This is a phase 3, randomized, double-blind study of adjuvant calderasib plus subcutaneous pembrolizumab and berahyaluronidase alfa (MK-3475A) versus adjuvant placebo plus MK-3475a in participants with completely resected stage IIA-IIIB (N2), KRAS G12C-mutant non-small cell lung cancer following receipt of either neoadjuvant pembrolizumab plus chemotherapy or adjuvant chemotherapy. The primary goal of the study is to compare adjuvant calderasib plus MK-3475A to adjuvant placebo plus MK-3475A with respect to disease-free survival (DFS) as assessed by the investigator.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
400
MK-1084 oral tablet
Fixed dose coformulated product of hyaluronidase/pembrolizumab administered via SC injection.
Placebo oral tablet
Lviv Territorial Medical Union Multidisciplinary Clinical Hospital
Lviv, Ukraine
RECRUITINGDisease-free Survival (DFS)
DFS is the time from randomization to any recurrence (local, locoregional, regional, or distant), occurrence of new primary NSCLC, or death due to any cause, whichever occurs first.
Time frame: Up to ~11 years
Overall Survival (OS)
OS is the time from randomization to death due to any cause.
Time frame: Up to ~11 years
Distant Metastasis-Free Survival (DMFS)
DMFS is the time from randomization to the first documented distant metastasis or death due to any cause, whichever occurs first. Distant metastasis refers to cancer that has spread from the original (primary) tumor to distant organs or distant lymph nodes.
Time frame: Up to ~11 years
Lung Cancer Specific Survival (LCSS)
LCSS is the time from randomization to the date of death due to lung cancer.
Time frame: Up to ~11 years
Change from Baseline in the European Organization for Research and Treatment of Cancer (EORTC)-Quality of Life Questionnaire-Core 30 (QLQ-C30) Global Health Status (Item 29) and Quality of Life (Item 30) Combined Score
Change from baseline in Global health status/QoL score (QLQ-C30 Items 29 and 30).
Time frame: Up to ~11 years
Change from Baseline in the EORTC-QLQ-C30 Physical Functioning (Items 1-5) Combined Score
Change from baseline in physical functioning score (QLQ-C30 Items 1 to 5).
Time frame: Up to ~11 years
Change from Baseline in the EORTC-QLQ-C30 Role Functioning (Items 6 and 7) Combined Score
Change from baseline in role functioning score (QLQ-C30 Items 6 and 7).
Time frame: Up to ~11 years
Change from Baseline in the EORTC-QLQ-C30 Dyspnea (Item 8) Score
Change from baseline in dyspnea (QLQ-C30 Item 8).
Time frame: Up to ~11 years
Change from Baseline in the EORTC-Quality of Life Questionnaire-Lung Cancer 24 (QLQ-LC24) Coughing (Items 31 and 52) Combined Score
Change from baseline in coughing scores (EORTC QLQ-LC24 Items 31 and 52).
Time frame: Up to ~11 years
Change from Baseline in the EORTC-QLQ-LC24 Chest Pain (Item 40) Score
Change from baseline in chest pain score (EORTC QLQ-LC24 Item 40).
Time frame: Up to ~11 years
Number of Participants Who Experience an Adverse Event (AE)
Number of participants with ≥1 AE.
Time frame: Up to ~13.5 years
Number of Participants Who Discontinue Study Treatment Due to an AE
Number of participants discontinuing from study therapy due to AE.
Time frame: Up to ~13.5 years
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