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Just three cycles of chemotherapy with the immunotherapy nivolumab before surgery wiped out all viable tumour in a quarter of patients and reduced relapse or death by about a third, without making surgery harder.
Open-label phase 3 trial of 358 patients with resectable stage IB-IIIA NSCLC randomised to three cycles of neoadjuvant nivolumab plus platinum-doublet chemotherapy or chemotherapy alone, followed by surgery. Primary endpoints were pathological complete response (pCR) and event-free survival (EFS).
pCR was 24.0% vs 2.2% and median EFS 31.6 vs 20.8 months (HR 0.63). Surgery rates and complications were not worse with nivolumab. A 2025 report confirmed an overall survival benefit (HR about 0.72). It was the first neoadjuvant immunotherapy approval in lung cancer and, together with the perioperative trials (KEYNOTE-671, AEGEAN, CheckMate 77T), moved immunotherapy before surgery.
Patients with operable stage II-III lung cancer without EGFR or ALK alterations should have chemo-immunotherapy discussed before surgery rather than only afterwards. Three pre-operative cycles do not compromise the operation and improve cure rates. Whether to continue immunotherapy after surgery, as the perioperative trials do, and whether patients with pCR need any further treatment, remain open questions.
Perioperative immunotherapy is now standard for resectable lung cancer without a targetable driver. The updated overall survival hazard ratio of 0.89, with a confidence interval crossing one, is the honest state of the evidence on whether it cures more people.
The strongest signal that neoadjuvant immunotherapy makes stage III lung cancer operable as well as more often curable. Twenty-four percentage points more patients reaching surgery is a result that only a neoadjuvant design can produce.
Adjuvant immunotherapy entered lung cancer here, and with it the question that still divides practice: whether it is better given before the operation, after it, or on both sides.
Shares Perioperative nivolumab and chemotherapy in stage III non-small-cell lung cancer, Adjuvant atezolizumab after adjuvant chemotherapy in resected stage IB-IIIA non-small-cell lung cancer (IMpower010), Perioperative durvalumab for resectable non-small-cell lung cancer, Lung cancer roadmap: from Doll and Hill and the naming of tobacco, through the cytotoxic plateau, computed tomography screening, EGFR and ALK, immunotherapy by PD-L1, the perioperative trials and PACIFIC, to DLL3 in small-cell disease and a 2032 registry watch.
Shares Event-free / disease-free survival (EFS, DFS, iDFS, RFS), Pathologic complete response (pCR), Dormant cells and minimal residual disease, No one can predict who responds to immunotherapy.
Shares Event-free / disease-free survival (EFS, DFS, iDFS, RFS), Pathologic complete response (pCR), Dormant cells and minimal residual disease, No one can predict who responds to immunotherapy.
Shares CheckMate 816, Perioperative durvalumab for resectable non-small-cell lung cancer, Resectable stage I to III non-small-cell lung cancer, Paclitaxel / nab-paclitaxel.
Shares Adjuvant atezolizumab after adjuvant chemotherapy in resected stage IB-IIIA non-small-cell lung cancer (IMpower010), Lung cancer roadmap: from Doll and Hill and the naming of tobacco, through the cytotoxic plateau, computed tomography screening, EGFR and ALK, immunotherapy by PD-L1, the perioperative trials and PACIFIC, to DLL3 in small-cell disease and a 2032 registry watch, Dormant cells and minimal residual disease, Neoadjuvant / adjuvant / perioperative.
Shares Event-free / disease-free survival (EFS, DFS, iDFS, RFS), Pathologic complete response (pCR), Neoadjuvant / adjuvant / perioperative, Bristol Myers Squibb.
Shares CheckMate 816, Resectable stage I to III non-small-cell lung cancer, Bristol Myers Squibb, Nivolumab.
Shares Shun Lu, Lung cancer roadmap: from Doll and Hill and the naming of tobacco, through the cytotoxic plateau, computed tomography screening, EGFR and ALK, immunotherapy by PD-L1, the perioperative trials and PACIFIC, to DLL3 in small-cell disease and a 2032 registry watch, Dormant cells and minimal residual disease, Neoadjuvant / adjuvant / perioperative.