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Taking peoplePhase 3

Tests calderasib with pembrolizumab in lung cancer with KRAS G12C mutation

Tests calderasib plus pembrolizumab as first treatment in adults with KRAS G12C lung cancer.

Plain-language title generated from the registry record
Registry title: 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)

Key facts

Where
Beijing, Changchun, Changsha, Chengdu, Chongqing, Fuzhou, Guangzhou, Hangzhou, Harbin, Hefei, Jiamusi, Jinan, Kunming, Linhai, Linyi, Nanchang, Nanjing, Neijiang, Shanghai, Suzhou, Taiyuan, Ürümqi, Wenzhou, Wuhan, Wuxi, Xi'an, Xiamen, Xian, and Zhengzhou, ChinaSee the 45 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 newly diagnosed advanced or metastatic non-small cell lung cancer who have a KRAS G12C mutation and a PD-L1 score of 50% or more. It tests calderasib plus pembrolizumab as first treatment.

Age
18 years or older
Sex
All sexes can join
Disease stage
Non-small cell lung cancer, newly diagnosed Stage IIIB/IIIC that cannot be treated with surgery or with chemotherapy/radiation meant to remove all of the disease, or Stage IV.
Earlier treatment
No earlier systemic anticancer treatment for locally advanced or metastatic lung cancer. Side effects from earlier treatments must have recovered to Grade 1 or baseline.
Biomarker or test result
KRAS G12C mutation and PD-L1 tumor proportion score of 50% or more, tested on a tumor sample.

Main reasons for not taking part

  • Small cell lung cancer, including mixed tumors with small cell parts
  • Active brain or spinal fluid cancer spread (CNS metastases or carcinomatous meningitis)
  • Active autoimmune disease treated in the past 2 years, or active inflammatory bowel disease
  • Past or current pneumonitis or interstitial lung disease that needed steroids
  • Earlier donor tissue or solid organ transplant

Read by machine on 11 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.

  • Which best describes your lung cancer?
  • Has the cancer spread to other parts of the body, or is it too advanced to be removed by surgery?
  • What was the PD-L1 result of your tumour test?
  • Has your cancer spread to the brain?
  • Has your cancer spread to the lining around the brain or spinal cord?

Source: NCT06345729, who can take part

Where in China

  • Beijing Cancer hospital (Site 3133)Beijing, ChinaNo longer taking part
  • Beijing Cancer hospital (Site 3134)Beijing, ChinaNo longer taking part
  • Beijing Chest Hospital,Capital Medical University (Site 3104)Beijing, ChinaNo longer taking part
  • Beijing Peking Union Medical College Hospital-pneumology department (Site 3102)Beijing, ChinaNo longer taking part
  • Jilin Province Tumor Hospital (Site 3107)Changchun, ChinaNo longer taking part
  • Hunan Cancer Hospital (Site 3141)Changsha, ChinaNo longer taking part
  • The Second Xiangya Hospital of Central South University (Site 3130)Changsha, ChinaNo longer taking part
  • Sichuan Cancer hospital. (Site 3109)Chengdu, ChinaNo longer taking part
  • The Third People's Hospital of Chengdu (CDTPH) (Site 3157)Chengdu, ChinaNo longer taking part
  • West China Hospital, Sichuan University (Site 3140)Chengdu, ChinaNo longer taking part
  • Army Medical Center of People's Liberation Army (Site 3142)Chongqing, ChinaNo longer taking part
  • Chongqing University Cancer Hospital (Site 3119)Chongqing, ChinaNo longer taking part
  • Fujian Cancer Hospital (Site 3127)Fuzhou, ChinaNo longer taking part
  • Southern Medical University Nanfang Hospital (Site 3128)Guangzhou, ChinaNo longer taking part
  • Sun Yat-sen University Cancer Center (Site 3137)Guangzhou, ChinaNo longer taking part
  • The First Affiliated Hospital of Guangzhou Medical University (Site 3108)Guangzhou, ChinaNo longer taking part
  • Sir Run Run Shaw Hospital of Zhejiang University School of Medicine (Site 3121)Hangzhou, ChinaNo longer taking part
  • The first Affiliated Hospital, Zhejiang University School of Medicine (Site 3115)Hangzhou, ChinaNo longer taking part
  • Harbin Medical University Cancer Hospital (Site 3123)Harbin, ChinaNo longer taking part
  • Anhui Provincial Cancer Hospital (Site 3136)Hefei, ChinaNo longer taking part
  • JIAMUSI TUBERCULOSIS HOSPITAL(CANCER HOSPITAL) (Site 3124)Jiamusi, ChinaNo longer taking part
  • Shandong Cancer Hospital (Site 3116)Jinan, ChinaNo longer taking part
  • Yunnan Province Cancer Hospital (Site 3153)Kunming, ChinaNo longer taking part
  • Taizhou Hospital of Zhejiang Province (Site 3145)Linhai, ChinaNo longer taking part
  • LinYi Cancer Hospital (Site 3111)Linyi, ChinaNo longer taking part
  • The First affiliated hospital of Nanchang University (Xianghu campus) (Site 3138)Nanchang, ChinaNo longer taking part
  • The Second Affiliated Hospital of Nanchang University (Site 3139)Nanchang, ChinaNo longer taking part
  • Nanjing First Hospital (Site 3154)Nanjing, ChinaNo longer taking part
  • Nanjing Gulou Hospital (Site 3122)Nanjing, ChinaNo longer taking part
  • The Second People's Hospital of Neijiang (Site 3105)Neijiang, ChinaNo longer taking part
  • Fudan University Shanghai Cancer Center (Site 3144)Shanghai, ChinaNo longer taking part
  • Shanghai Chest Hospital (Site 3100)Shanghai, ChinaNo longer taking part
  • Zhongshan Hospital,Fudan University (Site 3143)Shanghai, ChinaNo longer taking part
  • The First Affiliated Hospital of Soochow University (Site 3146)Suzhou, ChinaNo longer taking part
  • Shanxi Cancer Hospital (Site 3131)Taiyuan, ChinaNo longer taking part
  • Xinjiang Medical University Cancer Hospital - Urumqi (Site 3101)Ürümqi, ChinaNo longer taking part
  • The First Affiliated Hospital of Wenzhou Medical University (Site 3151)Wenzhou, ChinaNo longer taking part
  • Hubei Cancer Hospital (Site 3126)Wuhan, ChinaNo longer taking part
  • Tongji Hospital Tongji Medical,Science & Technology (Site 3113)Wuhan, ChinaNo longer taking part
  • Affiliated Hospital of Jiangnan University(Wuxi Fourth People's Hospital) (Site 3155)Wuxi, ChinaNo longer taking part
  • The First Affiliated Hospital of Xi'an Jiaotong University (Site 3150)Xi'an, ChinaNo longer taking part
  • The First Affiliated hospital of Xiamen University (Site 3148)Xiamen, ChinaNo longer taking part
  • The Second Affiliated Hospital of Air Force Medical University (Site 3117)Xian, ChinaNo longer taking part
  • The Second Affiliated Hospital of Air Force Medical University (Site 3152)Xian, ChinaNo longer taking part
  • Henan Cancer Hospital (Site 3149)Zhengzhou, ChinaNo longer taking part

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?
Print a page for my doctor

Trial details

Who runs it
Merck Sharp & Dohme LLC
Trial code
NCT06345729EU 2023-507776-42-00
Record updated
10 November 2026
Original description
This is a study evaluating the efficacy and safety of calderasib with pembrolizumab as first-line treatment in participants with locally advanced or metastatic non-small cell lung cancer (NSCLC) with identified Kirsten rat sarcoma viral oncogene homolog G12C (KRAS G12C) mutation and programmed cell death ligand 1 (PD-L1) tumor proportion score (TPS) ≥50%. There is one primary study hypothesis:Read full original descriptionShow less

A Phase 3, Randomized, Double-blind, Multicenter Study of MK-1084 in Combination With Pembrolizumab Compared With Pembrolizumab Plus Placebo as Firstline Treatment of Participants With KRAS G12C-Mutant, Locally Advanced or Metastatic NSCLC With PD-L1 TPS ≥50% (KANDLELIT-004)

This is a study evaluating the efficacy and safety of calderasib with pembrolizumab as first-line treatment in participants with locally advanced or metastatic non-small cell lung cancer (NSCLC) with identified Kirsten rat sarcoma viral oncogene homolog G12C (KRAS G12C) mutation and programmed cell death ligand 1 (PD-L1) tumor proportion score (TPS) ≥50%. There is one primary study hypothesis:

Combination of calderasib and pembrolizumab is superior to placebo plus pembrolizumab with respect to progression free survival (PFS) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) by blinded independent central review (BICR).

Inclusion: Has histologically or cytologically confirmed diagnosis of non-small cell lung cancer (NSCLC); Has newly diagnosed Stage IIIB/IIIC NSCLC, not eligible for curative resection or curative chemotherapy/radiation as determined by a multidisciplinary tumor board and/or by radiation oncologist, surgeon, and medical oncologist or Stage IV (M1a, M1b, or M1c) by American Joint Committee on Cancer (AJCC) Staging Manual, Version 8; Provides an archival tumor sample (≤5 years) or newly obtained core, incisional, or excisional biopsy or fine needle aspirate (FNA) of a tumor lesion, not previously irradiated to enable central laboratory testing of kirsten rat sarcoma (KRAS) G12C mutation status, programmed cell death ligand 1 (PD-L1) status, and biomarker research; If have had adverse events (AEs) due to previous anticancer therapies, must have recovered to < Grade 1 or baseline; If human immunodeficiency virus (HIV)-infected, must have well controlled HIV on antiretroviral therapy (ART); If Hepatitis B surface antigen (HBsAg) positive, have received Hepatitis B Virus (HBV) antiviral therapy for at least 4 weeks, and have undetectable HBV viral load; If a participant has a history of Hepatitis C virus (HCV) infection, HCV viral load is undetectable.

Exclusion: Has active inflammatory bowel disease requiring immunosuppressive medication or previous clear history of inflammatory bowel disease; Has received prior systemic anticancer therapy for their locally advanced or metastatic NSCLC; Has received radiation therapy to the lung that is >30 Gray within 6 months of start of study intervention; Has received radiotherapy to non-central nervous system (CNS) disease within 2 weeks of start of study intervention. Participants must have recovered from all radiation-related toxicities, not required corticosteroids, and not have had radiation pneumonitis; Has not fully recovered from any effects of major surgical procedure; Has diagnosis of small cell lung cancer. For mixed tumors, if small cell elements are present, the participant is ineligible; Has known history of, or active, neurologic paraneoplastic syndrome; Has an active infection requiring systemic therapy, with exceptions; Has uncontrolled, significant cardiovascular disease or cerebrovascular disease; Known additional malignancy that is progressing or has required active treatment within the past 3 years; Has active autoimmune disease that has required systemic treatment in the past 2 years; Has history of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease; Is HIV-infected and has a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease; Has history of allogenic tissue/solid organ transplant; Has known active CNS metastases and/or carcinomatous meningitis.

The main inclusion and exclusion criteria include but are not limited to the following:.

ClinicalTrials.gov NCT06345729 · EU CTIS 2023-507776-42-00