Carcinoma, Non-Small-Cell Lung
Conditions
Brief summary
This study aims to better understand people who have advanced or metastatic non-small cell lung cancer (NSCLC) with an EGFR mutation. NSCLC is an advanced stage cancer of the lung, occurring due to mutations (changes) in the EGFR gene. The study will assess the participant demographic background (that is age, gender etc.), the treatments they receive, how well those treatments work, and their health outcomes.
Interventions
None listed
Sponsors
Janssen-Cilag Farmaceutica Ltda.
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Histologically or cytologically confirmed diagnosis of advanced or metastatic unresectable non-small cell lung cancerNSCLC (TNM stages IIIB-IV), and a documented EGFR mutation, between 01 July 2018 and 31 March 2022 * Diagnosed and treated at one of the participating study centers within the defined study period
Exclusion criteria
* Participants who received any systemic cancer treatment outside the participating treatment centers * Participants diagnosed with any other malignancy within the 5 years prior to or during the study period, with the exception of cutaneous basal cell carcinoma or squamous cell carcinoma * Participants enrolled in clinical trials during the study period.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sociodemographic Characteristics: Disease Stage | Baseline | Number of participants based on the stage of disease will be reported. |
| Sociodemographic Characteristics: Cancer Metastasis | Baseline | Number of participants based on cancer metastasis will be reported. |
| EGFR Mutation Prevalence | Up to approximately 7 years 9 months | Number of participants with EGFR mutations will be reported. |
| Percentage of Participants by Type of Mutation of EGFR | Up to approximately 7 years 9 months | Percentage of participants by type of mutation of EGFR will be reported. |
| Sociodemographic Characteristics: Eastern Cooperative Oncology Group (ECOG) Performance Status | Baseline | ECOG performance status of the participants will be reported. |
| Sociodemographic Characteristics: Disease Histopathology | Baseline | Number of participants based on disease histopathology will be reported. |
| Sociodemographic Characteristics: Type of Mutation | Baseline | Number of participants based on type of mutation will be reported. |
| Sociodemographic Characteristics: Age | Baseline | Age in years of the participants will be reported. |
| Sociodemographic Characteristics: Sex | Baseline | Sex (male, female) of the participants will be reported. |
| Sociodemographic Characteristics: Weight | Baseline | Weight (in kilograms \[kg\]) of the participants will be reported. |
| Sociodemographic Characteristics: Smoking Status | Baseline | Participants smoking status that is current or former smoker will be reported. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Real-World Overall Response Rate (RW-ORR) | Up to approximately 7 years 9 months | RW-ORR is defined as the percentage of participants whose cancer show partial response or complete response of all target lesions following a specific line of treatment. |
| Number of Appointments | Up to approximately 7 years 9 months | Number of appointments related to NSCLC by line of treatment such as oncology, pulmonology, primary care, radio-oncology, thoracic surgery, nursing, psychology, nutrition, physiotherapy will be reported. |
| Number of Participants Receiving Complementary Diagnostic and Therapeutic Procedures | Up to approximately 7 years 9 months | Number of participants receiving complementary diagnostic and therapeutic procedures and type of complementary diagnostic and therapeutic procedures received (for example, imaging, laboratory tests, biopsies, radiotherapy sessions, surgery, medication) will be reported. |
| Number Participants with Emergency Room Visits Related to NSCLC | Up to approximately 7 years 9 months | Number of participants with emergency room visits related to NSCLC will be reported. |
| Percentage of Participants Hospitalized | Up to approximately 7 years 9 months | Percentage of participants with at least one hospitalization will be reported. |
| Number of Hospitalizations | Up to approximately 7 years 9 months | Total number of hospitalizations for the participants will be reported. |
| Median Length of Stay | Up to approximately 7 years 9 months | Median length of stay in days per hospitalization will be reported. |
| Net Costing | Up to approximately 7 years 9 months | The net cost of different treatment practices per participants will be reported. |
| Frequency of EGFR Mutations | Up to approximately 7 years 9 months | Frequency of EGFR mutations will be reported. |
| Number of Participants by Treatment Options | Up to approximately 7 years 9 months | Participants with different treatment options such as targeted therapy, chemotherapy, immunotherapy, surgery, radiotherapy stratified by type of mutation will be reported. |
| Real-World Overall Survival (RW-OS) | Up to approximately 7 years 9 months | RW-OS is defined as time elapsed between index date and date of death from any cause. |
| Real-World Progression-Free Survival (RW-PFS) | Up to approximately 7 years 9 months | RW-PFS is defined as the time elapsed between the start of a new line of treatment to the date of documented disease progression or death from any cause, whichever occurs first. |
| RW-PFS from First Line of Treatment (RW-PFS 2) | Up to approximately 7 years 9 months | RW-PFS 2 is defined as the time elapsed between the start of a first line of treatment to the date of documented second disease progression or death from any cause, whichever occurs first. |
| Real-World Time on Treatment (RW-TOT) | Up to approximately 7 years 9 months | RW-TOT is defined as the time elapsed between the start date of a line of treatment to the date of treatment discontinuation for any reason. |
| Real-World Time to Next Treatment (RW-TTNT) | Up to approximately 7 years 9 months | RW-TTNT is defined as the time elapsed between the start of a given line of treatment to the initiation of the subsequent line of systemic therapy. |
Contacts
CONTACTStudy Contact
STUDY_DIRECTORJanssen-Cilag Farmaceutica, Lda. Clinical Trial
Janssen-Cilag Farmaceutica, Lda.
Outcome results
None listed