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

PHASE2Active, not recruitingINTERVENTIONAL
Enrollment

76

Participants

Timeline

Start Date

April 21, 2024

Primary Completion Date

July 7, 2026

Study Completion Date

July 7, 2027

Conditions
Lung Cancer
Interventions
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%"

Trial Locations (40)

123

Research Site, Hanoi

704

Research Site, Tainan City

10210

Research Site, Bangkok

10330

Research Site, Bangkok

11217

Research Site, Taipei

13620

Research Site, Seongnam-si

16247

Research Site, Suwon

18016

Research Site, Granada

20014

Research Site, Donostia / San Sebastian

28007

Research Site, Madrid

28644

Research Site, Cheongju-si

31096

Research Site, Haifa

40002

Research Site, Khon Kaen

57000

Research Site, Chiang Rai

62748

Research Site, Tel Aviv

90110

Research Site, Hat Yai

91031

Research Site, Jerusalem

92093

Research Site, La Jolla

94304

Research Site, Palo Alto

100000

Research Site, Hanoi

100021

Research Site, Beijing

150081

Research Site, Harbin

200032

Research Site, Shanghai

230001

Research Site, Hefei

250117

Research Site, Jinan

300060

Research Site, Tianjin

310022

Research Site, Hangzhou

410013

Research Site, Changsha

430022

Research Site, Wuhan

430071

Research Site, Wuhan

450052

Research Site, Zhengzhou

510060

Research Site, Guangzhou

530021

Research Site, Nanning

700000

Research Site, Ho Chi Minh City

03080

Research Site, Seoul

03722

Research Site, Seoul

06351

Research Site, Seoul

08003

Research Site, Barcelona

06010

Research Site, Ankara

06560

Research Site, Yenimahalle

Sponsors

Lead Sponsor

All Listed Sponsors
lead

AstraZeneca

INDUSTRY