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New drug duo shows promise for tough lung cancer

NCT ID NCT06532032

Disease control Sponsor: Janssen Research & Development, LLC Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jul 31, 2026 · Updated 4 times

Summary

This completed Phase 1/2 trial tested a combination of two drugs, amivantamab and docetaxel, in 12 people with advanced non-small cell lung cancer that had spread. The goal was to find a safe dose and see if the combo could shrink tumors. The study focused on patients whose cancer had worsened after standard treatments like chemotherapy and immunotherapy.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Amivantamab and docetaxel
What this could lead to
If successful, this combination could offer a new treatment option for people with advanced non-small cell lung cancer that has stopped responding to standard therapies.
What could go wrong
This is an early-phase trial with only 12 participants, so results may not apply to everyone. Side effects can be serious, including severe toxicity and lung inflammation.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

12 people

The number who actually took part.

Started

Jul 2024

Finished

May 2026

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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 Exclusion Criteria: * 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

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Conditions

The condition(s) this trial relates to.

non-small cell lung carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Carcinoma, non-small-cell lung

Contacts and locations

Locations

  • Ankara Bilkent Sehir Hastanesi

    Çankaya, 06800, Turkey (Türkiye)

  • Cancer and Blood Specialty Clinic

    Los Alamitos, California, 90720, United States

  • Changhua Christian Hospital

    Changhua, 500, Taiwan

  • Chi Mei Medical Center Liu Ying

    Liou Ying Township, 736, Taiwan

  • Hunterdon Hematology Oncology

    Flemington, New Jersey, 08822, United States

  • Kaohsiung Medical University Hospital

    Kaohsiung City, 80708, Taiwan

  • Leeds Teaching Hospitals NHS Trust

    Leeds, LS9 7TF, United Kingdom

  • National Taiwan University Hospital

    Taipei, 10043, Taiwan

  • Oncology Hematology Associates

    Springfield, Missouri, 65807, United States

  • Taichung Veterans General Hospital

    Taichung, 40705, Taiwan

  • Taipei Medical University

    Taipei, 110, Taiwan

  • The Royal Marsden NHS Trust

    Sutton, SM2 5PT, United Kingdom

  • UCI Health Irvine Hospital

    Irvine, California, 92612, United States

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

    Orange, California, 92868, United States

  • Virginia Cancer Specialists

    Fairfax, Virginia, 22031, United States

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