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NCT Number: NCT02622581

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

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

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Key information

Conditions

Metastatic Non-Small Cell Lung Cancer (NSCLC) Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site 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 Respiratory Tract Diseases Respiratory Tract Neoplasms Small Cell Lung Carcinoma Small-cell Lung Cancer Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Data Collection

Other

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.

Primary outcomes

  1. 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

  2. treatment

    Time frame: 3 years

    To describe systemic treatments and sequential treatments applied in real-life practice

  3. Response rate

    Time frame: 3 years

    To assess effectiveness of systemic treatments in regards to response rate.

  4. progression free survival

    Time frame: 3 years

    To assess effectiveness of systemic treatments in regards to progression free survival.

  5. overall survival

    Time frame: 3 years

    To assess effectiveness of systemic treatments in regards overall survival.

  6. physician-reported factors

    Time frame: 3 years

    To describe physician-reported factors affecting treatment decision making besides biomarker profiling

  7. supportive therapies

    Time frame: 3 years

    to collect key data on specific supportive therapies

  8. changes during the project

    Time frame: 3 years

    To investigate changes in diagnostics, treatment or outcome during the course of the project

  9. 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

  10. physical and psychological well-being patient-reported outcomes

    Time frame: 3 years

    To evaluate patient-reported outcomes concerning physical and psychological well-being.

  11. anxiety patient-reported outcomes

    Time frame: 3 years

    To evaluate patient-reported outcomes concerning anxiety.

Study contacts

Contact information is provided by the study sponsor or research team.

Annika Groth

CONTACT

[email protected]

+49 30-8145344-39

Paula Ludwig

CONTACT

[email protected]

+49 30-8145344-63

Sponsors and collaborators

Lead sponsor

AIO-Studien-gGmbH

Other

Collaborators

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

Registry information

Acronym: CRISP

Important dates

Study start
2015
Primary completion
2026
Study completion
2027
First posted
Dec 4, 2015
Registry last updated
Feb 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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