A Study of Neoadjuvant Amivantamab With Either Lazertinib or Chemotherapy in Participants With Resectable EGFR-Mutated NSCLC (AmiNA)
A Phase 2 Study Evaluating the Safety and Efficacy of Neoadjuvant Amivantamab in Combination With Lazertinib or Chemotherapy in Resectable EGFR-Mutated Non-Small Cell Lung Cancer
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.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Studietyp
Inskrivning (Beräknad)
Fas
- Fas 2
Kontakter och platser
Studiekontakt
- Namn: Study Contact
- Telefonnummer: 844-434-4210
- E-post: Participate-In-This-Study1@its.jnj.com
Studieorter
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California
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Duarte, California, Förenta staterna, 91010
- Rekrytering
- City of Hope
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Irvine, California, Förenta staterna, 92618
- Rekrytering
- City of Hope 1
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Stanford, California, Förenta staterna, 94305
- Rekrytering
- Stanford Cancer Institute
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Oregon
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Portland, Oregon, Förenta staterna, 97213
- Rekrytering
- Providence Cancer Center
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Portland, Oregon, Förenta staterna, 97225
- Rekrytering
- Providence Oncology and Hematology Care Clinic Westside
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Virginia
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Fairfax, Virginia, Förenta staterna, 22031
- Rekrytering
- Virginia Cancer Specialists
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Ontario
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Toronto, Ontario, Kanada, M5G 2C1
- Rekrytering
- Princess Margaret Hospital
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Beijing, Kina, 100142
- Rekrytering
- Beijing Cancer Hospital of Peking University
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Cheng Du Shi, Kina, 610044
- Rekrytering
- Sichuan Cancer Hospital
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Chengdu, Kina, 610041
- Rekrytering
- West China Hospital Sichuan University
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Guangzhou, Kina, 510060
- Rekrytering
- Guangdong Provincial People's Hospital
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Jinan, Kina, 250117
- Rekrytering
- Shandong Cancer Hospital
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Shanghai, Kina, 200433
- Rekrytering
- Shanghai Pulmonary Hospital
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Tianjin, Kina, 300222
- Rekrytering
- Tianjin Chest Hospital
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Alicante, Spanien, 03010
- Rekrytering
- Hosp. Gral. Univ. Dr. Balmis
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Barcelona, Spanien, 8035
- Rekrytering
- Hosp Univ Vall D Hebron
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Madrid, Spanien, 28007
- Rekrytering
- Hosp. Gral. Univ. Gregorio Maranon
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Buk Gu, Sydkorea, 41404
- Rekrytering
- Kyungpook National University Chilgok Hospital
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Busan, Sydkorea, 49241
- Rekrytering
- Pusan National University Hospital
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Seoul, Sydkorea, 06351
- Rekrytering
- Samsung Medical Center
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Seoul, Sydkorea, 03722
- Rekrytering
- Severance Hospital Yonsei University Health System
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Seoul, Sydkorea, 152-703
- Rekrytering
- Korea University Guro Hospital
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Taichung, Taiwan, 40705
- Rekrytering
- Taichung Veterans General Hospital
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Tainan, Taiwan, 736
- Rekrytering
- Chi Mei Medical Center Liouying Branch
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Taipei, Taiwan, 10048
- Rekrytering
- National Taiwan University Hospital
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Taipei, Taiwan, 110
- Rekrytering
- Taipei Medical University Hospital
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Zhubei, Taiwan, 302
- Rekrytering
- NTU Biomedical Park Hospital
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
Inclusion Criteria:
- Participant must have histologically or cytologically confirmed non-squamous non-small cell lung cancer (NSCLC) with completely resectable Stage II-IIIB N2 disease
- Complete surgical resection of the primary NSCLC must be deemed achievable, as assessed by a multidisciplinary team evaluation
- Participant must consent to a screening biopsy, if clinically feasible, if no adequate tumor tissue is available for a baseline sample
- Participant may have a prior or concurrent second malignancy (other than the disease under study) which natural history or treatment is unlikely to interfere with any study endpoints of safety or the efficacy of the study treatment(s). Prior or concurrent second malignancies must be reviewed and agreed to with the medical monitor
- Have an eastern cooperative oncology group (ECOG) performance status of 0 or 1
Exclusion Criteria:
- History of uncontrolled illness
- Medical history of (non-infectious) interstitial lung disease (ILD)/pneumonitis, or has current interstitial lung disease (ILD)/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out by imaging at screening
- Suspected or known allergies, hypersensitivity, or intolerance to excipients of: the combination of amivantamab and lazertinib or carboplatin and pemetrexed
- Presence of primary driver mutations (anaplastic lymphoma kinase [ALK], mesenchymal-epithelial transition [MET], human epidermal growth factor receptor 2 [HER2], proto-oncogene tyrosine-protein kinase ROS [ROS1], neurotrophic tyrosine receptor kinase [NTRK], B-Raf proto-oncogene [BRAF], REarranged during transfection [RET], or kirsten rat sarcoma viral oncogene homolog [KRAS]) , besides EGFR Exon 19del or Exon 21 L858R mutations, as determined by local genomic testing
- Prior treatment with any systemic anti-cancer therapy for NSCLC including EGFR-tyrosine kinase inhibitor (TKI) therapy, chemotherapy, biologic therapy, immunotherapy, or any investigational drug
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Icke-randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: Cohort 1: Amivantamab plus Lazertinib
Participants will receive amivantamab in combination with lazertinib. |
Amivantamab will be administered.
Andra namn:
Lazertinib will be administered.
Andra namn:
|
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Experimentell: Cohort 2: Amivantamab plus Carboplatin and Pemetrexed
Participants will receive amivantamab in combination with carboplatin and pemetrexed. |
Amivantamab will be administered.
Andra namn:
Carboplatin will be administered. Pemetrexed will be administered. |
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Major Pathologic response (MPR)
Tidsram: Up to 1 year 8 months
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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
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Pathological Complete Response (pCR)
Tidsram: Up to 1 year 8 months
|
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
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Number of Participants with Pathologic Nodal Downstaging at the Time of Surgery
Tidsram: Baseline and up to 1 year 8 months
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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
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Disease Control Rate (DCR)
Tidsram: Up to 1 year 8 months
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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
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Number of Participants with Adverse Events (AEs) by Severity
Tidsram: Up to 1 year 8 months
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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
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Number of Participants with Abnormalities in Clinical Laboratory Parameters
Tidsram: Up to 1 year 8 months
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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
|
Samarbetspartners och utredare
Utredare
- Studierektor: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
- Neoplasmer efter plats
- Neoplasmer
- Luftvägssjukdomar
- Lungsjukdomar
- Neoplasmer i andningsvägarna
- Thoracic neoplasmer
- Lungneoplasmer
- Karcinom, bronkogent
- Bronkiella neoplasmer
- Karcinom, icke-småcellig lunga
- Aminosyror, peptider och proteiner
- Organiska kemikalier
- Heterocykliska föreningar
- Heterocykliska föreningar, 2-ring
- Heterocykliska föreningar, smältring
- Koordinationskomplex
- Guanin
- Hypoxantiner
- Purinoner
- Puriner
- Glutamater
- Aminosyror, sur
- Aminosyror
- Aminosyror, dikarboxyl
- Pemetrexed
- Karboplatin
- amivantamab
- lazertinib
Andra studie-ID-nummer
- 61186372PANSC2005
- 61186372PANSC2005 (Annan identifierare: Janssen Research & Development, LLC)
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
IPD-planbeskrivning
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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