PER-009-16Recruiting未知

An Open-label, Randomized Phase 3 Efficacy Study of ASP8273 vs. Erlotinib or Gefitinib in First-line Treatment of Patients with Stage IIIB/IV Non-small Cell Lung Cancer Tumors with EGFR Activating Mutations

ASTELLAS PHARMA GLOBAL DEVELOPMENT, INC.,0 sites13 target enrollmentStarted: May 19, 2016Last updated: September 4, 2023

Conditions

Trial Snapshot

No summary available.

•1. Institutional Review Board (IRB)/Independent Ethics Committee (IEC) approved written informed consent.2. Subject is ≥ 18 years of age.3. Subject agrees not to participate in another interventional study while on treatment.4. Female subject must either: Be of nonchildbearing potential: postmenopausal prior to Screening, or documented surgically sterile. if of childbearing potential: Agree not to try to become pregnant during the study and for 28 days after the final study drug administration And have a negative serum pregnancy test at Screening And, if heterosexually active, agree to consistently use 2 forms of highly effective birth control.5. Female subject must not be breastfeeding at Screening or during the study period, and for 28 days after the final study drug administration.6. Female subject must not donate ova starting at Screening and throughout the study period, and for 28 days after the final study drug administration.7. Male subject and their female spouse/partners who are of childbearing potential must be using highly effective contraception consisting of 2 forms of birth control. .FOR MORE DETAILS PLEASE SEE THE PROTOCO

•1. Subject has received intervening anticancer treatment or previous treatment with chemotherapy for metastatic disease. The administration of neoadjuvant or adjuvant chemotherapy is allowed as
•long as it has finalized ≥ 6 months before the first dose of study drug.2. Subject has received a prior treatment with a therapeutic agent targeting EGFR (e.g., afatinib,dacomitinib, ASP8273, etc).3. Subject has received investigational therapy within 28 days or 5 half-lives prior to the first dose of study drug.4. Subject has received radiotherapy within 1 week prior to the first dose of study drug. If the
•subject received radiotherapy > 1 week prior to study treatment, the irradiated lesion cannot be the only lesion used for evaluating response.5. Subject has symptomatic central nervous system (CNS) metastasis. 6. Subject has received blood transfusions or hematopoietic factor therapy within 14 days prior to the first dose of study drug. PARA MAYOR DETALLE VER LA SECCION DE CRITERIOS EN EL PROTOCOLO CLINICO

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