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JOURNAL ONKOLOGIE – STUDIE
PACIFIC-9

A Global Study to Assess the Effects of Durvalumab With Oleclumab or Durvalumab With Monalizumab Following Concurrent Chemoradiation in Patients With Stage III Unresectable Non-Small Cell Lung Cancer

Rekrutierend

NCT-Nummer:
NCT05221840

Studienbeginn:
Februar 2022

Letztes Update:
16.04.2024

Wirkstoff:
Durvalumab, Oleclumab, Monalizumab

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

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
Phase 3

Sponsor:
AstraZeneca

Collaborator:
-

Studienleiter

Fabrice Barlesi, MD
Principal Investigator
Gustave Roussy, Cancer Campus, Grand Paris

Kontakt

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

Studienlocations
(3 von 228)

Research Site
45147 Essen
(Nordrhein-Westfalen)
GermanyRekrutierend» Google-Maps
Research Site
73730 Esslingen
(Baden-Württemberg)
GermanyRekrutierend» Google-Maps
Research Site
49124 Georgsmarienhuette
(Niedersachsen)
GermanyRekrutierend» Google-Maps
Research Site
33332 Guetersloh
(Nordrhein-Westfalen)
GermanyRekrutierend» Google-Maps
Research Site
30459 Hannover
(Niedersachsen)
GermanyRekrutierend» Google-Maps
Research Site
26121 Oldenburg
(Niedersachsen)
GermanyRekrutierend» Google-Maps
Research Site
51353 Changwon-si
Korea, Republic ofRekrutierend» Google-Maps
Research Site
28644 Cheongju-si
Korea, Republic ofRekrutierend» Google-Maps
Research Site
13620 Seongnam-si
Korea, Republic ofRekrutierend» Google-Maps
Research Site
2755-009 Alcabideche
PortugalNoch nicht rekrutierend» Google-Maps
Research Site
3000-075 Coimbra
PortugalNoch nicht rekrutierend» Google-Maps
Research Site
630099 Novosibirsk
Russian FederationZurückgezogen» Google-Maps
Research Site
620036 Yekaterinburg
Russian FederationZurückgezogen» Google-Maps
Research Site
61018 Kharkiv Region
UkraineNoch nicht rekrutierend» Google-Maps
Research Site
25011 Kropyvnytskyi
UkraineNoch nicht rekrutierend» Google-Maps
Research Site
69000 Zaporizhzhia
UkraineNoch nicht rekrutierend» Google-Maps
Research Site
TS4 3BW Middlesborough
United KingdomRekrutierend» Google-Maps
Research Site
WV10 OQP Wolverhampton
United KingdomRekrutierend» Google-Maps
Alle anzeigen

Studien-Informationen

Brief Summary:

This is a Phase III, randomised, double-blind, multicentre, international study assessing the

efficacy and safety of durvalumab (MEDI4736) in combination with oleclumab (MEDI9447) or

durvalumab (MEDI4736) with monalizumab (IPH2201) in adults with locally advanced (Stage III),

unresectable NSCLC, who have not progressed following platinum-based cCRT.

Ein-/Ausschlusskriterien

INCLUSION CRITERIA:

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

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

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

- Provision of a tumour tissue sample obtained prior to CRT

- Documented tumour PD-L1 status by central lab

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

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

chemoradiotherapy

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

concurrent with radiation therapy

- 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.

- WHO performance status of 0 or 1 at randomization

- Adequate organ and marrow function

EXCLUSION CRITERIA:

- 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, adequately resected

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

carcinoma in situ or Ta tumours without evidence of disease.

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

- Participants who receive sequential (not inclusive of induction) chemoradiation

therapy for locally advanced (Stage III) unresectable NSCLC.

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

during platinum-based cCRT.

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

(excluding alopecia).

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

- 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 - diagnosed in the

past 6 months prior to randomization.

- Active or prior documented autoimmune or inflammatory disorders (with exceptions)

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

dose of durvalumab.

Studien-Rationale

Primary outcome:

1. Progression Free Surival (PFS) (Time Frame - Up to 5 years after first patient randomized.):
Progression Free Survival (PFS) as assessed by BICR, per RECIST 1.1.



Secondary outcome:

1. Overall Survival (OS) (Time Frame - Up to 9 years after first patient randomized):
Overall survival (OS)

2. Objective response rate (ORR) (Time Frame - Up to 5 years after first patient randomized):
Objective response rate (ORR) per RECIST 1.1 as assessed by BICR

3. Overall survival (OS) at 24 months (Time Frame - Up to 9 years after first patient randomized):
Overall survival (OS) at 24 months

4. Duration of response (DoR) (Time Frame - Up to 5 years after first patient randomized):
Duration of response (DoR) per RECIST 1.1 as assessed by BICR

5. Progression free survival (PFS) at 6, 12, 18, and 24 months (Time Frame - From date of randomization until 24 months):
Progression free survival (PFS) at 6, 12, 18, and 24 months respectively, per RECIST 1.1 as assessed by BICR

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

7. Time from randomization to first date of distant metastasis or death (TTDM) (Time Frame - Up to 5 years after first patient randomized):
Time from randomization to first date of distant metastasis or death (TTDM)

8. Time from randomization to start date of first subsequent therapy (TFST) (Time Frame - Up to 9 years after first patient randomized):
Time from randomization to start date of first subsequent therapy (TFST)

9. Progression free survival (PFS) as assessed by Investigator (Time Frame - Up to 5 years after first patient randomized):
Progression free survival (PFS) as assessed by Investigator

10. IHC analysis of PD-L1 TC expression (Time Frame - Up to 5 years after first patient randomized):
IHC analysis of PD-L1 TC expression relative to efficacy outcomes

11. Concentration of Durvalumab (Time Frame - From date of randomization until 3 months after date of last IP dose):
To assess the Pharmacokinetics of Durvalumab when in combination with Monalizumab or Oleclumab - serum peak and trough concentrations

12. Anti-drug antibodies (ADAs) (Time Frame - From date of randomization until 3 months after date of last IP dose):
The immunogenicity of durvalumab, oleclumab, and monalizumab as assessed by presence of anti-drug antibodies (ADAs)

13. Time to deterioration in pulmonary symptoms (TTFCD) (Time Frame - Up to 5 years after last patient randomized):
Time to deterioration in pulmonary symptoms (TTFCD)

14. Concentration of Oleclumab (Time Frame - From date of randomization until 3 months after last dose of IP):
To assess the Pharmacokinetics of Oleclumab when in combination with Durvulumab - serum peak and trough concentrations

15. Concentration of Monalizumab (Time Frame - From date of randomization until 3 months after last dose of IP):
To assess the Pharmacokinetics of Monalizumab when in combination with Durvalumab - serum peak and trough concentrations

Studien-Arme

  • Experimental: Arm A: Durvalumab and Oleclumab
    Durvalumab on Day 1 of each 28-day cycle + Oleclumab on Days 1 and 15 of cycles 1 and 2, then on Day 1 of each subsequent 28-day cycle for up to 12 months
  • Experimental: Arm B: Durvalumab and Monalizumab
    Durvalumab + Monalizumab on Day 1 of each 28-day cycle for up to 12 months. Placebo infusion will be administered on Day 15 of cycles 1 and 2 only
  • Active Comparator: Arm C: Durvalumab and Placebo
    Durvalumab on Day 1 of each 28-day cycle + Placebo on Days 1 and 15 of cycles 1 and 2, then on Day 1 of each subsequent 28-day cycle for up to 12 months

Geprüfte Regime

  • Durvalumab:
    Durvalumab IV (intravenous infusion)
  • Oleclumab:
    Oleclumab IV (intravenous infusion)
  • Monalizumab:
    Monalizumab IV (intravenous infusion)
  • Placebo:
    Placebo IV (intravenous infusion)

Quelle: ClinicalTrials.gov


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