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    Phase III: Divarasib in Non-Small Cell Lung Cancer, KRAS G12C Lung Cancer (Krascendo 2)

    Clinical Trial Overview Inclusion and Exclusion Criteria Study Site Locations Enrollment and Resources
    Clinical Trial Overview

    Clinical Trial Overview

    Recruiting

    A Phase III, Randomized, Open-Label Study Evaluating the Efficacy and Safety of Divarasib and Pembrolizumab Versus Pembrolizumab and Pemetrexed and Carboplatin or Cisplatin in Patients With Previously Untreated, KRAS G12C-Mutated, Advanced or Metastatic Non-Squamous Non-Small Cell Lung Cancer

    Objective

    The purpose of this study is to evaluate the efficacy and safety of divarasib and pembrolizumab compared with pembrolizumab and pemetrexed and carboplatin or cisplatin, for the first-line treatment of adult participants with KRAS G12C-mutated, advanced or metastatic non squamous non-small cell lung cancer (NSCLC).

    Primary Endpoints

    • Progression-Free Survival (PFS)
    • Overall Survival (OS)

    Secondary Endpoints

    • Objective Response
    • Change from Baseline on the European Organisation for Research and Treatment of Cancer Quality-of-Life Questionnaire-Supplemental Lung Cancer Module (EORTC QLQ-LC13) Cough Scale
    • Change from Baseline on the EORTC Quality of Life Questionnaire (QLQ-C30) Dyspnea Item and Physical Functioning Scale
    • Duration of Response (DOR)
    • Percentage of Participants with Adverse Events (AEs)
    • Number of Participants Reporting Presence, Frequency, Severity, and/or Degree of Interference with Daily Function of Symptomatic Treatment Toxicities Assessed by NCI Patient-Reported Outcomes Common Terminology Criteria for Adverse Events (PRO-CTCAE)
    • Change from Baseline in the Severity of Selected Symptomatic Treatment Toxicities as Assessed Through use of the NCI PRO-CTCAE
    • Frequency of Participants' Response of the Degree they are Troubled with Treatment Symptoms, as Assessed Through use of the single-item EORTC Item List (IL46)
    • Change from Baseline on the EORTC QLQ-C30 and QLQ-LC13 Functional and Global Health Status Score/Quality of Life Score (GHS/QoL)

    Divarasib

    Other names: GDC-6036

    Modality: Kirsten rat sarcoma virus gene (KRAS) G12C inhibitor

    Disease/Condition: Non-Small Cell Lung Cancer, KRAS G12C Lung Cancer

    View Molecule

    ADDITIONAL RESOURCES

    Contact an MSL
    Submit Medical Inquiry
    View Related Clinical Trials

    ID: NCT06793215

    View on ClinicalTrials.gov
    Inclusion and Exclusion Criteria

    Inclusion and Exclusion Criteria

    Inclusion Criteria
    • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
    • Histologically or cytologically confirmed diagnosis of advanced or metastatic non squamous NSCLC that is not eligible for curative surgery and/or definitive chemoradiotherapy
    • Measurable disease, as defined by RECIST v1.1
    • No prior systemic treatment for advanced or metastatic NSCLC
    • Documentation of the presence of a KRAS G12C mutation
    • Documentation of known PD-L1 expression status in tumor tissue
    • Availability of a representative tumor specimen
    • Adequate end-organ function
    • Eligible to receive a platinum-based chemotherapy regimen
    Exclusion Criteria
    • Exclusion Criteria Related to NSCLC:
    • Known concomitant second oncogenic driver with available targeted treatment
    • Symptomatic, untreated, or actively progressing central nervous system (CNS) metastases
    • Spinal cord compression not definitively treated with surgery and/or radiation or previously diagnosed and treated spinal cord compression without evidence that disease has been clinically stable for >=2 weeks prior to randomization
    • History of leptomeningeal disease
    • Uncontrolled tumor-related pain
    • Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures (once a month or more frequently)
    • Exclusion Criteria Related to Current or Prior Treatments:
    • Any anti-cancer systemic therapy, including hormonal therapy, within 21 days prior to randomization, or is expected to require any other form of antineoplastic therapy while in the study
    • Radiation therapy including palliative RT to bone metastases within 2 weeks prior to randomization and RT to the lung >30Gy within 6 months prior to randomization
    • Prior treatment with KRAS G12C inhibitors or pan-KRAS/RAS inhibitors
    • Treatment with systemic immunosuppressive or immunostimulatory medications, including CD137 agonists and immune checkpoint inhibitors
    • Current treatment with medications that are well known to prolong the QT interval
    • Treatment with therapeutic oral or IV antibiotics within 2 weeks prior to randomization
    • Prior allogeneic stem cell or solid organ transplantation
    • Exclusion Criteria Related to General Health:
    • History of malignancy other than NSCLC within 5 years prior to screening, with the exception of malignancies with a negligible risk of metastasis or death (e.g., 5-year overall survival [OS] rate >90%), such as adequately treated carcinoma in situ of the cervix, non melanoma skin carcinoma, localized prostate cancer, ductal breast carcinoma in situ, or Stage I uterine cancer
    • Individuals with chronic diarrhea, short bowel syndrome or significant upper gastrointestinal surgery including gastric resection, a history of inflammatory bowel disease (e.g., Crohn's disease or ulcerative colitis) or any active bowel inflammation (including diverticulitis), malabsorption syndrome, conditions that would interfere with enteral absorption
    • History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on the screening chest computed tomography scan
    • Significant cardiovascular disease within 3 months prior to screening

    ADDITIONAL RESOURCES

    Contact an MSL
    Submit Medical Inquiry
    View Related Clinical Trials

    ID: NCT06793215

    View on ClinicalTrials.gov
    Study Site Locations

    Study Site Locations

    Explore the map to find active sites closest to your location or search by your ZIP code.

    ADDITIONAL RESOURCES

    Contact an MSL
    Submit Medical Inquiry
    View Related Clinical Trials

    ID: NCT06793215

    View on ClinicalTrials.gov

    44 Results

      Enrollment and Resources

      Enrollment & Resources

      Enrollment

      For more information on eligibility criteria, view the study or reach out to our team.

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      Email

      [email protected]

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      ADDITIONAL RESOURCES

      Contact an MSL
      Submit Medical Inquiry
      View Related Clinical Trials

      ID: NCT06793215

      View on ClinicalTrials.gov

      Resources

      ClinicalTrials.gov

      Learn more about this trial (NCT06793215) on ClinicalTrials.gov.

      Visit CT.gov

      Patient Resources

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      Information is consistent with ClinicalTrials.gov as of June 02, 2026. Products under investigation have not been approved for use outside of the clinical trial setting. This information is presented only for the purposes of providing an overview of clinical trials and should not be construed as a recommendation for use of any product for unapproved purposes.

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      • AD
        Alzheimer's disease

      • ABC
        advanced breast cancer

      • bADLs
        Basic activities of daily living

      • ISLT
        International Shopping List Test

      • MCI
        Mild cognitive impairment

      • CV
        coefficient of variation

      • HEX
        cell hexagonality

      • nAMD
        neurovascular age-related macular degeneration

      • PDS
        Port Delivery System

      • Q24W
        once every 24 weeks

      • BMI
        Body mass index

      • HbA1c
        hemoglobin A1C

      • HOMA-IR
        Homeostasis Model Assessment of Insulin Resistance

      • NLM
        National Library of Medicine

      • QUICKI
        Quantitative Insulin Sensitivity Check Index

      • SC
        Subcutaneous

      • SGLT-2
        sodium-glucose cotransporter-2

      • SMBG
        Self-Monitored Blood Glucose

      • T1DM
        Type 1 Diabetes Mellitus

      • T2DM
        Type 2 diabetes mellitus

      • AE
        adverse events

      • AESI
        Adverse Events of Special Interest

      • MDD
        major depressive disorder

      • PHQ-9
        Patient Health Questionnaire-9

      • SAE
        serious adverse events

      • ABR
        Annualized Bleed Rate

      • CBR
        clinical benefit rate

      • CDK4/6i
        cyclin-dependent kinase 4 and 6 inhibitor

      • CNS
        central nervous system

      • CR
        complete response

      • DOR
        duration of response

      • ER
        estrogen receptor

      • HER2
        human epidermal growth factor receptor 2

      • HER2-
        human epidermal growth factor receptor 2-negative

      • HR
        hormone receptor

      • HR+
        hormone receptor-positive

      • HRQoL
        health-related quality of life

      • mut
        mutated

      • NIS
        non-interventional study

      • ORR
        objective response rate

      • OS
        overall survival

      • PFS
        progression-free-survival

      • PIK3CA
        phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha

      • PIK3CAm
        PIK3CA-mutated

      • PK
        pharmacokinetics

      • PROs
        patient-reported outcomes

      • SD
        stable disease

      • SoC
        standard of care

      • VWD
        von Willebrand disease

      • WHO
        World Health Organization

      • T2D
        Type 2 diabetes

      • T1D
        Type 1 Diabetes

      • ADA
        anti-drug antibody

      • DXA
        Dual-energy X-ray Absorptiometry

      • ASCVD
        atherosclerotic cardiovascular disease

      • FGF21
        fibroblast growth factor 21

      • SHTG
        severe hypertriglyceridemia

      • TG
        triglycerides

      • MASH
        metabolic dysfunction-associated steatohepatitis

      • NAFLD
        non-alcoholic fatty liver disease

      • NAS
        NAFLD Activity Score

      • NASH
        nonalcoholic steatohepatitis

      • pmMS
        partial modified Mayo

      • CD
        Crohn's disease

      • CMV
        cytomegalovirus

      • HIV
        human immunodeficiency virus

      • HBV
        Hepatitis B

      • HCV
        Hepatitis C

      • TB
        tuberculosis

      • UC
        ulcerative colitis

      • TL1A
        tumor necrosis factor-like ligand 1A

      • mMS
        modified Mayo Score

      • APS
        average daily abdominal pain scores in the past week

      • CDAI
        Crohn’s Disease Activity Index

      • IBDQ
        Inflammatory Bowel Disease Questionnaire

      • SF
        stool frequency subscore

      • PBO
        Placebo

      • EASI
        Eczema Area and Severity Index

      • IGA
        Investigator Global Assessment

      • NRS
        Numerical Rating Scale

      • IM
        intramuscular

      • IL
        intralesional

      • PDE-4
        Phosphodiesterase-4

      • ACE
        angiotensin-converting enzyme

      • ARBs
        angiotensin II receptor blockers

      • ASO
        Antisense Oligonucleotide

      • CKD-EPI
        Chronic Kidney Disease Epidemiology Collaboration

      • eGFR
        Estimated Glomerular Filtration Rate

      • FACIT-F
        Functional Assessment of Chronic Illness Therapy-Fatigue subscale

      • g/day
        gram per day

      • g/g
        gram per gram

      • GIP
        Glucose-dependent Insulinotropic Polypeptide

      • GLP-1
        Glucagon-like Peptide-1

      • IgAN
        IgA nephropathy

      • mg/day
        milligrams per day

      • TEAEs
        Treatment-Emergent Adverse Events

      • UPCR
        Urine Protein-to-Creatinine Ratio

      • AEs
        Adverse events

      • ALT
        Alanine aminotransferase

      • AST
        Aspartate aminotransferase

      • C-SSRS
        Columbia-Suicide Severity Rating Scale

      • DMT
        Disease-modifying therapy

      • ECG
        Electrocardiogram

      • EDSS
        Expanded Disability Status Scale

      • Gd
        Gadolinium

      • IPMSSG
        International Pediatric Multiple Sclerosis Study Group

      • MRI
        Magnetic resonance imaging

      • MS
        Multiple sclerosis

      • PD
        Pharmacodynamic

      • PPMS
        Primary progressive multiple sclerosis

      • RMS
        Relapsing multiple sclerosis

      • SI
        Suicidal ideation

      • SPMS
        Secondary progressive multiple sclerosis

      • CYP3A4
        cytochrome-p450-3a4

      • ADAS-Cog-13
        Alzheimer's Disease Assessment Scale-Cognition 13

      • ADAs
        Anti-drug antibodies

      • ADCS-ADL
        Alzheimer's Disease Cooperative Study Activities of Daily Living Inventory

      • ARIA
        Amyloid-related imaging abnormalities

      • CDR-GS
        Clinical Dementia Rating, Global Score

      • CDR-SB
        Clinical Dementia Rating, Sum of Boxes

      • CSF
        Cerebrospinal fluid

      • GFAP
        Glial fibrillar acidic protein

      • iADRS
        Integrated Alzheimer's Disease Rating Scale

      • IRR
        Infusion-related reactions

      • MMSE
        Mini-Mental State Examination

      • PET
        Positron emission tomography

      • RBANS DMI
        Repeatable Battery for the Assessment of Neuropsychological Status Delayed Memory Index

      • EORTC QLQ-C30
        European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire

      • PRO-CTCAE
        Patient-Reported Outcomes Common Terminology Criteria for Adverse Events

      • TTCD
        Time to Confirmed Deterioration

      • AJCC
        American Joint Committee on Cancer Staging System

      • ECOG
        Eastern Cooperative Oncology Group

      • FFPE
        formalin-fixed, paraffin-embedded

      • RECIST
        Response Evaluation Criteria in Solid Tumors

      • NSCLC
        non-small cell lung cancer

      • BICR
        blinded independent central review

      • CD137
        Cluster of Differentiation 137

      • EORTC QLQ-LC13
        European Organisation for Research and Treatment of Cancer Quality-of-Life Questionnaire-Supplemental Lung Cancer Module

      • KRAS G12C
        Kirsten rat sarcoma viral oncogene homolog G12C

      • PD-L1
        Programmed death-ligand 1

      • RAS
        RAt Sarcoma

      • RT
        Radiation therapy

      • DOCR
        duration of complete response

      • DFS
        disease-free survival

      • EFSeff
        event-free survival efficacy causes

      • FACT-Lym LymS
        lymphoma subscale within the functional assessment of cancer therapy-Lymphoma questionnaire

      • IPI
        international prognostic index

      • IRF
        Independent Review Facility

      • Pola-R-CHP
        polatuzumab vedotin plus rituximab, cyclophosphamide, doxorubicin, and prednisone

      • LBCL
        large B-cell lymphoma

      • PROMIS-29
        Patient-Reported Outcomes Measurement Information System-29

      • ESR1nmd
        ESR1 no-mutation-detected

      • IV
        intravenous

      • II
        2

      • ECD
        endothelial cell density

      • III
        3

      +