Clinical trial NCT02622581: Clinical Research Platform Into Molecular Testing, Treatment and Outcome of (Non-)Small Cell Lung Carcinoma Patients
Official title: Clinical Research Platform Into Molecular Testing, Treatment and Outcome of (Non-)Small Cell Lung Carcinoma Patients
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: 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
Lead sponsor: AIO-Studien-gGmbH
Sponsor class: OTHER
Collaborators: name: AstraZeneca
name: Celgene Corporation
name: Merck Sharp & Dohme LLC
name: Novartis Pharmaceuticals
name: Pfizer
name: Boehringer Ingelheim
name: Bristol-Myers Squibb
name: iOMEDICO AG
name: Eli Lilly and Company
name: Roche Pharma AG
name: Takeda
name: Amgen
name: Janssen-Cilag G.m.b.H
name: GlaxoSmithKline Research & Development Limited
name: Daiichi Sankyo
name: Regeneron Pharmaceuticals
name: Gilead Sciences
First posted: 2015-12-04
Enrollment: 12400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Main project (Metastatic NSCLC):

10000 patients with locally advanced or metastatic NSCLC at the start of palliative first-line systemic therapy or receiving best supportive care (BSC). 5000 will be patients with non-squamous cell carcinoma tested for molecular alterations at the start of first-line or patients with squamous cell carcinoma (CRISP patients). The remainder will be patients with untested non-squamous carcinoma (CRISP satellite untested patients stage IIIB/IIIC/IV).

Satellite Stage I/II/III (NSCLC):

1600 patients with NSCLC stage I,II,IIIA or IIIB/C eligible for curative surgery and/or radiochemotherapy or receiving BSC.

Satellite SCLC:

Up to 1200 patients with SCLC (limited stage or extensive stage) eligible for surgery and/or radio(chemo)therapy and/or systemic therapy or receiving BSC.

Patients will be recruited in up to 150 study sites (certified lung cancer centers, comprehensive cancer centers, hospitals and office-based oncology practices) in Germany.

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.

Eligibility criteria: 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

Primary outcomes:
measure: biomarker
timeFrame: 3 years
measure: treatment
timeFrame: 3 years
measure: Response rate
timeFrame: 3 years
measure: progression free survival
timeFrame: 3 years
measure: overall survival
timeFrame: 3 years
measure: physician-reported factors
timeFrame: 3 years
measure: supportive therapies
timeFrame: 3 years
measure: changes during the project
timeFrame: 3 years
measure: general health-related and individual quality of life (QoL) patient-reported outcomes
timeFrame: 3 years
measure: physical and psychological well-being patient-reported outcomes
timeFrame: 3 years
measure: anxiety patient-reported outcomes
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Oldenburg
country: Germany
facility: Pius-Hospital
Study officials:
affiliation: Pius-Hospital Oldenburg
name: Frank Griesinger, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Griesinger F, Eberhardt W, Nusch A, Reiser M, Zahn MO, Maintz C, Bernhardt C, Losem C, Stenzinger A, Heukamp LC, Buttner R, Marschner N, Janicke M, Fleitz A, Spring L, Sahlmann J, Karatas A, Hipper A, Weichert W, Heilmann M, Sadjadian P, Gleiber W, Grah C, Waller CF, Reck M, Rittmeyer A, Christopoulos P, Sebastian M, Thomas M; CRISP Registry Group. Biomarker testing in non-small cell lung cancer in routine care: Analysis of the first 3,717 patients in the German prospective, observational, nation-wide CRISP Registry (AIO-TRK-0315). Lung Cancer. 2021 Feb;152:174-184. doi: 10.1016/j.lungcan.2020.10.012. Epub 2020 Nov 2.