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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
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
Conditions
Interventions
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.
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
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Hong Kong, Hong Kong
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Hong Kong, Hong Kong
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Shatin, Hong Kong
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George Town, Malaysia
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Kota Bharu, Malaysia
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Kuala Lumpur, Malaysia
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Kuala Lumpur, Malaysia
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Kuantan, Malaysia
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Kuching, Malaysia
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Singapore, Singapore
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Singapore, Singapore
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Anyang-si, South Korea
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Busan, South Korea
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Daegu, South Korea
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Seoul, South Korea
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Seoul, South Korea
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Kaohsiung City, Taiwan
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Taichung, Taiwan
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Taichung, Taiwan
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Tainan, Taiwan
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Taipei, Taiwan
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Taipei, Taiwan
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Yunlin, Taiwan
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Bangkok, Thailand
Research Site
Bangkok, Thailand
Research Site
Bangkok, Thailand
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Chiang Mai, Thailand
Research Site
Songkhla, Thailand