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Monoclonal Antibodies

Amivantamab + Docetaxel for Non-Small Cell Lung Cancer (swalloWTail Trial)

Phase 1 & 2
Recruiting
Research Sponsored by Janssen Research & Development, LLC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Participant must have at least 1 measurable lesion, according to RECIST v1.1, that has not been previously irradiated
Have an ECOG performance status of 0 or 1
Must not have
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
Participant has: a.(Or has a history of) leptomeningeal disease (carcinomatous meningitis); b. Spinal cord compression not definitively treated with surgery or radiation
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 1 year 4 months
Awards & highlights

Summary

This trial aims to find the right dose of a combination of two drugs, amivantamab and docetaxel, for patients with advanced non-small cell lung cancer. The study will also assess

Who is the study for?
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.
What is being tested?
The 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.
What are the potential side effects?
Possible side effects include allergic reactions, skin rash, infusion-related reactions from Amivantamab, as well as fatigue, hair loss, nausea, and low blood cell counts from Docetaxel.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have at least one tumor that can be measured and hasn't been treated with radiation.
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I am fully active or can carry out light work.
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My lung cancer is confirmed and has spread to other parts.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have or had cancer spread to the lining of the brain and spine or untreated spinal cord compression.
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I had radiotherapy for symptom relief less than 2 weeks ago.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 1 year 4 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 1 year 4 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Phase 1: Number of Participants with Adverse events (AEs) by Severity
Phase 1: Number of Participants with Dose Limiting Toxicities (DLTs)
Phase 2: Objective Response Rate (ORR)
Secondary study objectives
Phase 1 and Phase 2: Number of Participants with AEs by Severity
Phase 1 and Phase 2: Number of Participants with Abnormalities in Clinical Laboratory Parameters
Phase 2 : Duration of Response (DoR)
+3 more

Trial Design

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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Docetaxel
1995
Completed Phase 4
~5620

Find a Location

Who is running the clinical trial?

Janssen Research & Development, LLCLead Sponsor
987 Previous Clinical Trials
6,385,559 Total Patients Enrolled
Janssen Research &Development, LLC Clinical TrialStudy DirectorJanssen Research & Development, LLC
~67 spots leftby Feb 2025
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