Combining Amivantamab with Lazertinib or Chemotherapy for Advanced Lung Cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study evaluates the effectiveness of amivantamab administered subcutaneously in combination with lazertinib or platinum-based chemotherapy for patients with advanced or metastatic non-small cell lung cancer (NSCLC) that has specific epidermal growth factor receptor mutations. The trial aims to determine the antitumor activity of these combinations in patients who are not candidates for curative treatment. Participants must have measurable lesions and meet specific health criteria to be eligible for the study.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Have histologically or cytologically confirmed advanced or metastatic non-small cell lung cancer (NSCLC) that is not amenable to curative intent therapy
* Epidermal growth factor resistance-mutation (EGFRm) must be an Ex19del or Ex21 L858R substitution, as detected by food and drug administration (FDA)-approved or other validated test in a clinical laboratory improvement amendments (CLIA)-certified laboratory (sites in the US), or an accredited local laboratory (sites outside of the US) in accordance with site standard of care. In the European union (EU), the local test must be Conformité Européenne (CE)-marked or an in-house laboratory-developed test from health institutions in the EU in accordance with Article 5(5) of the in vitro diagnostic regulations (IVDR ) 2071/746, as amended
* Have at least 1 measurable lesion, according to RECIST version (v)1.1, that has not been previously irradiated
* Any toxicities from prior systemic anticancer therapy must have resolved to national cancer institute common terminology criteria for adverse events (NCI-CTCAE) version 5.0 grade 1 or baseline level (except for alopecia \[any grade\], grade \<=2 peripheral neuropathy, or grade \<=2 hypothyroidism stable on hormone replacement)
* Have an eastern cooperative oncology group (ECOG) performance status of 0 to 1

Exclusion Criteria:

* Medical history of active interstitial lung disease (ILD), including drug-induced ILD or radiation pneumonitis. Participants with medical history of radiation pneumonitis, including radiation pneumonitis which required steroid treatment, should consult with the medical monitor and eligibility be assessed on a case-by-case basis
* Had major surgery excluding placement of vascular access or tumor biopsy or had significant traumatic injury within 4 weeks before the first dose of anticancer treatments or will not have fully recovered from surgery, or has surgery planned during the time the participant is expected to participate in the study
* Participant has uncontrolled tumor-related pain (symptomatic lesions amenable to palliative radiotherapy should be treated prior to first dosing)
* Received an investigational treatment that has not been cleared (based on at least 5 half lives of any pharmaceutical treatment) before the planned first dose of study treatment or is currently enrolled in an investigational study
* Has a prior or concurrent second malignancy (other than the disease under study) which natural history or treatment could likely interfere with any study endpoints of safety or the efficacy of the study treatment(s)

Where it's running

• City of Hope Antelope Valley
  Lancaster, California, United States Recruiting
• City of Hope Long Beach Elm
  Long Beach, California, United States Recruiting
• City of Hope South Pasadena
  South Pasadena, California, United States Recruiting
• City of Hope Upland
  Upland, California, United States Recruiting
• Memorial Regional Hospital
  Hollywood, Florida, United States Recruiting
• Memorial Cancer Institute
  Pembroke Pines, Florida, United States Recruiting

+155 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: Study Contact
• Email: Participate-In-This-Study1@its.jnj.com
• Phone: 844-434-4210

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Amivantamab with Lazertinib or Chemotherapy before surgery in EGFR-mutated NSCLC

  This study tests whether giving amivantamab together with lazertinib or with carboplatin and pemetrexed before surgery can slow or stop tumor growth in people with resectable EGFR-mutated NSCLC.

  Recruiting at 27 sites Phase 2 Janssen Research & Development, LLC · Duarte, California and 26 other locations · NCT07586202

• Clinical outcomes of amivantamab-based treatment for advanced EGFR-mutated non-small cell lung cancer in everyday care.

  This project will see how amivantamab-containing treatments work for people with advanced non-small cell lung cancer who have common EGFR mutations.

  Recruiting at 90 sites Janssen Research & Development, LLC · Graz and 89 other locations · NCT07230691

• Amivantamab plus olomorasib for metastatic KRAS G12C non-small cell lung cancer

  This trial tests whether combining amivantamab and olomorasib can slow tumor growth in people with metastatic non-small cell lung cancer that has a KRAS G12C mutation after platinum chemotherapy and PD‑L1 immunotherapy.

  Recruiting at 12 sites Phase 1/2 Janssen Research & Development, LLC · New York, New York and 11 other locations · NCT07227025

• Evaluating amivantamab for advanced non-small cell lung cancer

  This study is testing if a new treatment combining amivantamab and another drug can help people with advanced non-small cell lung cancer, especially those with certain genetic mutations.

  Recruiting at 82 sites Phase 2 Janssen Research & Development, LLC · La Jolla, California and 109 other locations · NCT05498428

• Lower starting lazertinib dose with magnesium to prevent nerve side effects in EGFR-mutant NSCLC

  This study tests whether starting lazertinib at a lower dose plus magnesium helps prevent peripheral neuropathy in newly diagnosed EGFR-mutant NSCLC patients.

  Recruiting Phase 2 Samsung Medical Center · Seoul, Gang-nam Gu · NCT07774520

• Amivantamab with intrathecal pemetrexed for leptomeningeal metastasis from EGFR-mutated lung adenocarcinoma

  This study tests whether giving amivantamab with intrathecal pemetrexed is safe and may help treat leptomeningeal metastasis in adults with EGFR-mutant lung cancer.

  Recruiting Phase 1/2 Second Affiliated Hospital, Zhejiang University, School of Medicine · Hangzhou, Zhejiang · NCT07744529

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.