A Study of Combination Therapy With Amivantamab and Docetaxel in Participants With Metastatic Non-small Cell Lung Cancer

Last updated: February 28, 2025
Sponsor: Janssen Research & Development, LLC
Overall Status: Active - Recruiting

Phase

1/2

Condition

N/A

Treatment

Docetaxel

Amivantamab

Clinical Study ID

NCT06532032
61186372PANSC2003
2023-507298-17-00
  • Ages > 18
  • All Genders

Study 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

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

Total Participants: 100
Treatment Group(s): 2
Primary Treatment: Docetaxel
Phase: 1/2
Study Start date:
July 23, 2024
Estimated Completion Date:
October 21, 2025

Connect with a study center

  • Changhua Christian Hospital

    ChangHua, 500
    Taiwan

    Active - Recruiting

  • Kaohsiung Medical University Hospital

    Kaohsiung City, 80708
    Taiwan

    Active - Recruiting

  • Chi Mei Medical Center Liu Ying

    Liou Ying Township, 736
    Taiwan

    Active - Recruiting

  • Taichung Veterans General Hospital

    Taichung, 40705
    Taiwan

    Active - Recruiting

  • National Taiwan University Hospital

    Taipei, 10043
    Taiwan

    Active - Recruiting

  • Taipei Medical University

    Taipei City, 110
    Taiwan

    Active - Recruiting

  • Ankara Bilkent Sehir Hastanesi

    Cankaya, 06800
    Turkey

    Active - Recruiting

  • Leeds Teaching Hospitals NHS Trust

    Leeds, LS9 7TF
    United Kingdom

    Active - Recruiting

  • The Royal Marsden NHS Trust

    Sutton, SM2 5PT
    United Kingdom

    Active - Recruiting

  • UCI Health Irvine Hospital

    Irvine, California 92612
    United States

    Active - Recruiting

  • Cancer and Blood Specialty Clinic

    Los Alamitos, California 90720
    United States

    Active - Recruiting

  • University of California Irvine Medical Center Chao Family Comprehensive Cancer Center

    Orange, California 92868
    United States

    Active - Recruiting

  • Oncology Hematology Associates

    Springfield, Missouri 65807
    United States

    Active - Recruiting

  • Hunterdon Hematology Oncology

    Flemington, New Jersey 08822
    United States

    Active - Recruiting

  • Virginia Cancer Specialists

    Fairfax, Virginia 22031
    United States

    Active - Recruiting

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