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Carcinoma, Non-Small-Cell LungPhase 1/2swalloWTailNCT06532032

A Study of Combination Therapy With Amivantamab and Docetaxel in Participants With Metastatic Non-small Cell Lung Cancer

A Phase 1/2 study testing Amivantamab and Docetaxel in people with Carcinoma, Non-Small-Cell Lung, run by Janssen Research & Development, LLC at 15 sites in 4 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Carcinoma, Non-Small-Cell Lung
What is being tested?
Amivantamab and Docetaxel
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
12 participants
Where
15 sitesin 4 countries
Study dates
23 Jul 2024to 14 May 2026
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Participant must have histologically or cytologically confirmed NSCLC and must have metastatic NSCLC at the time of enrollment
  • Participant must have at least 1 measurable lesion, according to RECIST v1.1, that has not been previously irradiated
  • May have brain metastases only if previously definitively treated, and participant is clinically stable and asymptomatic for >2 weeks and is off or receiving low-dose corticosteroid treatment (<=10 mg prednisone or equivalent) for at least 2 weeks prior to start of study treatment
  • May have a prior malignancy (other than the disease under study) if the natural history or treatment is unlikely to interfere with any study endpoints of safety or the efficacy of the study treatment(s)
  • Have an ECOG performance status of 0 or 1

Who cannot join

  • For Phase 2 only: Participant has known oncogenic driver mutations (EGFR, MET, HER2, ALK, ROS1, NTRK, BRAF, RET, or KRAS) as detected by local testing or by central ctDNA testing
  • Participant has received radiotherapy for palliative purposes less than 14 days prior to the first dose of study treatment
  • Participant has: a.(Or has a history of) leptomeningeal disease (carcinomatous meningitis); b. Spinal cord compression not definitively treated with surgery or radiation.
  • 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

Trial locations and contacts

15 sites in 4 countries.

15 sites in 4 countries

United States6 sites

  • Virginia Cancer Specialists

    Fairfax, Virginia, 22031

  • Hunterdon Hematology Oncology

    Flemington, New Jersey, 08822

  • UCI Health Irvine Hospital

    Irvine, California, 92612

  • Cancer and Blood Specialty Clinic

    Los Alamitos, California, 90720

  • University of California Irvine Medical Center Chao Family Comprehensive Cancer Center

    Orange, California, 92868

  • Oncology Hematology Associates

    Springfield, Missouri, 65807

Other trials in United States

Taiwan6 sites

  • Changhua Christian Hospital

    Changhua, 500

  • Kaohsiung Medical University Hospital

    Kaohsiung City, 80708

  • Chi Mei Medical Center Liu Ying

    Liou Ying Township, 736

  • Taichung Veterans General Hospital

    Taichung, 40705

  • National Taiwan University Hospital

    Taipei, 10043

  • Taipei Medical University

    Taipei, 110

Other trials in Taiwan

United Kingdom2 sites

  • Leeds Teaching Hospitals NHS Trust

    Leeds, LS9 7TF

  • The Royal Marsden NHS Trust

    Sutton, SM2 5PT

Other trials in United Kingdom

Turkey (Türkiye)1 site

  • Ankara Bilkent Sehir Hastanesi

    Çankaya, 06800

Other trials in Turkey (Türkiye)

About this study

Official title: 61186372PANSC2003: 61186372PANSC2003 ISA#3 Platform 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).

Being tested
Amivantamab, Docetaxel
Medical subject headings
Carcinoma, Non-Small-Cell Lung

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AmivantamabDrug

    Also called JNJ-61186372

    Amivantamab will be administered as IV infusion.

  • DocetaxelDrug

    Also called TAXOTERE

    Docetaxel will be administered as IV infusion.

Study groups in NCT06532032
Study groupRoleWhat they receive
Phase 1 (Combination Dose Selection)ExperimentalParticipants 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.
Receives: Drug: Amivantamab; Drug: Docetaxel
Phase 2 (Dose Expansion)ExperimentalParticipants 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.
Receives: Drug: Amivantamab; Drug: Docetaxel

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Phase 1: Number of Participants with Adverse events (AEs) by Severity

    An AE is any untoward medical occurrence in a clinical study participant administered a pharmaceutical (investigational or non-investigational) product. An adverse event does not necessarily have a causal relationship with the intervention. Severity will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCICTCAE) version 5.0. Severity scale ranges from Grade 1 (Mild) to Grade 5 (Death). Grade 1= Mild, Grade 2= Moderate, Grade 3= Severe, Grade 4= Life-threatening and Grade 5= Death related to adverse event.

    Measured: Up to 1 year 4 months

  2. Phase 1: Number of Participants with Dose Limiting Toxicities (DLTs)

    DLTs are specific adverse events and are defined as any of following: Any high grade (Grade 3, 4 or 5) non-hematologic toxicity with exceptions such as: Grade 3 fever resolved in <=48 hours, anorexia; Grade 3 nausea, vomiting or diarrhea, or constipation Grade 3 fatigue; rash that improves to Grade <; transient electrolyte abnormalities; symptoms of IRRs that are attributable to amivantamab or docetaxel; Tumor flare; hematologic toxicity (Grade 4 anemia or neutropenia, Febrile neutropenia; Grade 3 or 4 thrombocytopenia associated with bleeding or requiring transfusion); pulmonary toxicity (confirmed any grade pulmonary toxicity, including pneumonitis or interstitial lung disease [ILD]), liver enzyme elevation (ALT or AST elevation>=Grade 3 persisting >=7 days); or treatment delay greater than (>) 28 days due to unresolved toxicity.

    Measured: Up to 21 days

  3. Phase 2: Objective Response Rate (ORR)

    ORR is defined as the percentage of participants who achieve either a confirmed partial response (PR) or complete response (CR), using Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.

    Measured: Up to 1 year 4 months

Secondary outcomes (6)

  1. Phase 1 and Phase 2: Number of Participants with AEs by Severity

    An AE is any untoward medical occurrence in a clinical study participant administered a pharmaceutical (investigational or non-investigational) product. An adverse event does not necessarily have a causal relationship with the intervention. Severity will be graded according to the NCI-CTCAE version 5.0. Severity scale ranges from Grade 1 (Mild) to Grade 5 (Death). Grade 1= Mild, Grade 2= Moderate, Grade 3= Severe, Grade 4= Life-threatening and Grade 5= Death related to adverse event.

    Measured: Up to 1 year 4 months

  2. Phase 1 and Phase 2: Number of Participants with Abnormalities in Clinical Laboratory Parameters

    Number of participants with abnormalities in clinical laboratory parameters (serum chemistry, hematology, coagulation, serology, and urinalysis) will be reported.

    Measured: Up to 1 year 4 months

  3. Phase 2 : Duration of Response (DoR)

    DoR is defined as the time from the date of first documented response (PR or CR) until the date of documented progression or death from any case, whichever comes first, for participants who have PR or CR.

    Measured: Up to 1 year 4 months

  4. Phase 2: Disease Control Rate (DCR)

    DCR is defined as the percentage of participants who achieve a PR, CR, or stable disease using RECIST version 1.1.

    Measured: Up to 1 year 4 months

  5. Phase 2: Progression Free Survival (PFS)

    PFS is defined as the time from first dose date until the date of disease progression or death, whichever comes first, based on investigator assessment using RECIST version 1.1.

    Measured: Up to 1 year 4 months

  6. Phase 2: Overall Survival (OS)

    OS is defined as the time from the date of administration of the first study treatment until the date of death due to any cause.

    Measured: Up to 1 year 4 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Aug 2024
  2. Study start23 Jul 2024
  3. Primary completion14 May 2026
  4. Study completion14 May 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
12 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06532032
Sponsor's protocol ID
61186372PANSC2003
Other IDs
61186372PANSC2003
Acronym
swalloWTail
Status last verified
Jul 2026
First submitted
29 Jul 2024
Last updated
31 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: The data sharing policy of the Janssen Pharmaceutical Companies of Johnson \& Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Amivantamab and Docetaxel in people with Carcinoma, Non-Small-Cell Lung, run by Janssen Research & Development, LLC at 15 sites in 4 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 31 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 15 sites in United States, Taiwan, United Kingdom, Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Phase 1: Number of Participants with Adverse events (AEs) by Severity (time frame: Up to 1 year 4 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06532032.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2026.

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