Clinical Trials

23/010 ADOPT – Lung

A Study to Evaluate the Benefit of Adding Durvalumab After Chemotherapy, Durvalumab, and Surgery in Patients With Early-stage, Operable, Non-small Cell Lung Cancer. (ADOPT-lung)

Recruitment target:
40
(23 randomised)
Status:
Open to Recruitment

Summary:

The ADOPT-Lung study will examine disease free status (DFS) following 12 months of adjuvant durvalumab in addition to neoadjuvant chemotherapy and durvalumab in NSCLC patients who do not achieve a complete pathological response following surgery. ‘Operable’ patients will be given 3-4 cycles of neoadjuvant durvalumab and chemotherapy every 3 weeks, and provided the tumour is satisfactorily removed by surgery (R0 or R1), the patients will be randomised to 12 months of durvalumab given every 4 weeks, or observation. Participants will have CT scans every 12 weeks in the first year, and every 6 months in years 2 and 3. Blood will be collected at the scan visit to measure correlation of DFS with ctDNA clearance.

Clinical trial design:

Phase III randomised open-label study

Indication:

‘Operable’ Stage IIB-IIIB NSCLC with absence of EGFR mutation or ALK translocation

Intervention:

12 months of durvalumab (immunotherapy) every 4 weeks after surgery

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