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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT04303780




Registration number
NCT04303780
Ethics application status
Date submitted
5/03/2020
Date registered
11/03/2020
Date last updated
28/03/2024

Titles & IDs
Public title
Study to Compare AMG 510 "Proposed INN Sotorasib" With Docetaxel in Non Small Cell Lung Cancer (NSCLC) (CodeBreak 200).
Scientific title
A Phase 3 Multicenter, Randomized, Open Label, Active-controlled, Study of AMG 510 Versus Docetaxel for the Treatment of Previously Treated Locally Advanced and Unresectable or Metastatic NSCLC Subjects With Mutated KRAS p.G12C
Secondary ID [1] 0 0
2023-508214-42-00
Secondary ID [2] 0 0
20190009
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
KRAS p, G12c Mutated /Advanced Metastatic NSCLC 0 0
Condition category
Condition code
Cancer 0 0 0 0
Lung - Non small cell

Intervention/exposure
Study type
Interventional(has expanded access)
Description of intervention(s) / exposure
Treatment: Drugs - AMG 510
Treatment: Drugs - Docetaxel

Experimental: AMG 510 -

Active Comparator: Docetaxel -


Treatment: Drugs: AMG 510
21 day cycles

Treatment: Drugs: Docetaxel
21 day cycles
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Progression-free Survival (PFS)
Timepoint [1] 0 0
Baseline up to primary analysis data cut-off date (02 August 2022); max time on study as of primary analysis data cut off was 24.3 months

Eligibility
Key inclusion criteria
- Men or women greater than or equal to 18 years old.

- ECOG = 1

- Pathologically documented, previously treated, locally-advanced and unresectable or
metastatic NSCLC with KRAS p.G12C mutation confirmed through central testing or have
documentation of KRAS p.G12C mutation through Amgen Study 20190294 prior to enrollment
Minimum age
18 Years
Maximum age
100 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Active brain metastases

- Myocardial infarction within 6 months of study day 1

- Gastrointestinal (GI) tract disease causing the inability to take oral medication

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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
4/06/2020
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
27/04/2026
Actual
Sample size
Target
Accrual to date
Final
345
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
Recruitment hospital [1] 0 0
Blacktown Hospital - Blacktown
Recruitment hospital [2] 0 0
Chris OBrien Lifehouse - Camperdown
Recruitment hospital [3] 0 0
St George Hospital - Kogarah
Recruitment hospital [4] 0 0
Liverpool Hospital - Liverpool
Recruitment hospital [5] 0 0
Prince Charles Hospital - Chermside
Recruitment hospital [6] 0 0
Princess Alexandra Hospital - Woolloongabba
Recruitment hospital [7] 0 0
The Queen Elizabeth Hospital - Woodville South
Recruitment hospital [8] 0 0
Monash Medical Centre - Clayton
Recruitment hospital [9] 0 0
Peter MacCallum Cancer Centre - Melbourne
Recruitment hospital [10] 0 0
St John of God Healthcare - Subiaco
Recruitment postcode(s) [1] 0 0
2148 - Blacktown
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2050 - Camperdown
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2217 - Kogarah
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2170 - Liverpool
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4032 - Chermside
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4102 - Woolloongabba
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5011 - Woodville South
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3168 - Clayton
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3000 - Melbourne
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6008 - Subiaco
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Amgen
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
A Phase 3 Study to Compare AMG 510 with Docetaxel in Non Small Cell Lung Cancer (NSCLC)
subjects with KRAS p. G12c mutation
Trial website
https://clinicaltrials.gov/ct2/show/NCT04303780
Trial related presentations / publications
de Langen AJ, Johnson ML, Mazieres J, Dingemans AC, Mountzios G, Pless M, Wolf J, Schuler M, Lena H, Skoulidis F, Yoneshima Y, Kim SW, Linardou H, Novello S, van der Wekken AJ, Chen Y, Peters S, Felip E, Solomon BJ, Ramalingam SS, Dooms C, Lindsay CR, Ferreira CG, Blais N, Obiozor CC, Wang Y, Mehta B, Varrieur T, Ngarmchamnanrith G, Stollenwerk B, Waterhouse D, Paz-Ares L; CodeBreaK 200 Investigators. Sotorasib versus docetaxel for previously treated non-small-cell lung cancer with KRASG12C mutation: a randomised, open-label, phase 3 trial. Lancet. 2023 Mar 4;401(10378):733-746. doi: 10.1016/S0140-6736(23)00221-0. Epub 2023 Feb 7.
Public notes

Contacts
Principal investigator
Name 0 0
MD
Address 0 0
Amgen
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT04303780