Study on Amivantamab with Lazertinib or Chemotherapy for Treating Resectable EGFR-Mutated Non-Small Cell Lung Cancer
Sponsor: Janssen Research & Development, LLC
ClinicalTrials ID:NCT07586202
This clinical trial is exploring whether the combination of amivantamab with either lazertinib or chemotherapy can effectively slow down or stop the growth of a specific type of lung cancer that can be surgically removed. The study focuses on patients with Stage II-IIIB non-small cell lung cancer (NSCLC) that has a mutation in the EGFR gene.
Patient Parameters
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Program Overview
The aim of this study is to see if using amivantamab together with either lazertinib or chemotherapy drugs (carboplatin and pemetrexed) can help control the growth of non-small cell lung cancer (NSCLC) that has a specific mutation in the EGFR gene. This type of lung cancer is the most common and can sometimes be caused by changes in certain genes, including EGFR. The study is for patients whose cancer can be surgically removed and is at Stage II to IIIB.
Eligibility Criteria
Inclusion Criteria
- Have a confirmed diagnosis of non-squamous non-small cell lung cancer (NSCLC) that can be completely removed by surgery and is at Stage II to IIIB N2.
- Surgery to remove the primary lung cancer must be possible, as determined by a team of specialists.
- Agree to a biopsy before starting the study if there is no existing tumor sample available.
- May have another cancer that is not expected to interfere with the study treatment or outcomes.
- Have a performance status score of 0 or 1, indicating full activity or some restriction in strenuous activities.
Exclusion Criteria
- Have a history of uncontrolled illness.
- Have or had interstitial lung disease (ILD) or pneumonitis, or if these conditions cannot be ruled out by imaging tests.
- Have known allergies or intolerances to the study drugs or their components.
- Have other primary genetic mutations besides the specific EGFR mutations being studied.
- Have received any prior treatment for NSCLC, including specific targeted therapies, chemotherapy, or investigational drugs.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| City of Hope | 91010 | Duarte | California |
| City of Hope 1 | 92618 | Irvine | California |
| Providence Cancer Center | 97213 | Portland | Oregon |
| Providence Oncology and Hematology Care Clinic Westside | 97225 | Portland | Oregon |
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