Clinical trial NCT03353675
Conditions: Non Small Cell Lung Cancer Metastatic
Keywords: Metastatic NSCLC Advanced lung malignancy
Sponsor: Transgene
Start date: 2018-01-05; Completion date: 2021-02-17
Enrollment: 44 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This is a multicenter, single arm, open label phase II study in treatment-naïve for advanced stage of the disease and immunotherapy-naïve patients with advanced non-squamous NSCLC and with \< 50% of tumor cells expressing programmed death-ligand 1 (PD-L1) by immunohistochemical (IHC) staining.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: TG4010 intervention 2: Chemotherapy intervention 3: Nivolumab
Intervention descriptions: intervention 1: 1 dose (1x1E+08) Subcutaneous injection/week over 6 weeks then 1 dose/3 weeks intervention 2: Pemetrexed/Cisplatin or Carboplatin

Pemetrexed maintenance intervention 3: 360 mg IV administration every 3 weeks

Protocol documents:
Prot_000.pdf: 
transgene
SPONSOR: 
Clinical Study Protocol 
CONFIDENTIAL 
A phase II study evaluating the efficacy and the safety of first-line chemotherapy 
combined with TG4010 and nivolumab in patients with advanced non-squamous 
Non-Small-Cell Lung Cancer (NSCLC) 
Study phase: II 
PROTOCOL N° TG4010.24 
Amended Version 4.0 - 13 March 2018 
EUDRACT N° 2016-005115-41 
IND N° 8559 
NCT03353675 
Transgene S.A. 
Boulevard Gonthier d'Andernach 
Parc d'innovation - CS80166 
67405 Illkirch Graffenstaden Cedex - FRANCE 
The confidential infonnation contained in this document is the property ofTransgene. lt is provided to you in confidence, for review by you, 
your staff, regulatory authorities, and members of ethics committees or institutional review boards. lt is understood that this information will 
not be disclosed to any other third party, in any form, without prior authorization from Transgene, except to the extent necessary to obtain the 
written informed consent from the persons to whom the lnvestigalional Medicinal Product may be administered. 













































































































































































































SAP_001.pdf: 
SPONSOR: 
transgene
Statistical Analysis Plan (SAP) 
Final Version 3.0 / 13 November 2019 
CONFIDENTIAL 
A PHASE II STUDY EVALUATING THE EFFICACY AND THE SAFETY 
OF FIRST-LINE CHEMOTHERAPY COMBINED WITH TG4010 AND 
NIVOLUMAB IN PATIENTS WITH ADV ANCED NON-SQUAMOUS 
NON-SMALL-CELL LUNG CANCER (NSCLC) 
Study phase: II 
PROTOCOL N° TG4010.24 
EUDRACT N° 2016-005115-41 
IND N° 8559 
NCT03353675
Transgene 
Boulevard Gonthier d'Andemach 
Parc d'innovation - CS80166 
67405 Illkirch Graffenstaden Cedex - FRANCE 
The confidential information contained in this document is the property ofTransgene. lt is provided to you in confidence, for review by you, 
your staff, regulatory authorities, and members of ethics commiltees or institutional review boards. lt is understood that this information will 
not be disclosed to any other third party, in any form, without prior authorization from Transgene, except to the extent necessary to obtain the 
written informed consent from the persons to whom the Investigational Medicinal Product may be administered.