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A Clinical Study of Calderasib (MK-1084) and Other Treatments for Participants With Non-Small Cell Lung Cancer (MK-1084-007/KANDLELIT-007)

StatusRecruiting
PhasePhase 3
Started2025-10-08
View on ClinicalTrials.gov ↗

Amendment history

2026-10-02
minor
Trial sites expanded: 215 → 218 locations
2026-09-29
minor
Trial sites expanded: 212 → 215 locations
2026-09-10
minor
Study Status, Contacts/Locations v44
Trial sites expanded: 206 → 211 locations
2026-09-05
minor
Study Status, Contacts/Locations v43
Study sites205→206
2026-08-27
minor
Study Status, Contacts/Locations v42
Trial sites expanded: 200 → 205 locations
2026-08-20
minor
Study Status, Contacts/Locations v41
Trial sites expanded: 104 → 200 locations
2026-08-13
minor
Study Status, Contacts/Locations v40
Trial sites reduced: 198 → 104 locations
2026-08-06
minor
Study Status, Contacts/Locations v39
Trial sites expanded: 195 → 198 locations
2026-07-17
minor
Study Status, Contacts/Locations v38
Trial sites expanded: 192 → 195 locations
2026-07-08
minor
Study Status, Contacts/Locations v37
Trial sites expanded: 186 → 192 locations
2026-07-02
minor
Study Status, Contacts/Locations v36
Trial sites expanded: 181 → 186 locations
2026-06-10
minor
Study Status, Contacts/Locations v35
Trial sites expanded: 175 → 181 locations
2026-06-05
minor
Study Status, Contacts/Locations v34
Trial sites expanded: 170 → 175 locations
2026-05-28
minor
Study Status, Contacts/Locations v33
Trial sites expanded: 160 → 170 locations
2026-05-21
minor
Study Status, Contacts/Locations v32
Trial sites expanded: 156 → 160 locations
2026-05-14
minor
Study Status, Contacts/Locations v31
Trial sites expanded: 153 → 156 locations
2026-05-07
minor
Study Status, Contacts/Locations v30
Trial sites expanded: 149 → 153 locations
2026-04-30
minor
Study Status, Contacts/Locations v29
Trial sites expanded: 145 → 149 locations
2026-04-24
minor
Study Status, Contacts/Locations v28
Trial sites expanded: 134 → 145 locations
2026-04-16
minor
Study Status, Contacts/Locations v27
Trial sites expanded: 122 → 134 locations
2026-04-08
minor
Study Status, Contacts/Locations v26
Trial sites expanded: 116 → 122 locations
2026-04-02
minor
Study Status, Contacts/Locations v25
Trial sites expanded: 110 → 116 locations
2026-03-27
minor
Study Status, Contacts/Locations v24
Trial sites expanded: 104 → 110 locations
2026-03-18
minor
Study Status, Contacts/Locations v23
Study sites96→104
2026-03-13
minor
Study Status, Contacts/Locations v22
Study sites92→96
2026-03-04
minor
Study Status, Contacts/Locations v21
Study sites83→92
2026-02-26
minor
Study Status, Contacts/Locations v20
Study sites79→83
2026-02-18
minor
Study Status, Contacts/Locations v19
Study sites74→79
2026-02-10
minor
Study Status, Contacts/Locations v18
Study sites65→74
2026-02-08
minor
Study Identification, Study Status, Study Description, Arms and Interventions v17
InterventionsCarboplatin (Drug), Cisplatin (Drug), MK-1084 (Drug), Pembrolizumab (+) Berahyaluronidase alfa (Biological), Pemetrexed (Drug)→Calderasib (Drug), Carboplatin (Drug), Cisplatin (Drug), Pembrolizumab (+) Berahyaluronidase alfa (Biological), Pemetrexed (Drug)
Study title+13 characters
A Clinical Study of Calderasib (MK-1084) and Other Treatments for Participants With Non-Small Cell Lung Cancer (MK-1084-007/KANDLELIT-007)
2026-02-03
minor
Study Status, Contacts/Locations v16
Study sites56→65
2026-01-29
minor
Study Status, Contacts/Locations v15
Study sites45→56
2026-01-21
minor
Study Status, Contacts/Locations v14
Study sites42→45
2026-01-16
minor
Study Status, Contacts/Locations v13
Study sites33→42
2026-01-09
minor
Study Status, Contacts/Locations v12
Study sites31→33
2026-01-08
minor
Study Status v11
Re-verified, no change to tracked fields
2026-01-02
minor
Study Status, Contacts/Locations v10
Study sites30→31
2025-12-23
minor
Study Status, Contacts/Locations v9
Study sites19→30
2025-12-12
minor
Study Status, Contacts/Locations v8
Study sites14→19
2025-12-04
minor
Study Status, Contacts/Locations v7
Study sites11→14
2025-11-27
minor
Study Status, Contacts/Locations v6
Study sites9→11
2025-11-20
minor
Study Status, Contacts/Locations v5
Study sites8→9
2025-11-12
minor
Study Status, Contacts/Locations v4
Study sites7→8
2025-10-23
minor
Study Status, Contacts/Locations v3
Study sites2→7
2025-10-20
notable
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v2
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2025-10-27→confirmed 2025-10-08
Study sitesdetails revised at 2 of 2 sites
2025-10-15
minor
Study Identification, Study Status, Arms and Interventions, Contacts/Locations v1
Study sites0→2
2025-09-16
minor
Original filing
Researchers want to learn if the study medicines calderasib and subcutaneous (SC) pembrolizumab can be used to treat non-small cell lung cancer (NSCLC) when given together. Calderasib is a targeted therapy for the KRAS G12C mutation. The goal of this study is to learn if people who receive calderasib with SC pembrolizumab live longer without the cancer growing or spreading than in people who receive SC pembrolizumab with chemotherapy.
Trial Details
NCT Number NCT07190248
Lead Sponsor Merck Sharp & Dohme LLC
Conditions Non-small Cell Lung Cancer
Enrollment 675 participants
Start Date 2025-10-08
Primary Completion 2029-12-07 (estimated)
Study Completion 2032-08-06 (estimated)
Updated on ClinicalTrials.gov 2026-10-01