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

Recruiting

• Conditions: Metastatic Non-small Cell Lung Cancer (NSCLC); Non-small Cell Lung Cancer Stage II; Non Small Cell Lung Cancer Stage III; Non-small Cell Lung Cancer Metastatic; Small-cell Lung Cancer; Non-small Cell Lung Cancer Stage I
• Interventions: Other: data collection

• Registration Number: NCT02622581
• Lead Sponsor: AIO-Studien-gGmbH

Brief 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

Detailed 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.

Study Timeline

• Study Start: 2015-12
• Study First Submitted: 2015-12-02
• Study First Submitted QC: 2015-12-03
• Study First Posted: 2015-12-04
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-14
• Last Update Posted: 2025-02-18
• Primary Completion: 2026-09
• Study Completion: 2027-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 12400

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
NSCLC, Non-squamous cell carcinoma	data collection	Patients with locally advanced or metastatic NSCLC at the start of palliative first-line systemic therapy or receiving best supportive care. At least 3,250 patients with non-squamous cell carcinoma will be tested for molecular alterations. (CRISP)
NSCLC, Squamous cell carcinoma	data collection	Patients with locally advanced or metastatic NSCLC at the start of palliative first-line systemic therapy or receiving best supportive care. At least 1,750 patients with squamous cell carcinoma that possibly will be tested for molecular alterations. (CRISP)
Small cell lung cancer (SCLC)	data collection	Up to 1200 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, or are receiving best supportive care
NSCLC, Stage I/II/III	data collection	Up to 1600 patients with NSCLC stage I, or stage II, or stage IIIA, or with NSCLC stage IIIB/C if they are eligible for curative surgery and/or radiochemotherapy, or are receiving best supportive care
NSCLC, Non-squamous cell carcinoma (not tested)	data collection	Patients with locally advanced or metastatic NSCLC at the start of palliative first-line systemic therapy or receiving best supportive care. Up to 5,000 patients not tested for molecular alterations (CRISP satellite untested patients stage IIIB/IIIC/IV).).

Primary Outcome Measures

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

Trial Locations

Locations (1)

Pius-Hospital; 🇩🇪 Oldenburg, Germany