{"entity":{"id":"nct04999969","kind":"trial","name":"Safety, Pharmacokinetics and Clinical Activity of AZD0171 in Combination With Durvalumab and Chemotherapy in Locally Advanced or Metastatic Solid Tumours","aka":[],"tldr":"A phase 2 trial of Durvalumab and Gemcitabine in advanced solid tumours, run by AstraZeneca, active and no longer recruiting.","summary":"Safety, Pharmacokinetics and Clinical Activity of AZD0171 in Combination With Durvalumab and Chemotherapy in Locally Advanced or Metastatic Solid Tumours is a phase 2 interventional study registered as NCT04999969 by AstraZeneca, with 126 participants enrolled, started 2021-12-10 and due to reach its primary completion in 2024-10-07. Interventions recorded: AZD0171, Durvalumab, Gemcitabine and Nab-paclitaxel. Results have been posted on the registry.","status":"active","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT04999969","url":"https://clinicaltrials.gov/study/NCT04999969"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["durvalumab","gemcitabine"],"companies":["astrazeneca"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04999969","phase":"2","setting":"A Phase II Study to Evaluate the Safety, Pharmacokinetics, and Clinical Activity of AZD0171 in Combination With Durvalumab and Chemotherapy in Participants With Locally Advanced or Metastatic Solid Tumours","sponsor":"AstraZeneca","started":"2021-12-10","startedType":"actual","yearReported":2025,"enrolled":126,"enrolledBasis":"registry","outcomes":[{"endpoint":"Overall Survival at 12 Months (OS-12)","primary":true,"unit":"%","arms":[{"name":"AZD0171 + Durvalumab + Chemotherapy","n":126,"value":53.8,"note":"80% CI 47.79 to 59.50; Figures from the ClinicalTrials.gov results section (first posted 2025-11-26), not from a publication"}],"source":"https://clinicaltrials.gov/study/NCT04999969?tab=results"},{"endpoint":"Median Progression Free Survival (PFS)","unit":"months","arms":[{"name":"AZD0171 + Durvalumab + Chemotherapy","n":126,"value":7.33,"note":"80% CI 6.801 to 7.918; Figures from the ClinicalTrials.gov results section (first posted 2025-11-26), not from a publication"}],"source":"https://clinicaltrials.gov/study/NCT04999969?tab=results"},{"endpoint":"Objective Response Rate (ORR)","unit":"%","arms":[{"name":"AZD0171 + Durvalumab + Chemotherapy","n":126,"value":34.9,"note":"80% CI 29.30 to 40.91; Figures from the ClinicalTrials.gov results section (first posted 2025-11-26), not from a publication"}],"source":"https://clinicaltrials.gov/study/NCT04999969?tab=results"}]},"route":"/trials/nct04999969/","neighbours":{"cancer":[{"id":"metastatic-cancer","kind":"cancer","name":"Metastatic cancer (cancer that has spread)","route":"/cancers/metastatic-cancer/"}],"technology":[{"id":"checkpoint-inhibitor","kind":"technology","name":"Immune checkpoint inhibitors","route":"/technologies/checkpoint-inhibitor/"}],"drug":[{"id":"durvalumab","kind":"drug","name":"Durvalumab","route":"/drugs/durvalumab/"},{"id":"gemcitabine","kind":"drug","name":"Gemcitabine","route":"/drugs/gemcitabine/"}],"company":[{"id":"astrazeneca","kind":"company","name":"AstraZeneca","route":"/companies/astrazeneca/"}]}}