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

JRCT ID: jRCT2021210072

Registered date:05/03/2022

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Locally Advanced (Stage III), Unresectable Non-small Cell Lung Cancer
• Date of first enrollment: 18/02/2021
• Target sample size: 1000
• Countries of recruitment: Australia,Japan,Brazil,Japan,Canada,Japan,China,Japan,Colombia,Japan,France,Japan,Germany,Japan,Italy,Japan,Peru,Japan,Poland,Japan,Portugal,Japan,Russian Federation,Japan,South Korea,Japan,Spain,Japan,Taiwan,Japan,Thailand,Japan,Turkey,Japan,Ukraine,Japan,United Kingdom,Japan,United States of America,Japan,Vietnam,Japan
• Study type: Interventional

Intervention(s)

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

Outcome(s)

Primary Outcome

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.

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include 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

Exclude criteria

- 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.

Related Information

• Primary Sponsor: Yamaji Shigeyuki
• Secondary ID(s): NCT05221840