What is amivantamab studying for non-small cell lung cancer?

Amivantamab is being studied in combination with lazertinib or with chemotherapy to evaluate its activity against common EGFR-mutated non-small cell lung cancer. The trial aims to understand how well these treatments work in advanced or metastatic cases, led by Janssen Research & Development, LLC. Participants will help researchers learn more about these treatment options.

Who may be eligible for this non-small cell lung cancer clinical trial?

Adults aged 18 years and older with advanced or metastatic non-small cell lung cancer having a specific EGFR mutation may be eligible. This trial accepts all genders and requires participants to have good performance status and no uncontrolled pain. Please review eligibility criteria for more details.

Is there any cost to participate in this non-small cell lung cancer clinical trial?

Study-related care, including the study drugs and all trial visits, is provided at no cost. However, personal expenses such as travel costs may vary and are not guaranteed to be covered. Participants should plan accordingly for any additional costs.

Actively Recruiting

Phase 2

Age: 18Years +

All Genders

ID06667076

A Phase 2b, Open-Label Study of Amivantamab With Lazertinib or Platinum-Based Chemotherapy for Common EGFR-Mutated Locally Advanced or Metastatic Non-Small Cell Lung Cancer

Led by Janssen Research & Development, LLC · Updated on 2026-06-05

480

Participants Needed

201

Research Sites

83 weeks

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating the antitumor activity of amivantamab combined with lazertinib or with chemotherapy in participants who have common EGFR-mutated locally advanced or metastatic non-small cell lung cancer NSCLC. This Phase 2b open-label study aims to understand how well these combinations work as first-line or second-line treatments for this type of lung cancer. Participants will be assigned to one of two groups one group will receive amivantamab combined with lazertinib orally in 28-day cycles, and the other group will receive amivantamab combined with platinum-based chemotherapy carboplatin and pemetrexed given by intravenous infusion in 21-day cycles. Treatment will continue until disease progression, withdrawal, death, or investigator decision to stop treatment. During the study, participants will undergo regular assessments including monitoring for progression-free survival up to 4 years and 6 months. Additional evaluations include tracking dose changes, adverse events, overall survival, response rates, and time to treatment discontinuation. Safety and clinical outcomes will be closely observed throughout the treatment period and follow-up.

CONDITIONS

Brief Title

A Study of Amivantamab in Combination With Lazertinib, or Amivantamab in Combination With Platinum-Based Chemotherapy, for Common Epidermal Growth Factor Receptor (EGFR)-Mutated Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC)

Who Can Participate

Age: 18Years +

All Genders

Eligibility Criteria

You may qualify if you...

Have histologically or cytologically confirmed advanced or metastatic non-small cell lung cancer not suitable for curative therapy
Have an EGFR mutation of Ex19del or Ex21 L858R confirmed by FDA-approved or validated test in a certified laboratory
Have at least one measurable lesion that has not been previously irradiated
Any toxicities from prior cancer therapy must be resolved to grade 1 or baseline level except certain specified conditions
Have an ECOG performance status of 0 to 1

You will not qualify if you...

Have active interstitial lung disease, including drug-induced ILD or radiation pneumonitis
Had major surgery or significant injury within 4 weeks before first treatment or plan surgery during study participation
Have uncontrolled tumor-related pain not treated prior to dosing
Received investigational treatment not cleared by at least 5 half lives before study treatment or currently in another investigational study
Have prior or concurrent second malignancy that could interfere with study safety or efficacy endpoints

Research Team

Study Contact

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