About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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)
Stage IV (UICC8)
Disqualifiers
None
Trial population
Main project (NSCLC Stage IIIB/C, Stage IV, BSC; 2015-2025): Up to 12000 patients with locally advanced or metastatic NSCLC at the start of palliative first-line systemic therapy or receiving best supportive care. NSCLC stage IV (starting 2025): Up to 5000 patients with stage IV NSCLC at the start of first-line systemic therapy. Satellite NSCLC stage I-III: Up to 1600 patients with stage I-III NSCLC at the start of first antitumoral treatment (surgery, radio(chemo)therapy, systemic therapy). Satellite SCLC: Up to 2300 patients with SCLC (limited stage (LD) or extensive stage (ED)), if they are eligible for surgery and/or radio(chemo)therapy and/or systemic therapy, will be recruited (CRISP satellite SCLC patients). Patients will be recruited in up to 220 study sites (certified lung cancer centers, comprehensive cancer centers, hospitals and office-based oncology practices) in Germany.
Trial design
Cohort
Prospective
Treatments tested in this trial
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.
Treatment groups
6
Treatment groupsSee each treatment group below.
Trial outcomes
Primary outcomes
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.
Sponsors and contacts
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
Regeneron Pharmaceuticals
Collaborator
Astellas Pharma Global Development, Inc.
Collaborator
Daiichi Sankyo Europe, GmbH, a Daiichi Sankyo Company
Collaborator
Daiichi Sankyo Deutschland GmbH
Collaborator
Gilead Sciences
Collaborator