SPECTAlung: Screening Patients With Thoracic Tumors for Efficient Clinical Trial Access

SPECTAlung: Screening Patients With Thoracic Tumors for Efficient Clinical Trial Access

SPECTAlung is a program aiming at screening patients with thoracic tumors to identify the molecular characteristics of their disease. The thoracic tumors include lung cancer, malignant pleural mesothelioma, thymoma or thymic carcinoma at any stage. Once the molecular characteristics are identified, there might be the possibility to offer these patients access to targeted clinical trials.

Inclusion Criteria:

• Pathologically confirmed lung cancer, MPM, thymoma or thymic carcinoma at any stage;
• Mandatory availability of adequate Human Biological Material (HBM): FFPE tissue sample from the primary tumor, recurrent tumor, metastasis, obtained at the time of primary surgery or biopsy; minimal amount requested is detailed in the HBM guidelines; inclusion of samples taken at any recurrence diagnosed during follow-up is strongly encouraged but optional;
• Centrally performed confirmation of tumor tissue adequacy in terms of quality/ quantity for central screening;
• Age ≥ 18 years;
• At least three months life-expectancy;
• Written informed consent according to ICH/GCP and national/local regulations.

Exclusion Criteria:

• Any active malignancy, except pT1-2 prostatic cancer Gleason score < 6, non melanomatous skin cancer or carcinoma in situ of the cervix, in the 5 years before study entry;
• Active hepatitis B/C or HIV;
• Any secondary malignancy;
• Any severe organ dysfunction or other comorbidities that may prevent the inclusion into clinical trials.