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

Last Updated   April 25, 2025

Want to learn how to participate in this trial?

61186372PANSC2003

OVERVIEW

  • Sexes Eligible for Study
    all
  • Age
    18+ years
  • Phase
    phase 1
    1
  • Sites
    15 Sites
  • Status
    Recruiting

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).

CONDITIONS

  • Carcinoma, Non-Small-Cell Lung

ELIGIBILITY


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


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 ha

More...

DETAILS

LOCATIONS

Locations in:
Taiwan, United States, Türkiye, United Kingdom
Country (4) City or Province (15) Status
Taiwan Taipei City Taipei Medical University
RECRUITING
United States Irvine UCI Health Irvine Hospital
RECRUITING
United States Los Alamitos Cancer and Blood Specialty Clinic
RECRUITING
United States Orange University of California Irvine Medical Center Chao Family Comprehensive Cancer Center
RECRUITING
United States Springfield Oncology Hematology Associates
RECRUITING
United States Flemington Hunterdon Hematology Oncology
RECRUITING
United States Fairfax Virginia Cancer Specialists
RECRUITING
Taiwan ChangHua Changhua Christian Hospital
RECRUITING
Taiwan Kaohsiung City Kaohsiung Medical University Hospital
RECRUITING
Taiwan Liou Ying Township Chi Mei Medical Center Liu Ying
RECRUITING
Taiwan Taichung Taichung Veterans General Hospital
RECRUITING
Taiwan Taipei National Taiwan University Hospital
RECRUITING
Türkiye Cankaya Ankara Bilkent Sehir Hastanesi
RECRUITING
United Kingdom Leeds Leeds Teaching Hospitals NHS Trust
RECRUITING
United Kingdom Sutton The Royal Marsden NHS Trust
RECRUITING
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Geo Locations

25.04776, 121.53185

33.66946, -117.82311

33.80307, -118.07256

33.78779, -117.85311

37.21533, -93.29824

40.51233, -74.85933

38.84622, -77.30637

24.07327, 120.56276

22.61626, 120.31333

23.2806957, 120.3550808

24.1469, 120.6839

25.04776, 121.53185

39.9179, 32.86268

53.79648, -1.54785

51.35, -0.2

x
50

Indicates 50+ sites in this region: click to zoom in.

10

Indicates 10+ sites in this region: click to zoom in.

5

Indicates < 10 sites in this region: click to zoom in.

Corresponds to individual site.

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