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Carcinoma, Non-Small-Cell LungPhase 2AmiNANCT07586202

A Study of Neoadjuvant Amivantamab With Either Lazertinib or Chemotherapy in Participants With Resectable EGFR-Mutated NSCLC

A Phase 2 study testing Amivantamab, Lazertinib and Carboplatin in people with Carcinoma, Non-Small-Cell Lung, run by Janssen Research & Development, LLC at 27 sites in 6 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

The purpose of this study is to assess the ability to slow down or stop the growth of cancer with amivantamab combined with either lazertinib or chemotherapy (carboplatin and pemetrexed) in participants with resectable, epidermal growth factor receptor (EGFR) mutated, Stage II-IIIB non-small cell lung cancer (NSCLC). 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, Lazertinib and Carboplatin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
68 participants
Where
27 sitesin 6 countries
Study dates
28 Jul 2026to 3 Apr 2028
Phase
Phase 2
Are there results?
Not yet: the study is under way

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 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

Who cannot join

  • 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

Trial locations and contacts

27 sites in 6 countries. Contact the study team or a site near you to ask about taking part.

Study Contact contact

844-434-4210

Participate-In-This-Study1@its.jnj.com

27 sites in 6 countries

China7 sites, 7 recruiting

  • Beijing Cancer Hospital of Peking University

    Beijing, 100142

    Recruiting

  • Sichuan Cancer Hospital

    Cheng Du Shi, 610044

    Recruiting

  • West China Hospital Sichuan University

    Chengdu, 610041

    Recruiting

  • Guangdong Provincial People's Hospital

    Guangzhou, 510060

    Recruiting

  • Shandong Cancer Hospital

    Jinan, 250117

    Recruiting

  • Shanghai Pulmonary Hospital

    Shanghai, 200433

    Recruiting

  • Tianjin Chest Hospital

    Tianjin, 300222

    Recruiting

Other trials in China

United States6 sites, 6 recruiting

  • City of Hope

    Duarte, California, 91010

    Recruiting

  • Virginia Cancer Specialists

    Fairfax, Virginia, 22031

    Recruiting

  • City of Hope 1

    Irvine, California, 92618

    Recruiting

  • Providence Cancer Center

    Portland, Oregon, 97213

    Recruiting

  • Providence Oncology and Hematology Care Clinic Westside

    Portland, Oregon, 97225

    Recruiting

  • Stanford Cancer Institute

    Stanford, California, 94305

    Recruiting

Other trials in United States

South Korea5 sites, 5 recruiting

  • Kyungpook National University Chilgok Hospital

    Buk Gu, 41404

    Recruiting

  • Pusan National University Hospital

    Busan, 49241

    Recruiting

  • Severance Hospital Yonsei University Health System

    Seoul, 03722

    Recruiting

  • Samsung Medical Center

    Seoul, 06351

    Recruiting

  • Korea University Guro Hospital

    Seoul, 152-703

    Recruiting

Other trials in South Korea

Taiwan5 sites, 5 recruiting

  • Taichung Veterans General Hospital

    Taichung, 40705

    Recruiting

  • Chi Mei Medical Center Liouying Branch

    Tainan, 736

    Recruiting

  • National Taiwan University Hospital

    Taipei, 10048

    Recruiting

  • Taipei Medical University Hospital

    Taipei, 110

    Recruiting

  • NTU Biomedical Park Hospital

    Zhubei, 302

    Recruiting

Other trials in Taiwan

Spain3 sites, 3 recruiting

  • Hosp. Gral. Univ. Dr. Balmis

    Alicante, 03010

    Recruiting

  • Hosp Univ Vall D Hebron

    Barcelona, 8035

    Recruiting

  • Hosp. Gral. Univ. Gregorio Maranon

    Madrid, 28007

    Recruiting

Other trials in Spain

Canada1 site, 1 recruiting

  • Princess Margaret Hospital

    Toronto, Ontario, M5G 2C1

    Recruiting

Other trials in Canada

About this study

Official title: A Phase 2 Study Evaluating the Safety and Efficacy of Neoadjuvant Amivantamab in Combination With Lazertinib or Chemotherapy in Resectable EGFR-Mutated Non-Small Cell Lung Cancer

The purpose of this study is to assess the ability to slow down or stop the growth of cancer with amivantamab combined with either lazertinib or chemotherapy (carboplatin and pemetrexed) in participants with resectable, epidermal growth factor receptor (EGFR) mutated, Stage II-IIIB non-small cell lung cancer (NSCLC). NSCLC is the most common type of lung cancer. NSCLC may occur due to mutations (changes) in many genes, including EGFR.

Being tested
Amivantamab, Lazertinib, Carboplatin, Pemetrexed
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.

  • LazertinibDrug

    Also called JNJ-73841937

    Lazertinib will be administered.

  • CarboplatinDrug

    Carboplatin will be administered.

  • PemetrexedDrug

    Pemetrexed will be administered.

Study groups in NCT07586202
Study groupRoleWhat they receive
Cohort 1: Amivantamab plus LazertinibExperimentalParticipants will receive amivantamab in combination with lazertinib.
Receives: Drug: Amivantamab; Drug: Lazertinib
Cohort 2: Amivantamab plus Carboplatin and PemetrexedExperimentalParticipants will receive amivantamab in combination with carboplatin and pemetrexed.
Receives: Drug: Amivantamab; Drug: Carboplatin; Drug: Pemetrexed

What is being measured

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

  1. Major Pathologic response (MPR)

    MPR is defined as less than or equal to (<= ) 10 percent (%) residual cancer cells in the surgical specimen, per independent centralized pathology review.

    Measured: Up to 1 year 8 months

Secondary outcomes (5)

  1. Pathological Complete Response (pCR)

    pCR is defined as absence of any residual cancer cells in the surgical specimen, per independent centralized pathology review.

    Measured: Up to 1 year 8 months

  2. Number of Participants with Pathologic Nodal Downstaging at the Time of Surgery

    Pathologic nodal downstaging is defined as baseline N2 participants becoming N1/node negative N0 or baseline N1 patients becoming N0 at the time of surgery.

    Measured: Baseline and up to 1 year 8 months

  3. Disease Control Rate (DCR)

    DCR is defined as the percentage of participants who achieve a radiologic best overall response (BOR) of partial response (PR), complete response (CR), or stable disease (SD) using response evaluation criteria in solid tumors (RECIST) version 1.1.

    Measured: Up to 1 year 8 months

  4. 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 AE does not necessarily have a causal relationship with the treatment. Any new or worsening AE occurring at or after the initial administration of study treatment through the day of last dose plus 30 days or prior to the start of subsequent anticancer therapy, whichever is earlier, or any follow-up AE with onset date and time beyond 30 days after the last dose of study treatment but prior to the start of subsequent therapy or any AE that is considered treatment-related regardless of the start date of the event is considered to be treatment-emergent. TEAEs will be graded according to the National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 5.0. Severity scale ranges from Grade 1= mild, Grade 2= moderate, Grade 3= severe, Grade 4= life-threatening, to Grade 5= death related to adverse event.

    Measured: Up to 1 year 8 months

  5. Number of Participants with Abnormalities in Clinical Laboratory Parameters

    Number of participants with abnormalities in clinical laboratory parameters (which includes hematology, coagulation, clinical chemistry, routine urinalysis, serology and pregnancy test) will be reported.

    Measured: Up to 1 year 8 months

Timeline

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

  1. First posted14 May 2026
  2. Study start28 Jul 2026
  3. Primary completion2 Mar 2028 (estimated)
  4. Study completion3 Apr 2028 (estimated)

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 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
68 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07586202
Sponsor's protocol ID
61186372PANSC2005
Other IDs
61186372PANSC2005
Acronym
AmiNA
Status last verified
Nov 2026
First submitted
8 May 2026
Last updated
3 Nov 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 Johnson \& Johnson Innovative Medicine is available at www.innovativemedicine.jnj.com/our-innovation/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 2 study testing Amivantamab, Lazertinib and Carboplatin in people with Carcinoma, Non-Small-Cell Lung, run by Janssen Research & Development, LLC at 27 sites in 6 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 5 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: looking for participants now, as of the sponsor's last update on 3 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 27 sites in China, United States, South Korea, Taiwan, Spain and 1 more country. 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 phase mean?

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?

This study is still under way. Results are not available in the source record yet.

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

Contact Study Contact (844-434-4210, Participate-In-This-Study1@its.jnj.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Major Pathologic response (MPR) (time frame: Up to 1 year 8 months). 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 NCT07586202.

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 3 Nov 2026.

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