Carcinoma, Non-Small-Cell Lung
Conditions
Interventions
- 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
Sponsors
Anazawa Tomoko
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion 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
Exclusion criteria
Exclusion 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 ab | — |
Countries
Australia, Belgium, Brazil, Canada, China, France, Germany, Hungary, India, Israel, Italy, Japan, Korea Republic Of, Malaysia, Mexico, Poland, Portugal, Russian Federation, Spain, Taiwan, Province Of China,, Thailand, Turkey, Ukraine, United Kingdom Of Great Britain And Northe, United States Of America
Contacts
Public ContactMedical Information Center
Janssen Pharmaceutical K.K.
Outcome results
None listed