ClinicaliQ Trial Snapshot
- A Global Study to Assess the Effects of Durvalumab + Domvanalimab Following Concurrent Chemoradiation in Participants With Stage III Unresectable NSCLC — Recruiting • Phase III • Oncology • NCT05211895.
- Treatment being tested: Durvalumab combined with domvanalimab (a novel anti-CTLA-4 immune checkpoint inhibitor) versus durvalumab alone, given after concurrent chemoradiation in patients with unresectable Stage III NSCLC.
- Patient eligibility overview: Adults with locally advanced Stage III NSCLC that cannot be surgically removed, whose disease has not progressed following standard concurrent chemoradiation therapy.
Use This Page For
- Quick orientation before opening the registry record.
- Checking recruitment status, phase and sponsor at a glance.
- Connecting this trial to nearby guidelines, Drug Science and education.
What This Trial Is Studying
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 Snapshot
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- 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
- 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. 9. WHO performance status of 0 or 1 at randomization 10. Adequate organ and marrow function
Use the source registry for the full inclusion and exclusion criteria before discussing referral or enrolment.