A Randomized Phase 3 Study of Adagrasib in Combination with Cetuximab Versus Chemotherapy in Patients with Advanced Colorectal Cancer with KRAS G12C Mutation with Disease Progression On or After Standard First-Line Therapy

A Randomized Phase 3 Study of Adagrasib in Combination with Cetuximab Versus Chemotherapy in Patients with Advanced Colorectal Cancer with KRAS G12C Mutation with Disease Progression On or After Standard First-Line Therapy - KRYSTAL-10

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON54310

Enrollment

Registered

2021-07-12

Start date

2023-01-26

Completion date

Unknown

Last updated

2024-09-16

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

Conditions

Colon cancer

Interventions

The trial will compare the effectiveness of Adagrasib in combination with cetuximab (investigational arm) versus standard of care second-line treatment consisting of either FOLFIRI or mFOLFOX6 chemo

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: 1. Histologically confirmed diagnosis of colorectal carcinoma with KRAS G12C mutation in tumor tissue. 2. Prior receipt of 1st line treatment in the advanced CRC with a fluoropyrimidine-based chemotherapy regimen containing either oxaliplatin or irinotecan, and radiographically documented progression of disease on or after treatment.

Exclusion criteria

Exclusion criteria: 1. Prior treatment with both an oxaliplatin-and irinotecan-based regimen for CRC, concurrently or successively, in any setting (neoadjuvant, adjuvant or advanced) 2. Prior treatment with a therapy targeting KRAS G12C mutation (e.g., AMG 510). 3. Prior treatment with an anti-EGFR antibody (e.g., cetuximab or panitumumab).

Design outcomes

Primary

Measure	Time frame
• Progression-Free Survival (PFS), and • Overall Survival (OS).	—

Secondary

Measure	Time frame
• Safety characterized by type, incidence, severity, timing, seriousness and relationship to study treatment of adverse events, laboratory abnormalities, and number of patients discontinuing study treatment due to an adverse event. • Secondary efficacy endpoints: - Objective Response Rate (ORR), - Duration of Response (DOR), and *- 1-Year Survival Rate. • Plasma PK parameters of Adagrasib (and metabolites, if applicable). • Patient reported outcome (PROs) scores using the following: - European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire for Cancer Patients (QLQ-C30). - European Quality of Life Five Dimensions Questionnaire (EQ-5D-5L).	—

Measure

Time frame

• Safety characterized by type, incidence, severity, timing, seriousness and relationship to study treatment of adverse events, laboratory abnormalities, and number of patients discontinuing study treatment due to an adverse event. • Secondary efficacy endpoints: *- Objective Response Rate (ORR), *- Duration of Response (DOR), and *- 1-Year Survival Rate. • Plasma PK parameters of Adagrasib (and metabolites, if applicable). • Patient reported outcome (PROs) scores using the following: - European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire for Cancer Patients (QLQ-C30). - European Quality of Life Five Dimensions Questionnaire (EQ-5D-5L).

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Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)