Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2025-522038-29-00 | Registry Identifier | EU CT | |
| U1111-1321-6971 | Registry Identifier | UTN | |
| MK-1084-015 | Other Identifier | MSD | |
| KANDLELIT-015 | Other Identifier | MSD | |
| jRCT2021260021 | Registry Identifier | jRCT |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Researchers are looking for new ways to treat locally advanced non-small cell lung cancer (NSCLC) that is unresected and has a gene mutation called KRAS G12C. Researchers want to learn if calderasib (MK-1084) can be given with durvalumab, an immunotherapy, to treat NSCLC after chemotherapy and radiation therapy.
The goal of this trial is to learn if participants who receive calderasib and durvalumab live longer without the cancer growing or spreading compared to participants who receive placebo and durvalumab.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Calderasib + Durvalumab | Experimental | Participants will receive calderasib and durvalumab. |
|
| Placebo + Durvalumab | Active Comparator | Participants will receive placebo to calderasib and durvalumab. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Calderasib | Drug | Tablet for oral administration. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Progression-Free Survival (PFS) | PFS is defined as the time from randomization to the first documented disease progression or death due to any cause, whichever occurs first. | Up to approximately 6 years |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival (OS) | OS is defined as the time from randomization to death due to any cause. | Up to approximately 9 years |
| Number of Participants Who Experience an Adverse Events (AEs) | An AE is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an AE. The number of participants who experience an AE will be presented. |
Not provided
Inclusion Criteria:
The main inclusion criteria include but are not limited to the following:
Exclusion Criteria:
The main exclusion criteria include but are not limited to the following:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Toll Free Number | Contact | 1-888-577-8839 | Trialsites@msd.com |
| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Merck Sharp & Dohme LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NHO Revive Research Institute LLC ( Site 0118) | Recruiting | Lincoln | Nebraska | 68506 | United States |
Not provided
| Label | URL |
|---|---|
| Merck Clinical Trials Information | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Durvalumab | Biological | Solution for intravenous (IV) infusion. |
|
|
| Placebo to MK-1084 | Other | Placebo to MK-1084. |
|
| Up to approximately 9 years |
| Number of Participants Who Discontinue Study Treatment Due to an AE | An AE is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an AE. The number of participants who discontinue study treatment due to an AE will be presented. | Up to approximately 9 years |
| Objective Response Rate (ORR) | ORR is defined as the percentage of participants with Complete Response (CR) or Partial Response (PR) per RECIST 1.1. The percentage of participants who experience CR or PR as assessed by BICR will be presented. | Up to approximately 9 years |
| Duration of Response (DOR) | For participants who demonstrate confirmed CR or PR per RECIST 1.1 as assessed by BICR, duration of response is defined as the time from the first documented evidence of CR or PR until disease progression or death due to any cause, whichever occurs first. | Up to approximately 9 years |
| Distant Metastasis-Free Survival (DMFS) | DMFS is defined as the time from randomization to the first diagnosis of a distant metastasis as assessed by investigator, or death due to any cause, whichever occurs first. Distant metastasis refers to cancer that has spread beyond the original (primary) tumor/regional metastases to distant organs or distant lymph nodes. | Up to approximately 9 years |
| Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Global Health Status (GHS)/Quality of Life (QoL) (Items 29 & 30) Combined Score | EORTC QLQ-C30 is a questionnaire to assess the overall quality of life (QoL) of cancer patients. Participant responses to questions regarding Global Health Status (GHS; "How would you rate your overall health during the past week?") and QoL ("How would you rate your overall quality of life during the past week?") are scored on a 7-point scale (1= Very poor to 7=Excellent). The combined score of GHS (Item 29) and QoL (Item 30) is computed by averaging the raw scores of the 2 items and then applying a linear transformation to standardize the average score, so that the combined scores range from 0-100. A higher score indicates a better outcome. The change from baseline in GHS and QoL combined score will be presented. | Baseline and up to approximately 9 years |
| Change From Baseline in Physical Functioning (EORTC QLQ-C30 Items 1-5) Combined Score | EORTC QLQ-C30 is a questionnaire to assess the overall QoL of cancer patients. Participant responses to 5 questions about their physical functioning (Items 1 to 5) are scored on a 4-point scale (1=Not at All to 4=Very Much). The combined score of items 1 to 5 was computed by averaging the raw scores of the 5 items and then applying a linear transformation to standardize the average score, so that the combined scores range from 0-100. A higher score indicates a better outcome. The change from baseline in EORTC QLQ-C30 physical functioning (Items 1-5) combined score will be presented. | Baseline and up to approximately 9 years |
| Change from Baseline in Role Functioning (EORTC QLQ-C30 Items 6 & 7) Combined Score | The EORTC QLQ-C30 is a cancer specific health-related quality of life questionnaire. The role functioning score is based on participant responses to questions scored on a 4-point scale (1=Not at All to 4=Very Much). The combined score was computed by averaging the raw scores of Items 6 and 7 and then applying a linear transformation to standardize the average score, so that the combined scores range from 0-100. Higher scores indicate better role functioning. The change from baseline in EORTC QLQ-C30 Role Functioning (Items 6 and 7) combined score will be reported. | Baseline and up to approximately 9 years |
| Clinica Adventista Belgrano ( Site 0304) | Recruiting | Ciudad Autonoma de Buenos Aires | Buenos Aires | C1430EGF | Argentina |
|
| Instituto de Investigaciones ClÃnicas Mar del Plata ( Site 0303) | Recruiting | Mar del Plata | Buenos Aires | B7600FZO | Argentina |
|
| Hospital Britanico de Buenos Aires ( Site 0305) | Recruiting | Buenos Aires | Buenos Aires F.D. | C1280AEB | Argentina |
|
| Athens Medical Center ( Site 1201) | Recruiting | Athens | Attica | 151 25 | Greece |
|
| Leids Universitair Medisch Centrum ( Site 1503) | Recruiting | Leiden | South Holland | 2333 ZA | Netherlands |
|
| University Medical Center Groningen ( Site 1505) | Recruiting | Groningen | 9713 GZ | Netherlands |
|
| National Cancer Center ( Site 2505) | Recruiting | Goyang-si | Kyonggi-do | 10408 | South Korea |
|
| Ajou University Hospital ( Site 2504) | Recruiting | Suwon | Kyonggi-do | 16499 | South Korea |
|
| Chungbuk National University Hospital ( Site 2502) | Recruiting | Cheongju-si | North Chungcheong | 28644 | South Korea |
|
| Keimyung University Dongsan Hospital ( Site 2503) | Recruiting | Daegu | Taegu-Kwangyokshi | 42601 | South Korea |
|
| Severance Hospital, Yonsei University Health System ( Site 2501) | Recruiting | Seoul | 03722 | South Korea |
|
| Asan Medical Center ( Site 2500) | Recruiting | Seoul | 05505 | South Korea |
|
| Institut Català d'Oncologia (ICO) - Girona-OncologÃa Médica ( Site 1807) | Recruiting | Girona | Gerona | 17007 | Spain |
|
| Fundación Instituto Valenciano de OncologÃa ( Site 1809) | Recruiting | Valencia | Valenciana, Comunitat | 46009 | Spain |
|
| Hospital Clinico San Carlos ( Site 1810) | Recruiting | Madrid | 28040 | Spain |
|
| Hospital Universitario La Paz ( Site 1808) | Recruiting | Madrid | 28046 | Spain |
|
| Hospital Universitario Virgen Macarena ( Site 1805) | Recruiting | Seville | 41007 | Spain |
|
| National Cheng Kung University Hospital ( Site 2601) | Recruiting | Tainan | 704 | Taiwan |
|
| Mackay Memorial Hospital ( Site 2611) | Recruiting | Taipei | 10449 | Taiwan |
|
| Regional Municipal Non-profit Enterprise "Bukovinian Clinical Oncology Center" ( Site 2002) | Recruiting | Chernivtsi | Chernivetska Oblast | 58013 | Ukraine |
|
| Medical Center "Mriya Med-Service"-Clinical Research Department ( Site 2012) | Recruiting | Kryvyi Rih | Dnipropetrovsk Oblast | 50000 | Ukraine |
|
| Communal Non-Commercial Enterprise "Prykarpatski Clinical Oncological Center" of Ivano-Frankivsk Reg ( Site 2006) | Recruiting | Ivano-Frankivsk | Ivano-Frankivsk Oblast | 76018 | Ukraine |
|
| Private Enterprise Private Manufacturing Company Acinus-Medical and Diagnostic Centre ( Site 2013) | Recruiting | Kropyvnytskyi | Kirovohrad Oblast | 25006 | Ukraine |
|
| Ukrainian Center of Tomotherapy ( Site 2014) | Recruiting | Kropyvnytskyi | Kirovohrad Oblast | 25011 | Ukraine |
|
| Shalimov Institute of Surgery and Transplantation ( Site 2003) | Recruiting | Kyiv | Kyivska Oblast | 03680 | Ukraine |
|
| Lviv Oncology Regional Treatment and Diagnostic Center ( Site 2009) | Recruiting | Lviv | Lviv Oblast | 79031 | Ukraine |
|
| Lviv Territorial Medical Union Multidisciplinary Clinical Hospital ( Site 2000) | Recruiting | Lviv | Lviv Oblast | 79059 | Ukraine |
|
| Municipal non-profit enterprise'Odesa Regional Clinical Hospital'of Odesa Regional Council ( Site 2011) | Recruiting | Odesa | Odesa Oblast | 65025 | Ukraine |
|
| ME RIVNE REGIONAL ANTITUMOR CENTER ( Site 2001) | Recruiting | Rivne | Rivne Oblast | 33010 | Ukraine |
|
| Communal Noncommercial Enterprise "Podillia Regional Oncology Center Of Vinnytsia Regional Council" ( Site 2004) | Recruiting | Vinnytsia | Vinnytsia Oblast | 21029 | Ukraine |
|
| Volyn Regional Clinical Hospital ( Site 2010) | Recruiting | Lutsk | Volyn Oblast | 43018 | Ukraine |
|
| Medical Center "Universal Clinic "Oberig" of Limited Liability Company "Kapytal" ( Site 2005) | Recruiting | Kyiv | 03057 | Ukraine |
|
| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C000613593 | durvalumab |
Not provided
Not provided
Not provided