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OncoMatch/Clinical Trials/NCT06712355

Safety and Efficacy of BNT327, an Investigational Therapy in Combination With Chemotherapy for Patients With Untreated Small-cell Lung Cancer

Is NCT06712355 recruiting? Yes, currently enrolling (May 2026). This Phase 3 trial studies multiple treatments including Pumitamig and Atezolizumab for extensive-stage small-cell lung cancer.

Phase 3RecruitingBioNTech SENCT06712355Data as of May 2026

Treatment: Pumitamig · Atezolizumab · Etoposide · Carboplatin (or cisplatin if carboplatin is not tolerated)This is a Phase III, multisite, randomized, double-blinded study to investigate pumitamig (BNT327) combined with chemotherapy (etoposide/carboplatin) compared to atezolizumab combined with chemotherapy (etoposide/carboplatin) for the treatment of participants with previously untreated extensive-stage small-cell lung cancer (ES-SCLC).

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Extracted eligibility criteria

Cancer type

Non-Small Cell Lung Carcinoma

Disease stage

Required: Stage AJCC 8TH EDITION STAGE IV (T ANY, N ANY, M1A/B/C), T3~4 FOR MULTIPLE LUNG NODULES OR TUMOR/NODULE VOLUME THAT CANNOT BE ENCOMPASSED IN A TOLERABLE RADIOTHERAPY PLAN (AJCC 8th edition, VALG)

Metastatic disease required

AJCC 8th edition stage IV (T any, N any, M1a/b/c), or T3~4 for multiple lung nodules or tumor/nodule volume that cannot be encompassed in a tolerable radiotherapy plan

Performance status

ECOG 0–1(Restricted strenuous activity)

Prior therapy

No prior treatment (treatment-naive required)
Max 0 prior lines

Cannot have received: systemic therapy

Exception: Participants with prior chemoradiotherapy for limited-stage-SCLC must have been treated with curative intent and had a treatment-free interval of at least 6 months after the last chemotherapy, radiotherapy, or chemoradiotherapy before diagnosis of ES-SCLC to be eligible.

Have not had prior systemic therapy for ES-SCLC. However, participants with prior chemoradiotherapy for limited-stage-SCLC must have been treated with curative intent and had a treatment-free interval of at least 6 months after the last chemotherapy, radiotherapy, or chemoradiotherapy before diagnosis of ES-SCLC to be eligible.

Cannot have received: anti-VEGF monoclonal antibody

Have received prior treatment with anti-vascular endothelial growth factor (VEGF) monoclonal antibody

Cannot have received: PD-L1/VEGF bispecific antibody

Have received prior treatment with programmed death (ligand)-1 (PD[L]-1)/VEGF bispecific antibody

Lab requirements

Blood counts

Adequate hematologic and organ function as defined in the protocol

Kidney function

Adequate hematologic and organ function as defined in the protocol

Liver function

Adequate hematologic and organ function as defined in the protocol

Adequate hematologic and organ function as defined in the protocol

Structured fields extracted by AI. May contain errors — verify against the official protocol.

US trial sites

  • Clermont Oncology Center · Clermont, Florida
  • Cancer Care Centers of Brevard, Inc · Palm Bay, Florida
  • Illinois Cancer Specialists · Niles, Illinois
  • Fort Wayne Medical Oncology and Hematology, Inc · Fort Wayne, Indiana
  • McFarland Clinic · Ames, Iowa

Showing up to 5 US sites. See all sites on ClinicalTrials.gov →

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