{"entity":{"id":"nct03061812","kind":"trial","name":"Study Comparing Rovalpituzumab Tesirine Versus Topotecan in Subjects With Advanced or Metastatic Small Cell Lung Cancer With High Levels of Delta-like Protein 3 (DLL3) and Who Have First Disease Progression During or Following Front-line Platinum-based Chemotherapy (TAHOE)","aka":["TAHOE"],"tldr":"A phase 3 trial of Rovalpituzumab tesirine, Topotecan and Dexamethasone in Small-cell lung cancer, run by AbbVie, completed.","summary":"Study Comparing Rovalpituzumab Tesirine Versus Topotecan in Subjects With Advanced or Metastatic Small Cell Lung Cancer With High Levels of Delta-like Protein 3 (DLL3) and Who Have First Disease Progression During or Following Front-line Platinum-based Chemotherapy (TAHOE) is a phase 3 interventional study registered as NCT03061812 by AbbVie, with 444 participants recorded, started 2017-04-11 and reaching its primary completion in 2020-02-12. Interventions recorded: Rovalpituzumab tesirine, Topotecan, Dexamethasone. Conditions recorded: Small Cell Lung Cancer.\n\nLinked to the drug Rovalpituzumab tesirine because the registry names it among its interventions and Small-cell lung cancer among its conditions. Registry record only: no result has been read by an editor.","status":"completed","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT03061812","url":"https://clinicaltrials.gov/study/NCT03061812"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["sclc","extensive-stage-sclc"],"sections":[],"technologies":[],"targets":[],"drugs":["rovalpituzumab-tesirine","topotecan","dexamethasone"],"companies":["abbvie"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03061812","phase":"3","setting":"A Randomized, Open-Label, Multicenter, Phase 3 Study of Rovalpituzumab Tesirine Compared With Topotecan for Subjects With Advanced or Metastatic DLL3high Small Cell Lung Cancer (SCLC) Who Have First Disease Progression During or Following Front-Line Platinum-Based Chemotherapy (TAHOE)","sponsor":"AbbVie","started":"2017-04-11","startedType":"actual","yearReported":2021,"enrolled":444,"enrolledBasis":"registry","outcomes":[{"endpoint":"Overall Survival (OS)","primary":true,"unit":"months","arms":[{"name":"Topotecan","n":148,"value":8.57,"note":"95% CI 7.69 to 10.12; Figures from the ClinicalTrials.gov results section (first posted 2021-02-23), not from a publication"},{"name":"Rovalpituzumab Tesirine","n":296,"value":6.34,"note":"95% CI 5.55 to 7.33"}],"hr":1.46,"ci":[1.17,1.82],"p":"0.0051","source":"https://clinicaltrials.gov/study/NCT03061812?tab=results"},{"endpoint":"Progression Free Survival (PFS)","unit":"months","arms":[{"name":"Topotecan","n":148,"value":4.27,"note":"95% CI 3.75 to 5.42; Figures from the ClinicalTrials.gov results section (first posted 2021-02-23), not from a publication"},{"name":"Rovalpituzumab Tesirine","n":296,"value":3.02,"note":"95% CI 2.86 to 3.61"}],"hr":1.51,"ci":[1.22,1.87],"p":"<0.0001","source":"https://clinicaltrials.gov/study/NCT03061812?tab=results"},{"endpoint":"Objective Response Rate (ORR)","unit":"%","arms":[{"name":"Topotecan","n":129,"value":20.9,"note":"95% CI 14.27 to 28.97; Figures from the ClinicalTrials.gov results section (first posted 2021-02-23), not from a publication"},{"name":"Rovalpituzumab Tesirine","n":287,"value":14.6,"note":"95% CI 10.75 to 19.26"}],"p":"0.3352","source":"https://clinicaltrials.gov/study/NCT03061812?tab=results"}]},"route":"/trials/nct03061812/","neighbours":{"cancer":[{"id":"extensive-stage-sclc","kind":"cancer","name":"Extensive-stage small-cell lung cancer","route":"/cancers/extensive-stage-sclc/"},{"id":"sclc","kind":"cancer","name":"Small-cell lung cancer","route":"/cancers/sclc/"}],"drug":[{"id":"dexamethasone","kind":"drug","name":"Dexamethasone","route":"/drugs/dexamethasone/"},{"id":"rovalpituzumab-tesirine","kind":"drug","name":"Rovalpituzumab tesirine","route":"/drugs/rovalpituzumab-tesirine/"},{"id":"topotecan","kind":"drug","name":"Topotecan","route":"/drugs/topotecan/"}],"company":[{"id":"abbvie","kind":"company","name":"AbbVie (incl. ImmunoGen, Capstan)","route":"/companies/abbvie/"}]}}