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Combining Amivantamab with Lazertinib or Chemotherapy for Advanced Lung Cancer

A Phase 2b, Open-Label, Two-cohort Study of Subcutaneous Amivantamab in Combination With Lazertinib as First-Line Treatment, or Subcutaneous Amivantamab in Combination With Platinum-Based Chemotherapy as Second-line Treatment, for Common EGFR-Mutated Locally Advanced or Metastatic Non-Small Cell Lung Cancer

Phase 2 Interventional Janssen Research & Development, LLC · NCT06667076

This study tests if a new combination of amivantamab with lazertinib or chemotherapy can help people with advanced lung cancer that has certain genetic changes.

Quick facts

PhasePhase 2
Study typeInterventional
Enrollment480 (estimated)
Ages18 Years and up
SexAll
SponsorJanssen Research & Development, LLC Industry-sponsored
Drugs / interventionsradiation, amivantamab, lazertinib, chemotherapy
Locations200 sites (Daphne, Alabama and 199 other locations)
Trial IDNCT06667076 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are individuals with advanced or metastatic NSCLC harboring specific EGFR mutations who have not received curative treatment.

Not a fit: Patients with NSCLC that does not have the specified EGFR mutations or those who are candidates for curative intent therapy may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment approach could provide a new effective option for patients with advanced EGFR-mutated NSCLC.

How similar studies have performed: Other studies have shown promise in targeting EGFR mutations in lung cancer, suggesting that this approach may be effective.

Eligibility criteria

Show full inclusion / exclusion criteria 
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 this trial is running

Daphne, Alabama and 199 other locations

+150 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Carcinoma, Non-Small-Cell Lung
Last reviewed 2026-06-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.