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

Deep Learning-Enabled Exploration of Predictive Signatures in a Multicenter Retrospective and Prospective Observational Study Allowing the Analysis of the Aggregation of Multimodal Clinical, Biological, Genomic and Radiomics Data Associated With the Response to Treatment and Prognosis of Patients With Stage IV Non-small Cell Lung Cancer

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04994795

Acronym

DEEP-Lung-IV

Enrollment

4000

Registered

2021-08-06

Start date

2021-08-21

Completion date

2025-02-28

Last updated

2024-11-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non-small Cell Lung Cancer Metastatic

Keywords

NSCLC, Immunotherapy, Chemotherapy, Predictive models, Radiomics, Multimodal, Genomics, Machine learning

Brief summary

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.

Interventions

OTHERPredictive models (data collection)

Machine learning predictive models

Study design

Observational model

COHORT

Time perspective

OTHER

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
Treatment response at first evaluation	6-12 weeks after treatment start	Predict treatment response at first evaluation using baseline data

Secondary

Measure	Time frame	Description
Progression-Free Survival	Through study completion, expected 6-14 months contingent on cohort	Predict Progression-Free Survival (PFS) using data at baseline and first evaluation
Overall Survival	Through study completion, expected 8-20 months contingent on cohort	Predict Overall Survival (OS) using data at baseline and first evaluation
Duration of Response	Through study completion, expected 6-14 months contingent on cohort	Predict Duration of Response (DoR) using data at baseline and first evaluation
Time-To-Progression	Through study completion, expected 6-14 months contingent on cohort	Predict Time-To-Progression (TTP) using data at baseline and first evaluation

Countries

Brazil, Canada, France, Germany, Israel, Italy, Spain, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 29, 2026