A Study of Amivantamab and FOLFIRI Versus Cetuximab/Bevacizumab and FOLFIRI in Participants With KRAS/NRAS and BRAF Wild-type Colorectal Cancer Who Have Previously Received Chemotherapy

ملخص

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.

الأهلية

تصميم الدراسة

مقاييس النتائج

1. مقياس النتيجة الأولي

   Progression-Free Survival (PFS) as Assessed by Blinded Independent Central Review (BICR)

   PFS is defined as the time from randomization until the date of objective disease progression or death (due to any cause), whichever comes first, as assessed by BICR using response evaluation criteria in solid tumors (RECIST) version (v)1.1. Participants who have not progressed or have not died at the time of analysis will be censored at their last evaluable RECIST v1.1 assessment date.

   الإطار الزمني Up to 2 years 1 month

2. مقياس النتيجة الأولي

   Overall Survival (OS)

   OS is defined as the time from the date of randomization to the date of participant's death due to any cause.

   الإطار الزمني Up to 4 years 4 months

3. مقياس النتيجة الثانوي

   Objective Response Rate (ORR) as Assessed by BICR

   ORR is defined as the percentage of randomized participants achieving partial response (PR) or complete response (CR), as determined by BICR using RECIST v1.1 criteria.

   الإطار الزمني Up to 4 years 4 months

4. مقياس النتيجة الثانوي

   ORR as Assessed by Investigator

   ORR is defined as the percentage of randomized participants achieving partial response (PR) or complete response (CR), as determined by investigator using RECIST v1.1 criteria.

   الإطار الزمني Up to 4 years 4 months

5. مقياس النتيجة الثانوي

   Progression Free Survival as Assessed by Investigator

   PFS is defined as the time from randomization until the date of objective disease progression or death (due to any cause), whichever comes first, as assessed by investigator.

   الإطار الزمني Up to 4 years 4 months

6. مقياس النتيجة الثانوي

   Duration of Response (DoR) as Assessed by BICR

   DoR is defined as time from the date of first documented response (CR or PR) until the date of documented progression or death, whichever comes first, for participants who have PR or CR as assessed by BICR.

   الإطار الزمني Up to 4 years 4 months

7. مقياس النتيجة الثانوي

   Duration of Response as Assessed by Investigator

   DoR is defined as time from the date of first documented response (CR or PR) until the date of documented progression or death, whichever comes first, for participants who have PR or CR as assessed by investigator.

   الإطار الزمني Up to 4 years 4 months

8. مقياس النتيجة الثانوي

   Time to Response (TTR) as Assessed by BICR

   TTR is defined as the time from the date of randomization to the date of first documentation of a response (PR or CR) prior to any disease progression or subsequent systemic anti-cancer therapy or curative-intent procedure, for participants who have PR or CR as BOR, as assessed by BICR.

   الإطار الزمني Up to 4 years 4 months

9. مقياس النتيجة الثانوي

   TTR as Assessed by Investigator

   TTR is defined as the time from the date of randomization to the date of first documentation of a response (PR or CR) prior to any disease progression or subsequent systemic anti-cancer therapy or curative-intent procedure, for participants who have PR or CR as BOR, as assessed by investigator.

   الإطار الزمني Up to 4 years 4 months

10. مقياس النتيجة الثانوي

    Progression Free Survival After Subsequent Therapy (PFS2)

    PFS2 is defined as the time from randomization until the date of second objective disease progression, after initiation of subsequent systemic anticancer therapy, based on investigator assessment or death, whichever comes first.

    الإطار الزمني Up to 4 years 4 months

11. مقياس النتيجة الثانوي

    Disease Control Rate (DCR) as Assessed by BICR

    DCR is defined as the percentage of randomized participants achieving CR, PR, or stable disease (with a minimum duration of 7 weeks) as defined by BICR using RECIST v1.1.

    الإطار الزمني Up to 4 years 4 months

12. مقياس النتيجة الثانوي

    Disease Control Rate as Assessed by Investigator

    DCR is defined as the percentage of randomized participants achieving CR, PR, or stable disease (with a minimum duration of 7 weeks) as assessed by investigator.

    الإطار الزمني Up to 4 years 4 months

13. مقياس النتيجة الثانوي

    Time to Treatment Failure

    Time to treatment failure is defined as time from randomization to discontinuation of therapy for any reason including death, progression, toxicity, or initiation of new anticancer therapy.

    الإطار الزمني Up to 4 years 4 months

14. مقياس النتيجة الثانوي

    Curative Resection (R0) Rate

    Curative resection (R0) rate is defined as the percentage of randomized participants who underwent curative-intent surgery where the residual tumor classification was R0.

    الإطار الزمني Up to 4 years 4 months

15. مقياس النتيجة الثانوي

    Number of Participants with Adverse Events (AEs) by Severity

    An AE is any untoward medical occurrence in a participant administered a pharmaceutical (investigational or non investigational) product. An AE does not necessarily have a causal relationship with the treatment. Severity of AEs will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) v5.0. by using standard grades as follows: Grade 1: Mild; asymptomatic or mild symptoms; Grade 2: Moderate; minimal, local or noninvasive intervention indicated; Grade 3: Severe but not immediately life threatening; hospitalization or prolongation of hospitalization indicated; Grade 4: Life-threatening consequences; and Grade 5: Death related to AE.

    الإطار الزمني Up to 4 years 4 months

16. مقياس النتيجة الثانوي

    Number of Participants with Abnormalities in Laboratory Values

    Participants with abnormalities in laboratory values (such as serum chemistry, hematology) will be reported.

    الإطار الزمني Up to 4 years 4 months

17. مقياس النتيجة الثانوي

    Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Score

    The EORTC QLQ-C30, is a self-administered, 30-item questionnaire measuring the health-related quality of life (HRQoL) of participants with cancer. EORTC QLQ-C30 includes 5 functional scales, 3 symptom scales, a global health status/quality of life scale, and 6 single items. Responses to items 1-28 are rated on a 4-point Likert response scale ranging from 1 "Not at all" to 4 "Very much." Two global health status items are rated on a 7-point numeric rating scale from 1 "Very Poor" to 7 "Excellent." Higher scores indicate greater functioning, better global health status, and more severe symptoms.

    الإطار الزمني From baseline up to 4 years 4 months

18. مقياس النتيجة الثانوي

    Time to Worsening in Symptoms and Functioning as Measured by EORTC QLQ-C30

    Time to worsening in symptoms and functioning as measured by EORTC QLQ-C30 score will be reported. The EORTC QLQ-C30, is a self-administered, 30-item questionnaire measuring the health-related quality of life (HRQoL) of participants with cancer. EORTC QLQ-C30 includes 5 functional scales, 3 symptom scales, a global health status / quality of life scale, and 6 single items. Responses to items 1-28 are rated on a 4-point Likert response scale ranging from 1 "Not at all" to 4 "Very much." Two global health status items are rated on a 7-point numeric rating scale from 1 "Very Poor" to 7 "Excellent." Higher scores indicate greater functioning, better global health status, and more severe symptoms.

    الإطار الزمني Up to 4 years 4 months

19. مقياس النتيجة الثانوي

    Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-CR29) Score

    The EORTC QLQ-CR29, is a self-administered, 29-item questionnaire measuring the HRQoL of participants with colorectal cancer. The QLQ-CR29 includes items that evaluate symptoms (gastrointestinal, urinary, pain, and others) and functional areas (sexual, body image, weight, and anxiety) that are associated with colorectal cancer and its treatments. Responses are rated on a 4-point Likert response scale ranging from 1 "Not at all" to 4 "Very much." All scores are linearly converted into a scale from 0 to 100. Higher scores indicate greater functioning and more severe symptoms.

    الإطار الزمني From baseline up to 4 years 4 months

20. مقياس النتيجة الثانوي

    Time to Worsening in Symptoms and Functioning as Measured by EORTC QLQ-CR29 Score

    Time to worsening in symptoms and functioning as measured by EORTC QLQ-CR29 will be reported. EORTC QLQ-CR29, is a self-administered, 29-item questionnaire measuring the HRQoL of participants with colorectal cancer. The QLQ-CR29 includes items that evaluate symptoms (gastrointestinal, urinary, pain, and others) and functional areas (sexual, body image, weight, and anxiety) that are associated with colorectal cancer and its treatments. Responses are rated on a 4-point Likert response scale ranging from 1 "Not at all" to 4 "Very much." All scores are linearly converted into a scale from 0 to 100. Higher scores indicate greater functioning and more severe symptoms. Change from baseline in the EORTC QLQ-CR29 score will be reported.

    الإطار الزمني Up to 4 years 4 months

21. مقياس النتيجة الثانوي

    Overall Side Effect Burden as Measured by European Organisation for Research and Treatment of Cancer (EORTC) Item 168 Scale Score

    EORTC item 168 is a single item used to measure the overall impact of treatment side effects. Responses are rated on a 4-point Likert response scale ranging from 1 "Not at all" to 4 "Very much. Higher scores indicates severe symptoms.

    الإطار الزمني Up to 4 years 4 months

التواريخ

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المواقع

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التغيّرات عبر الزمن

1. 28 أغسطس 2026

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