Health Trials

Study of Sotorasib, Panitumumab and FOLFIRI Versus FOLFIRI With or Without Bevacizumab-awwb in Treatment-naïve Participants With Metastatic Colorectal Cancer With KRAS p.G12C Mutation

ConditionMetastatic Colorectal Cancer
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorAmgen

About this trial

The aim of this study is to compare progression free survival (PFS) in treatment-naïve participants with KRAS p.G12C mutated metastatic colorectal cancer (mCRC) receiving sotorasib, panitumumab and FOLFIRI vs FOLFIRI with or without bevacizumab-awwb.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Pathologically documented metastatic colorectal adenocarcinoma with KRAS p.G12C mutation by a locally validated assay.

Central laboratory detection of KRAS p.G12C mutation.

Measurable metastatic disease per RECIST v1.1 criteria.

Eastern Cooperative Oncology Group (ECOG) Performance Status of ≤ 1.

Disqualifiers

Active, untreated brain metastases.

Leptomeningeal disease

Previous treatment with a KRAS p.G12C inhibitor

History of interstitial pneumonitis or pulmonary fibrosis or evidence of interstitial pneumonitis or pulmonary fibrosis on baseline CT scan

Trial design

Design model

Parallel

Treatments tested in this trial

  • FOLFIRI Regimen

    Drug

    Combination of irinotecan, leucovorin, and 5-fluorouracil given via IV infusion Q2W.

  • Sotorasib

    Drug

    Immediate-release solid dosage form administered orally.

  • Panitumumab

    Drug

    Administered via IV infusion Q2W.

  • Bevacizumab-awwb

    Drug

    Administered via IV infusion Q2W.

Treatment groups

450 Participants
are divided into 2 treatment groups
Group A: Arm A: Sotorasib + Panitumumab + FOLFIRIExperimental treatment 3 interventions
Group B: Arm B: FOLFIRI with or Without Bevacizumab-awwbActive comparator 2 interventions

Trial outcomes

Primary outcomes

1

PFS per Response Evaluation Criteria in Solid Tumors (RECIST v1.1)

Time frame
Up to Approximately 3 Years

Secondary outcomes

1

Overall Survival (OS)

Time frame
Up to Approximately 5 Years
2

Objective Response Rate (ORR) per RECIST v1.1

Time frame
Up to Approximately 5 Years
3

Objective Response (OR) per RECIST v1.1

Time frame
Up to Approximately 5 Years
4

Duration of Response (DOR) per RECIST v1.1

Time frame
Up to Approximately 5 Years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Amgen

Lead sponsor

Source ClinicalTrials.gov
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