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A Phase III, double-blind, placebo-controlled, Randomised, Multicentre, International Study of Durvalumab Plus Oleclumab and Durvalumab Plus Monalizumab in Patients With Locally Advanced (Stage III), Unresectable Non-small Cell Lung Cancer (NSCLC) Who Have Not Progressed Following Definitive, Platinum-Based Concurrent Chemoradiation Therapy (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 (PACIFIC-9)

Yamaji Shigeyuki

Astrazeneka K.K

3-1, Ofuka-cho, Kita-ku, Osaka-shi

RD-clinical-information-Japan@astrazeneca.com

Yamaji Shigeyuki

Astrazeneka K.K

3-1, Ofuka-cho, Kita-ku, Osaka-shi

+81-6-4802-3533

RD-clinical-information-Japan@astrazeneca.com

Recruiting

Feb. 18, 2021

Interventional

randomized controlled trial

double blind

placebo control

parallel assignment

treatment purpose

- 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

- History of another primary malignancy except for malignancy treated with curative intent with no known active disease 5 years or more before the first dose of study intervention and of low potential risk for recurrence, adequately resected non-melanoma skin or cancer and curatively treated in situ disease, 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 or more), 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.

Both

Locally Advanced (Stage III), Unresectable Non-small Cell Lung Cancer

Drug: durvalumab
Drug: Oleclumab
Drug: Monalizumab
Other: Placebo

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.

Feb. 16, 2022

No

Australia/Brazil/Canada/China/Colombia/France/Germany/Italy/Peru/Poland/Portugal/Russian Federation/South Korea/Spain/Taiwan/Thailand/Turkey/Ukraine/United Kingdom/United States of America/Vietnam