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

A Phase 3 Multicenter, Randomized, Open Label, Active-controlled, Study of sotorasib Versus Docetaxel for the Treatment of Previously Treated Locally Advanced and Unresectable or Metastatic NSCLC Subjects With Mutated KRAS p.G12C

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080225266

Enrollment

345

Registered

2020-07-07

Start date

2020-06-04

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

KRAS p, G12c Mutated /Advanced Metastatic NSCLC

Interventions

investigational material(s) Generic name etc : sotorasib INN of investigational material : sotorasib - Therapeutic category code : 429 Other antitumor agents Dosage and Administration for Investigatio

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion 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

Exclusion criteria

Exclusion 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

Design outcomes

Primary

Measure	Time frame
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.	—

Measure

Time frame

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.

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Countries

Australia, Belgium, Brazil, Canada, Denmark, Finland, France, Germany, Greece, Hungary, Italy, Korea, Netherlands, Poland, Portugal, Russian, Spain, Sweden, Switzerland, Taiwan, United Kingdom, United States

Contacts

Public ContactContact Local

Amgen K.K.

clinicaltrials_japan@amgen.com+81-80-7217-8592

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026