A Study to Investigate Safety and Efficacy of Osimertinib and Amivantamab in Participants With Non-small Cell Lung Cancer With Common Epidermal Growth Factor Receptor Mutations

PHASE2Active, not recruitingINTERVENTIONAL
Enrollment

60

Participants

Timeline

Start Date

July 18, 2023

Primary Completion Date

October 1, 2027

Study Completion Date

October 1, 2027

Conditions
Non-Small Cell Lung Cancer (NSCLC)
Interventions
DRUG

Osimertinib

Osimertinib will be administered as 80 mg oral tablet once daily (from Day 2) until progression of disease or until a study intervention discontinuation criterion is met.

DRUG

Amivantamab

Amivantamab will be administered as an IV infusion at 1050 mg (\< 80 kg body weight) or 1400mg (≥ 80 kg body weight) (in 28-day cycles: once weekly in Cycle 1 (with a split dose on Days 1 to 2) and then every 2 weeks in subsequent cycles) until progression of disease or until a study intervention discontinuation criterion is met. The first cycle dose is spilt over 2 days- 350 mg on day 1 and 700 mg \[body weight \< 80 kg\] or 1050 mg \[body weight ≥ 80 kg\] on day 2.

Trial Locations (29)

110

Research Site, Taipei

404

Research Site, Taichung

640

Research Site, Yunlin

5030

Research Site, Seoul

10048

Research Site, Taipei

10330

Research Site, Bangkok

10400

Research Site, Bangkok

10700

Research Site, Bangkok

10990

Research Site, George Town

14068

Research Site, Anyang-si

15586

Research Site, Kota Bharu

25100

Research Site, Kuantan

40705

Research Site, Taichung

42415

Research Site, Daegu

49241

Research Site, Busan

50200

Research Site, Chiang Mai

50586

Research Site, Kuala Lumpur

59100

Research Site, Kuala Lumpur

73657

Research Site, Tainan City

82445

Research Site, Kaohsiung City

90110

Research Site, Songkhla

93200

Research Site, Kuching

150001

Research Site, Hong Kong

169610

Research Site, Singapore

308433

Research Site, Singapore

HKG

Research Site, Hong Kong

Unknown

Research Site, Hong Kong

00000

Research Site, Shatin

08308

Research Site, Seoul

Sponsors

Lead Sponsor

Collaborators (1)

All Listed Sponsors
collaborator

Parexel

INDUSTRY

lead

AstraZeneca

INDUSTRY