Et studie af kombinationsbehandling med Amivantamab og Olomorasib hos deltagere med metastatisk ikke-småcellet lungekraft (KaRAnaSa)
En fase 1/2-studie, der vurderer sikkerheden og effektiviteten af Amivantamab og Olomorasib-kombinationsbehandling ved metastatisk ikke-småcellet lungekræft
The main purpose of this study is to find out the most suitable dose (recommended phase 2 combination dose [RP2CD]) of amivantamab and olomorasib combination therapy and to assess how well the combination slows down or prevents the growth of tumors in participants with KRAS G12C mutant metastatic non-small cell lung cancer (NSCLC: the most common type of lung cancer; metastatic: has spread to other parts of the body; KRAS G12C mutant: mutation [change] in the kirsten rat sarcoma viral oncogene homolog [KRAS] gene in tumor cells in which glycine [G] at position 12 is replaced with cystine [C]).
Studieoversigt
Status
Betingelser
Intervention / Behandling
Undersøgelsestype
Tilmelding (Anslået)
Fase
- Fase 2
- Fase 1
Kontakter og lokationer
Studiekontakt
- Navn: Study Contact
- Telefonnummer: 844-434-4210
- E-mail: Participate-In-This-Study1@its.jnj.com
Studiesteder
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Ontario
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Toronto, Ontario, Canada, M5G 2M9
- Rekruttering
- Princess Margaret Hospital
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New York
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New York, New York, Forenede Stater, 10016
- Rekruttering
- New York University Langone Medical Center
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Virginia
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Fairfax, Virginia, Forenede Stater, 22031
- Rekruttering
- Virginia Cancer Specialists
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Guangzhou, Kina, 510060
- Rekruttering
- The First Affiliated Hospital Sun Yat sen University
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Harbin, Kina, 150000
- Rekruttering
- Harbin medical university cancer hospital
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Shanghai, Kina, 310000
- Rekruttering
- Shanghai East Hospital
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Seoul, Sydkorea, 05505
- Rekruttering
- Asan Medical Center
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Seoul, Sydkorea, 06351
- Rekruttering
- Samsung Medical Center
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Seoul, Sydkorea, 03722
- Rekruttering
- Severance Hospital Yonsei University Health System
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Ankara, Tyrkiet (Türkiye), 06620
- Rekruttering
- Ankara Universitesi Hastaneleri Tibbi Farmakoloji Anabilim Dali Faz 1 Klinik Arastirma Merkezi
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Istanbul, Tyrkiet (Türkiye), 34010
- Rekruttering
- Koc Universitesi Hastanesi Faz 1 Klinik Arastirma Merkezi
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Çankaya, Tyrkiet (Türkiye), 06800
- Rekruttering
- Ankara Bilkent Sehir Hastanesi
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion criteria:
- Participant must have histologically or cytologically confirmed metastatic NSCLC characterized by a KRAS G12C mutation at the time of enrollment. For Phase 1: Participant must have progressed on or after, or have intolerance to, platinum-based chemotherapy and Programmed Death-Ligand 1 (PD-L1)-targeted immunotherapy given in combination or sequentially. Receipt of additional lines of prior therapy is permitted. Progression must have occurred on or after the most recent line of systemic anticancer therapy. For Phase 2: Participant must have progressed on or after platinum-based chemotherapy and PD-L1-targeted immunotherapy given in combination or sequentially. Progression must have occurred on or after the most recent line of systemic anticancer therapy. Receipt of additional lines of prior therapy is not permitted
- Participant must have at least 1 measurable lesion, according to RECIST version.1.1, that has not been previously irradiated
- May have brain metastases only if previously definitively, locally treated, and participant is clinically stable and asymptomatic for greater than (>) 2 weeks and is off or receiving low-dose corticosteroid treatment for at least 2 weeks prior to start of study treatment
- Can have a prior or concurrent second malignancy (other than the disease under study) with natural history or treatment course that is unlikely to interfere with any study endpoints of safety or the efficacy of the study treatment(s)
- Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Exclusion criteria:
- Participant has history of uncontrolled illness
- Suspected or known allergies, hypersensitivity, or intolerance to amivantamab excipients or olomorasib excipients
- Medical history of (non-infectious) interstitial lung disease (ILD)/pneumonitis, or has current ILD/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out by imaging at screening
- Presence of primary driver mutations (epidermal growth factor receptor [EGFR], anaplastic lymphoma kinase [ALK], mesenchymal-epithelial transition [MET], human epidermal growth factor receptor 2 [HER2], ROS1, neurotrophic tyrosine receptor kinase [NTRK], B-Raf proto-oncogene [BRAF], rearranged during Transfection [RET], neuroblastoma RAS viral oncogene homolog [NRAS], and other KRAS mutations besides G12C) as determined by local genomic testing
- Prior treatment with any KRAS inhibitor
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Ikke-randomiseret
- Interventionel model: Sekventiel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Eksperimentel: Phase 1: Combination Dose Selection
Participants will receive amivantamab along with olomorasib to determine the RP2CD of the combination therapy until disease progression, significant toxicity, or until another criterion for discontinuation of study treatment is met. Eligible participants may have the option to transfer to a long-term extension (LTE) phase for continued access to study treatments. |
Amivantamab will be administered.
Andre navne:
Olomorasib will be administered.
Andre navne:
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Eksperimentel: Phase 2: Expansion
Participants will receive amivantamab and olomorasib combination therapy at the RP2CD determined in Phase 1 until disease progression, significant toxicity, or until another criterion for discontinuation of study treatment is met. Eligible participants may have the option to transfer to LTE phase for continued access to study treatments. |
Amivantamab will be administered.
Andre navne:
Olomorasib will be administered.
Andre navne:
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Phase 1: Number of Participants with Adverse Events (AEs) by Severity
Tidsramme: Up to approximately 3 years 2 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. An assessment of severity grade will be made by the investigator according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0 defined as follows: Grade 1 (mild; asymptomatic or mild symptoms; intervention not indicated); Grade 2 (moderate; minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental activities of daily living [ADL]); Grade 3 (severe or medically significant but not immediately life threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care ADL); Grade 4 (life-threatening consequences; urgent intervention indicated); Grade 5 (Death related to adverse event). |
Up to approximately 3 years 2 months
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Phase 1: Number of Participants with Dose-Limiting Toxicities (DLTs)
Tidsramme: Up to approximately 3 years 2 months
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DLT is defined as drug related adverse events and includes unacceptable non-hematologic toxicity, hematologic toxicity, pulmonary toxicity, or elevations in hepatic enzymes suggestive of drug-induced liver injury of Grade 3 or higher. Toxicities will be graded for severity according to the NCI-CTCAE, version 5.0. |
Up to approximately 3 years 2 months
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Phase 2: Confirmed Objective Response Rate (ORR)
Tidsramme: Up to approximately 3 years 2 months
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ORR is defined as the percentage of participants who achieve either a confirmed partial response (PR) or complete response (CR), using Response Evaluation Criteria in Solid Tumors (RECIST) version (v)1.1 by investigator review. Confirmatory analysis may be performed using Blinded Independent Central Review (BICR). |
Up to approximately 3 years 2 months
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Number of Participants with Adverse Events (AEs) by Severity
Tidsramme: Up to approximately 3 years 2 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. An assessment of severity grade will be made by the investigator according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0 defined as follows: Grade 1 (mild; asymptomatic or mild symptoms; intervention not indicated); Grade 2 (moderate; minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental activities of daily living [ADL]); Grade 3 (severe or medically significant but not immediately life threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care ADL); Grade 4 (life-threatening consequences; urgent intervention indicated); Grade 5 (Death related to adverse event). |
Up to approximately 3 years 2 months
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Number of Participants with Abnormalities in Clinical Laboratory Parameters
Tidsramme: Up to approximately 3 years 2 months
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Number of participants with abnormalities in clinical laboratory values (which includes serum chemistry, hematology, coagulation, urinalysis, and serology) will be reported. |
Up to approximately 3 years 2 months
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Phase 2: Duration of Response (DoR)
Tidsramme: Up to approximately 3 years 2 months
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DoR is defined as the time from the date of first documented response (PR or CR) until the date of documented progression or death from any case, whichever comes first, for participant who have PR or CR according to RECIST v1.1 by investigator review. |
Up to approximately 3 years 2 months
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Phase 2: Disease Control Rate (DCR)
Tidsramme: Up to approximately 3 years 2 months
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DCR is defined as the percentage of participants who achieve a PR, CR, or stable disease using RECIST v1.1. |
Up to approximately 3 years 2 months
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Phase 2: Progression-Free Survival (PFS)
Tidsramme: Up to approximately 3 years 2 months
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PFS is defined as the time from first dose date until the date of disease progression or death, whichever comes first, based on investigator assessment using RECIST v1.1 by investigator review. |
Up to approximately 3 years 2 months
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Phase 2: Overall Survival (OS)
Tidsramme: Up to approximately 3 years 2 months
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OS is defined as the time from the date of administration of the first dose of study treatment until the date of death due to any cause. |
Up to approximately 3 years 2 months
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Samarbejdspartnere og efterforskere
Efterforskere
- Studieleder: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 61186372PANSC2004
- 61186372PANSC2004 (Anden identifikator: Janssen Research & Development, LLC)
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (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.
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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