Divarasib
DrugDivarasib will be administered orally QD
NCT Number: NCT06497556
The purpose of this study is to assess the safety and efficacy of divarasib compared to locally approved KRAS G12C inhibitors (sotorasib or adagrasib) in participants with KRAS G12C-positive (KRAS G12C +) advanced or metastatic non-small cell lung cancer (NSCLC).
This study is active but is not currently recruiting participants.
Notify Me18 year and older
All sexes
Interventional
Phase 3
Hospital Britanico, Buenos Aires, Argentina
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Divarasib will be administered orally QD
Sotorasib will be administered orally QD
Adagrasib will be administred orally BID
Time frame: Up to approximately 4 years
PFS is defined as the time from randomization to the first occurrence of disease progression, as determined by blinded independent central review (BICR) according to RECIST v1.1, or death from any cause (whichever occurs first)
Time frame: Up to approximately 4 years
OS is defined as the time from randomization to death from any cause
Time frame: Up to approximately 4 years
Confirmed objective response is defined as complete response (CR) or partial response (PR) on two occasions ≥ 4 weeks apart, as determined by BICR according to RECIST v1.1
Time frame: Baseline up to approximately 4 years
Time frame: Baseline up to approximately 4 years
Time frame: Up to approximately 4 years
DOR is defined as the time from the first occurrence of a documented confirmed objective response to disease progression, as determined by BICR according to RECIST v1.1, or death from any cause (whichever occurs first)
Time frame: Up to approximately 4 years
Time frame: Up to approximately 4 years
Time frame: Baseline up to approximately 4 years
Time frame: Up to approximately 4 years
Time frame: Baseline up to approximately 4 years
Time frame: Up to approximately 4 years
Time frame: Up to approximately 4 years
Hoffmann-La Roche
Industry
A Phase III, Randomized, Open-Label, Multicenter Study Evaluating the Efficacy and Safety of Divarasib Versus Sotorasib or Adagrasib in Patients With Previously Treated KRAS G12C-Positive Advanced or Metastatic Non-Small Cell Lung Cancer
Acronym: Krascendo 1
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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