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

February 5, 2024 updated by: AIO-Studien-gGmbH
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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

12400

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
NSCLC, Non-squamous cell carcinoma

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
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.
NSCLC, Squamous cell carcinoma

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
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.
NSCLC, Non-squamous cell carcinoma (not tested)

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
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.
NSCLC, Stage I/II/III
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
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.
Small cell lung cancer (SCLC)
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
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.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AIO-Studien-gGmbH

Collaborators

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

Investigators

  • Principal Investigator: Frank Griesinger, Prof. Dr., Pius-Hospital Oldenburg

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2015

Primary Completion (Estimated)

September 1, 2026

Study Completion (Estimated)

December 1, 2027

Study Registration Dates

First Submitted

December 2, 2015

First Submitted That Met QC Criteria

December 3, 2015

First Posted (Estimated)

December 4, 2015

Study Record Updates

Last Update Posted (Actual)

February 6, 2024

Last Update Submitted That Met QC Criteria

February 5, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AIO-TRK-0315

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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