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

Small-cell Lung Cancer Clinical Trial

— CRISP  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02622581
• Other study ID #: AIO-TRK-0315
• Status: Recruiting
• Start date: December 2015
• Est. completion date: December 2027

Study information

• Verified date: February 2024
• Source: AIO-Studien-gGmbH
• Contact: Annette Hipper, Dr.
• Email: annette.hipper[@]aio-studien-ggmb.de
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 12400
• Est. completion date: December 2027
• Est. primary completion date: September 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Metastatic Non-small Cell Lung Cancer (NSCLC)
• Non Small Cell Lung Cancer Stage III
• Non-small Cell Lung Cancer Metastatic
• Non-small Cell Lung Cancer Stage I
• Non-small Cell Lung Cancer Stage II
• Small Cell Lung Carcinoma
• Small-cell Lung Cancer

Intervention

Other:
• data collection
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.

Locations

Country	Name	City	State
Germany	Pius-Hospital	Oldenburg

Sponsors (18)

Lead Sponsor	Collaborator
AIO-Studien-gGmbH	Amgen, AstraZeneca, Boehringer Ingelheim, Bristol-Myers Squibb, Celgene Corporation, Daiichi Sankyo, Inc., Eli Lilly and Company, Gilead Sciences, GlaxoSmithKline Research & Development Limited, iOMEDICO AG, Janssen-Cilag G.m.b.H, Merck Sharp & Dohme LLC, Novartis Pharmaceuticals, Pfizer, Regeneron Pharmaceuticals, Roche Pharma AG, Takeda

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	biomarker	To collect data on the frequency, methodology and results of molecular biomarker testing before first-line and later-line treatment	3 years
Primary	treatment	To describe systemic treatments and sequential treatments applied in real-life practice	3 years
Primary	Response rate	To assess effectiveness of systemic treatments in regards to response rate.	3 years
Primary	progression free survival	To assess effectiveness of systemic treatments in regards to progression free survival.	3 years
Primary	overall survival	To assess effectiveness of systemic treatments in regards overall survival.	3 years
Primary	physician-reported factors	To describe physician-reported factors affecting treatment decision making besides biomarker profiling	3 years
Primary	supportive therapies	to collect key data on specific supportive therapies	3 years
Primary	changes during the project	To investigate changes in diagnostics, treatment or outcome during the course of the project	3 years
Primary	general health-related and individual quality of life (QoL) patient-reported outcomes	To evaluate patient-reported outcomes concerning (1) general health-related and individual quality of life (QoL). and depression, (4) patient-caregiver communication	3 years
Primary	physical and psychological well-being patient-reported outcomes	To evaluate patient-reported outcomes concerning physical and psychological well-being.	3 years
Primary	anxiety patient-reported outcomes	To evaluate patient-reported outcomes concerning anxiety.	3 years

External Links

•   AIO - Working Group for Medical Oncology from the German Cancer Society