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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

No Placebo-Only Group

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 1 year 4 months

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

~6550

0 / 6Eligibility criteria met