Amivantamab + Docetaxel for Non-Small Cell Lung Cancer
(swalloWTail Trial)
Trial Summary
What is the purpose of this trial?
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).
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
What data supports the effectiveness of the drug combination Amivantamab and Docetaxel for treating non-small cell lung cancer?
Research shows that docetaxel, when combined with other drugs like ramucirumab, can improve survival and response rates in non-small cell lung cancer patients who have progressed after initial treatments. This suggests that docetaxel may be effective in combination therapies for this type of cancer.12345
Is the combination of Amivantamab and Docetaxel safe for humans?
The safety of docetaxel, one of the drugs in the combination, has been studied in patients with non-small cell lung cancer (NSCLC). These studies show that docetaxel can be used safely, but it may cause side effects like low blood cell counts and fatigue. However, there is no specific safety data available for the combination of Amivantamab and Docetaxel.678910
How is the drug combination of Amivantamab and Docetaxel unique for treating non-small cell lung cancer?
The combination of Amivantamab and Docetaxel is unique because Amivantamab is a novel antibody that targets specific proteins involved in cancer growth, while Docetaxel is a well-established chemotherapy drug that disrupts cell division. This combination may offer a new approach by potentially enhancing the effectiveness of treatment through different mechanisms of action.1112131415
Research Team
Janssen Research &Development, LLC Clinical Trial
Principal Investigator
Janssen Research & Development, LLC
Eligibility Criteria
This trial is for people with metastatic non-small cell lung cancer who have seen their disease progress after platinum-based chemotherapy and immune checkpoint inhibitor treatment. Participants should not have oncogenic driver mutations.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Phase 1: Combination Dose Selection
Participants receive amivantamab and docetaxel to determine the recommended Phase 2 combination dose (RP2CD). Doses are adjusted based on dose limiting toxicities.
Phase 2: Dose Expansion
Participants receive amivantamab and docetaxel at the RP2CD to evaluate antitumor effects. Treatment continues until disease progression or unacceptable toxicity.
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Amivantamab
- Docetaxel
Amivantamab is already approved in United States, European Union for the following indications:
- Locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion mutations
- Locally advanced or metastatic NSCLC with EGFR exon 19 deletions or exon 21 L858R substitution mutations
- Locally advanced or metastatic NSCLC with EGFR exon 20 insertion mutations
- Locally advanced or metastatic NSCLC with EGFR exon 19 deletions or exon 21 L858R substitution mutations
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Who Is Running the Clinical Trial?
Janssen Research & Development, LLC
Lead Sponsor
Giacomo Salvadore
Janssen Research & Development, LLC
Chief Medical Officer since 2023
MD from the University of Rome, Tor Vergata
Ricardo Attar
Janssen Research & Development, LLC
Chief Executive Officer since 2008
PhD in Molecular Biology from the University of Buenos Aires