{"entity":{"id":"keynote-407","kind":"trial","name":"KEYNOTE-407","aka":[],"tldr":"KEYNOTE-407 showed that adding pembrolizumab to chemotherapy helped people with squamous lung cancer live longer whatever their PD-L1 level, and made chemo-immunotherapy the standard first treatment for this type.","summary":"KEYNOTE-407 randomised 559 patients with untreated metastatic squamous non-small-cell lung cancer to carboplatin and either paclitaxel or nab-paclitaxel with pembrolizumab or with placebo, followed by pembrolizumab or placebo maintenance. Squamous tumours had been left behind by the targeted-therapy era and had no chemotherapy-free option beyond high-PD-L1 pembrolizumab.\n\nBoth primary endpoints, overall survival and progression-free survival, favoured the pembrolizumab arm, and the benefit was seen across PD-L1 expression groups. The combination was approved in the United States in October 2018 and became the first-line standard for squamous disease without a driver mutation.","status":"positive","asOf":"2026-09-17","links":[{"label":"ClinicalTrials.gov NCT02775435","url":"https://clinicaltrials.gov/study/NCT02775435"}],"tags":["subtype-trials"],"related":[],"cancers":["pdl1-high-nsclc","nsclc","lung-cancer"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["pembrolizumab","carboplatin","paclitaxel"],"companies":["merck"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":["luis-paz-ares"],"bottlenecks":[],"keyPapers":["paper-keynote-407-n-engl-j-med-2018","paper-keynote-407-j-clin-oncol-2023-update"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT02775435","phase":"3","setting":"Untreated metastatic squamous non-small-cell lung cancer: carboplatin with paclitaxel or nab-paclitaxel, with pembrolizumab or placebo","sponsor":"Merck & Co. (MSD)","result":"Pembrolizumab plus carboplatin and a taxane improved overall and progression-free survival over chemotherapy alone across PD-L1 levels; approved in October 2018.","started":"2016-06-09","startedType":"actual","yearReported":2018,"enrolled":559,"enrolledBasis":"registry","outcomes":[{"endpoint":"Overall survival","primary":true,"unit":"months","arms":[{"name":"Pembrolizumab + carboplatin + paclitaxel or nab-paclitaxel","value":15.9,"note":"Median follow-up 7.8 months; 559 randomised"},{"name":"Placebo + carboplatin + paclitaxel or nab-paclitaxel","value":11.3}],"hr":0.64,"ci":[0.49,0.85],"p":"<0.001","source":"https://doi.org/10.1056/nejmoa1810865"},{"endpoint":"Progression-free survival","primary":true,"unit":"months","arms":[{"name":"Pembrolizumab + carboplatin + paclitaxel or nab-paclitaxel","value":6.4},{"name":"Placebo + carboplatin + paclitaxel or nab-paclitaxel","value":4.8}],"hr":0.56,"ci":[0.45,0.7],"p":"<0.001","source":"https://doi.org/10.1056/nejmoa1810865"},{"endpoint":"Grade 3 or higher adverse events","unit":"%","arms":[{"name":"Pembrolizumab + carboplatin + paclitaxel or nab-paclitaxel","value":69.8},{"name":"Placebo + carboplatin + paclitaxel or nab-paclitaxel","value":68.2}],"source":"https://doi.org/10.1056/nejmoa1810865"},{"endpoint":"Discontinuation for adverse events","unit":"%","arms":[{"name":"Pembrolizumab + carboplatin + paclitaxel or nab-paclitaxel","value":13.3},{"name":"Placebo + carboplatin + paclitaxel or nab-paclitaxel","value":6.4}],"source":"https://doi.org/10.1056/nejmoa1810865"}]},"route":"/trials/keynote-407/","neighbours":{"cancer":[{"id":"basaloid-squamous-cell-carcinoma-lung","kind":"cancer","name":"Basaloid squamous cell carcinoma of the lung","route":"/cancers/basaloid-squamous-cell-carcinoma-lung/"},{"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":"pdl1-high-nsclc","kind":"cancer","name":"PD-L1-high non-small-cell lung cancer without a driver mutation","route":"/cancers/pdl1-high-nsclc/"},{"id":"lung-squamous-cell-carcinoma","kind":"cancer","name":"Squamous cell carcinoma of the lung","route":"/cancers/lung-squamous-cell-carcinoma/"}],"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":"paclitaxel","kind":"drug","name":"Paclitaxel / nab-paclitaxel","route":"/drugs/paclitaxel/"},{"id":"pembrolizumab","kind":"drug","name":"Pembrolizumab","route":"/drugs/pembrolizumab/"}],"company":[{"id":"merck","kind":"company","name":"Merck & Co. (MSD)","route":"/companies/merck/"}],"person":[{"id":"luis-paz-ares","kind":"person","name":"Luis Paz-Ares","route":"/people/luis-paz-ares/"}],"paper":[{"id":"paper-keynote-407-n-engl-j-med-2018","kind":"paper","name":"Pembrolizumab plus Chemotherapy for Squamous Non-Small-Cell Lung Cancer","route":"/key-papers/paper-keynote-407-n-engl-j-med-2018/"},{"id":"paper-keynote-407-j-clin-oncol-2023-update","kind":"paper","name":"Pembrolizumab Plus Chemotherapy in Squamous Non-Small-Cell Lung Cancer: 5-Year Update of the Phase III KEYNOTE-407 Study","route":"/key-papers/paper-keynote-407-j-clin-oncol-2023-update/"}],"trial":[{"id":"squire","kind":"trial","name":"SQUIRE","route":"/trials/squire/"}]}}