Colorectal Cancer MetastaticPhase 3FIRE-11NCT07004413
Continuous or Intermittent Cetuximab Plus FOLFIRI as First-line Treatment in RAS/BRAF Wild-type mCRC Patients
A Phase 3 study testing FOLFIRI+cetuximab and Guardant360 ctDNA assay in people with Colorectal Cancer Metastatic, run by Charite University, Berlin, Germany at 1 site in Germany.
Trial summary
The goal of this clinical trial is to learn if the application of the chemotherapy FOLFIRI and cetuximab works better when given with scheduled breaks or continuously in adults with metastatic colorectal cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer Metastatic
- What is being tested?
- FOLFIRI+cetuximab and Guardant360 ctDNA assay
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 267 participants
- Where
- 1 siteGermany
- Study dates
- 1 Oct 2026to 1 Oct 2031
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient's signed informed consent
- Histologically confirmed, UICC stage IV unresectable adenocarcinoma of the colon or rectum
- Locally confirmed RAS/BRAF wild-type tumor status (KRAS and NRAS exon 2, 3, 4, BRAF exon 11/15)
- Note: A maximum of two cycles FOLFIRI is allowed prior to start of induction treatment until the molecular characterization is fully reported
- Centrally confirmed RAS/BRAF wild-type status by liquid biopsy during screening phase
- Age 18 or older at the time of written informed consent
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- ECOG performance status below or equal 1
- Presence of at least one measurable reference lesion according to the RECIST 1.1 criteria
- Archival tumor tissue available
- Consent to storage, molecular and genetic profiling of tumor material and blood
- Adequate bone marrow function:
- Leukocytes ≥ 3.0 x 109/L with neutrophils ≥ 1.5 x 109/L
- Thrombocytes ≥ 100 x 109/L
- Hemoglobin ≥ 8 g/dL)
- Adequate hepatic function:
- Serum bilirubin ≤ 1.5 x upper limit of normal (ULN)
- ALAT and ASAT ≤ 2.5 x ULN (in the presence of hepatic metastases, ALAT and ASAT ≤ 5 x ULN)
- INR < 1.5 and aPTT < 1.5 x ULN (patients without anticoagulation). Therapeutic anticoagulation is allowed if INR and aPTT have remained stable within the therapeutic range for at least 2 weeks.
- Adequate renal function:
- Creatinine clearance (calculated according to Cockcroft and Gault) ≥ 50 mL/min
- Proficient fluorouracil metabolism as defined:
- Prior treatment with 5-FU or capecitabine without unusual toxicity OR
- If tested, normal DPD deficiency test according to the standard of the study site OR
- If tested, in patients with DPD deficiency test with a CPIC activity score of 1.0-1.5 fluoropyrimidine dosage should be reduced by 50%
- Females of childbearing potential (FCBPs) and men must agree to use highly effective contraceptive measures (Pearl index <1) or practice true abstinence from any heterosexual intercourse (true abstinence is acceptable when this is in line with the preferred and usual lifestyle of the subject) for the duration of the study treatment and for at least 6 months after last administration of study medication. A woman will be considered as being of childbearing potential unless she is at least 50 years old and moreover has gone through menopause for at least 2 years or has been surgically sterilized. For men: With female partners of childbearing potential, men must remain abstinent or use a condom plus an additional contraceptive method that together result in a failure rate of < 1% per year during the treatment period and for 6 months after the last dose of study treatment. Men must refrain from donating sperm during this same period. With pregnant female partners, men must remain abstinent or use a condom during the treatment period and for 6 months after the last dose of study medication to avoid exposing the embryo.
Who cannot join
- Proof of a RAS or BRAF mutation (KRAS/NRAS exons 2, 3, 4 or BRAF exon 15) in the tumor (proven in the primary tumor or metastasis) or liquid biopsy during screening phase.
- Previous chemotherapy for the colorectal cancer with the exception of adjuvant treatment, completed at least 6 months before written informed consent.
- New York Heart Association Class III or greater heart failure by clinical judgement.
- Myocardial infarction, balloon angioplasty (PTCA) with or without stenting, and cerebral vascular accident/stroke within the past 12 months before randomization
- Unstable angina pectoris
- Unstable cardiac arrhythmia > grade 2 NCI CTCAE despite anti-arrhythmic therapy.
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- Active uncontrolled infection by investigator's perspective.
- Pre-existing pulmonary fibrosis or immune pneumonitis
- Additional cancer treatment (chemotherapy, radiation, immunotherapy or hormone treatment) during the study treatment in first-line and third-line treatment (treatments that are conducted as part of an anthroposophical or homeopathic treatment approach, e.g. mistletoe therapy does not represent an exclusion criterion)
- Participation in a clinical study or experimental drug treatment within 30 days prior to written informed consent or within a period of 5 half-lives of the substances administered in a clinical study or during an experimental drug treatment prior to written informed consent, depending on which period is longest or simultaneous participation in another study while taking part in the study
- Known hypersensitivity or allergic reaction to any of the following substances: 5-fluorouracil, folinic acid, cetuximab, irinotecan and chemically related substances and/or hypersensitivity to any of the components in the formulations of the aforementioned substances, including known hypersensitivity reactions to monoclonal antibodies NCI CTC grade ≥ 3.
- Known hypersensitivity to Chinese hamster ovary cell (CHO) -cellular products or other recombinant human or humanized monoclonal antibodies
- Patients with known brain metastases or leptomeningeal disease. In case of clinical suspicion of brain metastasis, a cranial CT or MRI must be performed to rule out brain metastasis before study inclusion.
- History of acute or subacute intestinal occlusion, inflammatory bowel disease, immune colitis or chronic diarrhea
- Symptomatic peritoneal carcinosis
- Severe, non-healing wounds, ulcers or bone fractures
- Requirement for immunization with live vaccine including attenuated live vaccine from at least 4 weeks before begin of induction treatment until 6 months after the administration of IMPs.
- Hemorrhagic diathesis or known thrombophilia
- Known glucuronidation deficiency (Gilbert's syndrome) (specific screening not required)
- Treatment with nucleoside analogues including sorivudine or brivudine within 28 days before begin of induction treatment or requirement for concomitant antiviral treatment with sorivudine or brivudine or analogues
- History of a second primary malignancy during the past 5 years before written informed consent or during participation in the study, with the exception of a basal cell or squamous cell carcinoma of the skin or cervical carcinoma in situ, if these were treated curatively.
- Active alcohol or drug abuse
- Any significant adverse event that has not adequately resolved, severe acute or chronic concomitant disease or medical condition including psychiatric conditions (including recent i.e. within the past year or active suicidal ideation or behavior) or laboratory abnormalities that may increase the risk associated with study participation or study treatment administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the patient inappropriate for entry into this study.
- Absent or restricted legal capacity
- Patients who are institutionalized by order of court or public authority
- Patients who might be dependent on the sponsor/investigator or the trial site
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site
Charite University, Berlin
Berlin, 10117
Arndt Stahler, MD, +49 30 450 613 478, arndt.stahler@charite.de
About this study
Official title: Randomized Study to Compare First-line Treatment With Either Continuous or Intermittent Cetuximab Plus FOLFIRI in Patients With RAS/BRAF-wild-type Metastatic Colorectal Cancer (mCRC): AIO-KRK-0524 / FIRE-11
The goal of this clinical trial is to learn if the application of the chemotherapy FOLFIRI and cetuximab works better when given with scheduled breaks or continuously in adults with metastatic colorectal cancer. The main question it aims to answer is, whether worsening of disease after 12 months of treatment is lower when the treatment is given with breaks or given continuously. It will also answer the question whether the quality of life is better and side effects are less if chemotherapy is given with breaks.
Additionally, the treatment breaks will be controlled by blood tests and imaging examinations. A novel blood test will be introduced to investigate, whether worsening of the disease might be detected before the imaging, and whether a quicker reaction by re-starting the therapy would help the patients.
Read more
Participants will:
- receive an established chemotherapy mit FOLFIRI and cetuximab
- Receive blood tests every 4 weeks and imaging investigations every 12 weeks
- fill out questionnaires to report their quality of life
Read the detailed description
This is a combined multicenter, randomized phase III clinical trial and interventional clinical performance study according to IVDR investigating the superiority of intermittent application of FOLFIRI plus cetuximab followed by a scheduled treatment pause compared to continuous treatment with FOLFIRI plus cetuximab until disease progression or unacceptable toxicity. This study is accompanied by a translational research program.
This study protocol is driven by a CTR-conform question and primary endpoint, the PFS from randomization to progression on treatment at 12 months, and supplemented by a separate, complementary, interventional clinical performance study to assess ctDNA as biomarker of early disease progression as a key secondary endpoint. Details regarding the IVD part are specified in the complementary interventional clinical performance study protocol.
Treatment is planned until progression, death or unacceptable toxicity. Patients are followed up with regard to survival and if applicable subsequent anti - cancer treatments until death or -after end of study treatment- for at least 3 years after start of treatment, whichever date is earlier.
- Conditions
- Colorectal Cancer Metastatic
- Being tested
- FOLFIRI+cetuximab, Guardant360 ctDNA assay
- Keywords
- Metastatic colorectal cancer, RAS, BRAF, cetuximab, ctDNA, treatment break
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FOLFIRI+cetuximabDrug
Also called Cetuximab, Irinotecan, Folinic acid, 5-fluorouracil (FU)
Cetuximab 500 mg/m², 90 min IV infusion on d1; Irinotecan: 180 mg/m², 90-120 min IV infusion on d1; Folinic acid: 400mg/m², 1-2h IV Infusion on d1; 5-FU: 2400 mg/m², 46 h IV infusion on d1. Cycles are repeated on day 15.
Guardant360 ctDNA assayDiagnostic test
Determination of circulating tumor DNA (ctDNA) in the peripheral blood, part 1: retrospective threshold determination to predict radiological disease progression in Arm 2; part 2: prospective validation of the in part 1 identified ctDNA threshold to guide the scheduled treatment breaks and treatment in Arm 2
| Study group | Role | What they receive |
|---|---|---|
| FOLFIRI+cetuximab, continuously applied | Active comparator | Continuous application of FOLFIRI+cetuximab until disease progression according to standard of care Receives: Drug: FOLFIRI+cetuximab |
| FOLFIRI+cetuximab, applied with scheduled treatment breaks | Experimental | Scheduled treatment break after up to 6 cycles of FOLFIRI+cetuximab until radiological (or, in part 2, ctDNA-based) disease progression Receives: Drug: FOLFIRI+cetuximab; Diagnostic Test: Guardant360 ctDNA assay |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival (PFS) on treatment rate at 12 months
Percentage of patients who did not experience disease progression or death, whichever occurs first, while receiving active treatment for 12 months starting from randomization.
Measured: 12 months
Secondary outcomes (9)
PFS1 to PFSN
Each PFS from treatment start with FOLFIRI+cetuximab to the first disease progression in the respective treatment period
Measured: up to 24 months
Overall survival (OS)
Time from randomization to the date of death by any cause
Measured: At least 5 years after randomization
Objective Response Rate (ORR)
Radiological objective response as determined by RECIST 1.1 criteria
Measured: up to 24 months
Dynamics of the tumor markers CEA and CA19-9
Measured: Up to 24 months
Early Tumor Shrinkage (ETS)
Radiological reduction of tumor volume by 20% at the first re-staging (8 weeks)
Measured: 8 weeks
Depth of Response (DpR)
Maximum relative decrease of radiologically determined tumor mass in percent
Measured: up to 24 months
Circulating tumor DNA (ctDNA) as additional prospective biomarker of serum RAS/BRAF wild-type status and predictor early radiological disease progression
Prospective validation to use ctDNA based RAS/BRAF mutational analysis in addition to tissue-based RAS/BRAF testing to exclude RAS/BRAF mutant tumors from treatment, definition and validation of a threshold value in ctDNA change predicting progressive disease during treatment pause
Measured: Up to 24 months
Quality of Life (QoL)
QoL as assessed with the QoL questionnaire EQ-5D-5L
Measured: up to 24 months
Adverse events
Type, incidence, severity, and causal relationship to IMPs of non-serious adverse events and serious adverse events (severity evaluated according to CTCAE version 5.0)
Measured: up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2025
- Study start1 Oct 2026 (estimated)
- Primary completion1 Oct 2028 (estimated)
- Study completion1 Oct 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal Cancer MetastaticStudies of the same condition, open and under way.
- More trials run by Charite University, Berlin, GermanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- open-label, randomized, controlled, multicenter, phase III study with two parallel arms
- Masking
- None (open label)
- Enrolment
- 267 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Collaborators
- Guardant Health, Inc., Merck KGaA, Darmstadt, Germany
- Responsible party
- Principal investigator, Sebastian Stintzing, Charite University, Berlin, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07004413
- Sponsor's protocol ID
- U1111-1319-8357
- Other IDs
- 2025-522377-12-00, AIO-KRK-0524, 2025
- Acronym
- FIRE-11
- Status last verified
- Jul 2026
- First submitted
- 27 May 2025
- Last updated
- 29 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Study to Compare First-line Treatment With Either Continuous or Intermittent Cetuximab Plus FOLFIRI in Patients With RAS/BRAF-wild-type Metastatic Colorectal Cancer (mCRC): AIO-KRK-0524 / FIRE-11
- ClinicalTrials.gov ID
- NCT07004413
- Acronym / sponsor ID
- FIRE-11 / U1111-1319-8357
- Conditions
- Colorectal Cancer Metastatic
- Keywords
- Metastatic colorectal cancer, RAS, BRAF, cetuximab, ctDNA, treatment break
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 267 participants (estimated)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Collaborators
- Guardant Health, Inc., Merck KGaA, Darmstadt, Germany
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- 1 Oct 2028 (estimated)
- Study completion
- 1 Oct 2031 (estimated)
- First posted
- 4 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical trial is to learn if the application of the chemotherapy FOLFIRI and cetuximab works better when given with scheduled breaks or continuously in adults with metastatic colorectal cancer. The main question it aims to answer is, whether worsening of disease after 12 months of treatment is lower when the treatment is given with breaks or given continuously. It will also answer the question whether the quality of life is better and side effects are less if chemotherapy is given with breaks.
Additionally, the treatment breaks will be controlled by blood tests and imaging examinations. A novel blood test will be introduced to investigate, whether worsening of the disease might be detected before the imaging, and whether a quicker reaction by re-starting the therapy would help the patients.
Participants will:
- receive an established chemotherapy mit FOLFIRI and cetuximab
- Receive blood tests every 4 weeks and imaging investigations every 12 weeks
- fill out questionnaires to report their quality of life
Detailed description
This is a combined multicenter, randomized phase III clinical trial and interventional clinical performance study according to IVDR investigating the superiority of intermittent application of FOLFIRI plus cetuximab followed by a scheduled treatment pause compared to continuous treatment with FOLFIRI plus cetuximab until disease progression or unacceptable toxicity. This study is accompanied by a translational research program.
This study protocol is driven by a CTR-conform question and primary endpoint, the PFS from randomization to progression on treatment at 12 months, and supplemented by a separate, complementary, interventional clinical performance study to assess ctDNA as biomarker of early disease progression as a key secondary endpoint. Details regarding the IVD part are specified in the complementary interventional clinical performance study protocol.
Treatment is planned until progression, death or unacceptable toxicity. Patients are followed up with regard to survival and if applicable subsequent anti - cancer treatments until death or -after end of study treatment- for at least 3 years after start of treatment, whichever date is earlier.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- open-label, randomized, controlled, multicenter, phase III study with two parallel arms
| Arm | Type | Receives |
|---|---|---|
| FOLFIRI+cetuximab, continuously applied | Active comparator | Drug: FOLFIRI+cetuximabContinuous application of FOLFIRI+cetuximab until disease progression according to standard of care |
| FOLFIRI+cetuximab, applied with scheduled treatment breaks | Experimental | Drug: FOLFIRI+cetuximab, Diagnostic Test: Guardant360 ctDNA assayScheduled treatment break after up to 6 cycles of FOLFIRI+cetuximab until radiological (or, in part 2, ctDNA-based) disease progression |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (25 listed)
- Patient's signed informed consent
- Histologically confirmed, UICC stage IV unresectable adenocarcinoma of the colon or rectum
- Locally confirmed RAS/BRAF wild-type tumor status (KRAS and NRAS exon 2, 3, 4, BRAF exon 11/15)
- Centrally confirmed RAS/BRAF wild-type status by liquid biopsy during screening phase
- Age 18 or older at the time of written informed consent
Key exclusion criteria (26 listed)
- Proof of a RAS or BRAF mutation (KRAS/NRAS exons 2, 3, 4 or BRAF exon 15) in the tumor (proven in the primary tumor or metastasis) or liquid biopsy during screening phase.
- Previous chemotherapy for the colorectal cancer with the exception of adjuvant treatment, completed at least 6 months before written informed consent.
- New York Heart Association Class III or greater heart failure by clinical judgement.
- Myocardial infarction, balloon angioplasty (PTCA) with or without stenting, and cerebral vascular accident/stroke within the past 12 months before randomization
- Unstable angina pectoris
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FOLFIRI+cetuximabAlso: Cetuximab, Irinotecan, Folinic acid, 5-fluorouracil (FU)Cetuximab 500 mg/m², 90 min IV infusion on d1; Irinotecan: 180 mg/m², 90-120 min IV infusion on d1; Folinic acid: 400mg/m², 1-2h IV Infusion on d1; 5-FU: 2400 mg/m², 46 h IV infusion on d1. Cycles are repeated on day 15. | Drug | FOLFIRI+cetuximab, applied with scheduled treatment breaks, FOLFIRI+cetuximab, continuously applied |
| Guardant360 ctDNA assayDetermination of circulating tumor DNA (ctDNA) in the peripheral blood, part 1: retrospective threshold determination to predict radiological disease progression in Arm 2; part 2: prospective validation of the in part 1 identified ctDNA threshold to guide the scheduled treatment breaks and treatment in Arm 2 | Diagnostic test | FOLFIRI+cetuximab, applied with scheduled treatment breaks |
Primary outcome
Progression-free survival (PFS) on treatment rate at 12 months
Time frame: 12 months
Percentage of patients who did not experience disease progression or death, whichever occurs first, while receiving active treatment for 12 months starting from randomization.
9 secondary outcomes
PFS1 to PFSN
Time frame: up to 24 months
Overall survival (OS)
Time frame: At least 5 years after randomization
Objective Response Rate (ORR)
Time frame: up to 24 months
Dynamics of the tumor markers CEA and CA19-9
Time frame: Up to 24 months
Early Tumor Shrinkage (ETS)
Time frame: 8 weeks
Depth of Response (DpR)
Time frame: up to 24 months
Circulating tumor DNA (ctDNA) as additional prospective biomarker of serum RAS/BRAF wild-type status and predictor early radiological disease progression
Time frame: Up to 24 months
Quality of Life (QoL)
Time frame: up to 24 months
Adverse events
Time frame: up to 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing FOLFIRI+cetuximab and Guardant360 ctDNA assay in people with Colorectal Cancer Metastatic, run by Charite University, Berlin, Germany at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 25 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 29 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Arndt Stahler, MD (+49 30 450 613 478, arndt.stahler@charite.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free survival (PFS) on treatment rate at 12 months (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2026.