A Phase III, Randomised, Double-blind, Placebo-controlled, Multicentre, International Study of Durvalumab Plus Domvanalimab(AB154) in Participants With Locally Advanced (Stage III), Unresectable Non-small Cell Lung Cancer Whose Disease Has Not Progressed Following Definitive Platinum-based Concurrent Chemoradiation Therapy

JRCT ID: jRCT2061210088

Registered date:23/03/2022

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Non-Small Cell Lung Cancer
• Date of first enrollment: 04/04/2022
• Target sample size: 66
• Countries of recruitment: Belgium,Japan,Malaysia,Japan,Norway,Japan,Turkey,Japan
• Study type: Interventional
• Intervention(s): durvalumab, domvanalimab or placebo as an IV infusion

Outcome(s)

• Primary Outcome: Progression Free Survial - PFS. Time Frame UP to 8 years after first ptient randomised. Defined as time from randomisation until progression per RECIST 1.1 as assessed by Blinded independent Center Review - BICR or death due to any cause in particiants with PD L1 TC50 percent or more.

Key inclusion & exclusion criteria

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

Include criteria

1. Participant must be 18 years or older 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 1percent or more 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 percent more or less (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

Exclude criteria

1. 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. 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 higher than Grade 2 from the prior chemoradiation therapy (excluding alopecia).

6. Participants with grade 2 or higher 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 or more), 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.

11. Negative pregnancy test (serum) for WOCBP:

12. Female participants must be 1 year post menopausal, surgically sterile, or using 1 highly effective form of birth control.

13. Male participants who intend to be sexually active with a WOCBP must be surgically sterile or using an acceptable method of contraception.

Related Information

• Primary Sponsor: Yamaji Shigeyuki
• Secondary ID(s): NCT05211895