Carcinoma, Non-Small-Cell Lung
Conditions
Brief 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).
Interventions
DRUGAmivantamab
Amivantamab will be administered as IV infusion.
DRUGDocetaxel
Docetaxel will be administered as IV infusion.
Sponsors
Janssen Research & Development, LLC
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Participant must have histologically or cytologically confirmed NSCLC and must have metastatic NSCLC at the time of enrollment * Participant must have at least 1 measurable lesion, according to RECIST v1.1, that has not been previously irradiated * May have brain metastases only if previously definitively treated, and participant is clinically stable and asymptomatic for \>2 weeks and is off or receiving low-dose corticosteroid treatment (\<=10 mg prednisone or equivalent) for at least 2 weeks prior to start of study treatment * May have a prior malignancy (other than the disease under study) if the natural history or treatment is unlikely to interfere with any study endpoints of safety or the efficacy of the study treatment(s) * Have an ECOG performance status of 0 or 1
Exclusion criteria
* For Phase 2 only: Participant has known oncogenic driver mutations (EGFR, MET, HER2, ALK, ROS1, NTRK, BRAF, RET, or KRAS) as detected by local testing or by central ctDNA testing * Participant has received radiotherapy for palliative purposes less than 14 days prior to the first dose of study treatment * Participant has: a.(Or has a history of) leptomeningeal disease (carcinomatous meningitis); b. Spinal cord compression not definitively treated with surgery or radiation. * Medical history of (non-infectious) ILD/pneumonitis, or has current ILD/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out by imaging at screening- Participant has history of any significant drug allergy (such as anaphylaxis, hepatotoxicity, or immune-mediated thrombocytopenia or anemia) or has known allergies, hypersensitivity, or intolerance to: a. amivantamab or amivantamab excipients (refer to the amivantamab IB); b.docetaxel, docetaxel excipients or to other drugs formulated with polysorbate and paclitaxel
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Phase 1: Number of Participants with Adverse events (AEs) by Severity | Up to 1 year 4 months | 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. |
| Phase 1: Number of Participants with Dose Limiting Toxicities (DLTs) | Up to 21 days | 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. |
| Phase 2: Objective Response Rate (ORR) | Up to 1 year 4 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Phase 1 and Phase 2: Number of Participants with AEs by Severity | Up to 1 year 4 months | 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. |
| Phase 1 and Phase 2: Number of Participants with Abnormalities in Clinical Laboratory Parameters | Up to 1 year 4 months | Number of participants with abnormalities in clinical laboratory parameters (serum chemistry, hematology, coagulation, serology, and urinalysis) will be reported. |
| Phase 2 : Duration of Response (DoR) | Up to 1 year 4 months | 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. |
| Phase 2: Disease Control Rate (DCR) | Up to 1 year 4 months | DCR is defined as the percentage of participants who achieve a PR, CR, or stable disease using RECIST version 1.1. |
| Phase 2: Progression Free Survival (PFS) | Up to 1 year 4 months | 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. |
| Phase 2: Overall Survival (OS) | Up to 1 year 4 months | 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. |
Countries
Taiwan, Turkey (Türkiye), United Kingdom, United States
Contacts
STUDY_DIRECTORJanssen Research &Development, LLC Clinical Trial
Janssen Research & Development, LLC
Outcome results
None listed