Study of Durvalumab in combination with Domvanalimab (AB154) versus Durvalumab and placebo in patients with locally advanced (stage III), unresectable non-small cell lung cancer whose disease has not progressed after definitive platinum-based concurrent chemoradiotherapy.

ID di studio ICTRP
NCT05211895 (ICTRP)

Titolo ufficiale (approvato dal comitato etico)
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 (PACIFIC-8) (BASEC)

Titolo accademico
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 (ICTRP)

Titolo pubblico
A Global Study to Assess the Effects of Durvalumab + Domvanalimab Following Concurrent Chemoradiation in Participants With Stage III Unresectable NSCLC (ICTRP)

Malattie studiate
Non-Small Cell Lung Cancer (ICTRP)

Intervento studiato
Drug: DurvalumabDrug: DomvanalimabOther: Placebo (ICTRP)

Tipo di studio
Interventional (ICTRP)

Disegno dello studio
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor). (ICTRP)

Criteri di inclusione/esclusione
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. (ICTRP)

non disponibile

Endpoint primari e secondari
Progression Free Survival (PFS) (ICTRP)

Progression Free Survival (PFS);Overall Survival (OS);Objective Response Rate (ORR);Duration of Response (DoR);Time from randomization to second progression (PFS2);Time from randomization to first date of distant metastasis or death (TTDM);Time to first subsequent therapy (TFST);Concentration of Durvalumab and Domvanalimab;PFS6, PFS12, PFS18, PFS24;Anti-Drug Antibodies (ADAs);Time to deterioration in pulmonary symptoms (TTFCD);PFS investigator;OS 24 (ICTRP)

Data di registrazione
non disponibile

Inclusione del primo partecipante
non disponibile

Sponsor secondari
Arcus Biosciences, Inc. (ICTRP)

Contatti aggiuntivi
Hidehito Horinouchi, MD, PhD;Alexander Spira, MD, PhD;Jinming Yu, MD, PhD;AstraZeneca Clinical Study Information Center, information.center@astrazeneca.com, 1-877-240-9479, National Cancer Center Hospital,Virginia Cancer Specialists Research Institute,Shandong Cancer Hospital and Institute, (ICTRP)

ID secondari
2021-004327-32, D9075C00001 (ICTRP)

Risultati-Dati individuali dei partecipanti
non disponibile

Ulteriori informazioni sullo studio
https://clinicaltrials.gov/ct2/show/NCT05211895 (ICTRP)