{"entity":{"id":"nct03003962","kind":"trial","name":"Study of Durvalumab Alone or Chemotherapy for Patients With Advanced Non Small-Cell Lung Cancer (PEARL)","aka":["PEARL"],"tldr":"A phase 3 trial of Durvalumab, Carboplatin, Gemcitabine + cisplatin, Gemcitabine, Cisplatin and Pemetrexed in non-small-cell lung cancer, run by AstraZeneca, active and no longer recruiting.","summary":"Study of Durvalumab Alone or Chemotherapy for Patients With Advanced Non Small-Cell Lung Cancer (PEARL) is a phase 3 interventional study registered as NCT03003962 by AstraZeneca, with 669 participants enrolled, started 2017-01-02 and due to reach its primary completion in 2022-10-27. Interventions recorded: Durvalumab (MEDI4736), Paclitaxel + carboplatin, Gemcitabine + cisplatin, Gemcitabine + carboplatin, Pemetrexed + cisplatin and Pemetrexed + carboplatin. Results have been posted on the registry.","status":"active","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT03003962","url":"https://clinicaltrials.gov/study/NCT03003962"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["nsclc","pdl1-high-nsclc"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["durvalumab","carboplatin","gemcitabine-cisplatin","gemcitabine","cisplatin","pemetrexed"],"companies":["astrazeneca"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":["paper-nct03003962-j-thorac-oncol-2025"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03003962","phase":"3","setting":"A Phase III Randomized, Open-Label, Multi-Center Study of Durvalumab (MEDI4736) Versus Standard of Care (SoC) Platinum-Based Chemotherapy as First Line Treatment in Patients With PD-L1-High Expression Advanced Non Small-Cell Lung Cancer","sponsor":"AstraZeneca","started":"2017-01-02","startedType":"actual","yearReported":2023,"enrolled":669,"enrolledBasis":"registry","outcomes":[{"endpoint":"Overall Survival (OS)","primary":true,"unit":"months","arms":[{"name":"Durvalumab","n":335,"value":14.6,"note":"95% CI 12.2 to 16.9; Figures from the ClinicalTrials.gov results section (first posted 2023-12-26), not from a publication"},{"name":"Platinum-based SoC","n":334,"value":12.8,"note":"95% CI 10.1 to 14.7"}],"hr":0.84,"ci":[0.706,0.989],"p":"0.037","source":"https://clinicaltrials.gov/study/NCT03003962?tab=results"},{"endpoint":"OS in Participants With LREM","primary":true,"unit":"months","arms":[{"name":"Durvalumab","n":278,"value":14.6,"note":"95% CI 12.6 to 17.2; Figures from the ClinicalTrials.gov results section (first posted 2023-12-26), not from a publication"},{"name":"Platinum-based SoC","n":271,"value":15,"note":"95% CI 13.1 to 16.8"}],"hr":0.96,"ci":[0.793,1.151],"p":"0.628","source":"https://clinicaltrials.gov/study/NCT03003962?tab=results"},{"endpoint":"Objective Response Rate (ORR) as Per RECIST 1.1 Using Investigator Assessment","unit":"%","arms":[{"name":"Durvalumab","n":335,"value":37.6,"note":"Figures from the ClinicalTrials.gov results section (first posted 2023-12-26), not from a publication"},{"name":"Platinum-based SoC","n":334,"value":37.4}],"source":"https://clinicaltrials.gov/study/NCT03003962?tab=results"}]},"route":"/trials/nct03003962/","neighbours":{"cancer":[{"id":"nsclc","kind":"cancer","name":"Non-small-cell lung cancer","route":"/cancers/nsclc/"},{"id":"pdl1-high-nsclc","kind":"cancer","name":"PD-L1-high non-small-cell lung cancer without a driver mutation","route":"/cancers/pdl1-high-nsclc/"}],"technology":[{"id":"checkpoint-inhibitor","kind":"technology","name":"Immune checkpoint inhibitors","route":"/technologies/checkpoint-inhibitor/"}],"drug":[{"id":"carboplatin","kind":"drug","name":"Carboplatin","route":"/drugs/carboplatin/"},{"id":"cisplatin","kind":"drug","name":"Cisplatin","route":"/drugs/cisplatin/"},{"id":"durvalumab","kind":"drug","name":"Durvalumab","route":"/drugs/durvalumab/"},{"id":"gemcitabine","kind":"drug","name":"Gemcitabine","route":"/drugs/gemcitabine/"},{"id":"gemcitabine-cisplatin","kind":"drug","name":"Gemcitabine + cisplatin","route":"/drugs/gemcitabine-cisplatin/"},{"id":"pemetrexed","kind":"drug","name":"Pemetrexed","route":"/drugs/pemetrexed/"}],"company":[{"id":"astrazeneca","kind":"company","name":"AstraZeneca","route":"/companies/astrazeneca/"}],"paper":[{"id":"paper-nct03003962-j-thorac-oncol-2025","kind":"paper","name":"Durvalumab Versus Chemotherapy as First-line Treatment for Metastatic NSCLC With Tumor PD-L1 Expression of 25% or Higher: Results From the Randomized Phase 3 PEARL Study","route":"/key-papers/paper-nct03003962-j-thorac-oncol-2025/"}]}}