Clinical trial NCT06532032: A Study of Combination Therapy With Amivantamab and Docetaxel in Participants With Metastatic Non-small Cell Lung Cancer
Official title: A Phase 1/2 Study Evaluating the Safety and Efficacy of Amivantamab and Docetaxel Combination Therapy in Metastatic Non-small Cell Lung Cancer
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE1
PHASE2
Conditions: Carcinoma, Non-Small-Cell Lung
Lead sponsor: Janssen Research & Development, LLC
Sponsor class: INDUSTRY
First posted: 2024-08-01
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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).


Eligibility criteria: 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

Primary outcomes:
measure: Phase 1: Number of Participants with Adverse events (AEs) by Severity
timeFrame: Up to 1 year 4 months
measure: Phase 1: Number of Participants with Dose Limiting Toxicities (DLTs)
timeFrame: Up to 21 days
measure: Phase 2: Objective Response Rate (ORR)
timeFrame: Up to 1 year 4 months
Secondary outcomes:
measure: Phase 1 and Phase 2: Number of Participants with AEs by Severity
timeFrame: Up to 1 year 4 months
measure: Phase 1 and Phase 2: Number of Participants with Abnormalities in Clinical Laboratory Parameters
timeFrame: Up to 1 year 4 months
measure: Phase 2 : Duration of Response (DoR)
timeFrame: Up to 1 year 4 months
measure: Phase 2: Disease Control Rate (DCR)
timeFrame: Up to 1 year 4 months
measure: Phase 2: Progression Free Survival (PFS)
timeFrame: Up to 1 year 4 months
measure: Phase 2: Overall Survival (OS)
timeFrame: Up to 1 year 4 months
Other outcomes:
Locations:
city: Irvine
country: United States
facility: UCI Health Irvine Hospital
state: California
city: Los Alamitos
country: United States
facility: Cancer and Blood Specialty Clinic
state: California
city: Orange
country: United States
facility: University of California Irvine Medical Center Chao Family Comprehensive Cancer Center
state: California
city: Springfield
country: United States
facility: Oncology Hematology Associates
state: Missouri
city: Flemington
country: United States
facility: Hunterdon Hematology Oncology
state: New Jersey
city: Fairfax
country: United States
facility: Virginia Cancer Specialists
state: Virginia
city: ChangHua
country: Taiwan
facility: Changhua Christian Hospital
city: Kaohsiung City
country: Taiwan
facility: Kaohsiung Medical University Hospital
city: Liou Ying Township
country: Taiwan
facility: Chi Mei Medical Center Liu Ying
city: Taichung
country: Taiwan
facility: Taichung Veterans General Hospital
city: Taipei City
country: Taiwan
facility: Taipei Medical University
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
city: Cankaya
country: Turkey
facility: Ankara Bilkent Sehir Hastanesi
city: Leeds
country: United Kingdom
facility: Leeds Teaching Hospitals NHS Trust
city: Sutton
country: United Kingdom
facility: The Royal Marsden NHS Trust
Study officials:
affiliation: Janssen Research & Development, LLC
name: Janssen Research &Development, LLC Clinical Trial
role: STUDY_DIRECTOR
References: