Patient case: 54-year-old female with non-small cell lung cancer; genetic feature: EGFR (D770N)

Clinical trial: A Study to Allow Continued Treatment of Patients Who Have Participated in a Spectrum-Sponsored Poziotinib Study

Summary: This is an open-label extension study (Extension Study) designed to allow patients to continue to receive poziotinib treatment after they have completed the duration of treatment and all protocol-specified assessments and procedures in a previous Spectrum-sponsored poziotinib study (Original Study). Patients will proceed to the study with a maximum hiatus of 20 days following the End-of-Treatment (EOT) visit in the Original Study.
  This extension protocol is intended to provide clinical benefit of poziotinib to patients who are responding to treatment. The additional treatment is optional and voluntary.

Detailed description: Patients who wish to participate in the extension study must provide written Informed Consent. Treatment will begin after completion of the End of Study (EOS) or EOT visit of the Original Study. The assessments obtained at the EOS visit will serve as Baseline data for the extension study. If a patient in the Original Study was to undergo an EOT visit and an EOS visit with no treatment administered between these two assessments, the patient, if consented to this Extension Study must enroll right after (with a maximum hiatus of 20 days) the EOT Visit of the Original Study so that the treatment will continue without a break.
  Patients will continue to receive poziotinib treatment at the dose and regimen they were receiving at the end of the Original Study.
  Patients may receive treatment until disease progression or as long as the patient is deriving clinical benefit, as judged by the investigator (case-by-case decision with approval of Spectrum), death, withdrawal of consent, unacceptable toxicity, lost to follow-up, or poziotinib receives commercial approval in their country of residence or development is terminated by the Sponsor, whichever occurs first. There will be an EOS Visit 35 (±5) days after the last dose of poziotinib.

Eligibility: Inclusion Criteria:
  -  Patient has participated in and completed all protocol-specified assessments for a Spectrum-sponsored clinical Study with poziotinib.
  -  Patient must have completed the End of Treatment or End of Study visit of the original Spectrum-sponsored Study.
  -  Patient did not meet any treatment discontinuation criteria other than completing maximum treatment time of the original Spectrum-sponsored Study.
  -  Investigator opinion indicates that extended therapy with poziotinib is clinically appropriate for the patient and the patient is suitable for this Study.
  -  Patient agrees to continue study treatment as defined in the original clinical study protocol.
  -  Patient must provide written Informed Consent, must be able to adhere to dosing and visit schedules, and meet protocol-defined study requirements.
  -  Patient is willing to practice 2 forms of contraception, one of which must be a barrier method, from study entry until at least 30 days after the last dose of poziotinib.
  Exclusion Criteria:
  -  Patient has any ongoing adverse event that could impact tolerability to poziotinib.
  -  Patient has an active uncontrolled infection, bleeding disorder, underlying medical condition, or other serious illness that would impair the ability of the patient to receive poziotinib.
  -  Patient is receiving any other treatment modalities with curative intent for his or her malignancy, including investigational products other than poziotinib. Therapies to palliate local symptoms will be allowed (e.g. radiation for focal bone metastasis).
  -  Patient has any medical or non-medical condition that may not be suitable for poziotinib treatment, as determined by the investigator.
  -  Patient is pregnant or breastfeeding.

Relevance to patient case: not relevant