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JOURNAL ONKOLOGIE – STUDIE

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

Rekrutierend

NCT-Nummer:
NCT05048797

Studienbeginn:
Oktober 2021

Letztes Update:
10.04.2024

Wirkstoff:
Trastuzumab Deruxtecan, Cisplatin, Carboplatin, Pembrolizumab, Pemetrexed

Indikation (Clinical Trials):
Lung Neoplasms, Carcinoma, Non-Small-Cell Lung

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
Phase 3

Sponsor:
AstraZeneca

Collaborator:
Daiichi Sankyo

Kontakt

AstraZeneca Clinical Study Information Center
Kontakt:
Phone: 1-877-240-9479
E-Mail: information.center@astrazeneca.com» Kontaktdaten anzeigen

Studienlocations
(3 von 162)

Research Site
14165 Berlin-Zehlendorf
(Berlin)
GermanyZurückgezogen» Google-Maps
Research Site
69126 Heidelberg
(Baden-Württemberg)
GermanyZurückgezogen» Google-Maps
Research Site
50937 Köln
(Nordrhein-Westfalen)
GermanyRekrutierend» Google-Maps
Research Site
55131 Mainz
(Rheinland-Pfalz)
GermanyRekrutierend» Google-Maps
Research Site
68167 Mannheim
(Baden-Württemberg)
GermanyZurückgezogen» Google-Maps
Research Site
26121 Oldenburg
(Niedersachsen)
GermanyRekrutierend» Google-Maps
Research Site
88212 Ravensburg
(Baden-Württemberg)
GermanyZurückgezogen» Google-Maps
Research Site
812-8582 Fukuoka-shi
JapanAktiv, nicht rekrutierend» Google-Maps
Research Site
951-8566 Niigata-shi
JapanAktiv, nicht rekrutierend» Google-Maps
Research Site
700-8558 Okayama-shi
JapanAktiv, nicht rekrutierend» Google-Maps
Research Site
541-8567 Osaka-shi
JapanAktiv, nicht rekrutierend» Google-Maps
Research Site
589-8511 Osakasayama-shi
JapanAktiv, nicht rekrutierend» Google-Maps
Research Site
060-8638 Sapporo-shi
JapanAktiv, nicht rekrutierend» Google-Maps
Research Site
980-0873 Sendai-shi
JapanAktiv, nicht rekrutierend» Google-Maps
Research Site
411-8777 Sunto-gun
JapanAktiv, nicht rekrutierend» Google-Maps
Research Site
241-8515 Yokohama-shi
JapanAktiv, nicht rekrutierend» Google-Maps
Research Site
683-8504 Yonago-shi
JapanAktiv, nicht rekrutierend» Google-Maps
Research Site
28644 Cheongju-si
Korea, Republic ofAktiv, nicht rekrutierend» Google-Maps
Research Site
13620 Gyeonggi-do
Korea, Republic ofRekrutierend» Google-Maps
Research Site
08908 L'Hospitalet de Llobregat
SpainRekrutierend» Google-Maps
Alle anzeigen

Studien-Informationen

Detailed Description:

Eligible participants will be those diagnosed with unresectable, locally advanced or

metastatic histologically documented non-squamous NSCLC with HER2 exons 19 or 20 mutations

and who are treatment-naïve for palliative intent systemic therapy for locally advanced or

metastatic disease.

The study aims to evaluate the efficacy, safety and tolerability of trastuzumab deruxtecan as

first-line treatment of Non-Small Cell Lung Cancer (NSCLC) as compared with Standard of Care

treatment (Investigator's choice of cisplatin or carboplatin + pembrolizumab + pemetrexed).

This study aims to see if trastuzumab deruxtecan allows patients to live longer without the

cancer getting worse or simply to live longer, compared to patients receiving standard of

care treatment. This study is also looking to see how the treatment and the cancer affects

patients' quality of life.

Ein-/Ausschlusskriterien

Inclusion Criteria:

- Participants at least 18 years of age

- Locally advanced and unresectable NSCLC, 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

Exclusion Criteria:

- 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 untreated brain metastases, including asymptomatic or clinically inactive brain

metastases

- 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

Studien-Rationale

Primary outcome:

1. 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.



Secondary outcome:

1. 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.

2. 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.

3. 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

4. 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.

5. 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.

6. 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.

7. Landmark analysis of OS (OS24) (Time Frame - Assessed up to approximately 24 months):
Defined as proportion of participants alive at 24 months

8. 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.

9. 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.

10. 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.

11. Immunogenicity of T-DXd (Time Frame - Until progression, assessed up to approximately 13 months):
Presence of anti-drug antibodies (ADAs) for T-DXd.

12. 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).

13. 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.

14. 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.

15. 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.

Studien-Arme

  • Experimental: Arm 1
    Trastuzumab Deruxtecan (T-DXd)
  • Active Comparator: Arm 2
    Standard of Care Treatment (platinum, pemetrexed and pembrolizumab)

Geprüfte Regime

  • Trastuzumab Deruxtecan (DS-8201a; T-DXd):
    Trastuzumab Deruxtecan administered by intravenous infusion
  • Cisplatin:
    Investigator's choice of platinum chemotherapy (cisplatin) administered by intravenous infusion
  • Carboplatin:
    Investigator's choice of platinum chemotherapy (carboplatin) administered by intravenous infusion
  • Pembrolizumab:
    Pembrolizumab administered by intravenous infusion
  • Pemetrexed:
    Pemetrexed administered by intravenous infusion

Quelle: ClinicalTrials.gov


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