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
Age ≥ 18 years
Able to understand and willing to sign written Informed Consent and to complete patient-reported-outcome assessment instruments
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"
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.
Cohort
Prospective
data collection
Other interventionBaseline (demographic, clinical, tumor) characteristics, details on biomarker testing, including re-testing, treatment decision making, all systemic anticancer therapies including details, key data on radiotherapies, surgeries and specified supportive therapies, outcome (response, progression, survival), course of disease. Data will be documented at baseline and updated at least every three months.
biomarker
To collect data on the frequency, methodology and results of molecular biomarker testing before first-line and later-line treatment
treatment
To describe systemic treatments and sequential treatments applied in real-life practice
Response rate
To assess effectiveness of systemic treatments in regards to response rate.
progression free survival
To assess effectiveness of systemic treatments in regards to progression free survival.
Click on the lead sponsor to view all of their trials.
AIO-Studien-gGmbH
Lead sponsor
AstraZeneca
Collaborator
Celgene Corporation
Collaborator
Merck Sharp & Dohme LLC
Collaborator
Novartis Pharmaceuticals
Collaborator
Pfizer
Collaborator
Boehringer Ingelheim
Collaborator
Bristol-Myers Squibb
Collaborator
iOMEDICO AG
Collaborator
Eli Lilly and Company
Collaborator
Roche Pharma AG
Collaborator
Takeda
Collaborator
Amgen
Collaborator
Janssen-Cilag G.m.b.H
Collaborator
GlaxoSmithKline
Collaborator
Daiichi Sankyo
Collaborator
Regeneron Pharmaceuticals
Collaborator
Gilead Sciences
Collaborator
