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Monoclonal Antibodies
Amivantamab + Chemotherapy vs Cetuximab + Chemotherapy for Colorectal Cancer (OrigAMI-2 Trial)
Temple, TX
Phase 3
Recruiting
Research Sponsored by Janssen Research & Development, LLC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Must agree to the submission of fresh tumor tissue
Have an ECOG performance status of 0 or 1
Must not have
Has medical history of noninfectious interstitial lung disease (ILD), pneumonitis, or pulmonary fibrosis, or current ILD/pneumonitis/pulmonary fibrosis
Has a prior or concurrent second malignancy other than the disease under study
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 7 years 3 months
Awards & highlights
No Placebo-Only Group
Pivotal Trial
Summary
This trial aims to see how long patients with a specific type of colorectal cancer can remain free of the disease when treated with two different drug combinations.
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Who is the study for?
This trial is for adults with left-sided colorectal cancer that's spread and can't be removed by surgery. They must have a type of tumor without certain mutations (KRAS/NRAS/BRAF wild-type), be able to provide a fresh tissue sample, have measurable disease, and be in good physical condition (ECOG 0 or 1).Check my eligibility
What is being tested?
The study compares two treatments: Amivantamab combined with chemotherapy (mFOLFOX6 or FOLFIRI) versus Cetuximab with the same chemo options. The goal is to see which treatment keeps the disease from worsening longer.See study design
What are the potential side effects?
Possible side effects include reactions at the infusion site, skin issues, low blood counts leading to increased infection risk or bleeding problems, nerve damage causing numbness or tingling, diarrhea, and fatigue.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I agree to provide a fresh sample of my tumor for testing.
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I am fully active or restricted in physically strenuous activity but can do light work.
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My left-sided colorectal cancer is confirmed and cannot be surgically removed.
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My tumor is KRAS, NRAS, and BRAF wild-type.
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Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have a history of lung conditions not caused by infections.
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I have or had another type of cancer besides the one currently being treated.
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My cancer is HER2-positive and has dMMR/MSI-H status.
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I have been treated with drugs targeting EGFR or MET before.
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Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 7 years 3 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 7 years 3 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Progression-Free Survival (PFS) as Assessed by Blinded Independent Central Review (BICR)
Secondary study objectives
Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Score
Change from Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Colorectal Cancer Module 29 (EORTC-QLQ-C30) Score
Curative Resection (R0) Rate
+15 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Arm A: Amivantamab in Combination With ChemotherapyExperimental Treatment5 Interventions
Participants will receive amivantamab in combination with chemotherapy (mFOLFOX6 \[chemotherapy consisting of 5-fluorouracil, leucovorin calcium (folinic acid) or levoleucovorin, and oxaliplatin\] or FOLFIRI \[chemotherapy consisting of 5-fluorouracil, leucovorin calcium (folinic acid) or levoleucovorin, and irinotecan hydrochloride\]) for 28-days treatment cycles and will continue to receive the treatment until radiographic disease progression or other discontinuation criteria are met.
Group II: Arm B: Cetuximab in Combination With ChemotherapyActive Control5 Interventions
Participants will receive cetuximab in combination with chemotherapy (mFOLFOX6 or FOLFIRI) for 28-days treatment cycles and will continue to receive the treatment until radiographic disease progression or other discontinuation criteria are met.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
5-fluorouracil
2005
Completed Phase 4
~8440
Irinotecan Hydrochloride
2010
Completed Phase 3
~2050
Oxaliplatin
2011
Completed Phase 4
~2890
Find a Location
Closest Location:Baylor Scott and White Health· Temple, TX
Who is running the clinical trial?
Janssen Research & Development, LLCLead Sponsor
1,008 Previous Clinical Trials
6,402,169 Total Patients Enrolled
Janssen Research & Development, LLC Clinical TrialStudy DirectorJanssen Research & Development, LLC
773 Previous Clinical Trials
3,980,196 Total Patients Enrolled