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Taking people in ItalyPhase 2/3

Tests adagrasib alone and with pembrolizumab in lung cancer with a KRAS G12C change

Tests adagrasib, alone or with pembrolizumab, in adults with lung cancer.

Key facts

Who runs it
Mirati Therapeutics Inc.
Where
Bari, Bologna, Brescia, Candiolo, Florence, Genoa, Meldola, Milan, Monza, Naples, Padova, Parma, Perugia, Pesaro, Ravenna, Rome, and Varese, ItalySee the 20 sitesAlso in 46 other countries, 715 sites
Registry title
Phase 2 Trial of Adagrasib Monotherapy and in Combination With Pembrolizumab and a Phase 3 Trial of Adagrasib in Combination in Patients With a KRAS G12C Mutation KRYSTAL-7
Status
Recruiting
Phase
Phase 2/3
People taking part
626 people, planned
Started
2 Dec 2020
Expected to end
31 Oct 2029
Type of study
Interventional, 5 groupsOne group gets an existing treatment, for comparison.
Treatments tested
  • Adagrasib
  • Pembrolizumab
Record updated
30 October 2026

Who can take part

AI summary

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 advanced or metastatic non-small cell lung cancer (NSCLC) that has a KRAS G12C mutation and who have not yet had treatment for it.

Age
18 years or older
Sex
Men and women can join.
Disease stage
Non-small cell lung cancer that cannot be removed by surgery or has spread. Phase 3 asks for squamous or nonsquamous NSCLC with PD-L1 TPS of 50% or higher and measurable disease. Phase 2 accepts any PD-L1 TPS.
Earlier treatment
People cannot have had earlier systemic treatment for advanced or metastatic NSCLC, including chemotherapy, immune checkpoint inhibitor therapy, or a therapy targeting KRAS G12C (for example AMG 510).
Biomarker or test result
KRAS G12C mutation. Phase 3 also needs PD-L1 TPS of 50% or higher.

Main reasons for not taking part

  • Earlier systemic treatment for advanced or metastatic NSCLC
  • Phase 2: active brain metastases
  • Phase 3: untreated brain lesions larger than 2.0 cm (0.8 in), or any brainstem lesions
  • Phase 3: steroids above 10 mg of prednisone a day for brain lesion symptoms, or seizures more than 1 a week
  • Phase 3: radiation to the lung above 30 Gy within 6 months before the first dose

The registry criteria, word for word

Show all 8 criteriaShow less

Who can take part

  • Phase 2: Histologically confirmed diagnosis of unresectable or metastatic NSCLC with KRAS G12C mutation and any PD-L1 TPS
  • Phase 3: Histologically confirmed diagnosis of unresectable or metastatic squamous or nonsquamous NSCLC with KRAS G12C mutation and PD-L1 TPS>=50%
  • Phase 3: Presence of measurable disease per RECIST1.1
  • Phase 3: CNS Inclusion - Based on screening brain imaging, patients must have one of the following:; No evidence of brain metastases; Untreated brain metastases not needing immediate local therapy; Previously treated brain metastases not needing immediate local therapy

Who cannot take part

  • Phase 2 and Phase 3: Prior systemic treatment for locally advanced or metastatic NSCLC including chemotherapy, immune checkpoint inhibitor therapy, or a therapy targeting KRAS G12C mutation (e.g., AMG 510)
  • Phase 3: Patients with known central nervous system (CNS) lesions must not have any of the following:; Any untreated brain lesions > 2.0 cm in size; Any brainstem lesions; Ongoing use of systemic corticosteroids for control of symptoms of brain lesions at a total daily dose of > 10 mg of prednisone (or equivalent) prior to randomization; Have poorly controlled (> 1/week) generalized or complex partial seizures, or manifest neurologic progression due to brain lesions notwithstanding CNS-directed therapy
  • Phase 3: Radiation to the lung > 30 Gy within 6 months prior to the first dose of study treatment
  • Phase 2: Active brain metastases

Check if you might fit

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?

Where in Italy

Also in 46 other countries, 715 sites

  • Istituto Tumori Bari Giovanni Paolo IIBari, ItalyTaking people
  • Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere ScientificoBologna, ItalyTaking people
  • Azienda Socio Sanitaria Territoriale degli Spedali Civili di BresciaBrescia, ItalyTaking people
  • Istituto di Candiolo Fondazione del Piemonte per l'oncologia IRCCSCandiolo, ItalyTaking people
  • Careggi University HospitalFlorence, ItalyTaking people
  • IRCCS Ospedale Policlinico San MartinoGenoa, ItalyTaking people
  • Istituto Romagnolo per lo Studio dei Tumori "Dino Amadori" - IRST S.r.lMeldola, ItalyTaking people
  • Fondazione IRCCS - Istituto Nazionale dei TumoriMilan, ItalyTaking people
  • Istituto Europeo di Oncologia s.r.lMilan, ItalyTaking people
  • Ospedale San Raffaele S.r.l.Milan, ItalyTaking people
  • Fondazione IRCCS San Gerardo dei TintoriMonza, ItalyTaking people
  • IRCCS Istituto Nazionale Tumori Fondazione PascaleNaples, ItalyTaking people
  • Istituto Oncologico VenetoPadova, ItalyTaking people
  • Azienda Ospedaliero Universitaria ParmaParma, ItalyTaking people
  • University Hospital Of PerugiaPerugia, ItalyTaking people
  • Azienda Sanitaria Territoriale di Pesaro e UrbinoPesaro, ItalyTaking people
  • Azienda Unità Sanitaria Locale della RomagnaRavenna, ItalyTaking people
  • Fondazione Policlinico Universitario Agostino Gemelli IRCCSRome, ItalyTaking people
  • I.F.O. Istituti Fisioterapici OspitalieriRome, ItalyTaking people
  • Azienda Ospedaliera Ospedale Di Circolo E Fondazione MacchiVarese, ItalyTaking people

About the trial

What the trial wants to find out

The Phase 2 portion of this study evaluates the efficacy and safety of MRTX849 monotherapy and in combination with pembrolizumab in cohorts of patients with advanced NSCLC with KRAS G12C mutation and any PD-L1 TPS and who are candidates for first-line treatment.

Read full original descriptionShow less

The Phase 3 portion of the study compares the efficacy of adagrasib in combination with pembrolizumab versus pembrolizumab in patients with unresectable, locally advanced or metastatic squamous or nonsquamous NSCLC with KRAS G12C mutation and PD-L1 TPS >=50% and who are candidates for first line treatment.

The 5 groups in the trial

  • Phase 2 Cohort 1a: PD-L1 TPS <1%Treatment being tested

    Cohort 1a: Adagrasib twice daily (BID) in combination with pembrolizumab

    Treatment: Adagrasib

  • Phase 2 Cohort 1b: PD-L1 TPS <1%Treatment being tested

    Cohort 1b: Adagrasib BID monotherapy

    Treatment: Adagrasib

  • Phase 2 Cohort 2: PD-L1 TPS ≥1%Treatment being tested

    Cohort 2: Adagrasib BID in combination with pembrolizumab

    Treatment: Adagrasib

  • Phase 3 Cohort 3 Investigational ArmTreatment being tested

    Adagrasib BID in combination with pembrolizumab

    Treatment: Adagrasib

  • Phase 3 Cohort 4 Comparator ArmExisting treatment, for comparison

    Pembrolizumab

    Treatment: Pembrolizumab

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov and on the EU's official list of trials (CTIS).
Official title
A Phase 2 Trial of Adagrasib Monotherapy and in Combination With Pembrolizumab and a Phase 3 Trial of Adagrasib in Combination With Pembrolizumab Versus Pembrolizumab in Patients With Advanced Non-Small Cell Lung Cancer With KRAS G12C Mutation
Plain-language title
Tests adagrasib alone and with pembrolizumab in lung cancer with a KRAS G12C changeGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Fit questions
Built from NCT04613596, who can take part
Record updated
30 October 2026