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Non-Small Cell Lung CancerPhase 1/2KRAScendo 170NCT05789082

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

A Phase 1/2 study testing Divarasib, Pembrolizumab and Carboplatin in people with Non-Small Cell Lung Cancer, run by Hoffmann-La Roche at 71 sites in 18 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Non-Small Cell Lung Cancer
What is being tested?
Divarasib, Pembrolizumab and Carboplatin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
320 participants
Where
71 sitesin 18 countries
Study dates
20 Jun 2023to 29 Jan 2032
Phase
Phase 1/2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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
Show all 11Show fewer
  • 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

Trial locations and contacts

71 sites in 18 countries. Contact the study team or a site near you to ask about taking part.

Reference Study ID Number: BO44426 https://forpatients.roche.com/ No attachments to email below. contact

888-662-6728 (U.S. and Canada)

global-roche-genentech-trials@gene.com

Fastest response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry contact

71 sites in 18 countries

United States16 sites, 11 recruiting

  • Oncology & Hematology Associates of Southwest Virginia, Inc

    Blacksburg, Virginia, 24060

    Recruiting

  • City of Hope National Medical Center

    Duarte, California, 91010

    Withdrawn

  • Florida Cancer Specialists - SOUTH - SCRI - PPDS

    Fort Myers, Florida, 33901-8108

    Recruiting

  • MD Anderson Cancer Center

    Houston, Texas, 77030

    Recruiting

  • City of Hope - Seacliff

    Huntington Beach, California, 92648

    Withdrawn

  • City of Hope at Irvine Lennar

    Irvine, California, 92618

    Withdrawn

  • UCSD Moores Cancer Center

    La Jolla, California, 92093

    Withdrawn

  • City of Hope - Long Beach Elm

    Long Beach, California, 90813

    Withdrawn

  • NYU Langone Hospital - Long Island

    Mineola, New York, 11501

    Recruiting

  • Yale Cancer Center

    New Haven, Connecticut, 06520

    Recruiting

  • NYU Cancer Center

    New York, New York, 10016

    Recruiting

  • Mount SInai Medical Center

    New York, New York, 10029

    Recruiting

  • Virginia Oncology Associates

    Norfolk, Virginia, 23502

    Recruiting

  • Florida Cancer Specialists - NORTH - SCRI - PPDS

    St. Petersburg, Florida, 33705-1400

    Recruiting

  • Montefiore Medical Center - Montefiore Medical Park

    The Bronx, New York, 10461

    Recruiting

  • Florida Cancer Specialists - EAST - SCRI - PPDS

    West Palm Beach, Florida, 33401-3406

    Recruiting

Other trials in United States

Spain6 sites, 6 recruiting

  • ICO Badalona-H.U. Germans Trias i Pujol

    Badalona, Barcelona, 08916

    Recruiting

  • Vall d?Hebron Institute of Oncology (VHIO), Barcelona

    Barcelona, 08035

    Recruiting

  • Hospital General Universitario Gregorio Marañon

    Madrid, 28007

    Recruiting

  • Hospital Universitario 12 de Octubre

    Madrid, 28041

    Recruiting

  • Hospital Universitario Virgen del Rocio

    Seville, 41013

    Recruiting

  • Hospital Clinico Universitario de Valencia

    Valencia, 46010

    Recruiting

Other trials in Spain

Japan5 sites, 2 recruiting

  • National Cancer Center Hospital East

    Chiba, 277-8577

    Recruiting

  • Kindai University Hospital

    Osaka, 589-8511

    Recruiting

  • National Cancer Center Hospital

    Tokyo, 104-0045

    Completed

  • The Cancer Institute Hospital of JFCR

    Tokyo, 135-8550

    Withdrawn

  • Wakayama Medical University Hospital

    Wakayama, 641-8510

    Withdrawn

Other trials in Japan

South Korea5 sites, 5 recruiting

  • Pusan National University Hospital

    Busan, 49241

    Recruiting

  • Seoul National University Hospital

    Seoul, 03080

    Recruiting

  • Asan Medical Center

    Seoul, 05505

    Recruiting

  • Samsung Medical Center

    Seoul, 06351

    Recruiting

  • Korea University Guro Hospital

    Seoul, 08308

    Recruiting

Other trials in South Korea

Belgium4 sites, 4 recruiting

  • Cliniques Universitaires St-Luc

    Brussels, 1200

    Recruiting

  • Jessa Zkh (Campus Virga Jesse)

    Hasselt, 3500

    Recruiting

  • Clinique Ste-Elisabeth

    Namur, 5000

    Recruiting

  • AZ Delta (Campus Rumbeke)

    Roeselare, 8800

    Recruiting

Other trials in Belgium

Italy4 sites, 2 recruiting

  • Irccs Istituto Nazionale Dei Tumori (Int)

    Milan, Lombardy, 20133

    Recruiting

  • Istituto Nazionale Tumori Fondazione G. Pascale

    Naples, Campania, 80131

    Withdrawn

  • A.O. Universitaria S. Luigi Gonzaga

    Orbassano, Piedmont, 10043

    Recruiting

  • Policlinico Universitario Agostino Gemelli IRCCS

    Rome, Lazio, 00168

    Active, not recruiting

Other trials in Italy

Taiwan4 sites, 4 recruiting

  • Taichung Veterans General Hospital

    Taichung, 407

    Recruiting

  • National Cheng Kung University Hospital

    Tainan

    Recruiting

  • National Taiwan Uni Hospital

    Taipei, 100

    Recruiting

  • Chang Gung Medical Foundation - Linkou

    Taoyuan, 333

    Recruiting

Other trials in Taiwan

Argentina3 sites, 3 recruiting

  • Hospital Britanico

    Buenos Aires, C1280AEB

    Recruiting

  • Clinica Adventista Belgrano

    Ciudad Autonoma Buenos Aires, C1430EGF

    Recruiting

  • Centro Oncologico Riojano Integral (CORI)

    La Rioja, F5300COE

    Recruiting

Other trials in Argentina

Australia3 sites, 2 recruiting

  • Concord Repatriation General Hospital

    Concord, New South Wales, 2139

    Completed

  • Peter MacCallum Cancer Centre

    Melbourne, Victoria, 3000

    Recruiting

  • Alfred Health

    Melbourne, Victoria, 3004

    Recruiting

Other trials in Australia

Canada3 sites, 2 recruiting

  • Jewish General Hospital

    Montreal, Quebec, H3T 1E2

    Recruiting

  • Ottawa Hospital Regional Cancer Centre

    Ottawa, Ontario, K1H 8M2

    Recruiting

  • Princess Margaret Cancer Center

    Toronto, Ontario, M5G 1Z5

    Active, not recruiting

Other trials in Canada

China3 sites, 3 recruiting

  • Hunan Cancer Hospital

    Changsha, 410013

    Recruiting

  • Harbin Medical University Cancer Hospital

    Harbin, 150081

    Recruiting

  • Shanghai Pulmonary Hospital

    Shanghai, 200433

    Recruiting

Other trials in China

Israel3 sites, 3 recruiting

  • Rambam Medical Center

    Haifa, 3109601

    Recruiting

  • Rabin MC

    Petah Tikva, 4941492

    Recruiting

  • Tel Aviv Sourasky Medical Ctr

    Tel Aviv, 6423906

    Recruiting

Other trials in Israel

Poland3 sites, 3 recruiting

  • Uniwersyteckie Centrum Kliniczne

    Gda?sk, 80-214

    Recruiting

  • Krakowski Szpital Specjalistyczny im sw. Jana Paw?a II

    Krakow, 31-202

    Recruiting

  • Warminsko-Mazurskie Centrum Chorób P?uc w Olsztynie

    Olsztyn, 10-357

    Recruiting

Other trials in Poland

Brazil2 sites, 2 recruiting

  • Hospital de Cancer de Barretos

    Barretos, São Paulo, 14784-400

    Recruiting

  • Instituto do Cancer do Estado de Sao Paulo - ICESP

    São Paulo, São Paulo, 01246-000

    Recruiting

Other trials in Brazil

Netherlands2 sites, 1 recruiting

  • NKI The Netherlands Cancer Institute

    Amsterdam, 1066 CX

    Active, not recruiting

  • UMC St Radboud

    Nijmegen, 6525 GA

    Recruiting

Other trials in Netherlands

Switzerland2 sites, 1 recruiting

  • Universitätsspital Basel

    Basel, 4031

    Recruiting

  • Inselspital Bern

    Bern, 3010

    Withdrawn

Other trials in Switzerland

United Kingdom2 sites, 2 recruiting

  • Beatson West of Scotland Cancer Centre

    Glasgow, G12 0YN

    Recruiting

  • Barts & London School of Med

    London, EC1A 7BE

    Recruiting

Other trials in United Kingdom

Sweden1 site, 1 recruiting

  • Sahlgrenska University Hospital

    Gothenburg, 411 36

    Recruiting

Other trials in Sweden

About this study

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

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).

Being tested
Divarasib, Pembrolizumab, Carboplatin, Cisplatin, Pemetrexed
Medical subject headings
Carcinoma, Non-Small-Cell Lung

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DivarasibDrug

    Participants will receive divarasib orally (PO), QD on days 1-21 of each 21-day cycle.

  • PembrolizumabDrug

    Participants will receive a 200 mg IV infusion of pembrolizumab Q3W on Day 1 of each 21-day cycle.

  • CarboplatinDrug

    Participants will receive IV carboplatin Q3W for four 21-day cycles.

  • CisplatinDrug

    Participants will receive IV cisplatin Q3W for four 21-day cycles.

  • PemetrexedDrug

    Participants will receive IV pemetrexed Q3W.

Study groups in NCT05789082
Study groupRoleWhat they receive
Cohort A - Combination Dose Finding + Dose ExpansionExperimentalParticipants will be enrolled in different cohorts to receive divarasib (different dose levels will be evaluated) once a day (QD) combined with pembrolizumab 200 mg intravenous (IV) infusion every 3 weeks (Q3W). During the expansion stage, some participants are planned to be randomized to one divarasib combination dose level; other participants are planned to be randomized to another divarasib combination dose level. Divarasib will be given in combination with pembrolizumab.
Receives: Drug: Divarasib; Drug: Pembrolizumab
Cohort B - Combination Dose Finding + Dose ExpansionExperimentalParticipants enrolled in this cohort will receive divarasib (different dose levels will be evaluated) QD combined with pembrolizumab 200 mg IV Q3W plus investigator's choice of platinum-based chemotherapy (carboplatin or cisplatin) and pemetrexed.
Receives: Drug: Divarasib; Drug: Pembrolizumab; Drug: Carboplatin; Drug: Cisplatin; Drug: Pemetrexed
Cohort C - Dose ExpansionExperimentalParticipants enrolled in this cohort will receive one dose level of divarasib QD.
Receives: Drug: Divarasib
Cohort D - Dose ExpansionExperimentalParticipants enrolled in this cohort will receive one dose level of divarasib QD.
Receives: Drug: Divarasib

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of Participants with Adverse Events (AEs)

    Measured: 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 (11)

  1. Objective Response Rate (ORR)

    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

    Measured: Approximately 5 years

  2. Duration of Response (DOR)

    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

    Measured: Approximately 5 years

  3. Progression Free Survival (PFS)

    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

    Measured: Approximately 5 years

  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)

    Measured: Approximately 5 years

  5. Change from Baseline in Symptomatic Side Effects, as Assessed Through use of the PRO-CTCAE

    Measured: 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

    Measured: 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

    Measured: 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)

    Measured: Approximately 5 years

  9. Plasma or CSF Concentration of Divarasib at Specified Timepoints

    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.

    Measured: Approximately 5 years

  10. Identification of Divarasib Recommended Dose

    The recommended dose will be based upon the totality of safety, activity, and PK data.

    Measured: Approximately 5 years

  11. Central Nervous System (CNS) Response

    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

    Measured: Approximately 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Mar 2023
  2. Study start20 Jun 2023
  3. Primary completion29 Jan 2032 (estimated)
  4. Study completion29 Jan 2032 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Cohorts B, C, D, and a subset of Cohort A follow non-randomized allocation; other subsets of Cohort A are randomized.
Masking
None (open label)
Enrolment
320 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05789082
Sponsor's protocol ID
BO44426
Other IDs
2022-003048-28, 2023-507171-22-00, 2023
Acronym
KRAScendo 170
Status last verified
Nov 2026
First submitted
21 Feb 2023
Last updated
5 Nov 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: For eligible studies, qualified researchers may request access to individual patient level clinical data. See Roche's commitment to transparency of clinical study information here: https://go.roche.com/data\_sharing

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Divarasib, Pembrolizumab and Carboplatin in people with Non-Small Cell Lung Cancer, run by Hoffmann-La Roche at 71 sites in 18 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 5 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 71 sites in United States, Spain, Japan, South Korea, Belgium and 13 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Reference Study ID Number: BO44426 https://forpatients.roche.com/ No attachments to email below. (888-662-6728 (U.S. and Canada), global-roche-genentech-trials@gene.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants with Adverse Events (AEs) (time frame: 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)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05789082.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2026.

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