Brief Summary
The aim of this study is to determine whether additional adjuvant immunotherapya treatment that uses a person's immune system to fight cancer with durvalumab after neoadjuvant chemo-immunotherapy has an effect on disease-free survival (DFS) in patients who do not achieve complete pathological response (pCR) as per local assessment according to the IASLC recommendations.
Intervention/Treatment
- Drug: Adjuvant durvalumab
Inclusion Criteria
- Histologically confirmed NSCLC.
- Stage IIB-IIIB (T1-4 N0-2) according to 8th edition of the TNM stagingthe process of determining how big the cancer is, where it started and if it has spread to other areas system of lung cancera disease where abnormal cells split without control and spread to other nearby body tissue and/or organs.
- Stage III assessment should include samples of lymph nodessmall bean-shaped structures that filters harmful substances from lymph fluid at levels 4, bilaterally, and level 7 to rule out stage IIIB N3 disease.
- T4 tumours will only be eligible if they are defined as T4 based only on their size (>7cm); any other reason will be considered ineligible.
- Known PD-L1 status, as tested locally using a validated assay. To ensure comparability of results, it is strongly encouraged that PD-L1 testing is done with the Ventana PD-L1 (SP263) assay.
- Absence of EGFR mutation or ALK translocation, as tested locally.
- Primary tumoura tissue mass that forms from groups of unhealthy cells resectable and functionally operable as assessed per local multidisciplinary tumour board (cardiac evaluation, pulmonary function and diffusion capacity, comorbidity).
- Adequate haematological function:
- Haemoglobin greater than/equal to 90 g/L
- Absolute neutrophil count (ANC) greater than/equal to 1.5 x10^9/L
- Platelet count greater than/equal to 100 x10^9/L.
- Adequate renal function: Measured creatinine clearance (CL) >40 mL/min or calculated
CL >40 mL/min calculated by the Cockcroft-Gault formula (greater than/equal to 45mL/min for pemetrexed-based chemotherapya cancer treatment that uses drugs to kill or slow the growth of cancer cells, while minimising damage to healthy cells, greater than/equal to 60mL/min for cis-platinum-based chemotherapy). - Adequate liver function:
- ALT and AST less than/equal to 2.5x institutional ULN
- Total serum bilirubin less than/equal to 1.5x institutional ULN (patients with Gilbert’s syndrome may be allowed to be enrolled after consultation with the study team.
- Eastern Cooperative Oncologythe study, diagnosis and treatment of cancer Group (ECOG) performance status 0-1.
- Patient has to be fit to receive at least one of the platinum-based chemotherapy regimens as indicated in the protocol, according to local standards.
- Age greater than/equal to 18 at the time of enrolment.
- Body weight >30 kg.
- Life expectancy of at least 12 weeks.
- Women of childbearing potential, including women who had their last menstruation in the last 2 years, must have a negative urinary or serum pregnancy test at screeningtesting for cancer or conditions that can lead to cancer before symptoms appear, also known as cancer screening before enrolment. Pregnancy test must be repeated within 3 days before the first dosethe amount of medication taken of protocol treatment.
- Written IC for study participation must be signed and dated by the patient and the investigator prior to any study-related intervention.
Eligibility Criteria for randomisation:
- Surgical resectionsurgical removal of tissue or part/all of an organ must have been completed. Note: Participants who have had only had segmentectomy or wedge resections are not eligible for randomisation.
- Patients must have complete resection: R0 or R1 resection.
- Patients must be fit to receive adjuvant treatment with durvalumab.
- Patients must have no evidence of metastatic disease as assessed by CT scan.
- Documentation of pathological response as per local review must be available.