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

Study Overview
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Brief Summary
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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
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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.

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

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

Intervention / Treatment
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* Other: data collection


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| NSCLC, Non-squamous cell carcinoma<br>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) | Other: data collection<br>* 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.<br>|
| NSCLC, Squamous cell carcinoma<br>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) | Other: data collection<br>* 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.<br>|
| NSCLC, Non-squamous cell carcinoma (not tested)<br>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).). | Other: data collection<br>* 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.<br>|
| NSCLC, Stage I/II/III<br>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 | Other: data collection<br>* 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.<br>|
| Small cell lung cancer (SCLC)<br>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 | Other: data collection<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| biomarker | To collect data on the frequency, methodology and results of molecular biomarker testing before first-line and later-line treatment | 3 years | 
| treatment | To describe systemic treatments and sequential treatments applied in real-life practice | 3 years | 
| Response rate | To assess effectiveness of systemic treatments in regards to response rate. | 3 years | 
| progression free survival | To assess effectiveness of systemic treatments in regards to progression free survival. | 3 years | 
| overall survival | To assess effectiveness of systemic treatments in regards overall survival. | 3 years | 
| physician-reported factors | To describe physician-reported factors affecting treatment decision making besides biomarker profiling | 3 years | 
| supportive therapies | to collect key data on specific supportive therapies | 3 years | 
| changes during the project | To investigate changes in diagnostics, treatment or outcome during the course of the project | 3 years | 
| 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 | 
| physical and psychological well-being patient-reported outcomes | To evaluate patient-reported outcomes concerning physical and psychological well-being. | 3 years | 
| anxiety patient-reported outcomes | To evaluate patient-reported outcomes concerning anxiety. | 3 years |