2022
KeyVibe-008: Randomized, phase 3 study of first-line vibostolimab plus pembrolizumab plus etoposide/platinum versus atezolizumab plus EP in extensive-stage small cell lung cancer.
Sands J, Reck M, Navarro A, Chiang A, Lu S, Peled N, Paz-Ares L, Kerr S, Takahashi T, Smolin A, Chen X, Zhao B, El-Osta H, Califano R. KeyVibe-008: Randomized, phase 3 study of first-line vibostolimab plus pembrolizumab plus etoposide/platinum versus atezolizumab plus EP in extensive-stage small cell lung cancer. Journal Of Clinical Oncology 2022, 40: tps8606-tps8606. DOI: 10.1200/jco.2022.40.16_suppl.tps8606.Peer-Reviewed Original ResearchExtensive-stage small-cell lung cancerEtoposide/platinumPatient-reported outcomesSmall cell lung cancerPhase 3 studyLung cancerRECIST v1.1ECOG PSDisease progressionBlinded independent central reviewNeurologic paraneoplastic syndromesUntreated ES-SCLCFirst-line pembrolizumabFirst-line treatmentInterstitial lung diseaseCell lung cancerDuration of responseT cell immunoreceptorIndependent central reviewWithdrawal of consentPretreatment tumor samplesNew anticancer treatmentsCare immunotherapyCTCAE v5.0Measurable disease
2014
1473P Phase 1B Trial of Anti-Notch 2/3 Antibody Omp-59R5 in Combination with Etoposide and Cisplatin (Ep) in Patients (Pts) with Untreated Extensive-Stage Small-Cell Lung Cancer (Ed-Sclc): the Pinnacle Study
Pietanza M, Spira A, Jotte R, Gadgeel S, Mita A, Liu S, Gluck W, Kalemkerian G, Chiang A, Hart L, Kapoun A, Xu L, Hill D, Zhou L, Dupont J, Spigel D. 1473P Phase 1B Trial of Anti-Notch 2/3 Antibody Omp-59R5 in Combination with Etoposide and Cisplatin (Ep) in Patients (Pts) with Untreated Extensive-Stage Small-Cell Lung Cancer (Ed-Sclc): the Pinnacle Study. Annals Of Oncology 2014, 25: iv514. DOI: 10.1093/annonc/mdu355.11.Peer-Reviewed Original ResearchDose-limiting toxicityAnti-tumor activityDay 1Untreated extensive stage small cell lung cancerExtensive-stage small-cell lung cancerMain dose-limiting toxicitySmall cell lung cancerGrade 3 diarrheaGrade 3 nauseaPhase 2 partPhase 1b trialPK/pharmacodynamicsED-SCLCSCLC xenograftsDose cohortsRECIST 1.1Peripheral edemaUnacceptable toxicityAdverse eventsSupportive carePreliminary efficacyLung cancerDisease progressionEfficacy dataIgG2 antibodies