Informations générales (source: ClinicalTrials.gov)
A Phase II/III, Multisite, Randomized Master Protocol for a Global Trial of BNT327 in Combination With Chemotherapy and Other Investigational Agents in First-line Non-small Cell Lung Cancer
Interventional
Phase 2/Phase 3
BioNTech SE (Voir sur ClinicalTrials)
janvier 2025
mars 2030
02 mars 2026
This is a Phase 2/3, multisite, randomized, open-label study in participants with
first-line non-small cell lung cancer (NSCLC).
This study includes two substudies (substudy A and substudy B) that will recruit
participants according to histological subtypes due to differences in chemotherapy choice
for standard-of-care and type of NSCLC.
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CHI DE CRETEIL | Christos CHOUAID | 30/12/2025 09:20:03 | Contacter | ||
| CLCC INSTITUT GUSTAVE ROUSSY | Fabrice BARLESI | 06/05/2026 08:55:06 | Contacter | ||
Critères
Tous
- Have systemic treatment naive, histologically or cytologically confirmed diagnosis
of Stage IIIB or IIIC (who are not amenable to curative surgery or radiotherapy) or
Stage IV NSCLC per the Union Internationale contre le Cancer/American Joint
Committee on Cancer staging system, 9th edition.
- Have at least one measurable lesion as the targeted lesion based on RECIST v1.1.
Lesions treated after prior local treatment (radiotherapy, ablation, interventional
procedures, etc.) are generally not considered as target lesions. If the lesion with
prior local treatment is the only targeted lesion, evidence-based radiology must be
provided to demonstrate disease progression (the single bone metastasis or the
single central nervous system metastasis should not be considered as a measurable
lesion).
- Eastern Cooperative Oncology Group Performance Status of 0 or 1.
- Adequate organ function.
Key Exclusion Criteria:
- Have histologically or cytologically confirmed NSCLC with small-cell lung cancer
histologic or neuroendocrine component.
- Have received any of the following therapies or drugs within the noted time
intervals prior to study treatment:
- Previous chemotherapy (platinum-based) or PD(L)-1 for treating NSCLC in either
neo-adjuvant/adjuvant or locally advanced/metastatic setting.
- Participants who received prior treatment with anti-VEGF monoclonal antibody,
or PD(L)-1/VEGF bispecific antibody
- Have received systemic corticosteroids (at a dosage greater than 10 mg/day of
prednisone or an equivalent dose of other corticosteroids) within 7 days prior
to the initiation of study treatment. Note: local, intranasal, intraocular,
intra-articular or inhaled corticosteroids, short-term use (<=7 days) of
corticosteroids for prophylaxis (e.g., prevention of contrast agent allergy) or
treatment of non-autoimmune conditions (e.g., delayed hypersensitivity
reactions caused by exposure to allergens) are allowed.
- Have uncontrolled hypertension or poorly controlled diabetic conditions prior to
study treatment.
- Have a serious or non-healing wound, or (incompletely healed) bone fracture. This
includes history (within 6 months prior to study entry) or risk of abdominal
fistula, tracheoesophageal fistula, gastrointestinal perforation, or intra-abdominal
abscess or esophageal and gastric varices. In addition, the participant must have
undergone correction (or spontaneous healing) of the perforation/fistula and/or the
underlying process causing fistula/perforation.
- Participants with significant risk of hemorrhage (per investigator clinical
judgment).
- Have superior vena cava syndrome or symptoms of spinal cord compression.
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.