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

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Fondazione Ricerca Traslazionale

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Neoplasms [C04]

Trial duration

8 Jul 2025 → ongoing

Decision date (initial)

2025-03-27

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy, Safety

To evaluate the rate of radical surgery (R0) in patients with stage III PD-L1 positive NSCLC treated with tislelizumab plus platinum-based doublet chemotherapy as neoadjuvant treatment

Secondary objectives 1

1. To evaluate and compare the pathological major response (MPR) rate and pathological complete response (p CR) rate in patients with stage III PD-L1 positive NSCLC treated with tislelizumab plus platinum-based doublet chemotherapy as neoadjuvant treatment • To evaluate the rate of nodal downstaging in patients with stage III PD-L1 positive NSCLC after neoadjuvant tislelizumab plus platinum-based doublet chemotherapy • To evaluate event-free survival (EFS) assessed in patients with stage III PD-L1 positive NSCLC treated with tislelizumab plus platinum-based doublet chemotherapy as neoadjuvant treatment • To evaluate overall survival (OS) in patients with stage III PD-L1 positive NSCLC treated with tislelizumab plus platinum-based doublet chemotherapy as neoadjuvant treatment

Conditions and MedDRA coding

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

Regulatory references

Plan to share IPD

No

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 11

1. Histologically confirmed stage III disease.
2. PD-L1 TPS ≥ 1% according to local testing.
3. No evidence of EGFR mutations or ALK or ROS1 or RET rearrangements by local testing.
4. Mandatory baseline multidisciplinary assessment to confirm suitability of patient to local treatment with curative intent.
5. Pulmonary function tests within 6 months of the planned resection.
6. At least 1 measurable lesion as defined by RECIST v1.1.
7. ECOG Performance Status ≤ 1.
8. Eligibility to receive a platinum doublet chemotherapy regimen.
9. Adequate organ function as indicated by the following laboratory values obtained ≤ 14 days before the first dose of study drug
10. Age ≥ 18 years.
11. Written informed consent

Exclusion criteria 8

1. Evidence of stage IV NSCLC (metastatic disease).
2. Histology of large cell neuroendocrine carcinoma (LCNEC).
3. Any previous therapy for current lung cancer, including chemotherapy or radiation therapy
4. Previous treatment with an antibody or drug against the immune checkpoint pathway, including but not limited to, therapeutic anti-cytotoxic T-lymphocyte antigen-4-associated antibodies (anti-CTLA-4), anti-PD-1 and anti-PD-L1.
5. Never smoking patients.
6. Active autoimmune diseases or history of autoimmune diseases that may recur
7. Concomitant participation in another therapeutic clinical trial.
8. Pregnancy or breastfeeding.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

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

Secondary endpoints 4

1. Percentage of nodal downstaging defined as following neoadjuvant chemoimmunotherapy
2. 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.
3. 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.
4. Overall survival (OS) was defined as the time from study enrollment to death of any cause

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Auxiliary 4

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Fondazione Ricerca Traslazionale

Sponsor organisation

Fondazione Ricerca Traslazionale

Address

Via Dei Santi Quattro 61

City

Rome

Postcode

00184

Country

Italy

Scientific contact point

Organisation

Fondazione Ricerca Traslazionale

Contact name

Federico Cappuzzo

Public contact point

Organisation

Fondazione Ricerca Traslazionale

Contact name

Federico Cappuzzo

Locations

1 EU/EEA country · 1 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 9 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

2 submissions — initial application plus substantial / non-substantial modifications