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New drug cocktail aims to shrink lung tumors before surgery

NCT ID NCT07586202

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 study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Aug 28, 2026 · Updated 5 times

Summary

This Phase 2 trial tests whether giving a combination of amivantamab and either lazertinib or chemotherapy before surgery can shrink or stop the growth of EGFR-mutated non-small cell lung cancer. About 68 people with stage II-IIIB lung cancer that can be surgically removed will participate. The main goal is to see how many patients have very few or no cancer cells left in the removed tumor tissue.

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 lazertinib or chemotherapy (carboplatin and pemetrexed)
What this could lead to
If successful, this could offer a new treatment option before surgery to shrink or eliminate EGFR-mutated lung cancer, potentially improving long-term outcomes.
What could go wrong
This is an early Phase 2 trial with only 68 participants, so results may not apply to everyone. Side effects from the drug combinations could be significant, and the treatment may not work as hoped.

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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 68 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jul 2026

Expected to finish

Apr 2028

An estimate. End dates often move.

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 non-squamous non-small cell lung cancer (NSCLC) with completely resectable Stage II-IIIB N2 disease * Complete surgical resection of the primary NSCLC must be deemed achievable, as assessed by a multidisciplinary team evaluation * Participant must consent to a screening biopsy, if clinically feasible, if no adequate tumor tissue is available for a baseline sample * Participant may have a prior or concurrent second malignancy (other than the disease under study) which natural history or treatment is unlikely to interfere with any study endpoints of safety or the efficacy of the study treatment(s). Prior or concurrent second malignancies must be reviewed and agreed to with the medical monitor * Have an eastern cooperative oncology group (ECOG) performance status of 0 or 1 Exclusion Criteria: * History of uncontrolled illness * Medical history of (non-infectious) interstitial lung disease (ILD)/pneumonitis, or has current interstitial lung disease (ILD)/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out by imaging at screening * Suspected or known allergies, hypersensitivity, or intolerance to excipients of: the combination of amivantamab and lazertinib or carboplatin and pemetrexed * Presence of primary driver mutations (anaplastic lymphoma kinase \[ALK\], mesenchymal-epithelial transition \[MET\], human epidermal growth factor receptor 2 \[HER2\], proto-oncogene tyrosine-protein kinase ROS \[ROS1\], neurotrophic tyrosine receptor kinase \[NTRK\], B-Raf proto-oncogene \[BRAF\], REarranged during transfection \[RET\], or kirsten rat sarcoma viral oncogene homolog \[KRAS\]) , besides EGFR Exon 19del or Exon 21 L858R mutations, as determined by local genomic testing * Prior treatment with any systemic anti-cancer therapy for NSCLC including EGFR-tyrosine kinase inhibitor (TKI) therapy, chemotherapy, biologic therapy, immunotherapy, or any investigational drug

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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

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    20 sites in 6 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Chi Mei Medical Center Liouying Branch

    RECRUITING

    Tainan, 736, Taiwan

  • City of Hope

    RECRUITING

    Duarte, California, 91010, United States

  • City of Hope 1

    RECRUITING

    Irvine, California, 92618, United States

  • Guangdong Provincial People's Hospital

    RECRUITING

    Guangzhou, 510060, China

  • Hosp. Gral. Univ. Dr. Balmis

    RECRUITING

    Alicante, 03010, Spain

  • Hosp. Gral. Univ. Gregorio Maranon

    RECRUITING

    Madrid, 28007, Spain

  • Korea University Guro Hospital

    RECRUITING

    Seoul, 152-703, South Korea

  • Kyungpook National University Chilgok Hospital

    RECRUITING

    Buk Gu, 41404, South Korea

  • NTU Biomedical Park Hospital

    RECRUITING

    Zhubei, 302, Taiwan

  • Princess Margaret Hospital

    RECRUITING

    Toronto, Ontario, M5G 2C1, Canada

  • Providence Cancer Center

    RECRUITING

    Portland, Oregon, 97213, United States

  • Providence Oncology and Hematology Care Clinic Westside

    RECRUITING

    Portland, Oregon, 97225, United States

  • Pusan National University Hospital

    RECRUITING

    Busan, 49241, South Korea

  • Samsung Medical Center

    RECRUITING

    Seoul, 06351, South Korea

  • Shandong Cancer Hospital

    RECRUITING

    Jinan, 250117, China

  • Sichuan Cancer Hospital

    RECRUITING

    Cheng Du Shi, 610044, China

  • Taichung Veterans General Hospital

    RECRUITING

    Taichung, 40705, Taiwan

  • Taipei Medical University Hospital

    RECRUITING

    Taipei, 110, Taiwan

  • Tianjin Chest Hospital

    RECRUITING

    Tianjin, 300222, China

  • West China Hospital Sichuan University

    RECRUITING

    Chengdu, 610041, China

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