{"entity":{"id":"oak","kind":"trial","name":"OAK","aka":[],"tldr":"The trial that put a PD-L1 antibody alongside the PD-1 antibodies as second-line treatment for lung cancer, in the largest second-line immunotherapy trial run.","summary":"OAK recruited 1,225 patients at 194 centres in 31 countries between March 2014 and April 2015 and randomised them 1:1 to atezolizumab 1200 mg or docetaxel 75 mg/m2 every three weeks. Eligible patients had squamous or non-squamous disease, performance status 0 or 1, and one or two previous cytotoxic regimens including at least one platinum combination; patients with autoimmune disease or previous checkpoint exposure were excluded. The primary efficacy analysis was prespecified in the first 850 enrolled, 425 per arm, with co-primary endpoints in the intention-to-treat population and in the PD-L1-expressing population (1 percent or more on tumour cells or tumour-infiltrating immune cells).\n\nMedian overall survival was 13.8 months (95 percent confidence interval 11.8 to 15.7) with atezolizumab against 9.6 months (8.6 to 11.2) with docetaxel (hazard ratio 0.73). The benefit held in both co-primary populations, including in patients whose tumours had no detectable PD-L1.\n\nThe FDA approved atezolizumab for metastatic non-small-cell lung cancer after platinum chemotherapy in 2016. In England NICE TA520 (16 May 2018) recommends atezolizumab after chemotherapy for locally advanced or metastatic disease.","status":"positive","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT02008227","url":"https://clinicaltrials.gov/study/NCT02008227"},{"label":"OAK (Lancet 2017)","url":"https://doi.org/10.1016/S0140-6736(16)32517-X"},{"label":"NICE TA520: atezolizumab for locally advanced or metastatic non-small-cell lung cancer after chemotherapy","url":"https://www.nice.org.uk/guidance/ta520"}],"tags":[],"related":[],"cancers":["nsclc","lung-squamous-cell-carcinoma","lung-adenocarcinoma"],"sections":[],"technologies":["checkpoint-inhibitor","cytotoxic-chemotherapy"],"targets":["pdl1"],"drugs":["atezolizumab","docetaxel"],"companies":["roche-genentech"],"institutions":[],"pathways":[],"terms":["immune-checkpoint","pd-l1-testing"],"trials":["checkmate-017","checkmate-057"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT02008227","phase":"3","setting":"Squamous or non-squamous non-small-cell lung cancer after one or two previous cytotoxic regimens including a platinum doublet: atezolizumab 1200 mg versus docetaxel 75 mg/m2, both every three weeks, with co-primary overall survival endpoints in the intention-to-treat and PD-L1-expressing populations","sponsor":"Roche","result":"Median overall survival 13.8 against 9.6 months (hazard ratio 0.73), in both the intention-to-treat and PD-L1-expressing populations.","yearReported":2016,"enrolled":1225,"enrolledBasis":"randomised","enrolledNote":"1,225 patients were recruited; the primary efficacy analysis was prespecified in the first 850.","outcomes":[{"endpoint":"Overall survival (intention to treat)","primary":true,"unit":"months","arms":[{"name":"Atezolizumab","n":425,"value":13.8},{"name":"Docetaxel","n":425,"value":9.6}],"hr":0.73,"source":"https://doi.org/10.1016/S0140-6736(16)32517-X"}],"replication":"Consistent with CheckMate 017, CheckMate 057 and KEYNOTE-010; POPLAR was the randomised phase 2 that preceded it."},"route":"/trials/oak/","neighbours":{"cancer":[{"id":"lung-adenocarcinoma","kind":"cancer","name":"Adenocarcinoma of the lung","route":"/cancers/lung-adenocarcinoma/"},{"id":"lung-cancer","kind":"cancer","name":"Lung cancer (all types)","route":"/cancers/lung-cancer/"},{"id":"nsclc","kind":"cancer","name":"Non-small-cell lung cancer","route":"/cancers/nsclc/"},{"id":"lung-squamous-cell-carcinoma","kind":"cancer","name":"Squamous cell carcinoma of the lung","route":"/cancers/lung-squamous-cell-carcinoma/"}],"technology":[{"id":"cytotoxic-chemotherapy","kind":"technology","name":"Cytotoxic chemotherapy","route":"/technologies/cytotoxic-chemotherapy/"},{"id":"checkpoint-inhibitor","kind":"technology","name":"Immune checkpoint inhibitors","route":"/technologies/checkpoint-inhibitor/"}],"target":[{"id":"pdl1","kind":"target","name":"PD-L1","route":"/targets/pdl1/"}],"drug":[{"id":"atezolizumab","kind":"drug","name":"Atezolizumab","route":"/drugs/atezolizumab/"},{"id":"docetaxel","kind":"drug","name":"Docetaxel","route":"/drugs/docetaxel/"}],"company":[{"id":"roche-genentech","kind":"company","name":"Roche / Genentech","route":"/companies/roche-genentech/"}],"term":[{"id":"immune-checkpoint","kind":"term","name":"Immune checkpoint","route":"/terms/immune-checkpoint/"},{"id":"pd-l1-testing","kind":"term","name":"PD-L1 expression testing (22C3, SP142, SP263)","route":"/terms/pd-l1-testing/"}],"trial":[{"id":"checkmate-017","kind":"trial","name":"CheckMate 017","route":"/trials/checkmate-017/"},{"id":"checkmate-057","kind":"trial","name":"CheckMate 057","route":"/trials/checkmate-057/"},{"id":"keynote-010","kind":"trial","name":"KEYNOTE-010","route":"/trials/keynote-010/"}]}}