Overview
Sponsor-declared trial summary
Adult patients with a histologically confirmed TLS-positive advanced or metastatic NSCLC naïve from systemic treatment or previously treated with chemotherapy and PD1/PDL1 antagonist, and not having previously been treated with CD137 agonists or investigational immune checkpoint blockade therapies, including (but not limited) anti-TIGIT, anti-LAG3. Patients must have adequate organ function with a performance status (WHO 0-1; ECOG 0-1). Patients must not have active or history of autoimmune disease or immune deficiency. The pregnant or breastfeeding women will be excluded. Other eligibility criteria are described in the related section of the protocol.
Key facts
- Sponsor
- Institut Gustave Roussy
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Respiratory Tract Diseases [C08]
- Trial duration
- 30 Jan 2025 → 5 Sep 2025
- Decision date (initial)
- 2024-05-23
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Adult patients with a histologically confirmed TLS-positive advanced or metastatic NSCLC naïve from systemic treatment or previously treated with chemotherapy and PD1/PDL1 antagonist, and not having previously been treated with CD137 agonists or investigational immune checkpoint blockade therapies, including (but not limited) anti-TIGIT, anti-LAG3. Patients must have adequate organ function with a performance status (WHO 0-1; ECOG 0-1). Patients must not have active or history of autoimmune disease or immune deficiency. The pregnant or breastfeeding women will be excluded. Other eligibility criteria are described in the related section of the protocol.
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Institut Gustave Roussy
- Sponsor organisation
- Institut Gustave Roussy
- Address
- 114 Rue Edouard Vaillant
- City
- Villejuif
- Postcode
- 94800
- Country
- France
Scientific contact point
- Organisation
- Institut Gustave Roussy
- Contact name
- Docteur
Public contact point
- Organisation
- Institut Gustave Roussy
- Contact name
- Docteur
Locations
1 EU/EEA country · 5 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Ended | 115 | 5 |
| Rest of world | — | 0 | — |
Investigational sites
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| France | 2025-01-30 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-02-27 | France | Acceptable 2024-05-21
|
2024-05-23 |