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JRCT ID: jRCT2051200087

Registered date:18/11/2020

A Study of Combination Amivantamab and Carboplatin-Pemetrexed Therapy, Compared with Carboplatin-Pemetrexed, in Participants with Advanced or Metastatic Non-Small Cell Lung Cancer Characterized by Epidermal Growth Factor Receptor (EGFR) Exon 20 Insertions

Basic Information

Recruitment status	Not Recruiting
Health condition(s) or Problem(s) studied	Carcinoma, Non-Small-Cell Lung
Date of first enrollment	15/02/2021
Target sample size	308
Countries of recruitment	Australia,Japan,Belgium,Japan,Brazil,Japan,China,Japan,Germany,Japan,Spain,Japan,France,Japan,United Kingdom Of Great Britain And Northe,Japan,Hungary,Japan,India,Japan,Israel,Japan,Korea Republic Of,Japan,Mexico,Japan,Malaysia,Japan,Poland,Japan,Portugal,Japan,Russian Federation,Japan,Thailand,Japan,Turkey,Japan,Taiwan, Province Of China,,Japan,Ukraine,Japan,United States Of America,Japan,Canada,Japan,Italy,Japan
Study type	Interventional
Intervention(s)	- Amivantamab : Arm A: Amivantamab + Chemotherapy : Amivantamab will be administered as an IV infusion at a dose of 1400 mg (1750 mg if body weight is >=80 kilogram [kg]) by once weekly up to Cycle 2 Day 1, then 1750 mg (2100 mg if body weight is >=80 kg) on Day 1 of each 21-day cycle, starting with Cycle 3 and will continue the same treatment in OLE phase then in LTE phase. - Pemetrexed : Arm A: Amivantamab +Chemotherapy : Pemetrexed will be administered as 500 mg/m^2 IV infusion (with vitamin supplementation) on Day 1 of each 21-day cycle and then as maintenance monotherapy until disease progression in Arm A and will continue the same treatment in OLE phase then in LTE phase. - Carboplatin : Arm A: Amivantamab + Chemotherapy, Arm B: Chemotherapy Alone Carboplatin will be administered as AUC 5 IV infusion for up to 4 cycles on Day 1 of each 21-day cycle. - Pemetrexed : Arm B: Chemotherapy Alone : Pemetrexed will be administered as 500 mg/m^2 IV infusion (with vitamin supplementation) on Day 1 of each 21-day cycle and then as maintenance monotherapy until disease progression in Arm B and will continue the same treatment in OLE phase then in LTE phase.

TO Original Data: JRCT

Outcome(s)

Primary Outcome	Progression-Free Survival (PFS) According to RECIST v1.1 as Assessed by Blinded Independent Central Review (BICR) Up to 18 months PFS is defined as the time from randomization until the date of objective disease progression based on blinded independent central review (BICR) using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 or death (by any cause) in the absence of progression, whichever comes first.
Secondary Outcome	Objective Response Rate (ORR) Up to 48 months ORR is defined as the percentage of participants who achieve either a complete response (CR) or partial response (PR) as defined by BICR using RECIST v1.1 criteria. Duration of Response (DoR) Up to 48 months DoR 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, only for participants who achieve CR or PR as determined by the investigator using RECIST v1.1 criteria. Overall Survival (OS) Up to 48 months Overall Survival is defined as the time from the date of randomization to the date of participant's death due to any cause. Time to Subsequent Therapy (TST) Up to 48 months TST is defined as the time from the date of randomization to the start date of the subsequent anti-cancer therapy following study treatment discontinuation, or death. Progression-Free Survival After First Subsequent Therapy (PFS2) Up to 48 months PFS2 is defined as the time from the date of randomization to the earliest of the progression event subsequent to that used for the primary variable PFS or death after starting the next line of treatment. Time to Symptomatic Progression (TTSP) Up to 48 months TTSP is defined as the time from randomization to documentation in the electronic case report form (eCRF) of any of the following (whichever occurs earlier): onset of new symptoms or symptom worsening that is considered by the investigator to be related to lung cancer and requires either a change in anticancer treatment and/or clinical intervention to manage symptoms. Incidence and Severity of Adverse Events (AEs) Up to 48 months An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Number of Participants with Clinical Laboratory Abnormalities Up to 48 months Number of participants with clinical laboratory abnormalities (serum chemistry, hematology, blood coagulation, and urine samples) will be reported. Number of Participants with Vital Signs Abnormalities Up to 48 months Number of participants with vital signs abnormalities (temperature, heart rate, respiratory rate, oxygen saturation, blood pressure) will be reported. Number of Participants with Physical Examination Abnormalities Up to 48 months Number of participants with physical examination abnormalities will be reported. Serum Concentration of Amivantamab Up to 48 months Serum samples will be analyzed to determine concentrations of amivantamab. Number of Participants with Anti-Amivantamab Antibodies Up to 48 months Number of participants with antibodies to amivantamab will be reported. European Organization of Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC-QLQ-C30) Up to 48 months The EORTC QLQ-C30 includes 30 items in 5 functional scales, 1 global health status scale, 3 symptom scales, and 6 single symptom items. The responses are reported using a verbal rating scale. The item and scale scores are transformed to a 0 to 100 scale. A higher score represents greater HRQoL, better functioning, and more (worse) symptoms. Patient Reported Outcomes Measurement Information System-Physical Function (PROMIS-PF) Up to 48 months PROMIS-PF is used to characterize and better understand overall health, level of physical disability, and general well-being. Physical function is a foundation for commonly used general and cancer-specific patient reported outcomes (PRO) measures.

Primary Outcome

Progression-Free Survival (PFS) According to RECIST v1.1 as Assessed by Blinded Independent Central Review (BICR) Up to 18 months PFS is defined as the time from randomization until the date of objective disease progression based on blinded independent central review (BICR) using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 or death (by any cause) in the absence of progression, whichever comes first.

Secondary Outcome

Objective Response Rate (ORR) Up to 48 months ORR is defined as the percentage of participants who achieve either a complete response (CR) or partial response (PR) as defined by BICR using RECIST v1.1 criteria. Duration of Response (DoR) Up to 48 months DoR 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, only for participants who achieve CR or PR as determined by the investigator using RECIST v1.1 criteria. Overall Survival (OS) Up to 48 months Overall Survival is defined as the time from the date of randomization to the date of participant's death due to any cause. Time to Subsequent Therapy (TST) Up to 48 months TST is defined as the time from the date of randomization to the start date of the subsequent anti-cancer therapy following study treatment discontinuation, or death. Progression-Free Survival After First Subsequent Therapy (PFS2) Up to 48 months PFS2 is defined as the time from the date of randomization to the earliest of the progression event subsequent to that used for the primary variable PFS or death after starting the next line of treatment. Time to Symptomatic Progression (TTSP) Up to 48 months TTSP is defined as the time from randomization to documentation in the electronic case report form (eCRF) of any of the following (whichever occurs earlier): onset of new symptoms or symptom worsening that is considered by the investigator to be related to lung cancer and requires either a change in anticancer treatment and/or clinical intervention to manage symptoms. Incidence and Severity of Adverse Events (AEs) Up to 48 months An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Number of Participants with Clinical Laboratory Abnormalities Up to 48 months Number of participants with clinical laboratory abnormalities (serum chemistry, hematology, blood coagulation, and urine samples) will be reported. Number of Participants with Vital Signs Abnormalities Up to 48 months Number of participants with vital signs abnormalities (temperature, heart rate, respiratory rate, oxygen saturation, blood pressure) will be reported. Number of Participants with Physical Examination Abnormalities Up to 48 months Number of participants with physical examination abnormalities will be reported. Serum Concentration of Amivantamab Up to 48 months Serum samples will be analyzed to determine concentrations of amivantamab. Number of Participants with Anti-Amivantamab Antibodies Up to 48 months Number of participants with antibodies to amivantamab will be reported. European Organization of Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC-QLQ-C30) Up to 48 months The EORTC QLQ-C30 includes 30 items in 5 functional scales, 1 global health status scale, 3 symptom scales, and 6 single symptom items. The responses are reported using a verbal rating scale. The item and scale scores are transformed to a 0 to 100 scale. A higher score represents greater HRQoL, better functioning, and more (worse) symptoms. Patient Reported Outcomes Measurement Information System-Physical Function (PROMIS-PF) Up to 48 months PROMIS-PF is used to characterize and better understand overall health, level of physical disability, and general well-being. Physical function is a foundation for commonly used general and cancer-specific patient reported outcomes (PRO) measures.

Key inclusion & exclusion criteria

Age minimum	>= 18age old
Age maximum	Not applicable
Gender	Both
Include criteria	- Participant must have histologically or cytologically confirmed, locally advanced or metastatic, nonsquamous non-small cell lung cancer (NSCLC) with documented primary epidermal growth factor receptor (EGFR) Exon 20ins activating mutation - Participant must have measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. - Participant must have Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 - Participant must agree to genetic characterization of tumor status through the required pretreatment tumor biopsy (or submission of equivalent archival material), as well as baseline and periodic blood samples for analysis of tumor mutations in the bloodstream - A female participant of childbearing potential must have a negative serum or urine test at screening and within 72 hours of the first dose of study treatment and must agree to further serum or urine pregnancy tests during the study
Exclude criteria	- Participant has evidence of synchronous NSCLC disease (as suggested by genetic characterization or radiographic appearance) - Participant has untreated brain metastases (a participant with definitively, locally treated metastases who is clinically stable, asymptomatic, and off corticosteroid treatment for at least 2 weeks prior to randomization is eligible) - Participant has history of spinal cord compression that has not been treated definitively with surgery or radiation - Participant has a medical history of interstitial lung disease (ILD), including drug-induced ILD, or radiation pneumonitis - Participant has a contraindication to the use of carboplatin or pemetrexed (refer to local prescribing information for each agent). Participant has a history of hypersensitivity to, or cannot take, vitamin B12 or folic acid

Related Information

Primary Sponsor	Nakama Takahiro
Secondary Sponsor
Source(s) of Monetary Support
Secondary ID(s)	NCT04538664,2020-000633-40

Contact

Public contact
Name	Medical Information Center
Address	5-2, Nishi-kanda 3-chome, Chiyoda-ku, Tokyo Tokyo Japan 101-0065
Telephone	+81-120-183-275
E-mail	DL-JANJP-JCO_TL_TSG_EMP@its.jnj.com
Affiliation	Janssen Pharmaceutical K.K.
Scientific contact
Name	Takahiro Nakama
Address	5-2, Nishi-kanda 3-chome, Chiyoda-ku, Tokyo Tokyo Japan 101-0065
Telephone	+81-120-183-275
E-mail	DL-JANJP-JCO_TL_TSG_EMP@its.jnj.com
Affiliation	Janssen Pharmaceutical K.K.

TO Original Data: JRCT