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

NCT06532032

CompletedPhase 1, Phase 2

Sponsor: Janssen Research & Development, LLC

Conditions: Carcinoma, Non-Small-Cell Lung

Interventions: Amivantamab, Docetaxel

Countries: United States, Taiwan, Turkey (Türkiye), United Kingdom

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 overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

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
Locations (15)
  • Irvine, California, United States
  • Los Alamitos, California, United States
  • Orange, California, United States
  • Springfield, Missouri, United States
  • Flemington, New Jersey, United States
  • Fairfax, Virginia, United States
  • Changhua, Taiwan
  • Kaohsiung City, Taiwan
  • Liou Ying Township, Taiwan
  • Taichung, Taiwan
  • Taipei, Taiwan
  • Taipei, Taiwan
  • Çankaya, Turkey (Türkiye)
  • Leeds, United Kingdom
  • Sutton, United Kingdom