2024 World Conference on Lung Cancer (WCLC) - Posters-P4.07D.01 Neoadjuvant Osimertinib Followed by Radiation And/or Surgery in Stage III EGFR-Mutant NSCLC: An Open-Label, Single-Arm, Phase 2 Study

P4.07D.01 Neoadjuvant Osimertinib Followed by Radiation And/or Surgery in Stage III EGFR-Mutant NSCLC: An Open-Label, Single-Arm, Phase 2 Study

Back to course

Pdf Summary

The study investigates the use of neoadjuvant osimertinib in patients with stage III epidermal growth factor receptor (EGFR) mutant non-small cell lung cancer (NSCLC) prior to radiation therapy (RT) and/or surgery as an alternative to the standard chemoradiation therapy (cCRT) followed by durvalumab. This Phase 2 open-label, single-arm study enrolled 34 stage IIIA-C EGFRm NSCLC patients. Participants received osimertinib daily for 12 weeks before undergoing definitive RT and/or surgery. Positron Emission Tomography-Computed Tomography (PET-CT) scans were used at 6 and 12 weeks to assess treatment response. <br /><br />The primary endpoint of objective response rate (ORR) yielded a 94% success rate (26 partial responses, 3 complete responses, 1 stable disease, and 1 progressive disease). In addition, neoadjuvant osimertinib led to a notable reduction in the radiation field by almost 50%, attributable to a decrease in tumor size, with no significant adverse events reported during osimertinib or radiation phases.<br /><br />The study concludes that neoadjuvant osimertinib is a feasible and effective approach for stage III EGFR NSCLC patients, showing a high ORR and a favorable safety profile. However, the long-term efficacy of this chemotherapy-free strategy still needs to be evaluated in additional studies. The observed reduction in radiation field size suggests an advantage in preserving normal tissue, potentially minimizing side effects from radiation exposure.<br /><br />The study was funded by an Investigator Initiated Study grant from AstraZeneca, with necessary ethical approvals obtained. Further correspondence can be made to Prof. Nir Peled at peled.nir@gmail.com.

Asset Subtitle

Laila Roisman

Meta Tag

Speaker Laila Roisman

Topic Early-Stage NSCLC

Keywords

neoadjuvant osimertinib

stage III EGFR NSCLC

radiation therapy

chemoradiation therapy

objective response rate

tumor size reduction

safety profile

PET-CT scans

AstraZeneca

investigator initiated study