NSCLC.
Gregorc V, González-Cao M, Salvagni S, Koumarianou A, Gil-Bazo I, Maio M, Viteri S, Majem M, Gutiérrez V, Bernabe Caro R, Sanmamed M, Zhu H, Shen H, Wang Y, Rosell R. KROCUS: A phase II study investigating the efficacy and safety of fulzerasib (GFH925) in combination with cetuximab in patients with previously untreated advanced KRAS G12C mutated NSCLC. Journal Of Clinical Oncology 2024, 42: lba8511-lba8511. DOI: 10.1200/jco.2024.42.17_suppl.lba8511.Peer-Reviewed Original ResearchTreatment-related adverse eventsDisease control ratePhase II studyEpidermal growth factor receptorKRAS G12C inhibitorsDose reduction/interruptionBrain metastasesII studySafety profileG12C inhibitorsBaseline PD-L1 expressionBaseline brain metastasesActivation of epidermal growth factor receptorPD-L1 expressionTreating NSCLC patientsAnti-EGFR antibodiesFront-line treatmentKRAS G12C mutationGrowth factor receptorNSCLC ptsNSCLC modelsTumor shrinkageFrontline therapyNSCLC patientsOpen-labelSacituzumab Govitecan in Combination With Pembrolizumab for Patients With Metastatic Urothelial Cancer That Progressed After Platinum-Based Chemotherapy: TROPHY-U-01 Cohort 3
Grivas P, Pouessel D, Park C, Barthelemy P, Bupathi M, Petrylak D, Agarwal N, Gupta S, Fléchon A, Ramamurthy C, Davis N, Recio-Boiles A, Sternberg C, Bhatia A, Pichardo C, Sierecki M, Tonelli J, Zhou H, Tagawa S, Loriot Y. Sacituzumab Govitecan in Combination With Pembrolizumab for Patients With Metastatic Urothelial Cancer That Progressed After Platinum-Based Chemotherapy: TROPHY-U-01 Cohort 3. Journal Of Clinical Oncology 2024, 42: 1415-1425. PMID: 38261969, PMCID: PMC11095901, DOI: 10.1200/jco.22.02835.Peer-Reviewed Original ResearchMetastatic urothelial cancerPlatinum-based chemotherapyClinical benefit rateProgression-free survivalDuration of responseSacituzumab govitecanCheckpoint inhibitorsCohort 3Central reviewUrothelial cancerFirst-line platinum-based chemotherapyOpen-label phase II studyDay 1Median duration of responseMedian progression-free survivalTreatment-related adverse eventsMedian overall survivalMedian follow-upPhase II studySecondary end pointsAntibody-drug conjugatesMetastatic settingOverall survivalStandard therapyII studyTBCRC 039: a phase II study of preoperative ruxolitinib with or without paclitaxel for triple-negative inflammatory breast cancer
Lynce F, Stevens L, Li Z, Brock J, Gulvady A, Huang Y, Nakhlis F, Patel A, Force J, Haddad T, Ueno N, Stearns V, Wolff A, Clark A, Bellon J, Richardson E, Balko J, Krop I, Winer E, Lange P, Hwang E, King T, Tolaney S, Thompson A, Gupta G, Mittendorf E, Regan M, Overmoyer B, Polyak K. TBCRC 039: a phase II study of preoperative ruxolitinib with or without paclitaxel for triple-negative inflammatory breast cancer. Breast Cancer Research 2024, 26: 20. PMID: 38297352, PMCID: PMC10829369, DOI: 10.1186/s13058-024-01774-0.Peer-Reviewed Original ResearchConceptsInflammatory breast cancerPathological complete responseTriple-negative IBCPhase II studyTN-IBCIL-6/JAK/STAT3 signalingBreast cancerRandomized phase II studyRun-inInvestigation of novel therapiesDoxorubicin plus cyclophosphamideTreatment naive patientsImmune suppressive effectsGrowth inhibitory effectNeoadjuvant therapyPreoperative therapyComplete responsePhosphorylated STAT3Tumor biopsiesWorse survivalII studyPrimary endpointSecondary endpointsImmune suppressionT cells
2023
A randomized phase II study of metronomic cyclophosphamide and methotrexate (CM) with or without bevacizumab in patients with advanced breast cancer
Mayer E, Tayob N, Ren S, Savoie J, Spigel D, Burris H, Ryan P, Harris L, Winer E, Burstein H. A randomized phase II study of metronomic cyclophosphamide and methotrexate (CM) with or without bevacizumab in patients with advanced breast cancer. Breast Cancer Research And Treatment 2023, 204: 123-132. PMID: 38019444, DOI: 10.1007/s10549-023-07167-9.Peer-Reviewed Original ResearchObjective response rateProgression-free survivalAdvanced breast cancerPhase II studyMetastatic breast cancerOverall survivalArm ABreast cancerArm BII studyMetronomic chemotherapyRandomized phase II studyGrade adverse eventsMetronomic oral cyclophosphamideOral metronomic chemotherapyMedian overall survivalStandard-dose chemotherapyFurther clinical evaluationMetronomic cyclophosphamideOral cyclophosphamideArm B.Primary endpointSecondary endpointsAdverse eventsDose chemotherapy1803P Phase I/II study of bavdegalutamide, a PROTAC androgen receptor (AR) degrader in metastatic castration-resistant prostate cancer (mCRPC): Radiographic progression-free survival (rPFS) in patients (pts) with AR ligand-binding domain (LBD) mutations
Petrylak D, Garmezy B, Shen J, Kalebasty A, Sartor O, Dreicer R, Agarwal N, Hussain M, Percent I, Heath E, Gedrich R, Yu T, Healey D, Parameswaran J, Sternberg C, Gao X. 1803P Phase I/II study of bavdegalutamide, a PROTAC androgen receptor (AR) degrader in metastatic castration-resistant prostate cancer (mCRPC): Radiographic progression-free survival (rPFS) in patients (pts) with AR ligand-binding domain (LBD) mutations. Annals Of Oncology 2023, 34: s973-s974. DOI: 10.1016/j.annonc.2023.09.2751.Peer-Reviewed Original ResearchNUTMEG: A randomized phase II study of nivolumab and temozolomide versus temozolomide alone in newly diagnosed older patients with glioblastoma
Sim H, Wachsmuth L, Barnes E, Yip S, Koh E, Hall M, Jennens R, Ashley D, Verhaak R, Heimberger A, Rosenthal M, Hovey E, Ellingson B, Tognela A, Gan H, Wheeler H, Back M, McDonald K, Long A, Cuff K, Begbie S, Gedye C, Mislang A, Le H, Johnson M, Kong B, Simes J, Lwin Z, Khasraw M. NUTMEG: A randomized phase II study of nivolumab and temozolomide versus temozolomide alone in newly diagnosed older patients with glioblastoma. Neuro-Oncology Advances 2023, 5: vdad124. PMID: 37841696, PMCID: PMC10576515, DOI: 10.1093/noajnl/vdad124.Peer-Reviewed Original ResearchExperimental armStandard armOverall survivalAdverse eventsGrade-3 immune-related adverse eventImmune-related adverse eventsUnexpected serious adverse eventsRandomized phase II studyRandomized phase II trialCombination of nivolumabMedian overall survivalPhase II studySerious adverse eventsNew safety signalsOS hazard ratioPhase II trialPhase III trialsAdjuvant nivolumabImmunologic rationaleII trialHazard ratioII studyIII trialsOlder patientsImmunotherapy trialsPhase II study of trifluridine/tipiracil in metastatic breast cancers with or without prior exposure to fluoropyrimidines
Lim J, Ow S, Wong A, Lee M, Chan G, Low J, Sundar R, Choo J, Chong W, Ang Y, Tai B, Lee S. Phase II study of trifluridine/tipiracil in metastatic breast cancers with or without prior exposure to fluoropyrimidines. European Journal Of Cancer 2023, 193: 113311. PMID: 37717281, DOI: 10.1016/j.ejca.2023.113311.Peer-Reviewed Original ResearchMetastatic breast cancerObjective response rateProgression-free survivalPhase II studyCohort ABreast cancerDetermination of progression-free survivalSingle-arm phase II studyTreatment of metastatic breast cancerConsistent with known toxicitiesMedian progression-free survivalClinical benefit rateDose-confirmation phaseTreated with FTD/TPIDose modificationII studyCohort BBenefit rateFTD/TPISafety profileFluoropyrimidineGastric cancerPatientsResponse rateAntitumour activity[18F]-fluoroethyl-L-tyrosine (FET) in glioblastoma (FIG) TROG 18.06 study: protocol for a prospective, multicentre PET/CT trial
Koh E, Gan H, Senko C, Francis R, Ebert M, Lee S, Lau E, Khasraw M, Nowak A, Bailey D, Moffat B, Fitt G, Hicks R, Coffey R, Verhaak R, Walsh K, Barnes E, De Abreu Lourenco R, Rosenthal M, Adda L, Foroudi F, Lasocki A, Moore A, Thomas P, Roach P, Back M, Leonard R, Scott A. [18F]-fluoroethyl-L-tyrosine (FET) in glioblastoma (FIG) TROG 18.06 study: protocol for a prospective, multicentre PET/CT trial. BMJ Open 2023, 13: e071327. PMID: 37541751, PMCID: PMC10407346, DOI: 10.1136/bmjopen-2022-071327.Peer-Reviewed Original ResearchConceptsFET PETPositron emission tomographyPrimary central nervous system cancerTumor progressionCentral nervous system cancerL-tyrosine positron emission tomographyFET-PET imagingPhase II studyCo-primary outcomesProgression-free survivalMaximal safe resectionPost-chemotherapy treatmentNervous system cancersHealth economic impactHuman Research Ethics CommitteePatterns of failureTrue tumor progressionGood clinical practiceDeclaration of HelsinkiRadiological progressionConcurrent chemoradiationInitial surgeryPostoperative radiotherapyII studyOverall survivalOutcomes After Preoperative Chemoradiation With or Without Pazopanib in Non-Rhabdomyosarcoma Soft Tissue Sarcoma: A Report From Children's Oncology Group and NRG Oncology
Weiss A, Chen Y, Scharschmidt T, Xue W, Gao Z, Black J, Choy E, Davis J, Fanburg-Smith J, Kao S, Kayton M, Kessel S, Lim R, Million L, Okuno S, Ostrenga A, Parisi M, Pryma D, Randall R, Rosen M, Shulkin B, Terezakis S, Venkatramani R, Zambrano E, Wang D, Hawkins D, Spunt S. Outcomes After Preoperative Chemoradiation With or Without Pazopanib in Non-Rhabdomyosarcoma Soft Tissue Sarcoma: A Report From Children's Oncology Group and NRG Oncology. Journal Of Clinical Oncology 2023, 41: 4842-4848. PMID: 37523624, PMCID: PMC10852395, DOI: 10.1200/jco.23.00045.Peer-Reviewed Original ResearchConceptsNon-rhabdomyosarcoma soft tissue sarcomasSoft tissue sarcomasRegimen BPreoperative chemoradiationRegimen ATissue sarcomasPathological responseMedian survivor follow-upComplete pathologic response ratePathological response rateEvent-free survivalPhase II studyPrimary end pointChildren's Oncology GroupIntent-to-treat analysisSurvivor follow-upNon-rhabdomyosarcomasPreoperative radiotherapyPrimary resectionOverall survivalOncology GroupII studyClinical trial updateNRG OncologyEligible patientsEnfortumab Vedotin With or Without Pembrolizumab in Cisplatin-Ineligible Patients With Previously Untreated Locally Advanced or Metastatic Urothelial Cancer
O'Donnell P, Milowsky M, Petrylak D, Hoimes C, Flaig T, Mar N, Moon H, Friedlander T, McKay R, Bilen M, Srinivas S, Burgess E, Ramamurthy C, George S, Geynisman D, Bracarda S, Borchiellini D, Geoffrois L, Rey J, Ferrario C, Carret A, Yu Y, Guseva M, Moreno B, Rosenberg J. Enfortumab Vedotin With or Without Pembrolizumab in Cisplatin-Ineligible Patients With Previously Untreated Locally Advanced or Metastatic Urothelial Cancer. Journal Of Clinical Oncology 2023, 41: 4107-4117. PMID: 37369081, PMCID: PMC10852367, DOI: 10.1200/jco.22.02887.Peer-Reviewed Original ResearchConceptsTreatment-related adverse eventsCisplatin-ineligible patientsDuration of responseMetastatic urothelial cancerUrothelial cancerAdverse eventsHigher treatment-related adverse eventsPhase Ib/II studyMedian DORFirst-line treatment optionEnd pointBlinded independent central reviewCommon grade 3Objective response ratePrimary end pointSecondary end pointsNew safety signalsCisplatin-based therapyIndependent central reviewUntreated LACombination armDurable responsesII studyMaculopapular rashSurvival benefitA phase Ib adaptive study of dasatinib for the prevention of oxaliplatin-induced neuropathy in patients with gastrointestinal (GI) cancers receiving FOLFOX chemotherapy with or without bevacizumab.
Noonan A, Farid S, Schnell P, Trunzo D, Malalur P, Jin N, Manne A, Abushahin L, Rahman S, Hays J, Elkhatib R, Mittra A, Roychowdhury S, Lustberg M, Sparreboom A, Hu S. A phase Ib adaptive study of dasatinib for the prevention of oxaliplatin-induced neuropathy in patients with gastrointestinal (GI) cancers receiving FOLFOX chemotherapy with or without bevacizumab. Journal Of Clinical Oncology 2023, 41: e15613-e15613. DOI: 10.1200/jco.2023.41.16_suppl.e15613.Peer-Reviewed Original ResearchOrganic cation transporter 2Efficacy biomarkersRandomized phase II studyRat dorsal root gangliaAmount of oxaliplatinPhase 2 doseOxaliplatin-induced neuropathyPhase II studyPhase I trialDose-finding studyDorsal root gangliaLevels of biomarkersMajority of ptsFOLFOX chemotherapyFOLFOX regimenOX administrationII studyI trialPeripheral neuropathyGastrointestinal cancerGI cancersPreclinical dataRoot gangliaSerum biomarkersCohort 2ECOG-ACRIN LUNG-MAP S1900E substudy: A phase II study of sotorasib in participants (Pts) with previously treated stage IV or recurrent KRAS G12C mutant non-squamous (Non-sq) non-small cell lung cancer (NSCLC).
Padda S, Redman M, Gerber D, Stinchcombe T, Waqar S, Leal T, Minichiello K, Reckamp K, Herbst R, Borghaei H, Brahmer J, Gray J, Kelly K, Ramalingam S, Neal J. ECOG-ACRIN LUNG-MAP S1900E substudy: A phase II study of sotorasib in participants (Pts) with previously treated stage IV or recurrent KRAS G12C mutant non-squamous (Non-sq) non-small cell lung cancer (NSCLC). Journal Of Clinical Oncology 2023, 41: tps9143-tps9143. DOI: 10.1200/jco.2023.41.16_suppl.tps9143.Peer-Reviewed Original ResearchNon-squamous non-small cell lung cancerTarget sample sizeKRAS G12C inhibitorsCohort 1Eligible ptsBrain metastasesG12C inhibitorsPhase 2 open-label studyNon-small cell lung cancerAsymptomatic brain metastasesOpen-label studyPhase II studyUntreated brain metastasesCell lung cancerDuration of responsePresence of TP53Wild-type TP53Oral dailySecondary endpointsII studySystemic treatmentAccrual targetLung cancerCohort 2Clinical activity
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