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

NCT02622581 | Recruiting

• 1 other identifier: AIO-TRK-0315
• Study Type: observational
• Target: 12,400
• Locations: 1 country
• Sites: 1

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

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

Outcome Measures

Primary Outcomes (11)

• 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

Study Arms (5)

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

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

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

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

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

Interventions

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.

NSCLC, Non-squamous cell carcinoma; NSCLC, Non-squamous cell carcinoma (not tested); NSCLC, Squamous cell carcinoma; NSCLC, Stage I/II/III; Small cell lung cancer (SCLC)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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)

You may not qualify if:

• none

Sponsors & Collaborators

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

Study Sites (1)

Pius-Hospital

Oldenburg, 26121, Germany

RECRUITING

Related Publications (2)

• Metzenmacher M, Griesinger F, Hummel HD, Elender C, Schafer H, de Wit M, Kaiser U, Kern J, Janicke M, Spring L, Zacharias S, Kaiser-Osterhues A, Groth A, Hipper A, Zaun G, Dorfel S, Guldenzoph B, Muller L, Uhlig J, Thomas M, Sebastian M, Eberhardt WEE; CRISP Registry Group. Prognostic factors in nonsmall cell lung cancer: insights from the German CRISP registry. Eur Respir J. 2023 Feb 2;61(2):2201336. doi: 10.1183/13993003.01336-2022. Print 2023 Feb.

  PMID: 36180086 DERIVED

• 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.

  PMID: 33358484 DERIVED

Related Links

• AIO - Working Group for Medical Oncology from the German Cancer Society

Biospecimen

Retention: SAMPLES WITH DNA

All patients will be asked to give consent for their tumor samples to be used for future investigational translational research. If the patient agrees, contact details of the local pathology where the tumor sample is stored as well as the sample's identification number will be documented in the eCRF, creating the CRISP "decentralized clinically annotated tissue repository". Study sites will inform the local pathologists about the patient's consent and ask for the tissue sample to be reserved for future CRISP analyses.

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Small Cell Lung Carcinoma

Interventions

Data Collection

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Frank Griesinger, Prof. Dr.

  Pius-Hospital Oldenburg

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Annika Groth

CONTACT

+49 30-8145344-39; annika.groth@aio-studien-ggmb.de

Paula Ludwig

CONTACT

+49 30-8145344-63; Paula.Ludwig@aio-studien-ggmbh.de

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 2, 2015
• First Posted: December 4, 2015
• Study Start: December 1, 2015
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): December 1, 2027
• Last Updated: February 18, 2025

Record last verified: 2025-02

Locations

DE (1)