Uno studio della terapia di combinazione con Amivantamab e Olomorasib in partecipanti con carcinoma polmonare non a piccole cellule metastatico (KaRAnaSa)
Uno studio di Fase 1/2 che valuta la sicurezza e l'efficacia della terapia combinata con Amivantamab e Olomorasib nel carcinoma polmonare non a piccole cellule metastatico
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]).
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Tipo di studio
Iscrizione (Stimato)
Fase
- Fase 2
- Fase 1
Contatti e Sedi
Contatto studio
- Nome: Study Contact
- Numero di telefono: 844-434-4210
- Email: Participate-In-This-Study1@its.jnj.com
Luoghi di studio
-
-
Ontario
-
Toronto, Ontario, Canada, M5G 2M9
- Reclutamento
- Princess Margaret Hospital
-
-
-
-
-
Guangzhou, Cina, 510060
- Reclutamento
- The First Affiliated Hospital Sun Yat sen University
-
Harbin, Cina, 150000
- Reclutamento
- Harbin medical university cancer hospital
-
Shanghai, Cina, 310000
- Reclutamento
- Shanghai East Hospital
-
-
-
-
-
Seoul, Corea del Sud, 05505
- Reclutamento
- Asan Medical Center
-
Seoul, Corea del Sud, 06351
- Reclutamento
- Samsung Medical Center
-
Seoul, Corea del Sud, 03722
- Reclutamento
- Severance Hospital Yonsei University Health System
-
-
-
-
New York
-
New York, New York, Stati Uniti, 10016
- Reclutamento
- New York University Langone Medical Center
-
-
Virginia
-
Fairfax, Virginia, Stati Uniti, 22031
- Reclutamento
- Virginia Cancer Specialists
-
-
-
-
-
Ankara, Turchia (Türkiye), 06620
- Reclutamento
- Ankara Universitesi Hastaneleri Tibbi Farmakoloji Anabilim Dali Faz 1 Klinik Arastirma Merkezi
-
Istanbul, Turchia (Türkiye), 34010
- Reclutamento
- Koc Universitesi Hastanesi Faz 1 Klinik Arastirma Merkezi
-
Çankaya, Turchia (Türkiye), 06800
- Reclutamento
- Ankara Bilkent Sehir Hastanesi
-
-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
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
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Non randomizzato
- Modello interventistico: Assegnazione sequenziale
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Sperimentale: 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.
Altri nomi:
Olomorasib will be administered.
Altri nomi:
|
|
Sperimentale: 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.
Altri nomi:
Olomorasib will be administered.
Altri nomi:
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Phase 1: Number of Participants with Adverse Events (AEs) by Severity
Lasso di tempo: Up to approximately 3 years 2 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. 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
|
|
Phase 1: Number of Participants with Dose-Limiting Toxicities (DLTs)
Lasso di tempo: Up to approximately 3 years 2 months
|
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
|
|
Phase 2: Confirmed Objective Response Rate (ORR)
Lasso di tempo: Up to approximately 3 years 2 months
|
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
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Number of Participants with Adverse Events (AEs) by Severity
Lasso di tempo: Up to approximately 3 years 2 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. 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
|
|
Number of Participants with Abnormalities in Clinical Laboratory Parameters
Lasso di tempo: Up to approximately 3 years 2 months
|
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
|
|
Phase 2: Duration of Response (DoR)
Lasso di tempo: Up to approximately 3 years 2 months
|
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
|
|
Phase 2: Disease Control Rate (DCR)
Lasso di tempo: Up to approximately 3 years 2 months
|
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
|
|
Phase 2: Progression-Free Survival (PFS)
Lasso di tempo: Up to approximately 3 years 2 months
|
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
|
|
Phase 2: Overall Survival (OS)
Lasso di tempo: Up to approximately 3 years 2 months
|
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
|
Collaboratori e investigatori
Investigatori
- Direttore dello studio: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Stimato)
Completamento dello studio (Stimato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- 61186372PANSC2004
- 61186372PANSC2004 (Altro identificatore: Janssen Research & Development, LLC)
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
Descrizione del piano IPD
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.
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
prodotto fabbricato ed esportato dagli Stati Uniti
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .