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Everything in development, the medicines held by this cancer's subtypes, the open problems and what is being done about them, the roadmaps, and what changed on this record.
What is in development for Non-small-cell lung cancer, drawn from the whole corpus: 958 items. Drugs are grouped by the most advanced trial phase they have reached anywhere; approved treatments sit under standard of care. Technologies are the methods being tested for this cancer, trials are the studies recorded here, and ideas are proposals not yet in a trial.
6 medicines on record are linked to one of the types below rather than to Non-small-cell lung cancer itself. Grouped by the type that holds them; each list opens that type's own page.
Screening uptake is under 20% in the US and lower elsewhere; never-smoker adenocarcinoma has no screening pathway.
Also on OnCo: Symptoms and red flags · Early detection roadmap.
Resistance to every TKI is near-universal in metastatic disease; C797S has no approved fourth-generation EGFR inhibitor and small-cell transformation is undetectable by ctDNA.
Background: Circulating tumour DNA (ctDNA), Cross-resistance, Drug resistance (primary and acquired), EGFR C797S, Histologic transformation. Also on OnCo: Resistance: how tumours escape each drug class · Lines of therapy.
Squamous cell carcinoma has almost no targeted options and no approved ADC.
Background: p53 / RB / cell-cycle checkpoint, RAS / RAF / MEK / ERK (MAPK). Also on OnCo: Targets · KRAS roadmap.
KRAS G12C inhibitors add only ~1-2 months of PFS over docetaxel; non-G12C KRAS (G12D, G12V) remains undrugged outside trials.
Background: p53 / RB / cell-cycle checkpoint, RAS / RAF / MEK / ERK (MAPK). Also on OnCo: Targets · KRAS roadmap.
STK11/KEAP1 co-mutated and PD-L1-negative tumours respond poorly to immunotherapy.
ADCs after TKI failure have not yet shown a survival benefit over platinum chemotherapy (HERTHENA-Lung02, TROPION-Lung01), and ILD limits combinations.
Brain metastases occur in 30-50% of driver-positive patients; CNS activity now drives TKI choice, but leptomeningeal disease remains very hard to treat.
Background: Circulating tumour DNA (ctDNA), Epithelial-mesenchymal transition & drug efflux, Oligometastatic disease, Oligoprogression, The blood-brain barrier & brain metastasis. Also on OnCo: Atlas of advanced disease · How cancer spreads: the metastasis stages.
Global access: most of the world's lung cancer patients never receive genomic profiling.
Also on OnCo: Financial help · Coverage by country · Funding verdicts by country.
The disease is still found late, and that is where most of the lost survival is. Fifty-one percent of American cases are already distant at diagnosis and survive 10.5 percent at five years, against 65.5 percent for the quarter found while the cancer is confined to the lung (SEER). Screening changes this only where it is offered, and it is offered to a minority of the people at risk even in the countries that have programmes.
Also on OnCo: Symptoms and red flags · Early detection roadmap.
Screening cannot see never-smokers. Fifteen percent of UK cases and 15 to 25 percent worldwide arise in people who never smoked, and every eligibility rule starts from a smoking history, so the fastest-growing part of the disease is the part no programme is looking for.
Also on OnCo: Symptoms and red flags · Early detection roadmap.
Never-smoker disease has no measured risk factor set to build a rule from. The largest UK prospective study found only three significant factors of 34 examined in 634,039 never-smoking women, and two of them, height and ethnicity, are not actionable (Million Women Study 2016).
The staging change of January 2025 breaks every survival series that spans it. N2a and N2b patients were one group until 2024, several stage groups moved, and a cohort staged either side of the line cannot be pooled without restaging.
NICE's diagnostic guideline is anchored two staging editions behind the clinic. NG122 states that its recommendations were developed with the 7th edition of the AJCC system while the ninth edition of TNM has been in force since January 2025, and the thresholds in the guideline (for example which stage triggers brain imaging) were fixed against the older groupings.
More than half of KRAS-mutant lung adenocarcinoma has no approved inhibitor: G12C is 41 to 51% of KRAS records, and G12V, G12D, G12A, G13X and Q61X together are the rest.
Background: p53 / RB / cell-cycle checkpoint, RAS / RAF / MEK / ERK (MAPK). Also on OnCo: Targets · KRAS roadmap.
Squamous cell lung cancer still has no targeted therapy. Its three commonest alterations are a transcription factor amplicon (SOX2 and TP63), a tumour suppressor deletion (CDKN2A) and an antioxidant switch (NFE2L2 and KEAP1), and the one tractable-looking target, FGFR1 amplification, has not predicted response on its own.
Background: p53 / RB / cell-cycle checkpoint, RAS / RAF / MEK / ERK (MAPK). Also on OnCo: Targets · KRAS roadmap.
No biomarker selects patients for chemotherapy plus immunotherapy, the regimen most patients with driver-negative disease receive: tumour mutational burden, STK11, KEAP1 and KRAS status all failed to predict benefit from the combination in the randomised analyses.
Fusion detection depends on assay design rather than on biology. A coding-exon panel returns wild-type for ALK, ROS1, RET, NTRK and NRG1 rearrangements and for MET exon 14 skipping, together about 8 to 10% of lung adenocarcinoma, and the patients most likely to be under-tested are never smokers, who are the likeliest to have one.
The allelic phase of EGFR C797S with T790M decides whether a combination of inhibitors can work, and most reports do not state it.
The transcriptional subtypes of small-cell lung cancer have no approved assay, no prospective trial, and a moving target: 37% of tumours express two of the four markers at once and platinum shifts tumours towards the inflamed state.
PD-L1 thresholds are trial artefacts that cannot be transferred between assays, yet laboratories report a single percentage as though it were a property of the tumour.
Dated changes read from the records linked to this cancer: approvals, regulatory steps, reported trials, guideline versions and milestones. Newest first; no date is inferred.
On EdgeAll 322 changes by month →When this page itself was last checked or edited.
ROS1+ NSCLC after at least one prior ROS1 TKI (ARROS-1)
First-line HER2-mutant non-squamous NSCLC
BLA submitted by Summit for EGFR-mutant NSCLC after TKI (HARMONi)
Untreated advanced EGFR mutation-positive non-small-cell lung cancer (exon 19 deletion or L858R), with lazertinib
Untreated advanced non-small-cell lung cancer with an activating EGFR exon 20 insertion, with carboplatin and pemetrexed