A Phase 3 Study to Compare sotorasib with Docetaxel in Non Small Cell Lung Cancer (NSCLC) subjects with KRAS p. G12c mutation

JRCT ID: jRCT2080225266

Registered date:07/07/2020

Basic Information

• Recruitment status: completed
• Health condition(s) or Problem(s) studied: KRAS p, G12c Mutated /Advanced Metastatic NSCLC
• Date of first enrollment: 04/06/2020
• Target sample size: 345
• Countries of recruitment: United States,Australia,Belgium,Brazil,Canada,Denmark,Finland,France,Germany,Greece,Hungary,Italy,Korea,Netherlands,Poland,Portugal,Russian,Spain,Sweden,Switzerland,Taiwan,United Kingdom
• Study type: Interventional

Intervention(s)

investigational material(s)
Generic name etc : sotorasib
INN of investigational material : sotorasib -
Therapeutic category code : 429 Other antitumor agents
Dosage and Administration for Investigational material : sotorasib, 960 mg orally once daily

control material(s)
Generic name etc : Docetaxel
INN of investigational material : Docetaxel
Therapeutic category code : 424 Antineoplastic preparations extracted from plants
Dosage and Administration for Investigational material : Docetaxel 75 mg/m2 intravenously over 1 hour every 3 weeks

Outcome(s)

Primary Outcome

efficacy
1. Progression-free survival (PFS) [ Time Frame: 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 ]
PFS was defined as the time from randomization (baseline) until disease progression or death from any cause, whichever occurred first for all participants. Progression was based on blinded independent central review (BICR) of disease response per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1).
As pre-specified in the statistical analysis plan, for participants who crossed over from docetaxel to sotorasib, the participant's response post first progression or post crossover was not used for the primary analyses. Data are presented per original treatment randomized.

• Secondary Outcome: None

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: <= 100age old
• Gender: Both

Include criteria

1. Men or women greater than or equal to 18 years old.
2. ECOG <= 1
3. 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

Exclude criteria

1. Active brain metastases
2. Myocardial infarction within 6 months of study day 1
3. Gastrointestinal (GI) tract disease causing the inability to take oral medication

Related Information

• Primary Sponsor: Amgen K.K.
• Secondary ID(s): NCT04303780,JapicCTI-205362