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Looking for participantsPhase3

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

Sponsor: Hoffmann-La Roche

NCT ID: NCT06793215

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Access to the study treatment being tested
Type of study
Interventional (receives a drug or procedure)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
Divarasib (drug), Pembrolizumab (drug), Pemetrexed (drug), Carboplatin (drug)
How long the study runs
Study runs about 60 months (dates as stated)
About the drug or intervention
Divarasib — drug: Divarasib will be administered orally QD · Pembrolizumab — drug: Pembrolizumab will be administered via IV infusion Q3W · Pemetrexed — drug: Pemetrexed will be administered via IV infusion Q3W · Carboplatin — drug: Carboplatin will be administered via IV infusion Q3W · Cisplatin — drug: Cisplatin will be administered via IV infusion Q3W
Patient visit burden
Not specified by the sponsor
Type of study
Testing a treatment
Ages
18 Years and over
Who
All
Number of participants
600
Started
2025-10-24
Last checked
2026-10

Plain English Summary

What is this study?

  • • Testing a new treatment for non-small cell lung cancer
  • • Phase3 - 600 participants
  • • 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)

Who can take part?

  • • Ages 18 Years and over
  • • Diagnosed with non-small cell lung cancer

Where?

  • • Blackpool - Blackpool Teaching Hospitals NHS Foundation Trust , Victoria Hospital
  • • Bristol - Bristol Haematology & Oncology Centre
  • • Canterbury - East Kent Hospitals University NHS Foundation Trust
  • • Cardiff - Velindre NHS Trust - Velindre Cancer Centre
  • • +7 more UK sites

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

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).

Non-Small Cell Lung CancerKRAS G12C Lung Cancer

How this trial compares with your answers

Answer 2 more questions to improve match

What we know so far

Condition· Matched your search
Age· Tell us your age for better matching
Gender· Tell us your sex for better matching

Still need:

  • • Tell us your age for better matching
  • • Tell us your sex for better matching

Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 18 Years and over
  • Who can join: All genders

Biomarkers mentioned

KRASPD-L1CD137

Treatment history

Treatments you must have had:

  • ✓ any other form of antineoplastic therapy while in the study
  • ✓ KRAS G12C inhibit

What the study is looking for

  • ✓activity scale (ECOG) performance status of 0 or 1
  • ✓confirmed by testing a sample diagnosis of advanced or that has spread non squamous NSCLC that is not...
  • ✓cancer that can be measured on scans, as defined by (standard scan measurements)
  • ✓No prior systemic treatment for advanced or that has spread NSCLC
  • ✓Documentation of the presence of a KRAS G12C mutation
See the full 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 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

Where Is This Study? (11 UK sites)

Blackpool Teaching Hospitals NHS Foundation Trust , Victoria Hospital

Blackpool FY3 8NR, United Kingdom

Recruiting
Hospital R&D contact (matched)

Dr Angela Parker

bfwh.randd.office@nhs.net01253 (9) 51514 / (9) 55547

Bristol Haematology & Oncology Centre

Bristol BS2 8ED, United Kingdom

Recruiting

East Kent Hospitals University NHS Foundation Trust

Canterbury CT1 3NG, United Kingdom

Recruiting
Hospital R&D contact (matched)

Caroline Cowley, Research & Innovation/Clinical Trials Unit Manager

ekhuft.researchandinnovation@nhs.net01227 783169

Velindre NHS Trust - Velindre Cancer Centre

Cardiff CF14 2TL, United Kingdom

Recruiting
Hospital R&D contact (matched)

Sarah Townsend

Velindre.R&Doffice@wales.nhs.uk02920 196165

Hull University Teaching Hospitals NHS Trust

Hull HU3 2JZ, United Kingdom

Recruiting
Hospital R&D contact (matched)

James Illingworth

hyp-tr.development.research@nhs.net01482 461883 or 461903

Barts and the London NHS Trust

London E1 2ES, United Kingdom

Recruiting
Hospital R&D contact (matched)

Dr Mays Jawad

research.governance@qmul.ac.uk020 7882 6826

Royal Marsden Hospital - Fulham

London SW3 6JJ, United Kingdom

Recruiting
Hospital R&D contact (matched)

Mark Brandon-Grove

research.development@rmh.nhs.uk020 3186 5416

Sarah Cannon Research Institute

London W1G 6AD, United Kingdom

Recruiting

Maidstone and Tunbridge Wells NHS Trust

Maidstone ME16 9QQ, United Kingdom

Recruiting
Hospital R&D contact (matched)

Denise Day / Julie Knowles

mtw-tr.researchgovernance@nhs.net01622 225627

Oxford University Hospitals NHS Trust - Churchill Hospital

Oxford OX3 7LE, United Kingdom

Recruiting
Hospital R&D contact (matched)

Shahista Hussain

ouhtma@ouh.nhs.uk---

Royal Marsden NHS Foundation Trust

Sutton SM2 5PT, United Kingdom

Recruiting
Hospital R&D contact (matched)

Mark Brandon-Grove

research.development@rmh.nhs.uk020 3186 5416

How to Get in Touch

Reference Study ID Number: CO45042 https://forpatients.roche.com/ No attachments to email below.

Sponsor contact

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

Sponsor contact

CONTACT

Data sourced from ClinicalTrials.gov · Last verified: 2026-10