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ACTIVE NOT RECRUITING
NCT05801029
PHASE2

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

Sponsor: AstraZeneca

View on ClinicalTrials.gov

Summary

This study will assess the safety and efficacy of Osimertinib with Amivantamab as First-line Treatment in Participants with Epidermal Growth Factor Receptor Mutation-Positive, Locally Advanced or Metastatic Non-small Cell Lung Cancer (NSCLC).

Official title: A Phase II, Open-label, Single-arm, Multi-centre Study to Evaluate the Safety and Efficacy of Osimertinib With Amivantamab as First-line Treatment in Participants With Epidermal Growth Factor Receptor Mutation-Positive, Locally Advanced or Metastatic Non-small Cell Lung Cancer (OSTARA)

Key Details

Gender

All

Age Range

18 Years - 130 Years

Study Type

INTERVENTIONAL

Enrollment

60

Start Date

2023-07-18

Completion Date

2027-10-01

Last Updated

2026-03-20

Healthy Volunteers

No

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.

Locations (29)

Research Site

Hong Kong, Hong Kong

Research Site

Hong Kong, Hong Kong

Research Site

Hong Kong, Hong Kong

Research Site

Shatin, Hong Kong

Research Site

George Town, Malaysia

Research Site

Kota Bharu, Malaysia

Research Site

Kuala Lumpur, Malaysia

Research Site

Kuala Lumpur, Malaysia

Research Site

Kuantan, Malaysia

Research Site

Kuching, Malaysia

Research Site

Singapore, Singapore

Research Site

Singapore, Singapore

Research Site

Anyang-si, South Korea

Research Site

Busan, South Korea

Research Site

Daegu, South Korea

Research Site

Seoul, South Korea

Research Site

Seoul, South Korea

Research Site

Kaohsiung City, Taiwan

Research Site

Taichung, Taiwan

Research Site

Taichung, Taiwan

Research Site

Tainan, Taiwan

Research Site

Taipei, Taiwan

Research Site

Taipei, Taiwan

Research Site

Yunlin, Taiwan

Research Site

Bangkok, Thailand

Research Site

Bangkok, Thailand

Research Site

Bangkok, Thailand

Research Site

Chiang Mai, Thailand

Research Site

Songkhla, Thailand