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NCT Number: NCT04994795

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Non-small Cell Lung Cancer Metastatic

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

DASA - Hospital Brasilia, Brasília, Brazil

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Predictive models (data collection)

Other

Machine learning predictive models

Primary outcomes

  1. Treatment response at first evaluation

    Time frame: 6-12 weeks after treatment start

    Predict treatment response at first evaluation using baseline data

Secondary outcomes

  1. Progression-Free Survival

    Time frame: Through study completion, expected 6-14 months contingent on cohort

    Predict Progression-Free Survival (PFS) using data at baseline and first evaluation

  2. Overall Survival

    Time frame: Through study completion, expected 8-20 months contingent on cohort

    Predict Overall Survival (OS) using data at baseline and first evaluation

  3. Duration of Response

    Time frame: Through study completion, expected 6-14 months contingent on cohort

    Predict Duration of Response (DoR) using data at baseline and first evaluation

  4. Time-To-Progression

    Time frame: Through study completion, expected 6-14 months contingent on cohort

    Predict Time-To-Progression (TTP) using data at baseline and first evaluation

Sponsors and collaborators

Lead sponsor

Sophia Genetics SAS

Industry

Registry information

Official study title

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

Acronym: DEEP-Lung-IV

Important dates

Study start
2021
Primary completion
2024
Study completion
2025
First posted
Aug 6, 2021
Registry last updated
Nov 21, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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