Trial · NCT07885709
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 12 of 12
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Pathological complete response (pCR) rate in the treatment-escalation population | At the time of definitive surgery, approximately 13 to 18 weeks after initiation of neoadjuvant therapy | pCR is defined as the absence of residual viable tumor cells in the primary lung tumor and all sampled regional lymph nodes upon systematic pathological review of the surgical specimen, per the IASLC 2020 pathological evaluation criteria. The treatment-escalation population comprises patients with ctDNA non-clearance and radiological stable disease (SD) after two cycles of neoadjuvant therapy. |
| Secondary | Major pathological response (MPR) rate in the treatment-escalation population | At the time of definitive surgery, approximately 13 to 18 weeks after initiation of neoadjuvant therapy | MPR is defined as ≤10% residual viable tumor cells in the primary lung tumor and regional lymph nodes upon pathological review of the surgical specimen; carcinoma in situ is excluded from the MPR calculation. The treatment-escalation population comprises patients with ctDNA non-clearance and radiological stable disease (SD) after two cycles of neoadjuvant therapy. |
| Secondary | Pathological complete response (pCR) rate in the intention-to-treat (ITT) population | At the time of definitive surgery, approximately 13 to 18 weeks after initiation of neoadjuvant therapy | pCR is defined as the absence of residual viable tumor cells in the primary lung tumor and all sampled regional lymph nodes upon systematic pathological review of the surgical specimen, per the IASLC 2020 pathological evaluation criteria. The ITT population comprises all enrolled patients. |
| Secondary | Major pathological response (MPR) rate in the intention-to-treat (ITT) population | At the time of definitive surgery, approximately 13 to 18 weeks after initiation of neoadjuvant therapy | MPR is defined as ≤10% residual viable tumor cells in the primary lung tumor and regional lymph nodes upon pathological review of the surgical specimen; carcinoma in situ is excluded from the MPR calculation. The ITT population comprises all enrolled patients. |
| Secondary | 2-year event-free survival (EFS) rate in the treatment-escalation and ITT populations | 2 years | EFS is defined as the time from initiation of neoadjuvant therapy to the first occurrence of any of the following, whichever occurs first: radiological disease progression per RECIST 1.1 precluding surgery, local or distant recurrence, or death from any cause |
| Secondary | 2-year overall survival (OS) rate in the treatment-escalation and ITT populations | 2 years | OS is defined as the time from initiation of neoadjuvant therapy to death from any cause. |
| Secondary | Objective response rate (ORR) in the treatment-escalation and ITT populations | After completion of neoadjuvant therapy (3-4 cycles; each cycle is 21 days), before definitive surgery | Assessed per RECIST 1.1. ORR is defined as the proportion of patients achieving complete response (CR) or partial response (PR). |
| Secondary | Disease control rate (DCR) in the treatment-escalation and ITT populations | After completion of neoadjuvant therapy (3-4 cycles; each cycle is 21 days), before definitive surgery | Assessed per RECIST 1.1. DCR is defined as the proportion of patients achieving complete response (CR), partial response (PR), or stable disease (SD). |
| Secondary | Incidence and severity of treatment-related adverse events (TRAEs) | From first dose through 90 days after the last dose of study treatment | Adverse events graded and recorded according to NCI-CTCAE version 5.0. |
| Other | ctDNA-MRD clearance rate (proportion of patients with undetectable ctDNA) at each assessment time point | At baseline (Cycle 1 Day 1), on Cycle 2 Day 14, and preoperatively on the day of surgery (each cycle is 21 days) | |
| Other | Correlation between ctDNA-MRD status (cleared vs. not cleared) and pathological response (pCR/MPR) | At the time of definitive surgery | |
| Other | Correlation between ctDNA-MRD dynamics (time to clearance, rate of decline) and EFS | From treatment initiation through follow-up, up to 2 years |
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
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