NCT06194448

To Evaluate the Efficacy/Safety of Osimertinib Prior to CRT and Maintenance of it With Stage III, Unresectable NSCLC With EGFR Mutations

A Phase II, Open-label, Single-arm Study of Osimertinib as Induction Therapy Prior to CRT and Maintenance Osimertinib in Patients With Epidermal Growth Factor Receptor (EGFR) Mutation-positive, Stage III, Unresectable Non-small Cell Lung Cancer (NEOLA)

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 76 (actual)
• Sponsor: AstraZeneca · Industry
• Sex: All
• Age: 18 Years – 130 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to measure efficacy and safety of osimertinib as induction therapy prior to curative intent CRT and maintenance osimertinib in adult patients with Stage III, unresectable NSCLC with common EGFR mutations (exon 19 deletion or L858R).

Detailed description

The study duration will be approximately 2 years for recruitment and 2 years of follow-up from the last patient's initiation into the study. The induction treatment with osimertinib will be up to 8 weeks, followed by 6 weeks of CRT treatment and osimertinib maintenance treatment until PD or death. The visit frequency will be every 2 weeks to 4 weeks during the induction treatment period, every 3 weeks during the CRT period (every 3 weeks for chemotherapy and daily visits for RT), and every 12 weeks during the osimertinib maintenance treatment period.

Conditions

• Lung Cancer

Interventions

Type	Name	Description
DRUG	Osimertinib	80 mg daily (or 40 mg daily for dose reduction)
DRUG	Cisplatin or Carboplatin; Pemetrexed or Paclitaxel	Pemetrexed (500 mg/m2 to be administered on Day 1 of every 3-week cycle for 2 cycles) or Paclitaxel (175 mg/m2 on Day 1 of every 3-week cycle for 2 cycles) PLUS Cisplatin (75 mg/m2) or Carboplatin (AUC5) to be administered on Day 1 of every 3--week cycle for 2 cycles
DRUG	Radiation	Patients must have received a total dose of radiation of 60 Gy ± 10% (54 to 66 Gy) as part of the chemoradiation therapy. It is recommended but not required that patients have a: * Mean lung dose \< 20 Gy and/or V20 \< 35% * Mean oesophagus dose \< 34 Gy * Heart V50 \< 25%, V30 \< 50%, and V45 \< 35%

Timeline

• Start date: 2024-04-21
• Primary completion: 2026-07-07
• Completion: 2027-07-07
• First posted: 2024-01-08
• Last updated: 2026-03-06

Locations

39 sites across 9 countries: United States, China, Israel, South Korea, Spain, Taiwan, Thailand, Turkey (Türkiye), Vietnam

Regulatory

• FDA-regulated drug study