Phase
Condition
N/ATreatment
Amivantamab
Docetaxel
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
TaiwanSite Not Available
Changhua Christian Hospital
Changhua 1993459, 500
TaiwanSite Not Available
Kaohsiung Medical University Hospital
Kaohsiung City, 80708
TaiwanSite Not Available
Kaohsiung Medical University Hospital
Kaohsiung City 1673820, 80708
TaiwanSite Not Available
Chi Mei Medical Center Liu Ying
Liou Ying Township, 736
TaiwanSite Not Available
Taichung Veterans General Hospital
Taichung, 40705
TaiwanSite Not Available
Taichung Veterans General Hospital
Taichung 1668399, 40705
TaiwanSite Not Available
National Taiwan University Hospital
Taipei, 10043
TaiwanSite Not Available
National Taiwan University Hospital
Taipei 1668341, 10043
TaiwanSite Not Available
Taipei Medical University
Taipei 1668341, 110
TaiwanSite Not Available
Taipei Medical University
Taipei City, 110
TaiwanSite Not Available
Ankara Bilkent Sehir Hastanesi
Cankaya, 06800
TurkeySite Not Available
Ankara Bilkent Sehir Hastanesi
Çankaya 6955677, 06800
Turkey (Türkiye)Site Not Available
Leeds Teaching Hospitals NHS Trust
Leeds, LS9 7TF
United KingdomSite Not Available
Leeds Teaching Hospitals NHS Trust
Leeds 2644688, LS9 7TF
United KingdomSite Not Available
The Royal Marsden NHS Trust
Sutton, SM2 5PT
United KingdomSite Not Available
The Royal Marsden NHS Trust
Sutton 2636503, SM2 5PT
United KingdomSite Not Available
UCI Health Irvine Hospital
Irvine, California 92612
United StatesSite Not Available
Cancer and Blood Specialty Clinic
Los Alamitos, California 90720
United StatesSite Not Available
University of California Irvine Medical Center Chao Family Comprehensive Cancer Center
Orange, California 92868
United StatesSite Not Available
UCI Health Irvine Hospital
Irvine 5359777, California 5332921 92612
United StatesSite Not Available
Cancer and Blood Specialty Clinic
Los Alamitos 5368304, California 5332921 90720
United StatesSite Not Available
University of California Irvine Medical Center Chao Family Comprehensive Cancer Center
Orange 5379513, California 5332921 92868
United StatesSite Not Available
Oncology Hematology Associates
Springfield, Missouri 65807
United StatesSite Not Available
Oncology Hematology Associates
Springfield 4409896, Missouri 4398678 65807
United StatesSite Not Available
Hunterdon Hematology Oncology
Flemington, New Jersey 08822
United StatesSite Not Available
Hunterdon Hematology Oncology
Flemington 5098124, New Jersey 5101760 08822
United StatesSite Not Available
Virginia Cancer Specialists
Fairfax, Virginia 22031
United StatesSite Not Available
Virginia Cancer Specialists
Fairfax 4758023, Virginia 6254928 22031
United StatesSite Not Available

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