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Looking for participantsPhase3

A Study Evaluating Sotorasib Platinum Doublet Combination Versus Pembrolizumab Platinum Doublet Combination as a Front-Line Therapy in Participants With Stage IV or Advanced Stage IIIB/C Nonsquamous Non-Small Cell Lung Cancers (CodeBreaK 202)

Sponsor: Amgen

NCT ID: NCT05920356

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
Sotorasib (drug), Pembrolizumab (drug)
How long the study runs
Study runs about 103 months (dates as stated)
About the drug or intervention
Sotorasib — drug: Oral administration · Pembrolizumab — drug: Intravenous administration
Patient visit burden
Not specified by the sponsor
Type of study
Testing a treatment
Ages
18 Years to 100 Years
Who
All
Number of participants
750
Started
2023-11-16
Last checked
2026-09

Plain English Summary

What is this study?

  • • Testing a new treatment for non-small cell lung cancer (nsclc)
  • • Phase3 - 750 participants
  • • The primary objectives are to compare progression-free survival (PFS) and overall survival (OS) in participants who receive sotorasib with platinum doublet chemotherapy versus participants who receive pembrolizumab with platinum doublet chemotherapy

Who can take part?

  • • Ages 18 Years to 100 Years
  • • Diagnosed with non-small cell lung cancer (nsclc)

Where?

  • • Birmingham - Queen Elizabeth Hospital Birmingham
  • • Inverness - Raigmore Hospital
  • • London - Royal Marsden Hospital
  • • Northwood - Mount Vernon Cancer Centre
  • • +4 more UK sites

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

About This Trial

The primary objectives are to compare progression-free survival (PFS) and overall survival (OS) in participants who receive sotorasib with platinum doublet chemotherapy versus participants who receive pembrolizumab with platinum doublet chemotherapy.

Non-Small Cell Lung Cancer (NSCLC)

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 - 100 Years
  • Who can join: All genders

Biomarkers mentioned

KRASPD-L1and negative

What the study is looking for

  • ✓No history of systemic anticancer therapy in that has spread/non-curable settings
  • ✓activity scale (ECOG) ≤ 1

Who cannot take part

  • ✗Mixed histology NSCLC with either small-cell or large-cell neuroendocrine cell component or predominant squamous...
  • ✗Participants with tumors known to harbor molecular alterations for which treatment that targets specific changes in the cancer is locally approved as a...
  • ✗causing symptoms (treated or untreated) brain metastases
  • ✗Gastrointestinal (GI) tract disease causing the inability to take oral medication
  • ✗Myocardial infarction within 6 months of randomization, unstable arrhythmias, or unstable angina
See the full criteria
Inclusion Criteria: * Histologically or cytologically confirmed diagnosis of nonsquamous stage IV or advanced Stage IIIB or IIIC NSCLC with KRAS p. G12C mutation and negative for PD-L1 expression by central testing or local laboratory testing confirmed through central testing * No history of systemic anticancer therapy in metastatic/non-curable settings * Eastern Cooperative Oncology Group (ECOG) ≤ 1 Exclusion Criteria: * Mixed histology NSCLC with either small-cell or large-cell neuroendocrine cell component or predominant squamous cell histology * Participants with tumors known to harbor molecular alterations for which targeted therapy is locally approved as a front-line therapy * Symptomatic (treated or untreated) brain metastases * Gastrointestinal (GI) tract disease causing the inability to take oral medication * Myocardial infarction within 6 months of randomization, unstable arrhythmias, or unstable angina * Prior therapy with a KRAS G12C inhibitor

Where Is This Study? (8 UK sites)

Queen Elizabeth Hospital Birmingham

Birmingham B15 2TH, United Kingdom

Recruiting
Hospital R&D contact (matched)

Sarah Pountain Head of Research Governance

R&D@uhb.nhs.uk0121 371 4185

Raigmore Hospital

Inverness IV2 3UJ, United Kingdom

TERMINATED

Royal Marsden Hospital

London SW3 6JJ, United Kingdom

Recruiting
Hospital R&D contact (matched)

Mark Brandon-Grove

research.development@rmh.nhs.uk020 3186 5416

Mount Vernon Cancer Centre

Northwood HA6 2RN, United Kingdom

Recruiting

Nottingham City Hospital

Nottingham NG5 1PB, United Kingdom

Recruiting
Hospital R&D contact (matched)

Alison Lloyd

nuhnt.researchsponsor@nhs.net0115 9249924

Royal Marsden Hospital

Sutton SM2 5PT, United Kingdom

Recruiting
Hospital R&D contact (matched)

Mark Brandon-Grove

research.development@rmh.nhs.uk020 3186 5416

Torbay Hospital

Torquay TQ2 7AA, United Kingdom

Recruiting
Hospital R&D contact (matched)

Dr Fiona Roberts (R&D Director)

tsdft.research@nhs.net01803 656635

Royal Cornwall Hospital

Truro TR1 3LQ, United Kingdom

Recruiting
Hospital R&D contact (matched)

Abi Weeks

rch-tr.CornwallResearch@nhs.net01872 25 6424

How to Get in Touch

Amgen Call Center

Sponsor contact

CONTACT

866-572-6436 medinfo@amgen.com
Data sourced from ClinicalTrials.gov · Last verified: 2026-09