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.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Studietype
Registrering (Antatt)
Fase
- Fase 2
Kontakter og plasseringer
Studiekontakt
- Navn: Study Contact
- Telefonnummer: 844-434-4210
- E-post: Participate-In-This-Study1@its.jnj.com
Studiesteder
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Ontario
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Toronto, Ontario, Canada, M5G 2C1
- Rekruttering
- Princess Margaret Hospital
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California
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Duarte, California, Forente stater, 91010
- Rekruttering
- City of Hope
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Irvine, California, Forente stater, 92618
- Rekruttering
- City of Hope 1
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Stanford, California, Forente stater, 94305
- Rekruttering
- Stanford Cancer Institute
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Oregon
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Portland, Oregon, Forente stater, 97213
- Rekruttering
- Providence Cancer Center
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Portland, Oregon, Forente stater, 97225
- Rekruttering
- Providence Oncology and Hematology Care Clinic Westside
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Virginia
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Fairfax, Virginia, Forente stater, 22031
- Rekruttering
- Virginia Cancer Specialists
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Beijing, Kina, 100142
- Rekruttering
- Beijing Cancer Hospital of Peking University
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Cheng Du Shi, Kina, 610044
- Rekruttering
- Sichuan Cancer Hospital
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Chengdu, Kina, 610041
- Rekruttering
- West China Hospital Sichuan University
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Guangzhou, Kina, 510060
- Rekruttering
- Guangdong Provincial People's Hospital
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Jinan, Kina, 250117
- Rekruttering
- Shandong Cancer Hospital
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Shanghai, Kina, 200433
- Rekruttering
- Shanghai Pulmonary Hospital
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Tianjin, Kina, 300222
- Rekruttering
- Tianjin Chest Hospital
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Alicante, Spania, 03010
- Rekruttering
- Hosp. Gral. Univ. Dr. Balmis
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Barcelona, Spania, 8035
- Rekruttering
- Hosp Univ Vall D Hebron
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Madrid, Spania, 28007
- Rekruttering
- Hosp. Gral. Univ. Gregorio Maranon
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Buk Gu, Sør -Korea, 41404
- Rekruttering
- Kyungpook National University Chilgok Hospital
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Busan, Sør -Korea, 49241
- Rekruttering
- Pusan National University Hospital
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Seoul, Sør -Korea, 06351
- Rekruttering
- Samsung Medical Center
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Seoul, Sør -Korea, 03722
- Rekruttering
- Severance Hospital Yonsei University Health System
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Seoul, Sør -Korea, 152-703
- Rekruttering
- Korea University Guro Hospital
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Taichung, Taiwan, 40705
- Rekruttering
- Taichung Veterans General Hospital
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Tainan, Taiwan, 736
- Rekruttering
- Chi Mei Medical Center Liouying Branch
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Taipei, Taiwan, 10048
- Rekruttering
- National Taiwan University Hospital
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Taipei, Taiwan, 110
- Rekruttering
- Taipei Medical University Hospital
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Zhubei, Taiwan, 302
- Rekruttering
- NTU Biomedical Park Hospital
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
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
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Ikke-randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: Cohort 1: Amivantamab plus Lazertinib
Participants will receive amivantamab in combination with lazertinib. |
Amivantamab will be administered.
Andre navn:
Lazertinib will be administered.
Andre navn:
|
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Eksperimentell: Cohort 2: Amivantamab plus Carboplatin and Pemetrexed
Participants will receive amivantamab in combination with carboplatin and pemetrexed. |
Amivantamab will be administered.
Andre navn:
Carboplatin will be administered. Pemetrexed will be administered. |
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Major Pathologic response (MPR)
Tidsramme: 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
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Pathological Complete Response (pCR)
Tidsramme: Up to 1 year 8 months
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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
Tidsramme: 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)
Tidsramme: 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
Tidsramme: Up to 1 year 8 months
|
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
Tidsramme: 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
|
Samarbeidspartnere og etterforskere
Etterforskere
- Studieleder: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
- Neoplasmer etter nettsted
- Neoplasmer
- Sykdommer i luftveiene
- Lungesykdommer
- Neoplasmer i luftveiene
- Thoracale neoplasmer
- Lungeneoplasmer
- Karsinom, bronkogent
- Bronkiale neoplasmer
- Karsinom, ikke-småcellet lunge
- Aminosyrer, peptider og proteiner
- Organiske kjemikalier
- Heterocykliske forbindelser
- Heterocykliske forbindelser, 2-ring
- Heterocykliske forbindelser, smeltet ringen
- Koordinasjonskomplekser
- Guanin
- Hypoksantiner
- Purinoner
- Puriner
- Glutamater
- Aminosyrer, sure
- Aminosyrer
- Aminosyrer, dikarboksyl
- Pemetrexed
- Karboplatin
- Amivantamab
- Lazertinib
Andre studie-ID-numre
- 61186372PANSC2005
- 61186372PANSC2005 (Annen identifikator: Janssen Research & Development, LLC)
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
IPD-planbeskrivelse
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.
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Studerer et amerikansk FDA-regulert enhetsprodukt
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