ClinicaliQ Trial Snapshot
- Safety, Efficacy, and Pharmacokinetics of BNT327 in Combination With Chemotherapy and Other Investigational Agents for Lung Cancer — Recruiting • Phase II • Oncology • NCT06712316.
- What is being tested: BNT327 (an investigational agent) combined with chemotherapy and other experimental drugs in first-line treatment of non-small cell lung cancer (NSCLC), with separate substudies stratified by histological subtypes to account for disease heterogeneity.
- Patient eligibility overview: Adults with newly diagnosed, treatment-Phase IIïve NSCLC suitable for first-line chemotherapy, enrolled across multiple sites in a randomized, controlled design with stratification by histological subtype (adenocarcinoma vs. squamous cell carcinoma).
Use This Page For
- Quick orientation before opening the registry record.
- Checking recruitment status, phase and sponsor at a glance.
- Connecting this trial to nearby guidelines, Drug Science and education.
What This Trial Is Studying
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.
Eligibility Snapshot
- Key Inclusion Criteria: * 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
Use the source registry for the full inclusion and exclusion criteria before discussing referral or enrolment.