Tests adagrasib with chemotherapy and immunotherapy in untreated lung cancer
Tests adagrasib with pembrolizumab and chemotherapy in adults with KRAS G12C lung cancer.
Plain-language title generated from the registry record
Registry title: A Study of Adagrasib Plus Pembrolizumab Plus Chemotherapy vs. Placebo Plus Pembrolizumab Plus Chemotherapy in Participants With Previously Untreated Non-squamous Non-small Cell Lung Cancer With KRAS G12C Mutation (KRYSTAL-4)
Key facts
- Where
- Brisbane, Canberra, Elizabeth Vale, Frankston, Joondalup, Melbourne, North Tamworth, Orange, and Traralgon, AustraliaSee the 9 sites
- Phase
- Phase 3
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with non-squamous non-small cell lung cancer that has a KRAS G12C mutation, has spread or is locally advanced, and has not yet been treated with drugs for advanced disease.
- Age
- 18 years or older
- Sex
- All sexes
- Disease stage
- Non-squamous non-small cell lung cancer that is locally advanced or metastatic, with at least 1 lesion that can be measured on CT or MRI. Not a candidate for definitive therapy such as chemoradiation or complete surgery.
- Earlier treatment
- No earlier systemic anti-cancer treatment for advanced or metastatic disease. No earlier treatment aimed at KRAS G12C (for example sotorasib or adagrasib).
- Biomarker or test result
- KRAS G12C mutation found in a tumor sample and/or in circulating tumor DNA (ctDNA). Any PD-L1 level (0 to 100%) measured with an approved assay.
Main reasons for not taking part
- Active autoimmune or inflammatory disease needing systemic treatment within 2 years
- Uncontrolled or significant heart or blood vessel conditions within 6 months before enrollment
- Poor bone marrow or liver function, or abnormal ECG
- Ongoing medicines that prolong the QTc interval and cannot be switched
- Brain metastases that cause symptoms, need immediate local treatment, or are untreated and larger than 20 mm
Read by machine on 9 November 2026.
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Which best describes your lung cancer?
- Has the cancer spread to other parts of the body, or is it too advanced to be removed by surgery?
- Has your cancer spread to the brain?
Source: NCT06875310, who can take part
Where in Australia
- Princess Alexandra HospitalBrisbane, AustraliaTaking people
- Canberra HospitalCanberra, AustraliaTaking people
- Lyell McEwin HospitalElizabeth Vale, AustraliaTaking people
- Frankston HospitalFrankston, AustraliaTaking people
- Joondalup Health CampusJoondalup, AustraliaTaking people
- Northern HospitalMelbourne, AustraliaTaking people
- Tamworth HospitalNorth Tamworth, AustraliaTaking people
- Orange HospitalOrange, AustraliaTaking people
- Latrobe Regional HealthTraralgon, AustraliaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Mirati Therapeutics Inc.
- Trial code
- NCT06875310EU 2024-515698-85-00
- Record updated
- 27 October 2026
- Original description
This is a trial to evaluate the efficacy, safety, and tolerability of adagrasib plus pembrolizumab plus platinum-doublet chemotherapy versus placebo plus pembrolizumab plus platinum-doublet chemotherapy in participants with previously untreated, locally advanced or metastatic NSCLC with KRAS G12C mutationRead full original descriptionShow less
A Randomized, Double-Blind, Phase 3 Trial of Adagrasib Plus Pembrolizumab Plus Chemotherapy vs. Placebo Plus Pembrolizumab Plus Chemotherapy in Participants With Previously Untreated, Locally Advanced or Metastatic Non-squamous Non-small Cell Lung Cancer With KRAS G12C Mutation (KRYSTAL-4)
This is a trial to evaluate the efficacy, safety, and tolerability of adagrasib plus pembrolizumab plus platinum-doublet chemotherapy versus placebo plus pembrolizumab plus platinum-doublet chemotherapy in participants with previously untreated, locally advanced or metastatic NSCLC with KRAS G12C mutation
Inclusion: Histologically or cytologically confirmed diagnosis of non-squamous NSCLC with evidence of KRAS G12C mutation via tumor sample and/or circulating tumor deoxyribonucleic acid (ctDNA); Locally advanced or metastatic disease; Measurable disease via computed tomography (CT) or magnetic resonance imaging (MRI) per RECIST v1.1 criteria of at least 1 lesion; No prior systemic anti-cancer therapy given for advanced or metastatic disease; Not a candidate for definitive therapy (eg, chemoradiation or complete surgical resection); Participants with brain metastases are eligible for enrollment, including those with untreated brain metastases. Brain metastases must be asymptomatic and not in need of immediate local therapy. Any untreated brain metastases must be ≤ 20 mm in diameter; Any PD-L1 expression (0 to 100%) as determined by VENTANA PD-L1 (SP263) assay, Agilent PD-L1 IHC 22C3 pharmDx, or Agilent PD-L1 IHC 28-8 pharmDx.
Exclusion: Uncontrolled or significant cardiovascular conditions within 6 months prior to enrollment that are ongoing or with risk of recurrence; Participants with an active autoimmune or inflammatory disease requiring systemic treatment within 2 years; Ongoing treatment with concomitant medication known to cause prolonged QTc interval and that cannot be switched to alternative treatment prior to study entry; Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or study drug administration; Inadequate bone marrow or liver function or electrocardiogram (ECG) abnormalities; Treatment targeting KRAS G12C mutation (eg, sotorasib, adagrasib) in any setting; Other protocol-defined Inclusion/Exclusion criteria apply.