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Trial Title:
A Study of Combination Therapy With Amivantamab and Docetaxel in Participants With Metastatic Non-small Cell Lung Cancer
NCT ID:
NCT06532032
Condition:
Carcinoma, Non-Small-Cell Lung
Conditions: Official terms:
Carcinoma, Non-Small-Cell Lung
Docetaxel
Amivantamab-vmjw
Study type:
Interventional
Study phase:
Phase 1/Phase 2
Overall status:
Recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Sequential Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Amivantamab
Description:
Amivantamab will be administered as IV infusion.
Arm group label:
Phase 1 (Combination Dose Selection)
Arm group label:
Phase 2 (Dose Expansion)
Other name:
JNJ-61186372
Intervention type:
Drug
Intervention name:
Docetaxel
Description:
Docetaxel will be administered as IV infusion.
Arm group label:
Phase 1 (Combination Dose Selection)
Arm group label:
Phase 2 (Dose Expansion)
Other name:
TAXOTERE
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).
Criteria for 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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
UCI Health Irvine Hospital
Address:
City:
Irvine
Zip:
92612
Country:
United States
Status:
Recruiting
Facility:
Name:
Cancer and Blood Specialty Clinic
Address:
City:
Los Alamitos
Zip:
90720
Country:
United States
Status:
Recruiting
Facility:
Name:
University of California Irvine Medical Center Chao Family Comprehensive Cancer Center
Address:
City:
Orange
Zip:
92868
Country:
United States
Status:
Recruiting
Facility:
Name:
Hunterdon Hematology Oncology
Address:
City:
Flemington
Zip:
08822
Country:
United States
Status:
Recruiting
Facility:
Name:
Virginia Cancer Specialists
Address:
City:
Fairfax
Zip:
22031
Country:
United States
Status:
Recruiting
Facility:
Name:
Changhua Christian Hospital
Address:
City:
ChangHua
Zip:
500
Country:
Taiwan
Status:
Recruiting
Facility:
Name:
Chi Mei Medical Center Liu Ying
Address:
City:
Liou Ying Township
Zip:
736
Country:
Taiwan
Status:
Recruiting
Facility:
Name:
Taichung Veterans General Hospital
Address:
City:
Taichung
Zip:
40705
Country:
Taiwan
Status:
Recruiting
Facility:
Name:
Taipei Medical University
Address:
City:
Taipei City
Zip:
110
Country:
Taiwan
Status:
Recruiting
Facility:
Name:
Ankara Bilkent Sehir Hastanesi
Address:
City:
Cankaya
Zip:
06800
Country:
Turkey
Status:
Recruiting
Start date:
July 23, 2024
Completion date:
October 21, 2025
Lead sponsor:
Agency:
Janssen Research & Development, LLC
Agency class:
Industry
Source:
Janssen Research & Development, LLC
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06532032
