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Taking people in ChinaPhase 3

Tests calderasib with chemotherapy and cetuximab in colorectal cancer

Tests calderasib with chemotherapy in adults with KRAS G12C colorectal cancer.

Plain-language title generated from the registry record
Registry title: A Clinical Study of Calderasib (MK-1084) With Targeted Therapy and Chemotherapy in People With Colorectal Cancer (MK-1084-012/KANDLELIT-012)

Key facts

Where
Beijing, Changchun, Changsha, Chengdu, Chongqing, Fuzhou, Guangzhou, Hangzhou, Harbin, Hefei, Jinan, Kunming, Nanchang, Nanjing, Nanning, Shanghai, Shenzhen, Taiyuan, Wanzhou, Wenzhou, Wuhan, Xi'an, Xiamen, and Zhengzhou, ChinaSee the 36 sites
Phase
Phase 3

AI summary: who the study is looking for

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with colorectal cancer that has a KRAS G12C mutation and cannot be removed by surgery or has spread. Part 2 is for people who have not had cancer drug treatment for it yet.

Age
18 years or older
Sex
All sexes can join
Disease stage
Colorectal adenocarcinoma that is locally advanced and cannot be removed by surgery, or has spread (unresectable Stage III or Stage IV)
Earlier treatment
Part 2 only: no earlier drug treatment for the advanced or spread cancer. Exception: 1-2 cycles of FOLFOX or 1 cycle of CAPOX before or during screening. No other cancer treatment, including trial drugs, within 4 weeks before randomization.
Biomarker or test result
KRAS G12C mutation must be present

Main reasons for not taking part

  • Active inflammatory bowel disease needing immune-suppressing medicine, or a clear past history of it
  • Uncontrolled, significant heart or brain blood vessel disease
  • Known partial or complete DPD deficiency
  • Active brain or spinal cord spread of the cancer (CNS metastases, carcinomatous meningitis or leptomeningeal disease)
  • Another cancer that is getting worse or needed treatment in the past 3 years

Read by machine on 12 November 2026.

Could this be for you?

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Has a test of your tumour shown a change (mutation) in the KRAS, NRAS or BRAF genes?

Source: NCT06997497, who can take part

Where in China

  • Peking Union Medical College Hospital (Site 0824)Beijing, ChinaContact: Study CoordinatorTaking people
  • Peking University First Hospital(Daxing Area) (Site 0838)Beijing, ChinaContact: Study CoordinatorTaking people
  • Jilin Cancer Hospital (Site 0830)Changchun, ChinaContact: Study CoordinatorTaking people
  • Hunan Cancer Hospital (Site 0815)Changsha, ChinaContact: Study CoordinatorTaking people
  • The Third Xiangya Hospital of Central South University (Site 0834)Changsha, ChinaContact: Study CoordinatorTaking people
  • Sichuan Cancer hospital. (Site 0831)Chengdu, ChinaContact: Study CoordinatorTaking people
  • West China Hospital, Sichuan University (Site 0805)Chengdu, ChinaContact: Study CoordinatorTaking people
  • Chongqing University Cancer Hospital (Site 0808)Chongqing, ChinaContact: Study CoordinatorTaking people
  • Fujian Cancer Hospital (Site 0807)Fuzhou, ChinaContact: Study CoordinatorTaking people
  • Southern Medical University Nanfang Hospital (Site 0812)Guangzhou, ChinaContact: Study CoordinatorTaking people
  • Sun Yat-Sen University Cancer Center (Site 0800)Guangzhou, ChinaContact: Study CoordinatorTaking people
  • The Sixth Affiliated Hospital of Sun Yat-sen University (Site 0828)Guangzhou, ChinaContact: Study CoordinatorTaking people
  • The Second Affiliated Hospital Zhejiang University School of Medicine (Site 0801)Hangzhou, ChinaContact: Study CoordinatorTaking people
  • Zhejiang Cancer Hospital (Site 0821)Hangzhou, ChinaContact: Study CoordinatorTaking people
  • Harbin Medical University Cancer Hospital (Site 0847)Harbin, ChinaContact: Study CoordinatorTaking people
  • Anhui Provincial Cancer Hospital (Site 0803)Hefei, ChinaContact: Study CoordinatorTaking people
  • The Second Affiliated Hospital of Anhui Medical University (Site 0813)Hefei, ChinaContact: Study CoordinatorTaking people
  • Jinan Central Hospital (Site 0817)Jinan, ChinaContact: Study CoordinatorTaking people
  • Shandong Cancer Hospital (Site 1901)Jinan, ChinaContact: Study CoordinatorTaking people
  • First Affiliated Hospital of Kunming Medical University (Site 0845)Kunming, ChinaContact: Study CoordinatorTaking people
  • The First Affiliated Hospital of Nanchang University (Site 0826)Nanchang, ChinaContact: Study CoordinatorTaking people
  • Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School (Site 0825)Nanjing, ChinaContact: Study CoordinatorTaking people
  • Guangxi Medical University Affiliated Tumor Hospital (Site 0804)Nanning, ChinaContact: Study CoordinatorTaking people
  • Fudan University Shanghai Cancer Center (Site 0816)Shanghai, ChinaContact: Study CoordinatorTaking people
  • Shanghai Renji Hospital Affiliated to Jiao Tong University (Site 1906)Shanghai, ChinaContact: Study CoordinatorTaking people
  • Zhongshan Hospital of Fudan University (Site 0832)Shanghai, ChinaContact: Study CoordinatorTaking people
  • The University of Hong Kong - Shenzhen Hospital (Site 1903)Shenzhen, ChinaContact: Study CoordinatorTaking people
  • First Affiliated Hospital of Shanxi Medical University (Site 0843)Taiyuan, ChinaContact: Study CoordinatorTaking people
  • Chongqing University Three Gorges Hospital (Site 0837)Wanzhou, ChinaContact: Study CoordinatorTaking people
  • The First Affiliated Hospital of Wenzhou Medical University (Site 0840)Wenzhou, ChinaContact: Study CoordinatorTaking people
  • Hubei Cancer Hospital (Site 0814)Wuhan, ChinaContact: Study CoordinatorTaking people
  • Tongji Hospital Tongji Medical,Science & Technology (Site 0839)Wuhan, ChinaContact: Study CoordinatorTaking people
  • The First Affiliated Hospital of Xi an Jiaotong University (Site 0802)Xi'an, ChinaContact: Study CoordinatorTaking people
  • The First Affiliated Hospital of Xiamen University (Site 0806)Xiamen, ChinaContact: Study CoordinatorTaking people
  • Zhongshan Hospital Affiliated to Xiamen University (Site 1902)Xiamen, ChinaContact: Study CoordinatorTaking people
  • Henan Cancer Hospital (Site 0822)Zhengzhou, ChinaContact: Study CoordinatorTaking people

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Trial details

Who runs it
Merck Sharp & Dohme LLC
Trial code
NCT06997497EU 2024-517232-22-00
Record updated
12 November 2026
Original description
Researchers are looking for other ways to treat locally advanced or metastatic colorectal cancer (mCRC) that is unresectable and has a gene mutation called KRAS G12C.Read full original descriptionShow less

A Phase 3, Randomized, Open-label, Multicenter Clinical Study to Evaluate the Safety and Efficacy of MK-1084, Cetuximab, and mFOLFOX6 Versus mFOLFOX6 With or Without Bevacizumab as First-line Treatment of Participants With KRAS G12C-mutant, Locally Advanced Unresectable or Metastatic Colorectal Cancer (KANDLELIT-012)

Researchers are looking for other ways to treat locally advanced or metastatic colorectal cancer (mCRC) that is unresectable and has a gene mutation called KRAS G12C.

Standard (or usual) treatments for this type of colorectal cancer may include mFOLFOX6 with or without bevacizumab. Researchers want to learn if adding calderasib (the study medicine) and cetuximab to mFOLFOX6 can treat locally advanced or mCRC with the KRAS G12C mutation. Calderasib and cetuximab are targeted therapies.

The goals of this study are to learn:

* About the safety of calderasib with cetuximab and mFOLFOX6 and if people tolerate the treatments * If people who receive calderasib with cetuximab and mFOLFOX6 live longer without mCRC growing or spreading compared to people who receive mFOLFOX6 with or without bevacizumab.

Inclusion: The main inclusion criteria include but are not limited to the following:; Has a histologically confirmed diagnosis of locally advanced unresectable or metastatic (unresectable Stage III or Stage IV as defined by American Joint Committee on Cancer [AJCC] eighth edition) colorectal adenocarcinoma; Part 2 only: Has not received systemic anticancer therapy for locally advanced unresectable or metastatic colorectal cancer; an exception is permitted for 1-2 cycles of FOLFOX or 1 cycle of CAPOX as optional chemotherapy before or during the screening period; Demonstrates presence of a Kirsten rat sarcoma viral oncogene homolog G12C (KRAS G12C) mutation; Human immunodeficiency virus (HIV)-infected participants must have well controlled HIV on antiretroviral therapy (ART); Participants who are Hepatitis B surface antigen (HBsAg) positive are eligible if they have received hepatitis B virus (HBV) antiviral therapy and have undetectable HBV viral load; Participants with history of hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable.

Exclusion: Has active inflammatory bowel disease requiring immunosuppressive medication or previous clear history of inflammatory bowel disease (eg, Crohn's disease, ulcerative colitis, chronic diarrhea); Has received prior systemic anticancer therapy including investigational agents within 4 weeks before randomization, with the exception of the optional chemotherapy; Has 1 or more conditions that, in the opinion of the investigator, make the participant ineligible for treatment with bevacizumab; Has not adequately recovered from major surgery or have ongoing surgical complications; Has uncontrolled, significant cardiovascular disease or cerebrovascular disease; HIV-infected participants with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease; Has known additional malignancy that is progressing or has required active treatment within the past 3 years; Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis or leptomeningeal disease; Has active infection requiring systemic therapy; Has a history of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease; The main exclusion criteria include but are not limited to the following:; Has known partial or complete dihydropyrimidine dehydrogenase (DPD) deficiency.

ClinicalTrials.gov NCT06997497 · EU CTIS 2024-517232-22-00