A Real World Study of Participants With Non-Small Cell Lung Cancer (NSCLC) With Epidermal Growth Factor Receptor Mutation (EGFRm)

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorJanssen-Cilag Farmaceutica Ltda.

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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.

Trial population

Adult participants (aged greater than or equal to \[\>=\] 18 years) with a histologically or cytologically confirmed diagnosis of NSCLC, unresectable stage IIIB/C or IV at diagnosis, and a documented EGFR mutation.

Trial design

Design model

Cohort

Time perspective

Retrospective

Treatments tested in this trial

Not listed

Trial groups

250 Participants
are grouped into 1 trial group
Group A: Unresectable Epidermal Growth Factor Receptor Mutated (EGFRm) NSCLC

Trial outcomes

Primary outcomes

1

Sociodemographic Characteristics: Age

Age in years of the participants will be reported.

Time frame
Baseline
2

Sociodemographic Characteristics: Sex

Sex (male, female) of the participants will be reported.

Time frame
Baseline
3

Sociodemographic Characteristics: Weight

Weight (in kilograms \[kg\]) of the participants will be reported.

Time frame
Baseline
4

Sociodemographic Characteristics: Smoking Status

Participants smoking status that is current or former smoker will be reported.

Time frame
Baseline

Secondary outcomes

1

Frequency of EGFR Mutations

Frequency of EGFR mutations will be reported.

Time frame
Up to approximately 7 years 9 months
2

Number of Participants by Treatment Options

Participants with different treatment options such as targeted therapy, chemotherapy, immunotherapy, surgery, radiotherapy stratified by type of mutation will be reported.

Time frame
Up to approximately 7 years 9 months
3

Real-World Overall Survival (RW-OS)

RW-OS is defined as time elapsed between index date and date of death from any cause.

Time frame
Up to approximately 7 years 9 months
4

Real-World Progression-Free Survival (RW-PFS)

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.

Time frame
Up to approximately 7 years 9 months

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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