Tagrisso (osimertinib)

P=N/A, N=100, Not yet recruiting, AstraZeneca

P3, N=98, Active, not recruiting, AstraZeneca | Trial completion date: Jun 2026 --> Jun 2027

First-line Osimertinib induced a dramatic clinical and radiological response within days...This case underscores the critical difficulty of diagnosing lepidic-patterned tumors in an oncological emergency. It highlights the necessity of a multidisciplinary approach, combining cytology, radiology, and early molecular testing as a surrogate for traditional histopathology to guide urgent targeted therapy.

Gefitinib and osimertinib, the first-generation and third-generation EGFR-TKI, have shown promising results in patients with EGFR-mutated lung cancer in clinical treatment. Moreover, PDK1 inhibitor JX06 rendered cancer cells more sensitive to gefitinib treatment in vivo, and JX06 and gefitinib combination treatments have a synergic effect to inhibit tumor growth. In conclusion, the KDM3A/METTL16/PDK1 axis plays an important role in cancer development and TKI resistance, which may offer new prognostic biomarkers and therapeutic targets for TKI resistance in the future.

P2, N=60, Recruiting, Jonsson Comprehensive Cancer Center | Not yet recruiting --> Recruiting

Early loss of SMI was not associated with osimertinib exposure, yet an independent predictor of shorter OS. Future research should explore whether nutritional interventions to preserve muscle mass improve osimertinib effectiveness.

We diagnosed the patient with moderately severe AA and observed hematopoietic recovery following treatment with anabolic steroids and eltrombopag...Cyclosporine and romiplostim treatment were effective, allowing for outpatient management. In the two cases described herein, a small number of PNH-phenotype cells were confirmed. The clinical importance of the small PNH-phenotype populations and the mechanism underlying AA during OSIM therapy remain unclear and warrant further investigation.

The combination of osimertinib and crizotinib resulted in a marked clinical and metabolic response, was well tolerated, and the patient remained in remission. This rare case highlights that acquired CD74-ROS1 fusions may contribute to osimertinib resistance and suggests that combination targeted therapy may represent a potential therapeutic approach in selected patients.

P2, N=160, Active, not recruiting, Xiuning Le | Trial completion date: Jan 2026 --> Jan 2027 | Trial primary completion date: Dec 2025 --> Dec 2026

P1/2, N=66, Recruiting, Memorial Sloan Kettering Cancer Center

Importantly, when we combined osimertinib with D-PDMP, an inhibitor of the key enzyme responsible for the conversion of ceramide to glucosylceramide, we increased the sensitivity to osimertinib. Overall, we have identified the glycosphingolipid metabolic pathway as a potential therapeutic target to reinstate sensitivity to osimertinib in NSCLC.

Erlotinib (48.1%) and osimertinib (22.6%) were most frequently used. Conclusions TKIs demonstrated favorable disease control with low attributable ILD. Continued monitoring and structured risk assessment remain essential.