Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT07554339 | A Clinical Trial of Calderasib (MK-1084) and Durvalumab in People With Non-Small Cell Lung Cancer (MK-1084-015/KANDLELIT-015) | PHASE3 | RECRUITING | 310 | — | — | Jun 5, 2026 | Aug 17, 2037 | Jun 3, 2026 | 5 | United States, South Korea +2 |
| NCT07431827 | MK-3475A±Calderasib (MK-1084) in Completely Resected Stage IIA-IIIB (N2) KRAS G12Cm NSCLC (MK-1084-013) | PHASE3 | RECRUITING | 400 | — | — | Mar 18, 2026 | Oct 26, 2039 | Jun 3, 2026 | 36 | Argentina, China +6 |
| NCT07190248 | A Clinical Study of Calderasib (MK-1084) and Other Treatments for Participants With Non-Small Cell Lung Cancer (MK-1084-007/KANDLELIT-007) | PHASE3 | RECRUITING | 675 | — | — | Oct 8, 2025 | Aug 6, 2032 | Jun 8, 2026 | 175 | United States, Argentina +26 |
| NCT06345729 | A Study of Calderasib (MK-1084) Plus Pembrolizumab (MK-3475) in Participants With KRAS G12C Mutant Non-small Cell Lung Cancer (NSCLC) With Programmed Cell Death Ligand 1 (PD-L1) Tumor Proportion Score (TPS) ≥50% (MK-1084-004/KANDLELIT-004) | PHASE3 | RECRUITING | 600 | — | — | May 24, 2024 | Feb 18, 2031 | Jun 8, 2026 | 225 | United States, Argentina +25 |
| NCT06575933 | A Study of Calderasib (MK-1084) With Midazolam and Digoxin in Healthy Participants (MK-1084-009) | PHASE1 | COMPLETED | 28 | — | — | Sep 3, 2024 | Oct 28, 2024 | Feb 11, 2026 | 1 | United States |
PFS is defined as the time from randomization to the first documented disease progression or death due to any cause, whichever occurs first.
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.
PFS is defined as the time from randomization until either documented disease progression per Response Criteria in Solid Tumors Version 1.1 (RECIST 1.1) or death due to any cause, whichever occurs first. PFS as determined by blinded independent central review (BICR) will be presented.
OS is defined as the time from randomization to death due to any cause.
Blood samples will be collected to determine the AUC0-inf of midazolam.
Blood samples will be collected to determine the AUC0-last of midazolam.
Blood samples will be collected to determine the AUC0-24hr of midazolam.
Blood samples will be collected to determine the Cmax of midazolam.
Blood samples will be collected to determine the Tmax of midazolam.
Blood samples will be collected to determine the t1/2 of midazolam.
Blood samples will be collected to determine the CL/F of midazolam.
Blood samples will be collected to determine the Vz/F of midazolam.
Blood samples will be collected to determine the AUC0-inf of digoxin.
Blood samples will be collected to determine the AUC0-last of digoxin.
Blood samples will be collected to determine the AUC0-24hr of digoxin.
Blood samples will be collected to determine the Cmax of digoxin.
Blood samples will be collected to determine the Tmax of digoxin.
Blood samples will be collected to determine the t1/2 of digoxin.
Blood samples will be collected to determine the CL/F of digoxin.
Blood samples will be collected to determine the Vz/F of digoxin.
| Arm | Type | Description |
|---|---|---|
| Calderasib + Durvalumab | EXPERIMENTAL | Participants will receive calderasib and durvalumab. |
| Placebo + Durvalumab | ACTIVE_COMPARATOR | Participants will receive placebo to calderasib and durvalumab. |
| Calderasib + MK-3475A | EXPERIMENTAL | Participants receive calderasib daily (qd) and MK-3475A every 6 weeks (q6w) for up to 9 doses. |
| Placebo + MK-3475A | ACTIVE_COMPARATOR | Participants receive placebo qd and MK-3475A q6w for up to 9 doses. |
| Calderasib + Pembrolizumab (+) Berahyaluronidase alfa | EXPERIMENTAL | Participants will receive pembrolizumab (+) berahyaluronidase alfa at a fixed dose subcutaneously on Day 1 of each 6-week cycle for up to 18 cycles (approximately 2 years) plus calderasib until discontinuation criterion is met. |
| Pembrolizumab (+) Berahyaluronidase alfa + Chemotherapy | ACTIVE_COMPARATOR | Participants will receive pembrolizumab (+) berahyaluronidase alfa at a fixed dose subcutaneously on Day 1 of each 6-week cycle for up to 18 cycles (approximately 2 years) and pemetrexed via intravenous (IV) infusion at a dose of 500 mg/m\^2 on days 1 and 22 of cycles 1 and 3 until discontinuation criterion is met PLUS investigator's choice of carboplatin via IV infusion at area under curve (AUC) 5 mg/mL/minute on days 1 and 22 of cycles 1 and 3 (up to 4 doses, approximately 6 weeks) OR cisplatin via IV infusion at a dose of 75 mg/m\^2 on days 1 and 22 of cycles 1 and 3 (up to 4 doses, approximately 6 weeks). |
| Calderasib with Pembrolizumab | EXPERIMENTAL | Participants receive pembrolizumab 200 mg via intravenous (IV) infusion on Day 1 of each 21-day cycle (Q3W) for up to 35 cycles and calderasib by oral tablets until discontinuation criterion is met. |
| Placebo with Pembrolizumab | ACTIVE_COMPARATOR | Participants receive pembrolizumab 200 mg via intravenous (IV) infusion on Day 1 of each 21-day cycle (Q3W) for up to 35 cycles and placebo by oral tablets once daily until discontinuation criterion is met. |
| Period 1: Midazolam and Digoxin | EXPERIMENTAL | Participants will receive a single oral dose of midazolam and a single oral dose of digoxin on Day 1. |
| Period 2: Calderasib, Midazolam, and Digoxin | EXPERIMENTAL | A washout period of at least 10 days will occur following midazolam and digoxin dosing in Period 1 and the first calderasib dosing in Period 2. Participants will receive calderasib once daily on Days 1 through Day 15 with a single oral dose of midazolam on Days 1, 6, and 14 and a single oral dose of digoxin on Days 1 and 11. |
| Name | Type | Description |
|---|---|---|
| Calderasib | DRUG | Tablet for oral administration. |
| Durvalumab | BIOLOGICAL | Solution for intravenous (IV) infusion. |
| Placebo to MK-1084 | OTHER | Placebo to MK-1084. |
| MK-3475A | BIOLOGICAL | Fixed dose coformulated product of hyaluronidase/pembrolizumab administered via SC injection. |
| Placebo | DRUG | Placebo oral tablet |
| Pembrolizumab (+) Berahyaluronidase alfa | BIOLOGICAL | Administered as a SC injection |
| Pemetrexed | DRUG | Administered as an IV Infusion |
| Cisplatin | DRUG | Administered as an IV Infusion |
| Carboplatin | DRUG | Administered as an IV Infusion |
| Pembrolizumab | BIOLOGICAL | IV infusion |
| Midazolam | DRUG | Oral administration |
| Digoxin | DRUG | Oral administration |
Inclusion Criteria: The main inclusion criteria include but are not limited to the following: * Has a histological or cytological diagnosis of locally advanced, unresected Stage II (node-positive) to III non-small cell lung cancer (NSCLC) with predominantly nonsquamous histology. * Has completed d...