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Imfinzi NSCLC
Imfinzi NSCLC
JOURNAL ONKOLOGIE – STUDIE

PACIFIC-4 Durvalumab vs Placebo With Stereotactic Body Radiation Therapy in Early Stage Unresected Non-small Cell Lung Cancer Patients

Rekrutierend

NCT-Nummer:
NCT03833154

Studienbeginn:
März 2019

Letztes Update:
22.02.2021

Wirkstoff:
Durvalumab

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

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
Phase 3

Sponsor:
AstraZeneca

Collaborator:
-

Kontakt

AstraZeneca Clinical Study Information Center
Kontakt:
Phone: 1-877-240-9479
E-Mail: information.center@astrazeneca.com
» Kontaktdaten anzeigen
Astrazeneca Cancer Study Locator Service
Kontakt:
Phone: 1-877-400-4656
E-Mail: AstraZeneca@emergingmed.com
» Kontaktdaten anzeigen

Studienlocations (3 von 221)

Research Site
30459 Hannover
(Niedersachsen)
GermanyRekrutierend» Google-Maps
Research Site
69126 Heidelberg
(Baden-Württemberg)
GermanyRekrutierend» Google-Maps
Research Site
85719 Tucson
United StatesNoch nicht rekrutierend» Google-Maps
Research Site
92037 La Jolla
United StatesNoch nicht rekrutierend» Google-Maps
Research Site
95661 Roseville
United StatesNoch nicht rekrutierend» Google-Maps
Research Site
95816 Sacramento
United StatesNoch nicht rekrutierend» Google-Maps
Research Site
33744 Bay Pines
United StatesNoch nicht rekrutierend» Google-Maps
Research Site
60637 Chicago
United StatesNoch nicht rekrutierend» Google-Maps
Research Site
60068 Park Ridge
United StatesNoch nicht rekrutierend» Google-Maps
Research Site
62703 Springfield
United StatesNoch nicht rekrutierend» Google-Maps
Research Site
42701 Elizabethtown
United StatesNoch nicht rekrutierend» Google-Maps
Research Site
40202 Louisville
United StatesNoch nicht rekrutierend» Google-Maps
Research Site
21811 Ocean Pines
United StatesNoch nicht rekrutierend» Google-Maps
Research Site
21801 Salisbury
United StatesNoch nicht rekrutierend» Google-Maps
Research Site
48708 Bay City
United StatesNoch nicht rekrutierend» Google-Maps
Research Site
48043 Mount Clemens
United StatesNoch nicht rekrutierend» Google-Maps
Research Site
55416 Saint Louis Park
United StatesRekrutierend» Google-Maps
Research Site
64111 Kansas City
United StatesNoch nicht rekrutierend» Google-Maps
Research Site
44106 Cleveland
United StatesNoch nicht rekrutierend» Google-Maps
Research Site
44195 Cleveland
United StatesNoch nicht rekrutierend» Google-Maps
Research Site
74133 Tulsa
United StatesNoch nicht rekrutierend» Google-Maps
Research Site
19104 Philadelphia
United StatesNoch nicht rekrutierend» Google-Maps
Research Site
23230 Richmond
United StatesNoch nicht rekrutierend» Google-Maps
Research Site
98195 Seattle
United StatesNoch nicht rekrutierend» Google-Maps
Research Site
430022 Hankou,Wuhan
ChinaNoch nicht rekrutierend» Google-Maps
Research Site
28644 Cheongju-si
Korea, Republic ofAktiv, nicht rekrutierend» Google-Maps
Research Site
03722 Seoul
Korea, Republic ofAktiv, nicht rekrutierend» Google-Maps
Research Site
05505 Seoul
Korea, Republic ofAktiv, nicht rekrutierend» Google-Maps
Research Site
06351 Seoul
Korea, Republic ofAktiv, nicht rekrutierend» Google-Maps
Research Site
3844 DG Harderwijk
NetherlandsNoch nicht rekrutierend» Google-Maps
Research Site
00917 Hato Rey
Puerto RicoNoch nicht rekrutierend» Google-Maps
Research Site
00927 San Juan
Puerto RicoNoch nicht rekrutierend» Google-Maps
Research Site
420029 Kazan, Tatarstan
Russian FederationNoch nicht rekrutierend» Google-Maps
Research Site
115478 Moscow
Russian FederationNoch nicht rekrutierend» Google-Maps
Research Site
197758 Saint Petersburg
Russian FederationRekrutierend» Google-Maps
Research Site
450054 Ufa
Russian FederationNoch nicht rekrutierend» Google-Maps
Research Site
08907 L'Hospitalet de Llobregat
SpainRekrutierend» Google-Maps
Alle anzeigen

Studien-Informationen

Detailed Description:

Patients who are to receive SoC SBRT as definitive treatment of stage I-II lymph

node-negative NSCLC and confirmed to meet all eligibility criteria will be randomized 1:1 to

durvalumab or placebo.

The primary objective of this study is to assess the efficacy of durvalumab with SoC SBRT

compared to placebo with SoC SBRT in terms of PFS. Key secondary is to assess the efficacy of

Durvalumab with SoC SBRT compared to placebo with SoC SBRT in terms of OS.

Ein-/Ausschlusskriterien

Key Inclusion Criteria:

1. Age ≥18 years

2. Histologically or cytologically documented Stage I to II NSCLC, with clinical Stage

I/II lymph node-negative (T1 to T3N0M0) disease and planned to receive definitive

treatment with SBRT. Patients may be medically inoperable or are medically operable

and refusing surgery or choosing to have SBRT (Stereotactic Body Radiation Therapy) as

definitive therapy

3. Planned SoC SBRT as definitive treatment

4. World Health Organization (WHO)/Eastern Cooperative Oncology Group (ECOG) PS of 0, 1,

or 2

5. Life expectancy of at least 12 weeks

6. Body weight >30 kg

7. Submission of available tumor tissue sample

8. Adequate organ and marrow function required

9. Patients with central or peripheral lesions are eligible

10. Staging studies must be done within 10 weeks before randomization

11. Patients with a history of metachronus stage I/II (T1-T3N0M0) NSCLC treated

definitively surgery only or SBRT only >1 year prior to enrollment are eligible.

Key Exclusion Criteria:

1. Mixed small cell and non-small cell cancer

2. History of allogeneic organ transplantation

3. History of another primary malignancy with exceptions

4. History of active primary immunodeficiency

Studien-Rationale

Primary outcome:

1. Progression-Free Survival (PFS) assessed by BICR according to RECIST 1.1 in subpopulation of patients with Stage I/II NSCLC (Time Frame - up to 6 years)



Secondary outcome:

1. Progression-Free Survival (PFS) assessed by BICR per RECIST 1.1 in all randomised patients with Stage I/II NSCLC (Time Frame - up to 6 years)

2. Overall Survival (OS) (Time Frame - up to 7 years)

3. Lung cancer-specific mortality (Time Frame - up to 7 years)

4. Peak Plasma Concentration (Cmax) (Time Frame - up to 27 months)

5. Detection of ADA neutralising antibodies titers (Time Frame - up to 30 months)

6. Health-related quality of life in patients treated with durvalumab with SoC SBRT compared to placebo with SoC SBRT using the EORTC QLQ-C30 (Time Frame - up to 7 years)

7. Proportion of patients alive and progression free at 24 months from randomisation (PFS24) assessed by BICR according to RECIST 1.1 (Time Frame - at 24 months following randomization)

8. Time to progression (TTP) assessed by BICR according to RECIST 1.1 (Time Frame - up to 6 years)

9. Time to death or distant metastasis (TTDM) assessed by BICR according to RECIST 1.1 (Time Frame - up to 6 years)

10. Time from randomisation to second progression (PFS2) as defined by local standard clinical practice (Time Frame - up to 7 years)

11. Trough Concentration (Ctrough) (Time Frame - up to 27 months)

12. Assessment of AEs by CTCAE v 5.0 as measures of the safety and tolerability of durvalumab with SoC SBRT compared to placebo with SoC SBRT (Time Frame - up to 27 months)

Studien-Arme

  • Experimental: SoC SBRT + Durvalumab Therapy
    SBRT - delivered in 3, 4, 5 or 8 fractions. Durvalumab (PD-L1 monoclonal antibody) 1500 mg every 4 weeks [q4w] intravenously [iv] for up to 24 months or until progression or other discontinuation criteria are met.
  • Placebo Comparator: SoC SBRT + Placebo Therapy
    SBRT - delivered in 3, 4, 5 or 8 fractions. Placebo (matching placebo for infusion every 4 weeks iv for up to 24 months or until progression or other discontinuation criteria are met.

Geprüfte Regime

  • Durvalumab (MEDI4736):
    Durvalumab 1500 mg every 4 weeks [q4w] intravenously [iv] for up to 24 months or until progression or other discontinuation criteria are met.
  • Placebo:
    Matching placebo for infusion every 4 weeks iv for up to 24 months or until progression or other discontinuation criteria are met.
  • SBRT:
    Delivered in 3, 4, 5 or 8 fractions.
  • SBRT:
    Delivered in 3, 4, 5 or 8 fractions.

Quelle: ClinicalTrials.gov


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