Phase
Condition
N/ATreatment
Docetaxel
Amivantamab
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Participant must have histologically or cytologically confirmed NSCLC and must havemetastatic NSCLC at the time of enrollment
Participant must have at least 1 measurable lesion, according to RECIST v1.1, thathas not been previously irradiated
May have brain metastases only if previously definitively treated, and participantis clinically stable and asymptomatic for >2 weeks and is off or receiving low-dosecorticosteroid treatment (<=10 mg prednisone or equivalent) for at least 2 weeksprior to start of study treatment
May have a prior malignancy (other than the disease under study) if the naturalhistory or treatment is unlikely to interfere with any study endpoints of safety orthe efficacy of the study treatment(s)
Have an ECOG performance status of 0 or 1
Exclusion
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 centralctDNA testing
Participant has received radiotherapy for palliative purposes less than 14 daysprior to the first dose of study treatment
Participant has: a.(Or has a history of) leptomeningeal disease (carcinomatousmeningitis); b. Spinal cord compression not definitively treated with surgery orradiation.
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 knownallergies, hypersensitivity, or intolerance to: a. amivantamab or amivantamabexcipients (refer to the amivantamab IB); b.docetaxel, docetaxel excipients or toother drugs formulated with polysorbate and paclitaxel
Study Design
Connect with a study center
Changhua Christian Hospital
ChangHua, 500
TaiwanActive - Recruiting
Kaohsiung Medical University Hospital
Kaohsiung City, 80708
TaiwanActive - Recruiting
Chi Mei Medical Center Liu Ying
Liou Ying Township, 736
TaiwanActive - Recruiting
Taichung Veterans General Hospital
Taichung, 40705
TaiwanActive - Recruiting
National Taiwan University Hospital
Taipei, 10043
TaiwanActive - Recruiting
Taipei Medical University
Taipei City, 110
TaiwanActive - Recruiting
Ankara Bilkent Sehir Hastanesi
Cankaya, 06800
TurkeyActive - Recruiting
Leeds Teaching Hospitals NHS Trust
Leeds, LS9 7TF
United KingdomActive - Recruiting
The Royal Marsden NHS Trust
Sutton, SM2 5PT
United KingdomActive - Recruiting
UCI Health Irvine Hospital
Irvine, California 92612
United StatesActive - Recruiting
Cancer and Blood Specialty Clinic
Los Alamitos, California 90720
United StatesActive - Recruiting
University of California Irvine Medical Center Chao Family Comprehensive Cancer Center
Orange, California 92868
United StatesActive - Recruiting
Oncology Hematology Associates
Springfield, Missouri 65807
United StatesActive - Recruiting
Hunterdon Hematology Oncology
Flemington, New Jersey 08822
United StatesActive - Recruiting
Virginia Cancer Specialists
Fairfax, Virginia 22031
United StatesActive - Recruiting
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