Trial · NCT04302025
Registered outcomes15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 15 of 15
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Tyrosine Kinase Inhibitor (TKI) Cohort: Proportion of Participants With Major Pathologic Response (MPR) | After surgical resection (approximately study Week 8) | MPR is defined as ≤ 10% residual viable tumor cells as scored by local pathologists. |
| Primary | Checkpoint Inhibitor (CPI) Cohort: Pathological Complete Response (pCR) | After surgical resection (approximately study Week 8) | Scored by local pathologists; defined as lack of any viable tumor cells on review of hematoxylin and eosin (H\&E) slides after complete evaluation of a resected lung cancer specimen including all sampled regional lymph nodes. |
| Primary | KRAS G12C Cohort: Percentage of Participants With 3-5 Grade Adverse Events (AEs) | After surgical resection (approximately study Week 8) | |
| Primary | KRAS G12C Cohort: Percentage of Participants Without Delays of Surgery due to Treatment-related AEs as Reported by the Investigator | After surgical resection (approximately study Week 8) | |
| Secondary | Proportion of Participants With MPR | After surgical resection (approximately study Week 8) | Defined as ≤10% residual viable tumor cells) based on surgical resection as defined by Hellmann et al. (2014) and Travis et al. (2020). TKI cohorts: MPR will be scored by a central pathology committee consensus read. CPI cohort: MPR will be scored by local pathologists and central pathology committee consensus read. KRAS G12C cohort: MPR will be scored by local pathologists and central pathology committee consensus read. |
| Secondary | Proportion of Participants With pCR | After surgical resection (approximately study Week 8) | Defined as lack of any viable tumor cells on review of H\&E slides after complete evaluation of a resected lung cancer specimen, including all sampled regional lymph nodes. TKI cohorts: pCR will be scored by local pathologists and a central pathology committee consensus read. CPI cohort: pCR will be scored by a central pathology committee consensus read. KRAS G12C cohort: pCR will be scored by a central pathology committee consensus read. |
| Secondary | Pathological Regression Based on Weighted % Viable Tumor Cell Assessment | After surgical resection (approximately study Week 8) | |
| Secondary | Investigator-assessed Response Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) | After neoadjuvant treatment (after approximately study Week 8) | |
| Secondary | Disease-free Survival (DFS) | From the first date of no disease to local or distant recurrence or death from any cause, whichever occurs first, through the end of the study (up to 9 years) | |
| Secondary | Event-free Survival (EFS) | From first dose of study treatment to first documented disease progression per RECIST v1.1, or local or distant disease recurrence as determined by investigator, or death from any cause, whichever occurs first, through the end of study (up to 9 years) | |
| Secondary | Overall Survival (OS) | From the first dose of study medication to death from any cause, through the end of the study (up to 9 years) | |
| Secondary | Percentage of Participants With AEs | Up to 9 years | |
| Secondary | Nodal Downstaging | After surgical resection (approximately study Week 8) | Defined as percentage of participants with reduced stages in regional lymph nodes at surgery. |
| Secondary | Circulating tumor DNA (ctDNA) Clearance Rate | Prior to surgery (before study Week 8) | |
| Secondary | KRAS G12C Cohort: Plasma Concentration of Divarasib at Specified Timepoints | Neo-adjuvant: pre-dose & 2 hours post-dose on Day 1 of Cycles 1 & 2; Pre-surgery (before Week 8): pre-dose; Adjuvant treatment: pre-dose & 2 hours post-dose on Day 1 of Cycles 1-6, pre-dose on Day 1 of Cycle 9 (each cycle=28 days); | * Treatment completion/discontinuation; * Disease Progression or Recurrence during Neoadjuvant treatment or Surveillance; * Unscheduled (Tumor Evaluation and Response) \[Anytime up to 3 years\] |
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
Read this list from software.
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GET https://conductscience.org/api/trials/v1/NCT04302025/registered