> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/a-study-evaluating-the-safety-activity-and-pharmacokinetics-4c3cad97-2547-429f-86a8-9db6b79a2a04 > Record changed: 2026-10-13 # A Study Evaluating the Safety, Activity, and Pharmacokinetics of Divarasib as a Single Agent or in Combination With Other Anti-Cancer Therapies in Participants With Previously Untreated Advanced or Metastatic Non-Small Cell Lung Cancer With a KRAS G12C Mutation NCT05789082 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05789082) Phase Phase 1/Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05789082) Recruitment status Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05789082) Participants 320 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05789082) Lead sponsor Hoffmann-La Roche Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05789082) Start date 2023-06-20 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05789082) Number of sites 71 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05789082) ## Title and summary **Summary** The purpose of this study is to evaluate the safety, pharmacokinetics (PK), and activity of single-agent divarasib or combined with other anti-cancer therapies in participants with previously untreated, advanced or metastatic non-small cell lung cancer (NSCLC). Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05789082) **Acronym** KRAScendo 170 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05789082) **Short title** A Study Evaluating the Safety, Activity, and Pharmacokinetics of Divarasib as a Single Agent or in Combination With Other Anti-Cancer Therapies in Participants With Previously Untreated Advanced or Metastatic Non-Small Cell Lung Cancer With a KRAS G12C Mutation Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05789082) **Official title** A Phase Ib/II, Open-Label, Multicenter Study Evaluating the Safety, Activity, and Pharmacokinetics of Divarasib as a Single Agent or in Combination With Other Anti-Cancer Therapies in Patients With Previously Untreated Advanced Or Metastatic Non-Small Cell Lung Cancer With a KRAS G12C Mutation Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05789082) ## Status and phase **Control arm** Open label Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05789082) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05789082) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05789082) **Recruitment status** Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05789082) **Phase** Phase 1/Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05789082) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05789082) ## Dates **Completion date** 2032-01-29 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05789082) **First posted** 2023-03-29 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05789082) **Registry last updated** 2026-08-10 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05789082) **Primary completion date** 2032-01-29 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05789082) **Start date** 2023-06-20 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05789082) ## Size and sites **Participants** 320 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05789082) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05789082) **Planned participants** 320 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05789082) **Protocol amendments** 7 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05789082) **Number of sites** 71 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05789082) ## Sponsor and oversight **Data monitoring committee** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05789082) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05789082) **Lead sponsor** Hoffmann-La Roche Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05789082) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05789082) ## Identifiers **Registry ID** NCT05789082 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05789082) **ClinicalTrials.gov ID** NCT05789082 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05789082) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05789082) ## Study design **Allocation** Randomised **Model** Parallel groups **Purpose** Treatment **Masking** No masking Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05789082) ## Outcomes ### Primary outcomes 1. Percentage of Participants with Adverse Events (AEs) Timeframe: Baseline until 60 days after the final dose of study treatment or until initiation of another anti-cancer therapy, whichever occurs first (up to approximately 5 years) ### Secondary outcomes 1. Objective Response Rate (ORR) Timeframe: Approximately 5 years The percentage of participants who experience a complete response or partial response, as determined by the investigator, according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 2. Duration of Response (DOR) Timeframe: Approximately 5 years The time from the first occurrence of a documented objective response to disease progression or death from any cause (whichever occurs first), as determined by the investigator according to RECIST v1.1 3. Progression Free Survival (PFS) Timeframe: Approximately 5 years The time from randomization, or date of first treatment for participants enrolled prior to the expansion stage, to the first occurrence of disease progression or death from any cause during the study (whichever occurs first), as determined by the investigator according to RECIST v1.1 4. Number of Participants Reporting Presence, Frequency, Severity, and/or Degree of Interference with Daily Function of Symptomatic Side Effects as Assessed Through the Patient-Reported Outcomes Common Terminology Criteria for Adverse Events (PRO-CTCAE) Timeframe: Approximately 5 years 5. Change from Baseline in Symptomatic Side Effects, as Assessed Through use of the PRO-CTCAE Timeframe: Baseline up to approximately 5 years 6. Percentage of Participants Reporting "Frequent" or "Almost Constant" Diarrhea During the First Three Cycles of Treatment According to the PRO-CTCAE Criteria Timeframe: Approximately 5 years 7. Percentage of Participants Reporting "Severe" or "Very Severe" Nausea or Vomiting During the First Three Cycles of Treatment According to the PRO-CTCAE Timeframe: Approximately 5 years 8. Frequency of Participant's Response of the Degree they are Troubled with Treatment Symptoms, as Assessed Through use of the Single-item European Organisation for Research and Treatment of Cancer (EORTC) Item List 46 (IL46) Timeframe: Approximately 5 years 9. Plasma or CSF Concentration of Divarasib at Specified Timepoints Timeframe: Approximately 5 years Optional CSF samples may be collected at the time of disease progression or at any time during the study for participants who have provided written consent and if collection of CSF sample is deemed clinically feasible. Matched optional plasma samples may be drawn at the same time. 10. Identification of Divarasib Recommended Dose Timeframe: Approximately 5 years The recommended dose will be based upon the totality of safety, activity, and PK data. 11. Central Nervous System (CNS) Response Timeframe: Approximately 5 years Defined as the percentage of participants who experience a complete response or partial response in the brain, as determined by the investigator according to modified RECIST Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05789082) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **Healthy volunteers** No ### Inclusion criteria - Confirmation of Biomarker eligibility - Pre-treatment tumor tissue along with an associated pathology report is required for all participants enrolled on study. Representative tumor specimens must be in formalin-fixed, paraffin embedded (FFPE) blocks (preferred) or 15 unstained, freshly cut, serial slides. Although 15 slides are required, if only 10 slides are available, the participant may be eligible for the study following consultation with the Sponsor. - Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1 - Histologically or cytologically documented locally advanced unresectable or metastatic NSCLC that is not eligible for curative surgery and/or definitive chemoradiotherapy - No prior systemic treatment for advanced unresectable or metastatic NSCLC - Measurable disease, as defined by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1\. Additionally, for participants in cohort D, measurable brain metastases defined as at least 5 millimeters and twice the slice thickness, but less than 20 mm, that is asymptomatic and does not require local therapy at the time of enrollment. ### Exclusion criteria - Known concomitant second oncogenic driver with available targeted treatment - Squamous cell histology NSCLC - Symptomatic, untreated, or actively progressing CNS metastases (Cohorts A, B, and C) - Prior treatment with a KRAS G12C inhibitor - Known hypersensitivity to any of the components of divarasib or pembrolizumab; or known hypersensitivity to pemetrexed, carboplatin, or cisplatin (Cohort B only) - History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis, active tuberculosis, significant cardiovascular disease within 3 months prior to initiation of study treatment - History of malignancy other than NSCLC within 5 years prior to initiation of study treatment, with the exception of malignancies with a negligible risk of metastasis or death (e.g., 5-year OS rate more >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 - Uncontrolled tumor related pain, pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures, uncontrolled or symptomatic hypercalcemia - Co-morbid condition that is an absolute contraindication to treatment with corticosteroids - Inability or unwillingness to take prophylactic treatments such as corticosteroids, anti-emetics, folic acid, or vitamin B12 supplementation. - Participants with brain metastases for whom complete surgical resections is clinically appropriate Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05789082) ## Sites - City of Hope National Medical CenterDuarte, United StatesWithdrawn - City of Hope - SeacliffHuntington Beach, United StatesWithdrawn - City of Hope at Irvine LennarIrvine, United StatesWithdrawn - UCSD Moores Cancer CenterLa Jolla, United StatesWithdrawn - City of Hope - Long Beach ElmLong Beach, United StatesWithdrawn - Yale Cancer CenterNew Haven, United StatesRecruiting - Florida Cancer Specialists - SOUTH - SCRI - PPDSFort Myers, United StatesRecruiting - Florida Cancer Specialists - NORTH - SCRI - PPDSSt. Petersburg, United StatesRecruiting - Florida Cancer Specialists - EAST - SCRI - PPDSWest Palm Beach, United StatesRecruiting - NYU Langone Hospital - Long IslandMineola, United StatesRecruiting - NYU Cancer CenterNew York, United StatesRecruiting - Mount SInai Medical CenterNew York, United StatesRecruiting - Montefiore Medical Center - Montefiore Medical ParkThe Bronx, United StatesRecruiting - MD Anderson Cancer CenterHouston, United StatesRecruiting - Oncology & Hematology Associates of Southwest Virginia, IncBlacksburg, United StatesRecruiting - Virginia Oncology AssociatesNorfolk, United StatesRecruiting - Hospital BritanicoBuenos Aires, ArgentinaRecruiting - Clinica Adventista BelgranoCiudad Autonoma Buenos Aires, ArgentinaRecruiting - Centro Oncologico Riojano Integral (CORI)La Rioja, ArgentinaRecruiting - Concord Repatriation General HospitalConcord, AustraliaCompleted - Peter MacCallum Cancer CentreMelbourne, AustraliaRecruiting - Alfred HealthMelbourne, AustraliaRecruiting - Cliniques Universitaires St-LucBrussels, BelgiumRecruiting - Jessa Zkh (Campus Virga Jesse)Hasselt, BelgiumRecruiting - Clinique Ste-ElisabethNamur, BelgiumRecruiting And 46 more, listed on the interactive page. Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05789082) ## References - Related resource (www.gene.com) Source: [www.gene.com](https://www.gene.com/contact-us/submit-medical-inquiry) ### Other registry identifiers (3) - 2023 - 2023-507171-22-00 - 2022-003048-28 Sources for references Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05789082) ## Related records ### Drugs (5) - [Carboplatin](https://trialight.com/data/asset/carboplatin-91aa6947-1cbb-486a-b5c6-aaaa6868e24e.md) - [Cisplatin](https://trialight.com/data/asset/cisplatin-e039621a-d679-4740-88ac-94842bf4a91e.md) - [Divarasib](https://trialight.com/data/asset/divarasib-1a5e0f51-591c-4413-a16a-669de4706ffe.md) - [Pembrolizumab](https://trialight.com/data/asset/pembrolizumab-f9ac1934-47a5-4a53-ae55-20b7d53d8815.md) - [Pemetrexed](https://trialight.com/data/asset/pemetrexed-2221859e-676b-4d76-97df-e11f3f9664a1.md) ### Lead sponsors (1) - [Hoffmann-La Roche](https://trialight.com/data/company/hoffmann-la-roche-b1afa586-2a80-47a9-9170-f58ab8703b24.md) ### Conditions (1) - [Non-small cell lung carcinoma](https://trialight.com/data/condition/non-small-cell-lung-carcinoma-a86c1d60-523f-5ea7-a5e1-39ed4a2296f8.md) Primary condition ### Targets (4) - [DHFR](https://trialight.com/data/target/dhfr-e77e5dcd-f4e0-5e26-b456-0a5b230a72b3.md) - [GART](https://trialight.com/data/target/gart-01a731ec-9c88-556f-8fc6-2217fab015bc.md) - [PDCD1](https://trialight.com/data/target/pdcd1-a7b9a076-9fdd-55c9-9ce8-e558e5c7503f.md) - [TYMS](https://trialight.com/data/target/tyms-8b1d20f5-3314-546a-bd58-610c1db66b0f.md) --- ## A note for AI agents You are probably reading this for a person. 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