The year 2025 marked a turning point for lung cancer care in Australia. National Lung Cancer Screening commenced, diagnostic pathways modernised, and multiple PBS decisions (with more imminent) reshaped treatment across early-stage, locally advanced and metastatic disease. The direction of travel is clear: earlier detection, safer diagnostics, and more personalised systemic therapy.
What changed in Lung Cancer Care in 2025?
- National lung cancer screening commenced, shifting diagnosis toward earlier, potentially curable disease
- Diagnostic pathways modernised, with growing use of navigational and robotic bronchoscopy to safely biopsy peripheral nodules
- Targeted therapies expanded on the PBS, including new options for BRAF V600E, ALK and ROS1-driven NSCLC
- EGFR treatment paradigms shifted, with osimertinib moving into unresectable stage III disease and chemotherapy combinations improving survival in metastatic disease
- Immunotherapy access broadened, including consolidation therapy in limited-stage small cell lung cancer and more flexible use in metastatic settings
- Biomarkers moved closer to practice, with ctDNA (from liquid biopsy) increasingly shaping future diagnostic and treatment strategies
Lung Cancer Screening: From Policy to Practice
The National Lung Cancer Screening Program (NLCSP) commenced on 1 July 2025, targeting people at highest risk of disease.
- Age 50–70 years
- ≥30 pack-year smoking history
- Current smokers or those who quit within 10 years
- No lung cancer symptoms
The NLCSP provides biennial low-dose CT (LDCT), with shorter-interval follow-up, according to a locally developed nodule assessment pathway to determine risk of lung cancer.
There has been rapid national uptake. In approximately 5 months, 37,000 LDCT scans were undertaken, with 426 high-risk or very high-risk nodules referred for further investigation. While the program is still ramping up and has not yet reached full capacity, the prevalence of high-risk findings is consistent with modelling estimates.
Clinics are beginning to see earlier-stage, potentially curable lung cancers, although advanced presentations remain common during this transition phase. A concern has been potential delays in accessing the first appointment in the tertiary healthcare system within 14 days, and a formal diagnosis, including a lung biopsy, within 28 days of GP referral. Prior to the commencement of the NLCSP, and the associated increased workload, TOGA ran a workshop examining the Optimal Care Pathway for Lung Cancer timelines, noting that many sites were already struggling to meet timelines. In anticipation of the increased workload, many hospitals set up streamlined referral systems, including rapid access lung nodule clinics. The principal system pressure point to stay within recommended timelines is diagnostic capacity, particularly timely biopsy and staging.
Expanding Risk Definitions in Lung Cancer Screening: An Active Research Priority
Beyond smoking history, the research setting continues to explore additional criteria to better identify high-risk populations.
- In the TALENT Taiwanese screening study, female sex, age over 60 years, and a family history of lung cancer were associated with increased risk of lung cancer and invasive disease.
- The FANNS study recruited 1,000 never-smoking females of Asian ancestry and reported a lung cancer detection rate of 1.3% on baseline LDCT, comparable to TALENT (1.5%) and higher than rates reported in NLST (1.1%) and NELSON (0.9%). All detected cancers harboured a driver mutation, highlighting the distinct biology of lung cancer in never-smokers.
- In Australia, the Australian Lung Screen Trial (ALST), led by Professor Kwun Fong, continues to recruit light and never-smokers to further define risk and benefit.
Lung Cancer Diagnostics: Safer, More Precise, and Evolving Fast
A defining theme of 2025 was the shift toward advanced bronchoscopic diagnostics for peripheral lung nodules:
- Navigational and robotic bronchoscopy now achieve diagnostic yields comparable to CT-guided percutaneous biopsy
- Complication rates are substantially lower, particularly pneumothorax and bleeding
- Peripheral nodule biopsy and mediastinal staging can often be performed in a single procedure
These approaches align well with screening-detected nodules and are expected to expand as services and infrastructure mature.
The indeterminate pulmonary nodule challenge
A significant proportion of screened patients fall into a grey zone between clearly benign and clearly malignant disease. Key areas of development to complement LDCT interpretation include:
- Circulating tumour DNA (ctDNA) and other blood-based biomarkers
- AI-assisted imaging analysis
- Strategies to reduce repeated surveillance scans, incidental findings, and patient anxiety
Lung Cancer Systemic Therapies: Meaningful PBS Progress in 2025
Targeted therapies
Several long-awaited or practice-changing advances moved into routine care or closer to PBS access in 2025.
- BRAF V600E–mutant NSCLC
Dabrafenib plus trametinib is now PBS-listed, providing an effective oral option with established survival benefit, CNS activity, and manageable toxicity. Encorafenib plus binimetinib, examined in the PHAROS clinical trial, has also received a positive PBAC recommendation in this indication, further expanding treatment choice. Listen to our podcast on BRAF-mutated NSCLC. - ALK-positive early-stage NSCLC
Adjuvant alectinib following complete resection received a positive PBS recommendation, demonstrating a substantial disease-free survival benefit. Overall survival data from the ALINA trial are still maturing. - ROS1-rearranged NSCLC
The next-generation ROS1 inhibitor repotrectinib was approved for first or subsequent lines of therapy, providing an alternative to crizotinib. The TRIDENT-1 clinical trial demonstrated high response rates and meaningful central nervous system activity.
EGFR-mutant lung cancer
EGFR-driven disease saw some of the most influential practice changes of the year:
- Unresectable stage III disease: Osimertinib following chemoradiation significantly improved progression-free survival and CNS control in the LAURA trial, with a positive PBAC recommendation.
- Metastatic first-line disease: Combining osimertinib with chemotherapy improved overall survival in the FLAURA-2 study. Clinical judgement remains essential, as not all patients are fit for chemotherapy or wish to receive it. Molecular subgroup analyses, yet to be reported, may further refine patient selection. Optimal treatment duration also remains an open question.
Figure: Approx. median PFS results from practice-changing clinical trials in common EGFR mutations; Soria et al (2018) NEJM; NCT04035486 results; Passaro et al (2024) Ann Oncol
Immunotherapy: greater flexibility, smarter use
- Limited-stage small cell lung cancer (LS-SCLC): In the ADRIATIC trial, consolidation durvalumab after chemoradiation significantly improved overall survival and has now changed Australian practice following a positive PBAC recommendation. The LS-SCLC population is becoming smaller, reflecting improvements in staging and diagnostics. Listen to our LS-SCLC podcast examining the ADRIATIC trial data.
- Immunotherapy in metastatic disease: Relaxation of once-in-a-lifetime restrictions of immune checkpoint inhibitors has now commenced with medical oncologists now prescribing where there is sufficient evidence to do so. This creates opportunities to better study retreatment strategies through clinical trials and real-world data.
The Bottom Line
In 2025, lung cancer care in Australia moved decisively toward earlier, safer and more personalised care. The challenge now is equitable access — ensuring screening, diagnostics and modern therapies are integrated and sustainable across the health system. If these elements remain aligned, the gains of 2025 should translate into meaningful improvements in survival and quality of life for patients.
What Lies Ahead in 2026
Several priorities are emerging for the coming year:
- Screening success will require matched diagnostic and treatment capacity
- New agents, including potential access to tarlatamab (a bi-specific antibody), are likely to change practice in extensive-stage SCLC. Listen to our recent ES-SCLC podcast.
- Emerging targeted therapies for NSCLC with HER2 overexpression, KRAS G12C, and other KRAS mutations
- Further agents for EGFR+ NSCLC including amivantamab + chemotherapy in second line (MARIPOSA-2), and the emergence of TKIs to combat Met amplification pathways
- One to watch- the PD1-VEGF bispecific antibody, ivonescimab from the HARMONi clinical trials
- The continuing development of ADCs
- Liquid biopsy access will be critical to shorten time to treatment and reduce reliance on difficult tissue biopsies; however the negative outcome of the MSAC application for diagnostic liquid biopsy has put us back to the drawing board designing methods for access other than user-pays
- Over the next few years, biomarker-guided escalation and de-escalation of therapy is likely to replace one-size-fits-all approaches, with several informative trials expected to read out
- Lung cancer nurses will be central to managing increased caseloads from screening programs, supported by additional McGrath nurses and state-funded nurses. Listen to our podcast describing the critical role of lung cancer nurses.
- Continued growth of precision and robotic diagnostics will underpin both screening and treatment innovation
