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Neoadjuvant chemo-immunotherapy for stage III PD-L1 positive Non-Small Cell Lung Cancer (NSCLC)

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-519205-35-01
Acronym
CHALLENGE
Enrollment
30
Registered
2025-03-27
Start date
2025-07-08
Completion date
Unknown
Last updated
2025-09-10

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

Conditions

stage III PD-L1 positive Non-Small Cell Lung Cancer (NSCLC)

Brief summary

Complete tumor resection rate (R0). An R0 resection means that the surgical margin is microscopically negative for residual tumor.

Detailed description

Percentage of nodal downstaging defined as following neoadjuvant chemoimmunotherapy, Pathological complete response (pCR) and major pathological response (MPR). pCR means 0% residual viable tumor cells in the primary tumor and sampled lymph nodes; MPR means ≤10% residual viable tumor cells in the primary tumor and sampled lymph nodes., Event-free survival (EFS) was defined as the time from study enrollment to any progression of disease before local treatment (surgery or radiotherapy) or recurrence of disease after local treatment (surgery or radiotherapy), progression of disease in the absence of surgery, or death from any cause., Overall survival (OS) was defined as the time from study enrollment to death of any cause

Interventions

Sponsors

Fondazione Ricerca Traslazionale
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Secondary

MeasureTime frame
Percentage of nodal downstaging defined as following neoadjuvant chemoimmunotherapy, Pathological complete response (pCR) and major pathological response (MPR). pCR means 0% residual viable tumor cells in the primary tumor and sampled lymph nodes; MPR means ≤10% residual viable tumor cells in the primary tumor and sampled lymph nodes., Event-free survival (EFS) was defined as the time from study enrollment to any progression of disease before local treatment (surgery or radiotherapy) or recurrence of disease after local treatment (surgery or radiotherapy), progression of disease in the absence of surgery, or death from any cause., Overall survival (OS) was defined as the time from study enrollment to death of any cause

Primary

MeasureTime frame
Complete tumor resection rate (R0). An R0 resection means that the surgical margin is microscopically negative for residual tumor.

Countries

Italy

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026