Osimertinib Monotherapy or Combination With Chemotherapy for Advanced NSCLC Concurrent EGFR and T⦠(NCT04695925) | Clinical Trial Compass
Active β Not RecruitingPhase 3
Osimertinib Monotherapy or Combination With Chemotherapy for Advanced NSCLC Concurrent EGFR and TP53 Mutations
China294 participantsStarted 2021-03-29
Plain-language summary
This is a phase III randomized trial in patients with advanced non-squamous NSCLC harboring EGFR-sensitizing mutations and concurrent TP53 mutations with a performance status of 0 to1 who are planned to receive first-line therapy.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
β. Provision of informed consent prior to any study specific procedures;
β. Male or female, aged at least 18 years;
β. Eastern Cooperative Oncology Group (ECOG) performance-status score of 0 or 1;
β. Life expectancy of at least 3 months;
β. Histologically or cytologically confirmed stage IV or recurrent non-squamous non-small cell lung carcinoma with activating EGFR mutations (exon 19 deletion or exon 21 L858R point mutation) and concurrent TP53 mutations;
β. No prior palliative chemotherapy, or palliative biological (including targeted therapies such as EGFR and vascular epidermal growth factor (VGEF) inhibitors) or immunological therapy οΌPrevious adjuvant chemotherapy is permitted if treatment was completed more than 6 months before day 1. Palliative radiotherapy to a metastatic site is permitted, but palliative wide field radiotherapy to the lung must be completed at least 4 weeks before day 1 with no persistence of any radiotherapy-related toxicity;
β. Adequate organ function, including the following:
β. Females must be using highly effective contraceptive measures, and must have a negative pregnancy test prior to start of dosing if of child-bearing potential, or must have evidence of non-child-bearing potential by fulfilling one of the following criteria at screening
Exclusion criteria
β. Involvement in the planning and/or conduct of the study (applies to both Investigator staff and/or staff at the study site);
. Previous randomization in the present study or previous treatment with Osimertinib;
β. Known severe hypersensitivity to Osimertinib or any of the excipients of this product;
β. Known severe hypersensitivity to carboplatin, pemetrexed or any of the excipients of these products;
β. Known severe hypersensitivity to pre-medications required for treatment with carboplatin/ pemetrexed doublet chemotherapy;
β. History or presence of any other malignancy with the exception of basal cell carcinoma or cervical cancer in situ;
β. Past medical history of interstitial lung disease, drug induced interstitial disease, radiation pneumonitis which required steroid treatment or any evidence of clinically active interstitial lung disease;
β. Any unresolved chronic toxicity β₯ CTCAE grade 2 from previous anticancer therapy;