Clinical Research Platform Into Molecular Testing, Treatment and Outcome of (Non-)Small Cell Lung Carcinoma Patients

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorAIO-Studien-gGmbH

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • data collection

    Other intervention

    Baseline (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

14,500 Participants
are divided into 6 treatment groups

6

Treatment groups

See each treatment group below.

Group A: NSCLC, Non-squamous cell carcinoma1 intervention
Group B: NSCLC, Squamous cell carcinoma1 intervention
Group C: NSCLC, Non-squamous cell carcinoma (not tested)1 intervention
Group D: NSCLC, Stage I/II/III (2018-2023)1 intervention
Group E: Small cell lung cancer (SCLC)1 intervention
Group F: NSCLC stage I-III (starting 2026)1 intervention

Trial outcomes

Primary outcomes

1

biomarker

To collect data on the frequency, methodology and results of molecular biomarker testing before first-line and later-line treatment

Time frame
3 years
2

treatment

To describe systemic treatments and sequential treatments applied in real-life practice

Time frame
3 years
3

Response rate

To assess effectiveness of systemic treatments in regards to response rate.

Time frame
3 years
4

progression free survival

To assess effectiveness of systemic treatments in regards to progression free survival.

Time frame
3 years

Secondary outcomes

Other outcomes

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