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JOURNAL ONKOLOGIE – STUDIE
PACIFIC-8

A Global Study to Assess the Effects of Durvalumab + Domvanalimab Following Concurrent Chemoradiation in Participants With Stage III Unresectable NSCLC

Rekrutierend

NCT-Nummer:
NCT05211895

Studienbeginn:
Februar 2022

Letztes Update:
19.04.2024

Wirkstoff:
Durvalumab, Domvanalimab

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

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
Phase 3

Sponsor:
AstraZeneca

Collaborator:
Arcus Biosciences, Inc.

Studienleiter

Hidehito Horinouchi, MD, PhD
Principal Investigator
National Cancer Center Hospital
Alexander Spira, MD, PhD
Principal Investigator
Virginia Cancer Specialists Research Institute
Jinming Yu, MD, PhD
Principal Investigator
Shandong Cancer Hospital and Institute

Kontakt

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

Studienlocations
(3 von 229)

Research Site
14165 Berlin-Zehlendorf
(Berlin)
GermanyRekrutierend» Google-Maps
Research Site
38114 Braunschweig
(Niedersachsen)
GermanyRekrutierend» Google-Maps
Research Site
49124 Georgsmarienhuette
(Niedersachsen)
GermanyZurückgezogen» Google-Maps
Research Site
56073 Koblenz
(Rheinland-Pfalz)
GermanyRekrutierend» Google-Maps
Research Site
47805 Krefeld
(Nordrhein-Westfalen)
GermanyRekrutierend» Google-Maps
Research Site
51109 Köln
(Nordrhein-Westfalen)
GermanyRekrutierend» Google-Maps
Research Site
74245 Löwenstein
(Baden-Württemberg)
GermanyRekrutierend» Google-Maps
Research Site
47441 Moers
(Nordrhein-Westfalen)
GermanyRekrutierend» Google-Maps
Research Site
72076 Tübingen
(Baden-Württemberg)
GermanyRekrutierend» Google-Maps
Research Site
21224 Baltimore
United StatesNoch nicht rekrutierend» Google-Maps
Research Site
78234 Fort Sam Houston
United StatesRekrutierend» Google-Maps
Research Site
22060 Fort Belvoir
United StatesNoch nicht rekrutierend» Google-Maps
Research Site
86015-520 Londrina
BrazilNoch nicht rekrutierend» Google-Maps
Research Site
150001 Hong Kong
Hong KongNoch nicht rekrutierend» Google-Maps
Research Site
3100 Salgótarján
HungaryNoch nicht rekrutierend» Google-Maps
Research Site
21565 Incheon
Korea, Republic ofNoch nicht rekrutierend» Google-Maps
Research Site
20230 Aguascalientes
MexicoNoch nicht rekrutierend» Google-Maps
Research Site
1011 Lausanne
SwitzerlandNoch nicht rekrutierend» Google-Maps
Research Site
NE7 7DN High Heaton/Newcastle Upon Tyn
United KingdomRekrutierend» Google-Maps
Alle anzeigen

Studien-Informationen

Brief Summary:

This is a Phase III, randomised, double-blind, placebo-controlled, multicentre, international

study assessing the efficacy and safety of durvalumab (MEDI4736) and domvanalimab (AB154)

compared with durvalumab plus placebo in adults with locally advanced (Stage III),

unresectable NSCLC whose disease has not progressed following definitive platinum-based cCRT.

Ein-/Ausschlusskriterien

INCLUSION CRITERIA:

1. Participant must be ≥ 18 years at the time of screening.

2. Histologically- or cytologically-documented NSCLC and have been treated with

concurrent CRT for locally advanced, unresectable (Stage III) disease

3. Provision of a tumour tissue sample obtained prior to CRT

4. Documented tumour PD-L1 status ≥ 1% by central lab

5. Documented EGFR and ALK wild-type status (local or central).

6. Patients must not have progressed following definitive, platinum-based, concurrent

chemoradiotherapy

7. Participants must have received at least 2 cycles of platinum-based chemotherapy

concurrent with radiation therapy

8. Participants must have received a total dose of radiation of 60 Gy ±10% (54 Gy to 66

Gy) as part of the chemoradiation therapy, to be randomised. Radiation therapy should

be administered by intensity modulated RT (preferred) or 3D-conforming technique.

9. WHO performance status of 0 or 1 at randomization

10. Adequate organ and marrow function

EXCLUSION CRITERIA:

1. History of another primary malignancy except for malignancy treated with curative

intent with no known active disease ≥ 5 years before the first dose of study

intervention and of low potential risk for recurrence. Exceptions include adequately

resected non-melanoma skin cancer and curatively treated in situ disease, or

adequately treated carcinoma in situ or Ta tumours treated with curative intent and

without evidence of disease.

2. Mixed small cell and non-small cell lung cancer histology.

3. Participants who receive sequential (not inclusive of induction) chemoradiation

therapy for locally advanced (Stage III) unresectable NSCLC.

4. Participants with locally advanced (Stage III) unresectable NSCLC who have progressed

during platinum-based cCRT.

5. Any unresolved toxicity CTCAE >Grade 2 from the prior chemoradiation therapy

(excluding alopecia).

6. Participants with ≥ grade 2 pneumonitis from prior chemoradiation therapy.

7. History of idiopathic pulmonary fibrosis, drug-induced pneumonitis, or idiopathic

pneumonitis - regardless of time of onset prior to randomisation. Evidence of active

non-CRT induced pneumonitis (≥ Grade 2), active pneumonia, active ILD, active or

recently treated pleural effusion, or current pulmonary fibrosis

8. Active or prior documented autoimmune or inflammatory disorders (with exceptions)

9. Active EBV infection, or known or suspected chronic active EBV infection at screening

10. Current or prior use of immunosuppressive medication within 14 days before the first

dose of durvalumab.

Studien-Rationale

Primary outcome:

1. Progression Free Survival (PFS) (Time Frame - Up to 8 years after first patient randomised):
Defined as time from randomisation until progression per RECIST 1.1 as assessed by Blinded Independent Central Review (BICR), or death due to any cause in participants with PD-L1 TC ≥ 50%.



Secondary outcome:

1. Progression Free Survival (PFS) (Time Frame - Up to 8 years after first patient randomised):
Defined as time from randomisation until progression per RECIST 1.1 as assessed by Blinded Independent Central Review (BICR), or death due to any cause in participants with PD-L1 TC ≥ 1%

2. Overall Survival (OS) (Time Frame - Approximately 8 years after first patient randomized):
Overall Survival (OS)

3. Objective Response Rate (ORR) (Time Frame - Approximately 8 years after first patient randomized):
Objective Response Rate (ORR) per RECIST 1.1 as assessed by BICR

4. Duration of Response (DoR) (Time Frame - Approximately 8 years after first patient randomized):
Duration of Response (DoR) using BICR assessment according to RECIST 1.1

5. Time from randomization to second progression (PFS2) (Time Frame - Approximately 8 years after first patient randomized):
Time from randomization to second progression (PFS2)

6. Time from randomization to first date of distant metastasis or death (TTDM) (Time Frame - Approximately 8 years after first patient randomized):
Time from randomization until the first date of distant metastasis or death in the absence of distant metastasis (TTDM).

7. Time to first subsequent therapy (TFST) (Time Frame - Approximately 8 years after first patient randomized):
Time to first subsequent therapy (TFST)

8. Concentration of Durvalumab and Domvanalimab (Time Frame - Approximately 12 weeks after last IP dose):
The pharmacokinetics (PK) of Durvalumab and Domvanalimab as determined by concentration

9. PFS6, PFS12, PFS18, PFS24 (Time Frame - Approximately 6, 12, 18 and 24 months after last patient randomized):
PFS at 6, 12, 18 and 24 months (proportion per Kaplan-Meier)

10. Anti-Drug Antibodies (ADAs) (Time Frame - Approximately 12 weeks after last IP dose.):
The immunogenicity of Durvalumab and domvanalimab as assessed by presence of Anti-Drug Antibodies (ADAs)

11. Time to deterioration in pulmonary symptoms (TTFCD) (Time Frame - Approximately 8 years after first patient randomized):
Time to deterioration in pulmonary symptoms (TTFCD)

Studien-Arme

  • Experimental: Arm A: Durvalumab + Domvanalimab
    Durvalumab and domvanalimab as an IV infusion q4w, starting on Day 1 for up to a maximum of 12 months
  • Active Comparator: Arm B: Durvalumab + Placebo
    Durvalumab + placebo as an IV infusion q4w starting on Day 1 for up to a maximum of 12 months

Geprüfte Regime

  • Durvalumab:
    Durvalumab IV (Intravenous infusion)
  • Domvanalimab:
    Domvanalimab IV (Intravenous infusion)
  • Placebo:
    Placebo IV (Intravenous infusion)

Quelle: ClinicalTrials.gov


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