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cDC1 Prognostic and Predictive Role in Non-Small-Cell Lung Cancer Patients Receiving Immune Checkpoint Inhibitors

cDC1 Prognostic and Predictive Role in Non-Small-Cell Lung Cancer Patients Receiving Immune Checkpoint Inhibitors

Status
Withdrawn
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04069442
Acronym
LUNG-PREDICT
Enrollment
0
Registered
2019-08-28
Start date
2020-06-30
Completion date
2020-09-30
Last updated
2021-04-01

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

Brief summary

The response rate of immune checkpoint inhibitors remains relatively low and the identification of the new predictive biomarkers is necessary. The rare population of cDC1 is very interesting, as its mouse counterparts is essential for the cross presentation of tumor-associated antigens, tumor immunity and response to immunotherapies. Their role in humans has not been studied. This proposal aims to study the prognostic role of cDC1 in a cohort of patients with advanced NSCLC, possibly demonstrating their positive predictive value of immune checkpoint inhibitors response.

Detailed description

Multicenter study aiming to collect patient's clinical data retrospectively and their histological samples prospectively. The cohort will include: * 30 patients PD-L1 \> 50% treated with pembrolizumab in first line and having a progression free survival ≥ 3 months * 30 patients PD-L1 \> 50% treated with pembrolizumab in first line and having a progression free survival \< 3 months * 30 patients PD-L1 \< 50% treated with cisplatin-based chemotherapy in first line

Interventions

This is a non-interventional study

Sponsors

University Hospital, Grenoble
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* NSCLC diagnosis * Advanced disease (Stage III-IV) according to the TNM 7th/8th classification * Patients have to have performed pembrolizumab in first line if PD-L1 ≥ 50% or cisplastin-based chemotherapy if PD-L1 \< 50% * FFPE material available from diagnostic sample

Exclusion criteria

\-

Design outcomes

Primary

MeasureTime frameDescription
Progression free survival (PFS)1 yearTo validate the cDC1 infiltration as predictive biomarker of pembrolizumab response

Secondary

MeasureTime frameDescription
Overall response rate (ORR)1 yearTo compare the overall response rate (ORR) of cDC1-positive patients to cDC1 negative ones within those treated with pembrolizumab and on the entire cohort
Time to treatment failure (TTF)1 yearTo compare the time of treatment failure (TTF) on CDC1-positive patients to negatives ones within those treated with pembrolizumaband on the entire cohort

Other

MeasureTime frameDescription
Overall survival (OS)1 yearTo compare the overall survival (OS) of cDC1-positives patients to negatives ones within those treated with pembrolozumab and on the entire cohort

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026