A Study of Amivantamab in Addition to Standard of Care Agents (SOC) Compared With SOC Alone in Participants With Recurrent/Metastatic Head and Neck Cancer

Progression-Free Survival (PFS) Using RECIST Version 1.1, as Assessed by 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, based on BICR assessment using RECIST v1.1, regardless of treatment discontinuation or start of subsequent anticancer therapy.

Time frame: Up to approximately 3 years 7 months

Duration of Response (DOR) As Assessed by BICR

DOR as assessed by BICR is defined as the 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 best response.

Time frame: Up to approximately 3 years 7 months

ORR as Assessed by Investigator

ORR as assessed by the investigator is defined as the percentage of randomized participants achieving CR or PR, as defined by investigator assessment using RECIST v1.1 criteria.

Time frame: Up to approximately 3 years 7 months

Number of Participants with Treatment-Emergent Adverse Events (TEAEs)

TEAE is defined as any new or worsening adverse event (AE) occurring at or after the initial administration of study treatment through the day of last dose plus 30 days or prior to the start of subsequent anticancer therapy, whichever is earlier, or any follow-up AE with onset date and time beyond 30 days after the last dose of study treatment but prior to the start of subsequent therapy or any AE that is considered treatment-related regardless of the start date of the event.

Time frame: Up to approximately 3 years 7 months

Number of Participants with Laboratory Abnormalities

Blood samples will be collected to determine the laboratory (serum chemistry and hematology) abnormalities.

Time frame: Up to approximately 3 years 7 months

Percentage of Participants with Improved or Stable Symptoms Compared to Baseline as Measured by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Head and Neck Module 43 (EORTC QLQ-HN43) Symptom Scale Score

EORTC QLQ-HN43, is a self-administered, 43-item questionnaire measuring the health-related quality of life (HRQoL) of participants with head and neck cancer. EORTC QLQ-HN43 includes 19 scales (anxiety, body image, coughing, dry mouth and sticky saliva, neurological problems, opening mouth, pain in the mouth, social contact, problems with senses, shoulder problems, skin problems, swelling in the neck, social eating, speech, swallowing, sexuality, problems with teeth, weight loss, and problems with wound healing). Responses to items are rated on a 4-point Likert response scale ranging from 1 "Not at all" to 4 "Very much". Higher scores indicate worse health outcomes.

Time frame: Baseline, up to approximately 3 years 7 months

Percentage of Participants with Improved or Stable Symptoms Compared to Baseline as Measured by EORTC QLQ-Core (C) 30 Symptom Scale Score

EORTC QLQ-C30, is a self-administered, 30-item questionnaire measuring the HRQoL of participants with cancer. EORTC QLQ-C30 includes 3 symptom scales (fatigue, pain, and nausea and vomiting), and 6 single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). 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, or more severe symptoms.

Time frame: Baseline, up to approximately 3 years 7 months

Change from Baseline in Functioning HRQoL, as Measured by Functioning Scales of the EORTC QLQ-C30

EORTC QLQ-C30, is a self-administered, 30-item questionnaire measuring the HRQoL of participants with cancer. EORTC QLQ-C30 includes 5 functional scales (physical, role, cognitive, emotional, and social), 3 symptom scales (fatigue, pain, and nausea and vomiting), a global health status / quality of life scale, and 6 single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). 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, or more severe symptoms.

Time frame: Baseline, up to approximately 3 years 7 months

Change from Baseline in Overall HRQoL, as Measured by Global Health Scales of the EORTC QLQ-C30

EORTC QLQ-C30, is a self-administered, 30-item questionnaire measuring the HRQoL of participants with cancer. EORTC QLQ-C30 includes 5 functional scales (physical, role, cognitive, emotional, and social), 3 symptom scales (fatigue, pain, and nausea and vomiting), a global health status / quality of life scale, and 6 single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). 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, or more severe symptoms.

Time frame: Baseline, up to approximately 3 years 7 months

Differences Between Treatment Groups (Arms A and B) for EORTC Quality of Life (QLG) Item Library-46 (IL-46) Tolerability Scale Scores

EORTC IL46 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 score indicates more impact of treatment side-effects.

Time frame: Up to approximately 3 years 7 months

Serum Concentration of Amivantamab

Serum concentrations of amivantamab will be analyzed.

Time frame: Up to approximately 3 years 7 months

Number of Participants with Serum Anti-Amivantamab Antibodies

Participants who are positive to serum anti-amivantamab antibodies will be reported.

Time frame: Up to approximately 3 years 7 months