Trial · NCT06788912
Registered outcomes13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 13 of 13
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Pathological Complete Response (pCR) | Up to approximately 20 weeks | pCR is defined as absence of residual viable invasive cancer on hematoxylin- and eosin-stained slides of the resected lung specimen and lymph nodes. |
| Primary | Percent Residual Viable Tumor (%RVT) | Up to approximately 20 weeks | %RVT is defined as the percentage of residual tumor estimated by comparing the estimated cross-sectional area of viable tumor with estimated cross-sectional areas of remainder of tumor bed. The tumor bed is defined as the area of tissue occupied by viable tumor or tumoral regression (includes areas of necrosis, foamy macrophages, giant cell reaction, cholesterol cleft granuloma, and inflammation.) |
| Secondary | Percentage of Participants Who Report at Least 1 Adverse Event (AE) | Up to approximately 5 years | An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. |
| Secondary | Percentage of Participants Who Discontinue Study Treatment Due to an AE | Up to approximately 1 year | An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. |
| Secondary | Event-free Survival (EFS) | Up to approximately 5 years | EFS is defined as the time from randomization to any of the following events: radiographic disease progression per Response Evaluation Criteria In Solid Tumors 1.1 (RECIST 1.1) (for participants who have not had or will not have surgery, or participants who have gross residual disease after an incomplete resection \[R2 resection\]); local progression (primary tumor or regional lymph nodes) or distant metastasis precluding planned surgery; tumor determined to be unresectable in the operating room; local or distant recurrence (for participants who are disease free after surgery or participants with microscopic positive margins \[R1 resection\]); occurrence of new primary NCSLC; death due to any cause. |
| Secondary | Overall Survival (OS) | Up to approximately 5 years | OS is defined as the time from randomization to death due to any cause. |
| Secondary | Distant Metastasis-Free Survival (DMFS) | Up to approximately 5 years | DMFS is defined as the time from randomization to the date of diagnosis of distant metastasis or death, whichever occurs first. |
| Secondary | Objective Response Rate (ORR) | Up to approximately 12 weeks | OR is defined as a complete response or partial response with or without confirmation per RECIST 1.1 as assessed by the investigator during the Neoadjuvant Phase. |
| Secondary | Percentage of Participants Who Experience a Perioperative Complication | Up to approximately 20 weeks | Perioperative Complications include both intraoperative and postoperative complications. |
| Secondary | Mean Length of Hospital Stay | Up to approximately 20 weeks | Hospital Stay is the length of inpatient time spent in hospital. |
| Secondary | Percentage of Participants Who Require Hospital Readmission after Discharge | Up to approximately 20 weeks | In participants previously discharged from hospital, the percentage requiring readmission to hospital. |
| Secondary | Mean Length of Surgery | Up to approximately 20 weeks | Length of surgery is the time spent in surgery. |
| Secondary | Percentage of Participants Who Require a Blood Transfusion | Up to approximately 20 weeks | Blood transfusion is the transfer of donated blood into the vein of a recipient. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license 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.
For software
Read this list from software.
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GET https://conductscience.org/api/trials/v1/NCT06788912/registered