CompletedNot Applicable

Nivolumab in the Real World: Analysis of the Expanded Use in Spanish Patient

Spain676 participantsStarted 2017-06-01

Plain-language summary

The investigators will be retrospectively review the case note of patients registered in the EAP of Nivolumab. A standard anonymous data collection form will be used to collect data and to analyze it. Patients with advanced Non-Small Cell Lung Cancer previously treated and included in the SPANISH expanded access programme of nivolumab.

Who can participate

SexALL

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Inclusion criteria

✓. Squamous or Non-Squamous, non small cell lung cancer (NSCLC), Stage IIIb/IV (histologically or cytologically confirmed), relapsed after 1 prior platinum-based systemic treatment and who received treatment within the SPANISH expanded access programme of nivolumab (EAP)
✓. Alive patients must have signed and dated an IRB/IEC-approved written informed consent form in accordance with regulatory and institutional guidelines. This must be obtained before the performance of any protocol-related procedures that are not part of normal subject care

Exclusion criteria

✕. Alive patients who do not want to sign and date an IRB/IEC-approved written informed consent form
✕. Patients who were accepted in the EAP but do not receive treatment

What they're measuring

Progression Free survival

Timeframe: At 12 months

Trial details

NCT IDNCT03132493

SponsorSpanish Lung Cancer Group

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2017-12-01

View on ClinicalTrials.gov More Non Small Cell Lung Cancer trials