Study on Combination Therapy with Amivantamab and Docetaxel for Metastatic Non-Small Cell Lung Cancer

Sponsor: Janssen Research & Development, LLC

Sponsor score: 60
Inactive

ClinicalTrials ID:NCT06532032

Provider View

This clinical trial is testing a new combination of drugs, Amivantamab and Docetaxel, to find the best dose and evaluate its effectiveness in treating metastatic non-small cell lung cancer (NSCLC) that has progressed after standard treatments.

Patient Parameters

Program Overview

The aim of this study is to determine the best dose of a new combination treatment using Amivantamab and Docetaxel for patients with metastatic non-small cell lung cancer (NSCLC). In the first phase, researchers will identify the optimal dose. In the second phase, they will assess how well this combination works in patients whose cancer has worsened despite previous treatments, including platinum-based chemotherapy and immune checkpoint inhibitors, and who do not have specific genetic mutations driving their cancer.

Eligibility Criteria

Inclusion Criteria

  • Must have a confirmed diagnosis of metastatic non-small cell lung cancer (NSCLC).
  • Must have at least one measurable tumor that has not been treated with radiation.
  • Can have brain metastases if they have been treated and are stable, with no symptoms for more than two weeks, and are on low-dose steroids or none at all.
  • Can have had another type of cancer if it does not interfere with the study treatment.
  • Must be in good overall health, with an ECOG performance status of 0 or 1, meaning fully active or restricted in physically strenuous activity but ambulatory.

Exclusion Criteria

  • For Phase 2: Cannot have specific genetic mutations known to drive cancer growth (such as EGFR, MET, HER2, ALK, ROS1, NTRK, BRAF, RET, or KRAS).
  • Cannot have received radiation therapy for symptom relief within 14 days before starting the study treatment.
  • Cannot have or have had cancer spread to the brain's lining (leptomeningeal disease) or untreated spinal cord compression.
  • Cannot have a history of lung inflammation (ILD/pneumonitis) or current lung inflammation that cannot be ruled out by imaging.
  • Cannot have a history of severe allergic reactions to the study drugs or their ingredients.

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