Tests amivantamab with chemotherapy in colorectal cancer that returned or spread

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with colorectal cancer that has come back, cannot be removed by surgery, or has spread. The cancer must be KRAS/NRAS and BRAF wild-type. They must have had one earlier line of chemotherapy.

Age

18 years or older

Sex

All sexes can join.

Disease stage

Adenocarcinoma of the colon or rectum that is recurrent, unresectable or metastatic, with measurable disease (RECIST v1.1). ECOG performance status of 0 or 1.

Earlier treatment

Must have had 1 line of systemic therapy (fluoropyrimidine-based and oxaliplatin-based) for metastatic disease, with scans showing the disease got worse. Anti-VEGF as the earlier therapy is allowed. Must not have had irinotecan, or drugs that target EGFR or MET.

Biomarker or test result

KRAS/NRAS G12, G13 and BRAF V600X wild-type status by next-generation sequencing (NGS) testing.

Main reasons for not taking part

• History of or current interstitial lung disease, pneumonitis or pulmonary fibrosis
• Known allergy or intolerance to amivantamab, cetuximab, bevacizumab or any part of FOLFIRI
• Another cancer that could interfere with the trial results
• Known dMMR/MSI-H tumor without earlier immunotherapy
• Known HER2-positive/amplified tumor

The registry criteria, word for word

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

• How many different drug treatment plans (such as chemotherapy) have you had for cancer that has spread?None1 treatment plan2 treatment plans3 or more treatment plansI don't know
• Which best describes how well you can look after yourself and be active?I am fully active and can do everything I did before my illnessI cannot do hard physical work, but I can do light work such as housework or office workI can look after myself but cannot work, and I am up and about more than half of the dayI am in bed or in a chair for more than half of the dayI don't know
• Do you have now, or have you ever had, a lung disease with scarring or swelling of the lungs, such as pulmonary fibrosis (scarring of the lungs) or pneumonitis?YesNo

What the trial wants to find out

The purpose of this study is to compare how long the participants are disease-free (progression-free survival) and and the length of time until a participant dies (overall survival), when treated with amivantamab and chemotherapy with 5-fluorouracil, leucovorin calcium (folinic acid) or levoleucovorin, and irinotecan hydrochloride (FOLFIRI) versus either cetuximab or bevacizumab and FOLFIRI given to participants with Kirsten rat sarcoma viral oncogene/ neuroblastoma RAS viral oncogene homolog (KRAS/ NRAS) and v-raf murine sarcoma viral oncogene homolog B (BRAF) wild-type recurrent, unresectable or metastatic colorectal cancer who have previously received chemotherapy.

The 2 groups in the trial

• Arm A: Amivantamab + FOLFIRITreatment being tested

  Participants will receive amivantamab along with FOLFIRI (consisting of 5-fluorouracil, leucovorin calcium \[folinic acid\] or levoleucovorin, and irinotecan) as a chemotherapy regimen for 28-days treatment cycles and will continue to receive the treatment until radiographic disease progression or other discontinuation criteria are met.

  Treatment: Amivantamab, 5-fluorouracil, Leucovorin calcium/Levoleucovorin, and Irinotecan

• Arm B: Cetuximab or Bevacizumab + FOLFIRIExisting treatment, for comparison

  Participants will receive either cetuximab or bevacizumab along with FOLFIRI as a chemotherapy regimen for 28-days treatment cycles and will continue to receive the treatment until radiographic disease progression or other discontinuation criteria are met.

  Treatment: Cetuximab, Bevacizumab, 5-fluorouracil, Leucovorin calcium/Levoleucovorin, and Irinotecan