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

Trial number:
NCT05801029
Trial phase:
2
Study type:
Targeted therapy
Overall status:
Not yet recruiting

Study start date

July, 2023

Scientific 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)

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).

Histologically or cytologically documented non-squamous NSCLC. NSCLC of mixed histology is allowed.Newly diagnosed locally advanced or metastatic NSCLC or recurrent non-squamous NSCLC, not amenable to curative surgery or radiotherapy. WHO PS of 0 to 1 with no deterioration over the 2 weeks prior to enrolment. Minimum life expectancy > 12 weeks at Day 1. Confirmation by the locally accredited laboratory that the tumour harbours one of the 2 common EGFRm known to be associated with (Epidermal Growth Factor Receptor- Tyrosine Kinase Inhibitor) EGFR-TKI sensitivity. At least 1 lesion that can be accurately measured at baseline as ≥10 mm in the longest diameter with computed tomography (CT) or magnetic resonance imaging (MRI) and that is suitable for accurate repeated measurements. Contraceptive use by males or females should be consistent with local regulations

Study design

Primary purpose: Treatment, Allocation: N/A, Intervention model: Single Group Assignment, Masking: None (Open Label),

Conditions

Non-Small Cell Lung Cancer (NSCLC)

Other study ID numbers

D5162C00052

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