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 local 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: NA, Intervention model: SINGLE_GROUP, Masking: NONE,

Conditions

Non-Small Cell Lung Cancer (NSCLC)

Other study ID numbers

D5162C00052

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