Health Condition 1: C399- Malignant neoplasm of lower respiratory tract, part unspecified
Conditions
Interventions
Intervention1: Lazertinib: Participants will receive
lazertinib tablets orally
Intervention2: Amivantamab: Participants will receive
amivantamab 1050mg intravenously for body weight
less than 80kg and
Sponsors
Johnson and Johnson Private Limited
Eligibility
Inclusion criteria
Inclusion criteria: Participant must have at least 1 measurable lesion according to Response Evaluation Criteria in Solid Tumors RECIST version 1 point 1 that has not been previously irradiated Participant must have histologically or cytologically confirmed, locally advanced or metastatic, non-squamous non-small cell lung cancer NSCLC, characterized at or after the tine of locally advanced metastatic disease diagnosis by either epidermal growth factor receptor EGFR Exon 19del or Exon 21 L858R mutation A participant with definitively locally treated brain metastases must be clinically stable and asymptomatic, with or without low-dose corticosteroid treatment less than or equal to 10 milligrams mg prednisone or equivalent, for at least 14 days prior to randomization Participant must have Eastern Cooperative Oncology Group ECOG status of 0 or 1 Any toxicities from prior systemic anticancer therapy must have resolved to National Cancer Institute Common Terminology Criteria for Adverse Events NCI CTCAE Version 5 point 0 Grade 1 or baseline level except for alopecia any grade, Grade less than or equal to 2 peripheral neuropathy, or Grade less than or equal to two hypothyroidism stable on hormone replacement A woman of childbearing potential must have a negative serum pregnancy 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 Participant must have progressed on or after osimertinib monotherapy as the most recent line of treatment Osimertinib must have been administered as either the first-line treatment for locally advanced or metastatic disease or in the second line setting after prior treatment with first or second generation EGFR tyrosine kinase inhibitor TKI. Participants who received either neoadjuvant and/or adjuvant treatment are eligible if progression to locally advanced or metastatic disease occurred at least 12 months after the last dose of such therapy and then the participant progressed on or after osimertinib in the locally advanced or metastatic setting. Treatment with osimertinib must be discontinued at least 8 days 4 half lives prior to randomization that is last dose no later than Day 8
Exclusion criteria
Exclusion criteria: Participant received radiotherapy for palliative treatment of NSCLC less than 14 days prior to randomization Participant has active brain metastases not definitively treated with local therapy Participant has leptomeningeal disease or participant has spinal cord compression not definitively treated with surgery or radiation Participant has known small cell transformation Participant has a medical history of interstitial lung disease ILD including drug induced ILD or radiation pneumonitis
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-Free Survival (PFS) According to RECIST v1.1 Guidelines as Assessed by Blinded Independent Central Review (BICR)Timepoint: Upto 17 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Duration of Response (DoR)Timepoint: Up to 17 months;European Organization of Research and Treatment of Cancer Quality of Life Questionnaire Core 30Timepoint: Up to 17 months;Intracranial PFSTimepoint: Up to 17 months;Non-Small Cell Lung Cancer - Symptom Assessment QuestionnaireTimepoint: Up to 17 months;Number of Participants with Adverse Events AEs Timepoint: Up to 48 months;Number of Participants with AntiAmivantamab AntibodiesTimepoint: Upto 17 months;Number of Participants with Clinical Laboratory Abnormalities Timepoint: Upto 48 months;Objective Response as Assessed by BICRTimepoint: Up to 17 months;Overall Survival (OS)Timepoint: Up to 48 months;Patient Reported Outcomes Measurement Information System Physical FunctionTimepoint: Up to 17 months;Plasma Concentration of LazertinibTimepoint: Up to 17 months;Progression-Free Survival After First Subsequent Therapy (PFS2) Timepoint: Up to 17 months;Serum Concentration of AmivantamabTimepoint: Up to 17 months;Time to Subsequent Therapy (TTST)Timepoint: Up to 17 months;Time to Symptomatic ProgressionTimepoint: Upto 17 months | — |
Countries
Argentina, Belgium, Brazil, Bulgaria, Canada, China, Czech Republic, Denmark, France, Germany, Hong Kong, India, Israel, Italy, Japan, Malaysia, Mexico, Netherlands, Poland, Portugal, Republic of Korea, Russian Federation, Spain, Sweden, Taiwan, Turkey, United Kingdom
Contacts
Public ContactDr Sanish Davis
Janssen Pharmaceutical Companies of Johnson & Johnson
Outcome results
None listed