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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06875310




Registration number
NCT06875310
Ethics application status
Date submitted
7/03/2025
Date registered
13/03/2025

Titles & IDs
Public 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)
Scientific title
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)
Secondary ID [1] 0 0
CA2390004
Secondary ID [2] 0 0
CA239-0004
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Carcinoma, Non-Small-Cell Lung 0 0
Condition category
Condition code
Cancer 0 0 0 0
Lung - Non small cell

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Adagrasib
Treatment: Drugs - Pembrolizumab
Treatment: Drugs - Carboplatin
Treatment: Drugs - Pemetrexed
Treatment: Drugs - Placebo
Treatment: Drugs - Cisplatin

Experimental: Adagrasib -

Placebo comparator: Placebo -


Treatment: Drugs: Adagrasib
Specified dose on specified days

Treatment: Drugs: Pembrolizumab
Specified dose on specified days

Treatment: Drugs: Carboplatin
Specified dose on specified days

Treatment: Drugs: Pemetrexed
Specified dose on specified days

Treatment: Drugs: Placebo
Specified dose on specified days

Treatment: Drugs: Cisplatin
Specified dose on specified days
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Progression Free Survival (PFS) as Assessed per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 by Blinded Independent Central Review (BICR)
Timepoint [1] 0 0
Up to 7 years
Primary outcome [2] 0 0
Overall Survival (OS)
Timepoint [2] 0 0
Up to 7 years
Secondary outcome [1] 0 0
Overall Response (OR) as Assessed per RECIST v1.1 by BICR
Timepoint [1] 0 0
Up to 7 years
Secondary outcome [2] 0 0
Duration of Response (DOR) as Assessed per RECIST 1.1 by BICR
Timepoint [2] 0 0
Up to 7 years
Secondary outcome [3] 0 0
PFS as Assessed per RECIST v1.1 by Investigator
Timepoint [3] 0 0
Up to 7 years
Secondary outcome [4] 0 0
Number of Participants With Adverse Events (AEs)
Timepoint [4] 0 0
Up to 90 days from last dose
Secondary outcome [5] 0 0
Number of Participants With Serious Adverse Events (SAEs)
Timepoint [5] 0 0
Up to 90 days from last dose
Secondary outcome [6] 0 0
Number of Participants With AEs Leading to Dose Interruption
Timepoint [6] 0 0
Up to 90 days from last dose
Secondary outcome [7] 0 0
Number of Participants With AEs Leading to Dose Reduction
Timepoint [7] 0 0
Up to 90 days from last dose
Secondary outcome [8] 0 0
Number of Participants With AEs Leading to Treatment Discontinuation
Timepoint [8] 0 0
Up to 90 days from last dose
Secondary outcome [9] 0 0
Number of Deaths
Timepoint [9] 0 0
Up to 90 days from last dose
Secondary outcome [10] 0 0
Time to Definitive Deterioration by Non-Small Cell Lung Cancer-Symptom Assessment Questionnaire (NSCLC-SAQ) Total Score
Timepoint [10] 0 0
Up to 7 years
Secondary outcome [11] 0 0
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-30) Scale/item Score
Timepoint [11] 0 0
Up to 90 days from last dose

Eligibility
Key inclusion criteria
* Histologically or cytologically confirmed diagnosis of non-squamous NSCLC with evidence of KRAS G12C mutation via tumor tissue 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Participants with an active, known, prior documented, or suspected autoimmune or inflammatory disease.
* Uncontrolled or significant cardiovascular conditions within 6 months prior to enrollment.
* Inadequate bone marrow or liver function or electrocardiogram (ECG) abnormalities.
* Ongoing treatment with concomitant medication known to cause prolonged QTc interval and that cannot be switched to alternative treatment prior to study entry.
* Treatment targeting KRAS G12C mutation (eg, sotorasib, adagrasib) in any setting.
* 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.
* Other protocol-defined Inclusion/Exclusion criteria apply.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
30/04/2025
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
30/04/2032
Actual
Sample size
Target
630
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,QLD,SA,VIC,WA
Recruitment hospital [1] 0 0
Local Institution - 0126 - Canberra
Recruitment hospital [2] 0 0
Tamworth Hospital - North Tamworth
Recruitment hospital [3] 0 0
Local Institution - 0128 - Orange
Recruitment hospital [4] 0 0
Local Institution - 0127 - Brisbane
Recruitment hospital [5] 0 0
Lyell McEwin Hospital - Elizabeth Vale
Recruitment hospital [6] 0 0
Frankston Hospital - Frankston
Recruitment hospital [7] 0 0
Local Institution - 0121 - Melbourne
Recruitment hospital [8] 0 0
Local Institution - 0160 - Traralgon
Recruitment hospital [9] 0 0
Joondalup Health Campus - Joondalup
Recruitment postcode(s) [1] 0 0
2605 - Canberra
Recruitment postcode(s) [2] 0 0
2340 - North Tamworth
Recruitment postcode(s) [3] 0 0
2800 - Orange
Recruitment postcode(s) [4] 0 0
4102 - Brisbane
Recruitment postcode(s) [5] 0 0
5112 - Elizabeth Vale
Recruitment postcode(s) [6] 0 0
3199 - Frankston
Recruitment postcode(s) [7] 0 0
3076 - Melbourne
Recruitment postcode(s) [8] 0 0
3844 - Traralgon
Recruitment postcode(s) [9] 0 0
6027 - Joondalup
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
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United States of America
State/province [2] 0 0
California
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United States of America
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Colorado
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Florida
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United States of America
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Georgia
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United States of America
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Illinois
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United States of America
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Indiana
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United States of America
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Kentucky
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United States of America
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Louisiana
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United States of America
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Maryland
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Massachusetts
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Pennsylvania
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South Carolina
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Texas
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Argentina
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Buenos Aires
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Argentina
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Ciudad Autónoma De Buenos Aires
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Argentina
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Córdoba
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Argentina
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Santa Fe
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Austria
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Oberösterreich
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Austria
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Steiermark
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Linz
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Liège
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Bahia
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Rondonia
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Pazardzhik
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Sofia (stolitsa)
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Ruse
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Stara Zagora
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Nova Scotia
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Quebec
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Chile
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Región Metropolitana De Santiago
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Jilin
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Liaoning
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Tianjin
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Zhejiang
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Colombia
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Antioquia
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Atlántico
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Cesar
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COR
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Santander
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Île-de-France
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Germany
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Baden-Württemberg
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Germany
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Bayern
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Germany
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Hessen
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Germany
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Niedersachsen
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Germany
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Nordrhein-Westfalen
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Germany
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Sachsen-Anhalt
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Germany
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Schleswig-Holstein
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Germany
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Thüringen
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Germany
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Berlin
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Germany
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Heidelberg
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Germany
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Hemer
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Germany
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Stuttgart
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Germany
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Wuerzburg
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Greece
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Attikí
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Greece
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Thessalía
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Hong Kong
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Hksar
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Gyor-Moson-Sopron
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Hungary
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Heves
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Komárom-Esztergom
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Somogy
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Veszprém
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Budapest
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India
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Andhra Pradesh
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India
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Delhi
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India
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Gujarat
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India
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Kerala
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Maharashtra
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Odisha
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India
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Tamil Nadu
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India
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India
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Uttar Pradesh
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India
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West Bengal
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India
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Hyderabad
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Ireland
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Cork
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Ireland
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Dublin
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Israel
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HaMerkaz
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Israel
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Yerushalayim
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Israel
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?eifa
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Italy
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Emilia-Romagna
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Italy
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Napoli
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Italy
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Piemonte
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Italy
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Puglia
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Italy
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Roma
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Italy
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Toscana
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Italy
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Umbria
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Italy
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Genova
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Italy
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Padova
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Parma
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Italy
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Pavia
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Italy
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Varese
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Japan
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Aichi
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Japan
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Hokkaido
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Ishikawa
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Kanagawa
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Miyagi
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Nara
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Okayama
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Osaka
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Saitama
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Shizuoka
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Tochigi
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Toyama
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Yamaguchi
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Akashi
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Aomori
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Fukuoka
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Kumamoto
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Noord-Holland
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Bydgoszcz
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Katowice
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Cluj
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Constan?a
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Romania
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Dolj
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Timi?
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State/province [195] 0 0
Ia?i
Country [196] 0 0
Romania
State/province [196] 0 0
Ploie?ti
Country [197] 0 0
Saudi Arabia
State/province [197] 0 0
Makkah Al Mukarramah
Country [198] 0 0
Saudi Arabia
State/province [198] 0 0
Riyadh
Country [199] 0 0
Spain
State/province [199] 0 0
A Coruña [La Coruña]
Country [200] 0 0
Spain
State/province [200] 0 0
Barcelona [Barcelona]
Country [201] 0 0
Spain
State/province [201] 0 0
Catalunya [Cataluña]
Country [202] 0 0
Spain
State/province [202] 0 0
Illes Balears [Islas Baleares]
Country [203] 0 0
Spain
State/province [203] 0 0
Madrid, Comunidad De
Country [204] 0 0
Spain
State/province [204] 0 0
Pontevedra [Pontevedra]
Country [205] 0 0
Spain
State/province [205] 0 0
València
Country [206] 0 0
Spain
State/province [206] 0 0
Madrid
Country [207] 0 0
Spain
State/province [207] 0 0
Málaga
Country [208] 0 0
Spain
State/province [208] 0 0
Sevilla
Country [209] 0 0
Switzerland
State/province [209] 0 0
Sankt Gallen
Country [210] 0 0
Switzerland
State/province [210] 0 0
Münsterlingen
Country [211] 0 0
Taiwan
State/province [211] 0 0
Tainan
Country [212] 0 0
Taiwan
State/province [212] 0 0
Taipei
Country [213] 0 0
Taiwan
State/province [213] 0 0
New Taipei
Country [214] 0 0
Thailand
State/province [214] 0 0
Khon Kaen
Country [215] 0 0
Thailand
State/province [215] 0 0
Krung Thep Maha Nakhon
Country [216] 0 0
Thailand
State/province [216] 0 0
Songkhla
Country [217] 0 0
Turkey
State/province [217] 0 0
Istanbul
Country [218] 0 0
Turkey
State/province [218] 0 0
Izmir
Country [219] 0 0
Turkey
State/province [219] 0 0
Adana
Country [220] 0 0
Turkey
State/province [220] 0 0
Ankara
Country [221] 0 0
Turkey
State/province [221] 0 0
Malatya
Country [222] 0 0
United Kingdom
State/province [222] 0 0
London, City Of
Country [223] 0 0
United Kingdom
State/province [223] 0 0
Birmingham
Country [224] 0 0
United Kingdom
State/province [224] 0 0
Guildford
Country [225] 0 0
United Kingdom
State/province [225] 0 0
Manchester

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Mirati Therapeutics Inc.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
Address 0 0
Country 0 0
Phone 0 0
855-907-3286
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT06875310