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| ID | Type | Description | Link |
|---|---|---|---|
| 61186372PANSC2005 | Other Identifier | Janssen Research & Development, LLC |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1: Amivantamab plus Lazertinib | Experimental | Participants will receive amivantamab in combination with lazertinib. |
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| Cohort 2: Amivantamab plus Carboplatin and Pemetrexed | Experimental | Participants will receive amivantamab in combination with carboplatin and pemetrexed. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Amivantamab | Drug | Amivantamab will be administered. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | Up to 1 year 8 months |
| Measure | Description | Time Frame |
|---|---|---|
| Pathological Complete Response (pCR) | pCR is defined as absence of any residual cancer cells in the surgical specimen, per independent centralized pathology review. | Up to 1 year 8 months |
| Number of Participants with Pathologic Nodal Downstaging at the Time of Surgery |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Study Contact | Contact | 844-434-4210 | Participate-In-This-Study1@its.jnj.com |
| Name | Affiliation | Role |
|---|---|---|
| Janssen Research & Development, LLC Clinical Trial | Janssen Research & Development, LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Taipei Medical University Hospital | Recruiting | Taipei | 110 | Taiwan |
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.
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| Lazertinib | Drug | Lazertinib will be administered. |
|
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| Carboplatin | Drug | Carboplatin will be administered. |
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| Pemetrexed | Drug | Pemetrexed will be administered. |
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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. |
| Baseline and up to 1 year 8 months |
| 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. | Up to 1 year 8 months |
| 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. | Up to 1 year 8 months |
| 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. | Up to 1 year 8 months |
| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| C000718215 | amivantamab |
| C000707992 | lazertinib |
| D016190 | Carboplatin |
| D000068437 | Pemetrexed |
| ID | Term |
|---|---|
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
| D006147 | Guanine |
| D007042 | Hypoxanthines |
| D011688 | Purinones |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D005971 | Glutamates |
| D024342 | Amino Acids, Acidic |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D000600 | Amino Acids, Dicarboxylic |
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