A Study of Combination Therapy With Amivantamab and Docetaxel in Participants With Metastatic Non-small Cell Lung Cancer
NCT Number: NCT06532032
Acronym: swalloWTail
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1|PHASE2
Conditions: Carcinoma, Non-Small-Cell Lung
Interventions: DRUG: Amivantamab|DRUG: Docetaxel
Sponsor: Janssen Research & Development, LLC
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 100
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: SEQUENTIAL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-07-23
Completion Date: 2025-10-21
Locations: Cancer and Blood Specialty Clinic, Los Alamitos, California, 90720, United States|Taipei Medical University, Taipei City, 110, Taiwan

Summary:
The purpose of this study is to identify the recommended Phase 2 (combination) dose (RP2CD) of the amivantamab and docetaxel combination therapy in participants with metastatic non-small cell lung cancer (NSCLC) in Phase 1 (combination dose selection); and to evaluate the antitumor effect of the combination at the selected RP2CD in participants with NSCLC without oncogenic driver mutations with disease progression on platinum-based chemotherapy and immune checkpoint inhibitor, in the Phase 2 (expansion).

Primary Outcome Measures: Phase 1: Number of Participants with Adverse events (AEs) by Severity, An AE is any untoward medical occurrence in a clinical study participant administered a pharmaceutical (investigational or non-investigational) product. An adverse event does not necessarily have a causal relationship with the intervention. Severity will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCICTCAE) version 5.0. Severity scale ranges from Grade 1 (Mild) to Grade 5 (Death). Grade 1= Mild, Grade 2= Moderate, Grade 3= Severe, Grade 4= Life-threatening and Grade 5= Death related to adverse event., Up to 1 year 4 months|Phase 1: Number of Participants with Dose Limiting Toxicities (DLTs), DLTs are specific adverse events and are defined as any of following: Any high grade (Grade 3, 4 or 5) non-hematologic toxicity with exceptions such as: Grade 3 fever resolved in \<=48 hours, anorexia; Grade 3 nausea, vomiting or diarrhea, or constipation Grade 3 fatigue; rash that improves to Grade \<; transient electrolyte abnormalities; symptoms of IRRs that are attributable to amivantamab or docetaxel; Tumor flare; hematologic toxicity (Grade 4 anemia or neutropenia, Febrile neutropenia; Grade 3 or 4 thrombocytopenia associated with bleeding or requiring transfusion); pulmonary toxicity (confirmed any grade pulmonary toxicity, including pneumonitis or interstitial lung disease \[ILD\]), liver enzyme elevation (ALT or AST elevation\>=Grade 3 persisting \>=7 days); or treatment delay greater than (\>) 28 days due to unresolved toxicity., Up to 21 days|Phase 2: Objective Response Rate (ORR), ORR is defined as the percentage of participants who achieve either a confirmed partial response (PR) or complete response (CR), using Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1., Up to 1 year 4 months
Secondary Outcome Measures: Phase 1 and Phase 2: Number of Participants with AEs by Severity, An AE is any untoward medical occurrence in a clinical study participant administered a pharmaceutical (investigational or non-investigational) product. An adverse event does not necessarily have a causal relationship with the intervention. Severity will be graded according to the NCI-CTCAE version 5.0. Severity scale ranges from Grade 1 (Mild) to Grade 5 (Death). Grade 1= Mild, Grade 2= Moderate, Grade 3= Severe, Grade 4= Life-threatening and Grade 5= Death related to adverse event., Up to 1 year 4 months|Phase 1 and Phase 2: Number of Participants with Abnormalities in Clinical Laboratory Parameters, Number of participants with abnormalities in clinical laboratory parameters (serum chemistry, hematology, coagulation, serology, and urinalysis) will be reported., Up to 1 year 4 months|Phase 2 : Duration of Response (DoR), DoR is defined as the time from the date of first documented response (PR or CR) until the date of documented progression or death from any case, whichever comes first, for participants who have PR or CR., Up to 1 year 4 months|Phase 2: Disease Control Rate (DCR), DCR is defined as the percentage of participants who achieve a PR, CR, or stable disease using RECIST version 1.1., Up to 1 year 4 months|Phase 2: Progression Free Survival (PFS), PFS is defined as the time from first dose date until the date of disease progression or death, whichever comes first, based on investigator assessment using RECIST version 1.1., Up to 1 year 4 months|Phase 2: Overall Survival (OS), OS is defined as the time from the date of administration of the first study treatment until the date of death due to any cause., Up to 1 year 4 months