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Trial · NCT07538193

Registered outcomes12

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

ListOutcomeTime frameDescription
PrimaryPathological Complete Response (pCR) rateAt the time of surgery, approximately 9-15 weeks after enrollmentThe percentage of subjects with no residual viable tumor cells in the resected primary tumor bed and lymph nodes after lung cancer resection.
SecondaryMajor Pathological Response (MPR) rateAt the time of surgery, approximately 9-15 weeks after enrollmentThe percentage of subjects with ≤10% residual viable tumor cells in the resected primary tumor bed and lymph nodes after lung cancer resection.
SecondaryObjective Response Rate (ORR)From enrollment to pre-surgery assessment, approximately 9-15 weeksThe proportion of subjects achieving complete response (CR) or partial response (PR) on imaging according to RECIST v1.1 criteria prior to surgery.
SecondaryR0 Resection RateAt the time of surgeryThe percentage of subjects undergoing lung cancer resection who achieve complete resection with negative margins.
SecondaryEvent-Free Survival (EFS)From enrollment to up to 2 years post-surgeryDefined as the time from first study drug administration to the occurrence of disease progression precluding surgery, local or distant recurrence, or death from any cause.
SecondaryOverall Survival (OS)From enrollment to up to 2 years post-surgery or deathDefined as the time from first study drug administration to death from any cause.
SecondarySafety and TolerabilityFrom first dose to 90 days after last doseIncidence and severity of adverse events (AEs) and serious adverse events (SAEs), graded according to NCI-CTCAE v5.0; rates of dose interruptions, modifications, and discontinuations due to AEs.
SecondaryRate of Delayed or Cancelled SurgeryFrom completion of neoadjuvant therapy to scheduled surgery date, approximately 6 weeksThe percentage of subjects whose planned surgery is delayed beyond the protocol-specified window or cancelled.
SecondarySurgery DurationAt the time of surgeryThe total time from surgical incision to closure, measured in minutes.
SecondaryHospitalization DurationFrom surgery date to hospital discharge, approximately 1-4 weeksThe total number of days from surgery to hospital discharge.
SecondarySurgical MethodAt the time of surgeryThe type of surgical procedure performed (e.g., lobectomy, pneumonectomy, sleeve resection, etc.) and surgical approach (e.g., open thoracotomy, video-assisted thoracoscopic surgery \[VATS\]).
SecondaryIncidence of Surgery-Related Adverse EventsFrom surgery to 90 days post-surgery
The incidence and severity of surgery-related adverse events, including intraoperative complications (e.g., pneumonia, respiratory distress syndrome, packed red blood cell transfusion, bronchopleural fistula, air leak), readmission to intensive care unit, atrial fibrillation, and other supraventricular tachycardia (SVT).

Source ClinicalTrials.govtrials-2026-11-12-0.4.0

Sources 3

  • ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
  • ClinicalTrials.govNone stated
  • NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
  • ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
  • ClinicalTrials.govnone stated
  • NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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