Study to Compare AMG 510 "Proposed INN Sotorasib" With Docetaxel in Non Small Cell Lung Cancer (NSCLC) (CodeBreak 200).

Amgen

Status and phase: Active, not recruiting; Phase 3

Conditions: KRAS p, G12c Mutated /Advanced Metastatic NSCLC

Treatments: Drug: AMG 510; Drug: Docetaxel

Study type: Interventional

Funder types: Industry

Identifiers

NCT04303780

2023-508214-42-00 (Other Identifier)

20190009

Details and patient eligibility

About

A Phase 3 Study to Compare AMG 510 with Docetaxel in Non Small Cell Lung Cancer (NSCLC) subjects with KRAS p. G12c mutation

Enrollment: 345 patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

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

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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345 participants in 2 patient groups

AMG 510

Experimental group

Treatment:

Drug: AMG 510

Docetaxel

Active Comparator group

Treatment:

Drug: Docetaxel