A Global Study to Assess the Effects of Durvalumab + Domvanalimab Following Concurrent Chemoradiation in Participants With Stage III Unresectable NSCLC
18 Years and older, Male and Female
D9075C00001 (primary)
NCI-2023-06450
2021-004327-32
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.
Eligibility
- 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:
- Malignancies treated with curative intent and adequate follow-up with no known
active disease and have not required active treatment within the past 3 years
before the first dose of study intervention and of low potential risk of
recurrence.
- Adequately resected non melanoma skin cancer or lentigo maligna without
evidence of disease .
- Adequately treated carcinoma in situ, including Ta tumors 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.
Treatment Sites in Georgia
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