Predictive Multimodal Signatures Associated With Response to Treatment and Prognosis of Patients With Stage IV Non-small Cell Lung Cancer (DEEP-Lung-IV)

Sophia Genetics

Status: Active, not recruiting

Conditions: Non-small Cell Lung Cancer Metastatic

Treatments: Other: Predictive models (data collection)

Study type: Observational

Funder types: Industry

Identifiers

NCT04994795

SGDLIV

Details and patient eligibility

About

Predicting response to therapy and disease progression in stage IV NSCLC patients treated with pembrolizumab monotherapy, chemotherapy-pembrolizumab combination therapy or chemotherapy alone in the first-line setting.

Enrollment: 4,000 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adult ≥18 years old
• Patient diagnosed with Stage IV NSCLC (de novo or earlier stage progression to stage IV)
• Absence of oncogene activating mutations eligible patients to targeted therapy (EGFR, ALK)
• Cohort A: Received first line treatment with pembrolizumab monotherapy
• Cohort B: Received first line treatment with chemotherapy and pembrolizumab combination therapy
• Cohort C: Received first line treatment with chemotherapy doublet

Exclusion criteria

• Prior anti-cancer therapy for actual stage IV NSCLC
• Critical data missing (e.g., PD-L1 status, baseline millimetric imaging, first evaluation millimetric imaging)
• Patients participating in other clinical trials that modify the standard of care

Trial design

4,000 participants in 3 patient groups

Pembrolizumab monotherapy

Treatment:

Other: Predictive models (data collection)

Chemotherapy and pembrolizumab combination therapy

Treatment:

Other: Predictive models (data collection)

Chemotherapy doublet

Treatment:

Other: Predictive models (data collection)