Calderasib Clinical Trials (2026): 15 Studies for Healthy & Non-small Cell Lung Cancer
Hipa.ai Research · Source: ClinicalTrials.gov / AACT
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15 Calderasib clinical trials are catalogued on Hipa.ai from the AACT mirror of ClinicalTrials.gov, spanning 5 indications (including Healthy & Non-small Cell Lung Cancer) and 3,722 total planned enrollment. 5 Phase 3 Calderasib trials and 1 Phase 2 are listed. 8 Calderasib clinical trials are actively recruiting at 63 U.S. sites across 29 states. Most recent activity: NCT07431827 (Oct 2039).
Where to Participate: All Calderasib Trial Sites in the U.S. (63 sites across 29 states)
Every actively recruiting Calderasibtrial site, sorted by state then city. Each row links to the trial detail page (eligibility, contacts, full study record). Sites no longer enrolling at the location level are excluded. ClinicalTrials.gov / AACT does not provide street-level addresses; the map link uses the facility's geocoded coordinates where available.
| State | Facility | City | Trial | Map |
|---|---|---|---|---|
| AL | Central Alabama Research ( Site 0108) | Birmingham35209 | NCT07190248 | Map |
| AZ | Arizona Clinical Trials ( Site 0003) | Chandler85225 | NCT07219550 | Map |
| CA | CBCC Global Research, Inc. ( Site 0123) | Bakersfield93309 | NCT06345729 | Map |
| CA | Beverly Hills Cancer Center ( Site 0116) | Beverly Hills90211 | NCT06345729 | Map |
| CA | Los Angeles Hematology Oncology Medical Group ( Site 0084) | Los Angeles90017 | NCT06997497 | Map |
| CO | University of Colorado Health - Harmony-Cancer Care and Hematology - Ft. Collins ( Site 0087) | Fort Collins80528 | NCT06997497 | Map |
| CO | Rocky Mountain Cancer Centers (RMCC) ( Site 8000) | Lone Tree80124 | NCT06997497 | Map |
| CT | Stamford Hospital ( Site 0126) | Stamford06902 | NCT07190248 | Map |
| CT | Stamford Hospital ( Site 0136) | Stamford06902 | NCT06345729 | Map |
| FL | Florida Cancer Specialists - South ( Site 7002) | Fort Myers33901 | NCT06997497 | Map |
| FL | Orlando Clinical Research Center ( Site 0001) | Orlando32809 | NCT07219550 | Map |
| FL | Orlando Health Cancer Institute ( Site 0065) | Orlando32806 | NCT06997497 | Map |
| FL | Florida Cancer Specialists - North ( Site 7001) | St. Petersburg33705 | NCT06997497 | Map |
| FL | Moffitt Cancer Center ( Site 0261) | Tampa33612 | NCT05067283 | Map |
| FL | Florida Cancer Specialists - East ( Site 7000) | West Palm Beach33401 | NCT06997497 | Map |
| IL | Orchard Healthcare Research Inc. ( Site 0115) | Skokie60077 | NCT06345729 | Map |
| IN | Indiana University Health Arnett Cancer Center ( Site 0116) | Lafayette47904 | NCT07190248 | Map |
| IA | University of Iowa ( Site 0074) | Iowa City52242 | NCT06997497 | Map |
| KY | University of Kentucky ( Site 0055) | Lexington40536 | NCT06997497 | Map |
| KY | Norton Cancer Institute, Audubon Hospital Campus ( Site 0054) | Louisville40217 | NCT06997497 | Map |
| ME | New England Cancer Specialists ( Site 0139) | Westbrook04092 | NCT07190248 | Map |
| MD | Greater Baltimore Medical Center ( Site 0068) | Baltimore21204 | NCT06997497 | Map |
| MD | Greater Baltimore Medical Center ( Site 1104) | Baltimore21204 | NCT07209111 | Map |
| MI | START Midwest ( Site 0267) | Grand Rapids49546 | NCT05067283 | Map |
| MI | START Midwest ( Site 1103) | Grand Rapids49546 | NCT07209111 | Map |
| MS | Hattiesburg Clinic ( Site 0064) | Hattiesburg39401 | NCT06997497 | Map |
| MO | Truman Medical Center ( Site 0126) | Kansas City64108 | NCT06345729 | Map |
| MO | Cox Medical Center North ( Site 0133) | Springfield65807 | NCT06345729 | Map |
| MT | Intermountain Health St. Vincent Regional Hospital - Cancer Centers of Montana ( Site 2000) | Billings59102 | NCT06997497 | Map |
| MT | St. Vincent Frontier Cancer Center-Research ( Site 0105) | Billings59102 | NCT06345729 | Map |
| NE | NHO Revive Research Institute LLC ( Site 0118) | Lincoln68506 | NCT07554339 | Map |
| NE | University Of Nebraska Medical Center ( Site 0078) | Omaha68198 | NCT06997497 | Map |
| NV | Comprehensive Cancer Centers of Nevada ( Site 1109) | Las Vegas89169 | NCT07209111 | Map |
| NV | Renown Regional Medical Center ( Site 0056) | Reno89502 | NCT06997497 | Map |
| NJ | John Theurer Cancer Center at Hackensack University Medical Center ( Site 0060) | Hackensack07601 | NCT06997497 | Map |
| NJ | John Theurer Cancer Center at Hackensack University Medical Center ( Site 0260) | Hackensack07601 | NCT05067283 | Map |
| NJ | Atlantic Health System Morristown Medical Center ( Site 0121) | Morristown07960 | NCT06345729 | Map |
| NJ | Rutgers Cancer Institute of New Jersey ( Site 1100) | New Brunswick08903 | NCT07209111 | Map |
| NM | San Juan Oncology Associates, P.C ( Site 2011) | Farmington87401 | NCT06997497 | Map |
| NY | New York Oncology Hematology, P.C. ( Site 0119) | Albany12206 | NCT07190248 | Map |
| NY | New York Oncology Hematology, P.C. ( Site 0132) | Albany12206 | NCT06345729 | Map |
| NY | Ellis Hospital ( Site 0098) | Schenectady12308 | NCT06997497 | Map |
| OH | Miami Valley Hospital South ( Site 0075) | Centerville45459 | NCT06997497 | Map |
| OH | University of Cincinnati Medical Center-University of Cincinnati Cancer Center ( Site 0103) | Cincinnati45219 | NCT06345729 | Map |
| OR | St. Charles Health System, Inc ( Site 0146) | Bend97701 | NCT07190248 | Map |
| PA | Lancaster General Hospital - Ann B Barshinger Cancer Institute ( Site 0111) | Lancaster17601 | NCT07190248 | Map |
| PA | Lancaster General Hospital - Ann B Barshinger Cancer Institute ( Site 0134) | Lancaster17601 | NCT06345729 | Map |
| TX | Texas Oncology - DFW ( Site 8002) | Dallas75246 | NCT06997497 | Map |
| TX | UT Southwestern Medical Center ( Site 0059) | Dallas75390 | NCT06997497 | Map |
| TX | Texas Oncology - Northeast Texas ( Site 8001) | Denison75020 | NCT06997497 | Map |
| TX | Oncology Consultants P.A. ( Site 0113) | Houston77030 | NCT06345729 | Map |
| TX | Texas Oncology - San Antonio ( Site 8004) | San Antonio78240 | NCT06997497 | Map |
| TX | The Texas Liver Institute ( Site 0002) | San Antonio78215 | NCT07219550 | Map |
| UT | Community Cancer Trials of Utah ( Site 0086) | Ogden84405 | NCT06997497 | Map |
| UT | START Mountain Region ( Site 1106) | West Valley City84119 | NCT07209111 | Map |
| VA | University of Virginia ( Site 0080) | Charlottesville22908 | NCT06997497 | Map |
| VA | NEXT Virginia ( Site 0271) | Fairfax22031 | NCT05067283 | Map |
| VA | Virginia Cancer Specialists ( Site 1102) | Fairfax22031 | NCT07209111 | Map |
| VA | Virginia Cancer Specialists, PC ( Site 0069) | Fairfax22031 | NCT06997497 | Map |
| VA | Blue Ridge Cancer Care ( Site 0144) | Roanoke24014 | NCT07190248 | Map |
| WA | Fred Hutchinson Cancer Center ( Site 0076) | Seattle98109 | NCT06997497 | Map |
| WI | Circuit Clinical/SSM Health Dean Medical Group ( Site 0129) | Madison53715 | NCT06345729 | Map |
| WI | MEDICAL COLLEGE OF WISCONSIN-Cancer Center Clinical Trials Office ( Site 0262) | Milwaukee53226 | NCT05067283 | Map |
Calderasib clinical trials at a glance: phase × recruitment status
| Phase | recruiting | completed | Total |
|---|---|---|---|
| P1 | 2 | 7 | 9 |
| P2 | 1 | 1 | |
| P3 | 5 | 5 |
Recruiting Calderasib clinical trials (8)
Studies currently enrolling participants. Click any NCT ID to view the trial detail page (eligibility, sites, contacts).
| NCT ID | Title | Phase | Indication | Enrollment | Started |
|---|---|---|---|---|---|
| NCT07431827 | KANDLELIT-013MK-3475A±Calderasib (MK-1084) in Completely Resected Stage IIA-IIIB (N2) KRAS G12Cm NSCLC (MK-1084-013) | P3 | Non-small Cell Lung Cancer | 400 | Mar 2026 |
| NCT07554339 | MK-1084A Clinical Trial of Calderasib (MK-1084) and Durvalumab in People With Non-Small Cell Lung Cancer (MK-1084-015/KANDLELIT-015) | P3 | Non-small Cell Lung Cancer | 310 | Jun 2026 |
| NCT07190248 | MK-1084A Clinical Study of Calderasib (MK-1084) and Other Treatments for Participants With Non-Small Cell Lung Cancer (MK-1084-007/KANDLELIT-007) | P3 | Non-small Cell Lung Cancer | 675 | Oct 2025 |
| NCT07209111 | KANDLELIT-014A Clinical Study of Calderasib (MK-1084) in People With Advanced Solid Tumors (MK-1084-014) | P2 | Neoplasm Malignant | 150 | Dec 2025 |
| NCT06345729 | MK-1084A 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) | P3 | Non-small Cell Lung Cancer | 600 | May 2024 |
| NCT06997497 | MK-1084A Clinical Study of Calderasib (MK-1084) With Targeted Therapy and Chemotherapy in People With Colorectal Cancer (MK-1084-012/KANDLELIT-012) | P3 | Colon Adenocarcinoma | 477 | Jul 2025 |
| NCT05067283 | KANDLELIT-001A Study of Calderasib (MK-1084) in KRAS Mutant Advanced Solid Tumors (MK-1084-001) | P1 | Advanced Solid Tumors | 830 | Dec 2021 |
| NCT07219550 | MK-1084A Study of Calderasib (MK-1084) in Participants With Hepatic Impairment and Healthy Volunteers (MK-1084-017) | P1 | Healthy | 58 | Nov 2025 |
Calderasib clinical trials by indication
Healthy (7)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT07219550 | MK-1084 | P1 | recruiting | A Study of Calderasib (MK-1084) in Participants With Hepatic Impairment and Healthy Volunteers (MK-1084-017) |
| NCT06814119 | MK-1084 | P1 | completed | A Clinical Study of Calderasib (MK-1084) in Participants With Renal Impairment (MK-1084-010) |
| NCT07222098 | MK-1084 | P1 | completed | A Clinical Study of Calderasib (MK-1084) With Rosuvastatin and Metformin in Healthy People (MK-1084-016) |
| NCT06942741 | MK-1084 | P1 | completed | A Study to Evaluate the Effect of Formulation and Food on Calderasib (MK-1084) in Healthy Adult Participants (MK-1084-011) |
| NCT06687759 | MK-1084 | P1 | completed | A Study of Calderasib (MK-1084) Human Absorption, Distribution, Metabolism, and Excretion in Healthy Adult Participants (MK-1084-006) |
| NCT06719557 | MK-1084 | P1 | completed | A Study of the Effect of Itraconazole and Phenytoin on Calderasib (MK-1084) in Healthy Adults (MK-1084-008) |
| NCT06619314 | PPI | P1 | completed | A Study to Evaluate the Effect of Food, Formulation, and a Proton Pump Inhibitor (PPI) on Calderasib (MK-1084) in Healthy Adult Participants (MK-1084-003) |
Non-small Cell Lung Cancer (5)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT07431827 | KANDLELIT-013 | P3 | recruiting | MK-3475A±Calderasib (MK-1084) in Completely Resected Stage IIA-IIIB (N2) KRAS G12Cm NSCLC (MK-1084-013) |
| NCT07554339 | MK-1084 | P3 | recruiting | A Clinical Trial of Calderasib (MK-1084) and Durvalumab in People With Non-Small Cell Lung Cancer (MK-1084-015/KANDLELIT-015) |
| NCT07190248 | MK-1084 | P3 | recruiting | A Clinical Study of Calderasib (MK-1084) and Other Treatments for Participants With Non-Small Cell Lung Cancer (MK-1084-007/KANDLELIT-007) |
| NCT06345729 | MK-1084 | P3 | recruiting | 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) |
| NCT06575933 | MK-1084 | P1 | completed | A Study of Calderasib (MK-1084) With Midazolam and Digoxin in Healthy Participants (MK-1084-009) |
Neoplasm Malignant (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT07209111 | KANDLELIT-014 | P2 | recruiting | A Clinical Study of Calderasib (MK-1084) in People With Advanced Solid Tumors (MK-1084-014) |
Colon Adenocarcinoma (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT06997497 | MK-1084 | P3 | recruiting | A Clinical Study of Calderasib (MK-1084) With Targeted Therapy and Chemotherapy in People With Colorectal Cancer (MK-1084-012/KANDLELIT-012) |
Advanced Solid Tumors (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT05067283 | KANDLELIT-001 | P1 | recruiting | A Study of Calderasib (MK-1084) in KRAS Mutant Advanced Solid Tumors (MK-1084-001) |
Calderasib pivotal trial highlights (Phase 2/3/4)
Phase-2/3/4 studies with named acronyms — the registration-grade trials most cited in label discussions and Wikipedia.
| Acronym | NCT | Phase | Status | Indication | Enrollment | PubMed |
|---|---|---|---|---|---|---|
| KANDLELIT-013 | NCT07431827 | P3 | recruiting | Non-small Cell Lung Cancer | 400 | — |
| MK-1084 | NCT07554339 | P3 | recruiting | Non-small Cell Lung Cancer | 310 | — |
| MK-1084 | NCT07190248 | P3 | recruiting | Non-small Cell Lung Cancer | 675 | — |
| MK-1084 | NCT06345729 | P3 | recruiting | Non-small Cell Lung Cancer | 600 | — |
| MK-1084 | NCT06997497 | P3 | recruiting | Colon Adenocarcinoma | 477 | — |
| KANDLELIT-014 | NCT07209111 | P2 | recruiting | Neoplasm Malignant | 150 | — |
All Calderasib trials (15)
Sorted by most recent activity (completion → start → posted date). Each row links to the trial detail page on Hipa.ai.
| NCT ID | Acronym | Title | Phase | Status | Enrollment | Sponsor | Started |
|---|---|---|---|---|---|---|---|
| NCT07431827 | KANDLELIT-013 | MK-3475A±Calderasib (MK-1084) in Completely Resected Stage IIA-IIIB (N2) KRAS G12Cm NSCLC (MK-1084-013) | P3 | recruiting | 400 | Merck Sharp & Dohme LLC | Mar 2026 |
| NCT07554339 | MK-1084 | A Clinical Trial of Calderasib (MK-1084) and Durvalumab in People With Non-Small Cell Lung Cancer (MK-1084-015/KANDLELIT-015) | P3 | recruiting | 310 | Merck Sharp & Dohme LLC | Jun 2026 |
| NCT07190248 | MK-1084 | A Clinical Study of Calderasib (MK-1084) and Other Treatments for Participants With Non-Small Cell Lung Cancer (MK-1084-007/KANDLELIT-007) | P3 | recruiting | 675 | Merck Sharp & Dohme LLC | Oct 2025 |
| NCT07209111 | KANDLELIT-014 | A Clinical Study of Calderasib (MK-1084) in People With Advanced Solid Tumors (MK-1084-014) | P2 | recruiting | 150 | Merck Sharp & Dohme LLC | Dec 2025 |
| NCT06345729 | MK-1084 | 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) | P3 | recruiting | 600 | Merck Sharp & Dohme LLC | May 2024 |
| NCT06997497 | MK-1084 | A Clinical Study of Calderasib (MK-1084) With Targeted Therapy and Chemotherapy in People With Colorectal Cancer (MK-1084-012/KANDLELIT-012) | P3 | recruiting | 477 | Merck Sharp & Dohme LLC | Jul 2025 |
| NCT05067283 | KANDLELIT-001 | A Study of Calderasib (MK-1084) in KRAS Mutant Advanced Solid Tumors (MK-1084-001) | P1 | recruiting | 830 | Merck Sharp & Dohme LLC | Dec 2021 |
| NCT07219550 | MK-1084 | A Study of Calderasib (MK-1084) in Participants With Hepatic Impairment and Healthy Volunteers (MK-1084-017) | P1 | recruiting | 58 | Merck Sharp & Dohme LLC | Nov 2025 |
| NCT06814119 | MK-1084 | A Clinical Study of Calderasib (MK-1084) in Participants With Renal Impairment (MK-1084-010) | P1 | completed | 34 | Merck Sharp & Dohme LLC | Apr 2025 |
| NCT07222098 | MK-1084 | A Clinical Study of Calderasib (MK-1084) With Rosuvastatin and Metformin in Healthy People (MK-1084-016) | P1 | completed | 16 | Merck Sharp & Dohme LLC | Nov 2025 |
| NCT06942741 | MK-1084 | A Study to Evaluate the Effect of Formulation and Food on Calderasib (MK-1084) in Healthy Adult Participants (MK-1084-011) | P1 | completed | 52 | Merck Sharp & Dohme LLC | May 2025 |
| NCT06575933 | MK-1084 | A Study of Calderasib (MK-1084) With Midazolam and Digoxin in Healthy Participants (MK-1084-009) | P1 | completed | 28 | Merck Sharp & Dohme LLC | Sep 2024 |
| NCT06687759 | MK-1084 | A Study of Calderasib (MK-1084) Human Absorption, Distribution, Metabolism, and Excretion in Healthy Adult Participants (MK-1084-006) | P1 | completed | 8 | Merck Sharp & Dohme LLC | Jun 2024 |
| NCT06719557 | MK-1084 | A Study of the Effect of Itraconazole and Phenytoin on Calderasib (MK-1084) in Healthy Adults (MK-1084-008) | P1 | completed | 28 | Merck Sharp & Dohme LLC | May 2024 |
| NCT06619314 | PPI | A Study to Evaluate the Effect of Food, Formulation, and a Proton Pump Inhibitor (PPI) on Calderasib (MK-1084) in Healthy Adult Participants (MK-1084-003) | P1 | completed | 56 | Merck Sharp & Dohme LLC | Sep 2023 |
Calderasib clinical trials: frequently asked questions
- How many Calderasib clinical trials are there?
- 15 Calderasib clinical trials are catalogued on Hipa.ai, sourced from the AACT mirror of ClinicalTrials.gov. 8 are actively recruiting participants. 7 are marked completed.
- Are Calderasib clinical trials recruiting in 2026?
- Yes — 8 Calderasib trials are actively recruiting in 2026, with 63 U.S. sites across 29 states. See the recruiting trials and the per-state site list further down this page.
- What conditions is Calderasib being studied for?
- Calderasib is being studied for Healthy, Non-small Cell Lung Cancer, Hepatic Impairment, Neoplasm Malignant, Rectal Adenocarcinoma and 3 more. The trials are grouped by indication on this page.
- What phase is Calderasib in?
- Calderasib clinical trials span 5 Phase 3, 1 Phase 2, 9 Phase 1. The phase × status matrix at the top of this page breaks down counts by phase and recruitment status.
- Who sponsors Calderasib clinical trials?
- The lead sponsor across the most Calderasib trials is Merck Sharp & Dohme LLC. Each trial row links to the full study detail page including sponsor information.
Sources and methodology
Trial inventory derived from the AACT mirror of ClinicalTrials.gov. Trials are filtered to those naming Calderasibas an intervention. Phase, status, enrollment, sponsor, and dates are taken from the source `studies` table; primary indication is the first listed condition. Acronyms are extracted from each trial's brief title where present. PubMed links are populated for trials whose published primary outcomes have been indexed in our evidence cache.
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