100 Participants Needed

Amivantamab + Docetaxel for Non-Small Cell Lung Cancer

(swalloWTail Trial)

Recruiting at 14 trial locations
SC
Overseen ByStudy Contact
Age: 18+
Sex: Any
Trial Phase: Phase 1 & 2
Sponsor: Janssen Research & Development, LLC
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

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

JR

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

I have at least one tumor that can be measured and hasn't been treated with radiation.
I had another type of cancer, but it won't affect this study's treatment.
I am fully active or can carry out light work.
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Exclusion Criteria

I have or had cancer spread to the lining of the brain and spine or untreated spinal cord compression.
My cancer has specific genetic changes (like EGFR, MET).
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
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Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

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.

Up to 21 days
Multiple visits per 21-day cycle

Phase 2: Dose Expansion

Participants receive amivantamab and docetaxel at the RP2CD to evaluate antitumor effects. Treatment continues until disease progression or unacceptable toxicity.

Up to 1 year 4 months
Regular visits per 21-day cycle

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

  • Amivantamab
  • Docetaxel
Trial OverviewThe study is testing a combination of two drugs, Amivantamab and Docetaxel, to determine the best dose for Phase 2 trials and to assess how well this combo works in treating NSCLC at that dose.
Participant Groups
2Treatment groups
Experimental Treatment
Group I: Phase 2 (Dose Expansion)Experimental Treatment2 Interventions
Participants will receive amivantamab in combination with docetaxel in 2 cohorts (Cohort A \[adenocarcinoma\] and Cohort B \[squamous\]) at the RP2CD determined in Phase 1. Participants will continue study treatment until disease progression, unacceptable toxicity, or until another criterion for discontinuation of study treatment is met.
Group II: Phase 1 (Combination Dose Selection)Experimental Treatment2 Interventions
Participants will receive amivantamab intravenous (IV) infusion administered based on body weight from Cycle 1 Day 1, Day 2, and subsequent doses on Days 8 and 15, and then on Day 1 of each 21-day treatment cycle. Docetaxel will be administered on Day 2 of Cycle 1 (before Day 2 amivantamab infusion) and then on Day 1 of each 21-day treatment cycle, thereafter. Doses will be escalated or de-escalated based on the dose limiting toxicities (DLTs) and the recommended Phase 2 combination dose (RP2CD) will be determined. Participants will continue study treatment until disease progression, unacceptable toxicity, or until another criterion for discontinuation of study treatment is met.

Amivantamab is already approved in United States, European Union for the following indications:

🇺🇸
Approved in United States as Rybrevant for:
  • 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
🇪🇺
Approved in European Union as Rybrevant for:
  • 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

Find a Clinic Near You

Who Is Running the Clinical Trial?

Janssen Research & Development, LLC

Lead Sponsor

Trials
1,022
Recruited
6,408,000+
Giacomo Salvadore profile image

Giacomo Salvadore

Janssen Research & Development, LLC

Chief Medical Officer since 2023

MD from the University of Rome, Tor Vergata

Ricardo Attar profile image

Ricardo Attar

Janssen Research & Development, LLC

Chief Executive Officer since 2008

PhD in Molecular Biology from the University of Buenos Aires

Findings from Research

In a phase 2 trial involving 40 chemotherapy-naïve patients with advanced nonsquamous NSCLC, the combination of carboplatin, docetaxel, and bevacizumab resulted in a median progression-free survival of 7.9 months and a median overall survival of 16.5 months, indicating its effectiveness as a front-line treatment.
The treatment was generally tolerable, with a high disease control rate of 95%, although some patients experienced significant adverse events, including infections and bleeding, highlighting the need for careful monitoring during treatment.
Phase 2 study of carboplatin, docetaxel, and bevacizumab as frontline treatment for advanced nonsmall-cell lung cancer.William, WN., Kies, MS., Fossella, FV., et al.[2018]
In a study of 39 chemotherapy-naïve patients with advanced non-small cell lung cancer, the combination of irinotecan and docetaxel resulted in a partial response in 23% of patients, with a median survival time of 10.8 months and a 1-year survival rate of 42.2%.
The treatment was associated with manageable side effects, including grade 4 neutropenia in 10.3% of patients and grade 3 or 4 diarrhea in 23.1%, indicating that this non-platinum-based regimen could be a viable option for patients who cannot tolerate traditional platinum-based therapies.
Front-line treatment of advanced non-small cell lung cancer with irinotecan and docetaxel: a multicentre phase II study.Ziotopoulos, P., Androulakis, N., Mylonaki, E., et al.[2018]
This phase 2 study aims to evaluate the safety and preliminary efficacy of a combination treatment of docetaxel, ramucirumab, and pembrolizumab in 41 patients with metastatic or recurrent non-small-cell lung cancer (NSCLC) who have progressed after standard therapies.
The primary goal is to assess the 6-month progression-free survival (PFS) rate, which could provide insights into new treatment strategies for NSCLC, especially for patients who have not responded to previous therapies.
A Phase 2 Study of Docetaxel, Ramucirumab, and Pembrolizumab for Patients With Metastatic or Recurrent Non-Small-Cell Lung Cancer (NSCLC) who Progressed on Platinum-Doublet and PD-1/PD-L1 Blockade.Osta, BE., Carlisle, J., Steuer, C., et al.[2023]

References

Phase 2 study of carboplatin, docetaxel, and bevacizumab as frontline treatment for advanced nonsmall-cell lung cancer. [2018]
Front-line treatment of advanced non-small cell lung cancer with irinotecan and docetaxel: a multicentre phase II study. [2018]
A Phase 2 Study of Docetaxel, Ramucirumab, and Pembrolizumab for Patients With Metastatic or Recurrent Non-Small-Cell Lung Cancer (NSCLC) who Progressed on Platinum-Doublet and PD-1/PD-L1 Blockade. [2023]
Bevacizumab with Single-agent Chemotherapy in Previously Treated Non-squamous Non-small-cell Lung Cancer: Phase II Study. [2019]
East Asian Subgroup Analysis of a Randomized, Double-Blind, Phase 3 Study of Docetaxel and Ramucirumab Versus Docetaxel and Placebo in the Treatment of Stage IV Non-small Cell Lung Cancer Following Disease Progression after One Prior Platinum-Based Therapy (REVEL). [2023]
Phase I trial to investigate the safety, pharmacokinetics and efficacy of sorafenib combined with docetaxel in patients with advanced refractory solid tumours. [2018]
A randomized, double-blind, phase II study of ramucirumab plus docetaxel vs placebo plus docetaxel in Japanese patients with stage IV non-small cell lung cancer after disease progression on platinum-based therapy. [2023]
Comparison of docetaxel and docetaxel-irinotecan combination as second-line chemotherapy in advanced non-small-cell lung cancer: a randomized phase II trial. [2020]
A Phase II NCCTG study of irinotecan and docetaxel in previously treated patients with non-small cell lung cancer. [2018]
[Efficacy of docetaxel in non-small cell lung cancer patients previously treated with platinum-containing chemotherapy. French Group of Pneumo-Cancerology]. [2018]
Docetaxel in non-small cell lung cancer: a review. [2019]
Docetaxel (Taxotere) in combination chemotherapy and in association with thoracic radiotherapy for the treatment of non-small-cell lung cancer. Thoracic Oncology Program. [2022]
Docetaxel in advanced non-small cell lung cancer. [2018]
14.United Statespubmed.ncbi.nlm.nih.gov
Docetaxel (Taxotere) in the treatment of non-small cell lung cancer: an international update. [2019]
15.United Statespubmed.ncbi.nlm.nih.gov
Docetaxel (Taxotere) in the treatment of non-small cell lung cancer: An international update. [2019]