ADOPT-Lung Clinical Trial Recruitment Now Open

The ADOPT-Lung clinical trial is designed to determine if early-stage NSCLC patients who receive chemotherapy and immunotherapy prior to surgery have longer disease-free survival if they are also treated with immunotherapy after surgery. Immunotherapy has been one of the great modern-day discoveries in cancer, with the drug combatting one of the mechanisms tumours use to hide from the patient’s own immune system.

The first introduction of immunotherapy into early-stage NSCLC was as adjuvant (after surgery) treatment for 12 months. This was followed by the introduction of 3-4 cycles of neoadjuvant chemoimmunotherapy. ADOPT-Lung investigates if treating resectable NSCLC with neoadjuvant chemoimmunotherapy and adjuvant immunotherapy offers superior disease-free survival to just neoadjuvant chemoimmunotherapy. Secondary objectives include safety and tolerability, event-free survival and overall survival, among others.

Led locally by A/Prof Malinda Itchins and Prof Ben Solomon, Australia was one of the first countries to open this study, conducted in collaboration with the European Thoracic Oncology Platform (ETOP) and Prof Solange Peters. TOGA hopes to be an important contributor to the study as we see more patients undergoing resection for early-stage disease as a result of the National Lung Cancer Screening Program, launched in July 2025.

The collection of circulating tumour DNA from blood samples will enable exploration of patient outcomes (EFS, OS) in groups that achieve:
– ctDNA clearance after neoadjuvant treatment but not achieving pCR.
– No ctDNA clearance after neoadjuvant treatment but achieving pCR.

It is hoped to further define the role of ctDNA clearance as a biomarker for additional adjuvant immunotherapy, and how it relates to the more conventional biomarker of pCR. The role of ctDNA clearance from liquid biopsy extends the power of precision medicine beyond ‘oncogene-addicted’ NSCLC, and may ultimately be used to determine who requires both neo-adjuvant and adjuvant immunotherapy in this population.

“The ADOPT-Lung trial is an opportunity to examine if there is any improvement in survival in early-stage NSCLC patients using immunotherapy before and then after surgery. There is no high-level evidence to inform us whether this is needed over having it only before the surgery. The study will use liquid biopsies to also understand how this extra information could inform how we tailor treatment and treat early stage lung cancer better.” – A/Prof Malinda Itchins, Lead Investigator for ADOPT-Lung Australia

Keep up to date with ADOPT- Lung via TOGA.

The following sites have ADOPT-Lung open.

Learn more about neoadjuvant immunotherapy in NSCLC in this podcast, noting that Australia no longer faces exactly the same ‘once in a lifetime restriction’ of immunotherapy, but still have no means of accessing adjuvant immunotherapy if a patient has received neoadjuvant immunotherapy.