Clinical Trial 23576

• Overview

  Study Title:

  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

  Summary:

  The purpose of this study is to evaluate the effects of two different doses of BNT327 (the study drug) when combined with chemotherapy (carboplatin with either paclitaxel or pemetrexed) to find out: best dose of BNT327, if the study drug can shrink cancer of prevent the cancer from getting worse, if the study drug is safe, tolerable and effective against this cancer, how the study drug is processed in the body, and how the study drug and cancer affect with participant's quality of life.

  Objective:

  Primary Phase II * To evaluate the safety and tolerability of BNT327 at two dose levels in combination with chemotherapy * To evaluate the efficacy of BNT327 at two dose levels in combination with chemotherapy Primary Phase III * To compare efficacy of BNT327 in combination with chemotherapy a to pembrolizumab plus chemotherapy a in terms of a HR for PFS as assessed by BICR in the ITT Set. * To compare efficacy of BNT327 in combination with chemotherapy a followed by any subsequent therapy to pembrolizumab plus chemotherapy a followed by any subsequent therapy in terms of a HR for OS in the ITT Set. Secondary Phase II * To evaluate the antitumor activity of BNT327 at two dose levels in combination with chemotherapy a in the ITT Set as measured by ORR, DOR, and DCR. Secondary Phase II * To evaluate the efficacy of BNT327 in combination with chemotherapy a compared to pembrolizumab plus chemotherapy a in the ITT Set as measured by PFS according to RECIST v1.1 assessed by investigator. * To evaluate the antitumor activity of BNT327 in combination with chemotherapy a compared to pembrolizumab plus chemotherapy a in the ITT Set as measured by ORR. * To evaluate the PFS rate and OS rate at fixed timepoints in each treatment arm for the ITT Set. * To evaluate PRO scores of quality-of-life using the EORTC QLQ-C30, QLQ-LC29, NSCLCSAQ, and FACT-GP5 for the ITT Set. * To evaluate the safety and tolerability of BNT327 in combination with chemotherapy versus pembrolizumab plus chemotherapy.

• Treatments

  Therapies:

  Chemotherapy (NOS); Immunotherapy

  Medications:

  Alimta (Pemetrexed); BNT327 (); Paraplatin (carboplatin); Pembrolizumab (Keytruda); Pemetrexed (); Taxol (paclitaxel); carboplatin (); paclitaxel ()

• Inclusion Criteria

  Key Inclusion Criteria:
  • Have 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, 8th edition without actionable epidermal growth factor receptor mutation or anaplastic lymphoma kinase (ALK) rearrangement.
  • 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.
  • Other criteria apply

• Exclusion Criteria

  Key Exclusion Criteria:
  • Have histologically or cytologically confirmed NSCLC with small-cell lung cancer histologic component.
  • Have received any of the following therapies or drugs within the noted time intervals prior to study treatment: -Participants who received prior treatment with anti-VEGF monoclonal antibody, or PD(L)-1/VEGF bispecific antibody or received platinum-based chemotherapy and/or anti-PD(L)-1 as part of adjuvant or neoadjuvant treatment -Have received systemic corticosteroids (at a dosage greater than 10 mg/day of prednisone or an equivalent dose of other corticosteroids) within 14 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 non-healing wound, ulcer, or 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. 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 evidence of major coagulation disorders or other significant risks of hemorrhage.
  • Have superior vena cava syndrome or symptoms of spinal cord compression.
  • Other criteria apply

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