{"entity":{"id":"nct04606771","kind":"trial","name":"A Study Comparing Savolitinib Plus Osimertinib vs Savolitinib Plus Placebo in Patients With EGFRm+ and MET Amplified Advanced NSCLC","aka":[],"tldr":"A phase 2 trial of Osimertinib, Savolitinib in non-small-cell lung cancer and small-cell lung cancer, run by AstraZeneca, active and no longer recruiting.","summary":"A Study Comparing Savolitinib Plus Osimertinib vs Savolitinib Plus Placebo in Patients With EGFRm+ and MET Amplified Advanced NSCLC is a phase 2 interventional study registered as NCT04606771 by AstraZeneca, with 30 participants enrolled, started 2020-09-28 and due to reach its primary completion in 2022-12-21. Interventions recorded: Osimertinib + Savolitinib, Savolitinib + Placebo. Conditions listed: Non-Small Cell Lung Cancer. Results were posted on ClinicalTrials.gov in 2024; the figures recorded here are the registry's, not a publication's.","status":"active","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT04606771","url":"https://clinicaltrials.gov/study/NCT04606771"}],"tags":["ctgov-ingest"],"related":[],"cancers":["nsclc","sclc","met-altered-nsclc"],"sections":[],"technologies":["kinase-inhibitors"],"targets":[],"drugs":["osimertinib","savolitinib"],"companies":["astrazeneca"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04606771","phase":"2","setting":"A Multi-centre Phase II, Double-Blind, Randomised Study of Savolitinib in Combination With Osimertinib vs Savolitinib in Combination With Placebo in Patients With EGFRm+ and MET Amplified Locally Advanced or Metastatic Non-Small Cell Lung Cancer Who Have Progressed Following Treatment With Osimertinib","sponsor":"AstraZeneca","started":"2020-09-28","startedType":"actual","yearReported":2024,"enrolled":30,"enrolledBasis":"registry","outcomes":[{"endpoint":"Objective Response Rate (ORR)","primary":true,"unit":"%","arms":[{"name":"Savolitinib Plus Osimertinib","n":14,"value":57.1,"note":"95% CI 28.86 to 82.34; Figures from the ClinicalTrials.gov results section (first posted 2024-09-24), not from a publication"},{"name":"Savolitinib Plus Placebo","n":16,"value":12.5,"note":"95% CI 1.55 to 38.35"}],"source":"https://clinicaltrials.gov/study/NCT04606771?tab=results"},{"endpoint":"Overall Survival (OS)","unit":"months","arms":[{"name":"Savolitinib Plus Osimertinib","n":14,"note":"NA - Not calculated, estimates cannot be calculated due to too few events; Figures from the ClinicalTrials.gov results section (first posted 2024-09-24), not from a publication"},{"name":"Savolitinib Plus Placebo","n":16,"value":13.37,"note":"95% CI 7.82 to NA"}],"source":"https://clinicaltrials.gov/study/NCT04606771?tab=results"},{"endpoint":"Progression-free Survival (PFS)","unit":"months","arms":[{"name":"Savolitinib Plus Osimertinib","n":14,"value":7.36,"note":"95% CI 5.55 to NA; Figures from the ClinicalTrials.gov results section (first posted 2024-09-24), not from a publication"},{"name":"Savolitinib Plus Placebo","n":16,"value":1.64,"note":"95% CI 1.28 to 4.07"}],"source":"https://clinicaltrials.gov/study/NCT04606771?tab=results"}]},"route":"/trials/nct04606771/","neighbours":{"cancer":[{"id":"met-altered-nsclc","kind":"cancer","name":"MET exon 14 and MET-amplified non-small-cell lung cancer","route":"/cancers/met-altered-nsclc/"},{"id":"nsclc","kind":"cancer","name":"Non-small-cell lung cancer","route":"/cancers/nsclc/"},{"id":"sclc","kind":"cancer","name":"Small-cell lung cancer","route":"/cancers/sclc/"}],"technology":[{"id":"kinase-inhibitors","kind":"technology","name":"Small-molecule kinase inhibitors","route":"/technologies/kinase-inhibitors/"}],"drug":[{"id":"osimertinib","kind":"drug","name":"Osimertinib","route":"/drugs/osimertinib/"},{"id":"savolitinib","kind":"drug","name":"Savolitinib","route":"/drugs/savolitinib/"}],"company":[{"id":"astrazeneca","kind":"company","name":"AstraZeneca","route":"/companies/astrazeneca/"}]}}