protocolSection identificationModule nctId: NCT06284317, orgStudyIdInfo id: ETOP 25-23, briefTitle: A Study to Evaluate the Benefit of Adding Durvalumab After Chemotherapy, Durvalumab and Surgery in Patients With Early-stage, Operable, Non-small Cell Lung Cancer., acronym: ADOPT-lung, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-10, primaryCompletionDateStruct date: 2029-10, completionDateStruct date: 2030-03, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-04-05, sponsorCollaboratorsModule leadSponsor name: ETOP IBCSG Partners Foundation, class: NETWORK, collaborators name: AstraZeneca AG Switzerland, descriptionModule briefSummary: ADOPT-LUNG is an international, multicentre, open-label randomised phase III trial. Protocol treatment consists of 3-4 cycles of neoadjuvant durvalumab in combination with platinum-based doublet chemotherapy, followed by surgery. Patients with R0 and R1 only resection will be randomised to receive either adjuvant durvalumab for 12 cycles (experimental arm) or observation (control arm). The primary objective of the study is to determine whether additional adjuvant immunotherapy with durvalumab after neoadjuvant chemo-immunotherapy has an effect on disease-free survival (DFS) in patients who do not achieve complete pathological response (pCR) as per local assessment according to the IASLC recommendations., conditionsModule conditions: Non Small Cell Lung Cancer, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 290, type: ESTIMATED, armsInterventionsModule interventions name: Adjuvant durvalumab, outcomesModule primaryOutcomes measure: Disease-free survival (DFS), secondaryOutcomes measure: Response rate as per investigator assessment., secondaryOutcomes measure: Proportion of patients undergoing surgery, secondaryOutcomes measure: Proportion of patients with surgical outcome R0 and R1, secondaryOutcomes measure: pCR rate, secondaryOutcomes measure: Proportion of patients eligible for randomisation, secondaryOutcomes measure: Proportion of patients effectively randomised, secondaryOutcomes measure: Toxicity according to CTCAE v5.0, secondaryOutcomes measure: DFS in patients with pCR, secondaryOutcomes measure: Overall survival (OS) in patients with/without pCR, secondaryOutcomes measure: DFS in patients with/without ctDNA clearance, secondaryOutcomes measure: Time to recurrence (TTR) in patients with/without pCR, secondaryOutcomes measure: Time to treatment discontinuation (TTD) in patients with/without pCR, secondaryOutcomes measure: Toxicity according to CTCAE v5.0, otherOutcomes measure: Correlation between ctDNA clearance and pathological response, otherOutcomes measure: Correlation between ctDNA clearance and DFS, otherOutcomes measure: Correlation between ctDNA clearance and OS, otherOutcomes measure: Correlation between ctDNA clearance and initial PD-L1 assessment, otherOutcomes measure: Outcome (OS), otherOutcomes measure: Outcome (event-free survival), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False