Open, non-interventional, prospective, multi-center clinical research platform with the main objective to assess molecular biomarker testing, treatment and outcome of patients with NSCLC or SCLC in Germany

Thorough knowledge of the treatment reality, e.g. characteristics, diagnostic, treatment and outcome of unselected patients in real-life practice, is crucial to evaluate and improve the quality of care for patients with non-small cell lung cancer (NSCLC) and small cell lung cancer (SCLC).

The purpose of CRISP is to set up a national clinical research platform to document uniform data on the molecular testing, treatment, course of disease in patients with NSCLC or SCLC. A particular focus is on molecular biomarker testing before the start of first-line treatment of patients with advanced or metastatic NSCLC. The data shall be used to assess the current state of care and to develop recommendations concerning topics that could be improved.

PRO assessment will provide large-scale data on quality of life and anxiety/depression for real-life patients with NSCLC or SCLC in routine practice. In addition, two questionnaires (concerning individual quality of life and patient-caregiver communication) will be validated in German patients with metastatic NSCLC.

Furthermore, CRISP will set up a decentralized clinically annotated tissue repository for future collaborative, investigational scientific biomarker testing.

Inclusion Criteria:

Patients who meet all of the following criteria are eligible for the project:

• Age ≥ 18 years
• Able to understand and willing to sign written Informed Consent and to complete patient-reported-outcome assessment instruments

Main project (Metatstatic NSCLC):

• Confirmed non-small cell lung cancer (NSCLC)
• Informed consent no later than four weeks after start of first-line systemic treatment or no later than four weeks after diagnosis for patients receiving "best supportive care only"
• Stage IV, or stage IIIB/C (UICC8) if patient is ineligible for curative surgery and/or radiochemotherapy
• Systemic therapy or best supportive care

Satellite Stage I/II/III (NSCLC):

• Confirmed non-small cell lung cancer (NSCLC)
• Informed consent no later than four weeks after start of first anti-tumor treatment (including surgery and radiotherapy) or no later than four weeks after diagnosis for patients receiving "best supportive care only" (i.e. no anti-tumor treatment = no surgery, radiotherapy or systemic therapy)
• Stage I, Stage II, stage IIIA, or stage IIIB/C (UICC8)
• Systemic (chemo)therapy and/or radiation therapy and/or surgery or best supportive care

Satellite SCLC

• Confirmed Small cell lung cancer (SCLC)
• Informed consent no later than four weeks after start of first anti-tumor treatment or no later than four weeks after diagnosis for patients receiving "best supportive care only" (i.e. no anti-tumor treatment = no surgery, radiotherapy or systemic therapy)
• Systemic (chemo)therapy and/or radiation therapy and/or surgery or best supportive care

Exclusion Criteria:

none

Main project (Metastatic NSCLC):

10000 patients with locally advanced or metastatic NSCLC at the start of palliative first-line systemic therapy or receiving best supportive care (BSC). 5000 will be patients with non-squamous cell carcinoma tested for molecular alterations at the start of first-line or patients with squamous cell carcinoma (CRISP patients). The remainder will be patients with untested non-squamous carcinoma (CRISP satellite untested patients stage IIIB/IIIC/IV).

Satellite Stage I/II/III (NSCLC):

1600 patients with NSCLC stage I,II,IIIA or IIIB/C eligible for curative surgery and/or radiochemotherapy or receiving BSC.

Satellite SCLC:

Up to 1200 patients with SCLC (limited stage or extensive stage) eligible for surgery and/or radio(chemo)therapy and/or systemic therapy or receiving BSC.

Patients will be recruited in up to 150 study sites (certified lung cancer centers, comprehensive cancer centers, hospitals and office-based oncology practices) in Germany.