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DESTINY LUNG 04 - A Study to Investigate the Efficacy and Safety of Trastuzumab Deruxtecan as the First Treatment Option for Unresectable, Locally Advanced/Metastatic Non-Small Cell Lung Cancer With HER2 Mutations - D967SC00001

Studio Clinico

Patologia: Neoplasie del polmone

Osservazionale-Sperimentale: Sperimentale

Monocentrico-Multicentrico: Multicentrico

Randomizzato: 

Fase di studio: III

Richiesta mandatoria di tessuto: 

Linee di trattamento: Prima linea

Criteri di inclusione: 

- Participants at least 18 years of age
- Locally advanced not amenable to curative therapy, or metastatic disease
- Histologically documented non-squamous NSCLC with HER2 mutation in exons 19 or 20 by tissue NGS or ctDNA
- Treatment-naïve for palliative intent systemic therapy for locally advanced or metastatic disease
- Left ventricular ejection fraction (LVEF) ≥ 50%
- Measurable disease assessed by Investigator based on RECIST 1.1
- Protocol-defined adequate organ function including cardiac, renal, hepatic function
- ECOG 0-1
- Having tumour tissue available for central testing.

Criteri di esclusione: 

- Tumors with targetable alterations to EGFR (or other targetable mutations including but not limited to ALK, if routinely tested as a targetable alteration with approved available therapy)
- Any clinically active brain metastases; previously treated brain metastases allowed
- Active autoimmune or inflammatory disorders
- Medical history of myocardial infarction within 6 months prior to randomization
- History of non-infectious pneumonitis/ILD, current or suspected ILD
- Lung-specific intercurrent clinical significant severe illness
- Contraindication to platinum-based doublet chemotherapy or pembrolizumab.

Trattamento sperimentale: 

Trastuzumab Deruxtecan administered by intravenous infusion

Trattamento di controllo: 

Drug: Cisplatin- Investigator's choice of platinum chemotherapy (cisplatin) administered by intravenous infusion
Drug: Carboplatin- Investigator's choice of platinum chemotherapy (carboplatin) administered by intravenous infusion
Drug: Pembrolizumab administered by intravenous infusion
Drug: Pemetrexed administered by intravenous infusion

Obiettivi primari dello studio: 

Progression Free Survival (PFS) by Blinded Independent Central Review (BICR) [ Time Frame: Until progression or death, assessed up to approximately 12 months ]
Defined as time from randomization until progression per RECIST 1.1 as assessed by Blinded Independent Central Review (BICR), or death due to any cause.

Obiettivi secondari dello studio: 

- Overall Survival (OS) [ Time Frame: Until death, assessed up to approximately 28 months. ]
Defined as time from randomization until the date of death due to any cause.
- Progression Free Survival (PFS) by investigator assessment [ Time Frame: Until progression, assessed up to approximately 12 months ]
Defined as time from randomization until progression per RECIST 1.1 as assessed by the investigator, or death due to any cause.
- Objective Response Rate (ORR) [ Time Frame: Until progression, assessed up to approximately 12 months ]
Defined as the proportion of participants who have a complete response (CR) or partial response (PR) as assessed by Blinded Independent Central Review (BICR) and investigator according to RECIST 1.1
- Duration of Response (DoR) [ Time Frame: Until progression, assessed up to approximately 12 months ]
Defined as the time from the date of first documented response until date of documented progression as assessed by Blinded Independent Central Review (BICR) and investigator assessment according to RECIST 1.1.
- Time to second progression or death (PFS2) [ Time Frame: Assessed up to approximately 20 months ]
Defined as the time from randomization until second progression on next-line of treatment as assessed by investigator at the local site using assessments conducted per local standard clinical practice, or death due to any cause.
- Landmark analysis of PFS (PFS12) [ Time Frame: Assessed up to approximately 12 months ]
Defined as proportion of participants alive and progression-free at 12 months, as assessed by Blinded Independent Central Review (BICR) and investigator.
- Landmark analysis of OS (OS24) [ Time Frame: Assessed up to approximately 24 months ]
Defined as proportion of participants alive at 24 months
- Central Nervous System (CNS) - Progression Free Survival (PFS) [ Time Frame: Until CNS progression or death, assessed up to approximately 12 months ]
Defined as time from randomization until Central Nervous System (CNS) progression per RECIST 1.1 as assessed by Blinded Independent Central Review (BICR) or death due to any cause in the absence of CNS progression.
- Safety and tolerability of T-DXd versus Standard of Care treatment [ Time Frame: Until progression or death, assessed up to approximately 28 months ]
- Assessed by the occurrence of AEs, SAEs, and changes from baseline in laboratory parameters, vital signs, ECG, and ECHO/MUGA scan results.
 - Pharmacokinetics (PK) of T-DXd, total anti-HER2 antibody and DXd in serum [ Time Frame: Up to cycle 4, approximately 12 weeks ]
Serum concentration of T-DXd, total anti-HER2 antibody and DXd.
- Immunogenicity of T-DXd [ Time Frame: Until progression, assessed up to approximately 13 months ]
Presence of anti-drug antibodies (ADAs) for T-DXd.
- Patient-reported pulmonary symptoms associated with Non-Small Cell Lung Cancer [ Time Frame: Until progression, assessed up to approximately 13 months ]
Time to sustained deterioration in pulmonary symptoms (cough, dyspnea, chest pain) while on treatment using the Non-Small Cell Lung Cancer-Symptom Assessment Questionnaire (NSCLC-SAQ).
- Patient-reported tolerability of T-DXd described using symptomatic AEs [ Time Frame: Until progression, assessed up to approximately 13 months ]
Symptomatic AEs: Descriptive summary of the proportion of participants reporting symptomatic AEs while on treatment, as assessed by the Patient-reported outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) and items from the European Organisation for Research and Treatment of Cancer (EORTC) Item Library.
- Patient-reported tolerability of T-DXd described using overall side-effect bother [ Time Frame: Until progression, assessed up to approximately 13 months ]
Overall side-effect bother: Descriptive summary of the proportion of participants reporting overall side-effect bother on the Patient's Global Impression of Treatment Tolerability (PGI-TT) while on treatment.
- Patient-reported tolerability of T-DXd described using physical function [ Time Frame: Until progression, assessed up to approximately 13 months ]
Physical Function: The proportion of participants with maintained or improved physical function while on treatment, based on the European Organisation for Research and Treatment of Cancer 30-item core quality of life questionnaire (EORTC-QLQ-C30) physical functioning scale.

Data di inizio dell'arruolamento: 28.10.2021

Centri partecipanti

Nord Italia

Istituto Europeo di Oncologia
Via Ripamonti 435 - 20141 Milano - MI
NB: Arruolamento pazienti non ancora attivo

 

A.O. San Gerardo
Via Pergolesi 33 - 20900 Monza - MB
NB: Arruolamento pazienti non ancora attivo

 

Azienda Ospedaliero-Universitaria di Parma
Via Gramsci 14 - 43126 Parma - PR
NB: Arruolamento pazienti non ancora attivo

 

A.O.U San Luigi Gonzaga
Regione Gonzole 10 - 10043 Orbassano - TO

 

AOUI Verona - Borgo Roma
Piazzale Ludovico Antonio Scuro 10 - 37134 Verona - VR
Centro Ricerche Cliniche di Verona - NB: Arruolamento pazienti non ancora attivo

 

Centro Italia

Fondazione Policlinico A. Gemelli
Largo Agostino Gemelli 8 - 00168 Roma - RM
NB: Arruolamento pazienti non ancora attivo

Informazioni Generali

Protocollo

Numero di iscrizione a registro: 2021-000634-33

Data di inserimento: 24.02.2022

Promotore

AstraZeneca

Principal Investigator ITALIA

Azienda Ospedaliera Universitaria San Luigi Gonzaga, Orbassano (TO)

Riferimento: Dr. Non disponibile

Telefono: 00000

Email: nd@nd.it

Localita: Orbassano (TO)

 

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