Health Trials

Safety, Efficacy, and Pharmacokinetics of BNT327 in Combination With Chemotherapy and Other Investigational Agents for Lung Cancer

ConditionNon-small Cell Lung Cancer
Trial statusRecruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorBioNTech SE

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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 as defined in the protocol.

Disqualifiers

Have histologically or cytologically confirmed NSCLC with small-cell lung cancer or neuroendocrine histologic component.

Previous chemotherapy (platinum-based) or PD(L)-1 for treating NSCLC in either neoadjuvant/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.

Trial design

Design model

Sequential

Treatments tested in this trial

  • Pumitamig

    Drug

    Intravenous infusion

  • Pembrolizumab

    Drug

    Intravenous infusion

  • Carboplatin

    Drug

    Intravenous infusion

  • Pemetrexed

    Drug

    Intravenous infusion

  • Paclitaxel

    Drug

    Intravenous infusion

Treatment groups

1,580 Participants
are divided into 10 treatment groups

10

Treatment groups

See each treatment group below.

Group A: Substudy A Phase 2 (Arm 1) - Pumitamig Dose 1 + Carboplatin + PemetrexedExperimental treatment 3 interventions
Group B: Substudy A Phase 2 (Arm 2) - Pumitamig Dose 2 + Carboplatin + PemetrexedExperimental treatment 3 interventions
Group C: Substudy A Phase 2 (Arm 1A - China only) - Pumitamig Dose 3 + Carboplatin + PemetrexedExperimental treatment 3 interventions
Group D: Substudy A Phase 3 (Arm 3) - Pumitamig Dose 3 + Carboplatin + PemetrexedExperimental treatment 3 interventions
Group E: Substudy A Phase 3 (Arm 4) - Pembrolizumab + Carboplatin + PemetrexedActive comparator 3 interventions
Group F: Substudy B Phase 2 (Arm 1) - Pumitamig Dose 1 + Carboplatin + PaclitaxelExperimental treatment 3 interventions
Group G: Substudy B Phase 2 (Arm 2) - Pumitamig Dose 2 + Carboplatin + PaclitaxelExperimental treatment 3 interventions
Group H: Substudy B Phase 2 (Arm 1A, China only) - Pumitamig Dose 3 + Carboplatin + PaclitaxelExperimental treatment 3 interventions
Group I: Substudy B Phase 3 (Arm 3) - Pumitamig Dose 3 + Carboplatin + PaclitaxelExperimental treatment 3 interventions
Group J: Substudy B Phase 3 (Arm 4) - Pembrolizumab + Carboplatin + PaclitaxelActive comparator 3 interventions

Trial outcomes

Primary outcomes

1

Phase 2 - Occurrence of treatment-emergent adverse events (TEAE) (including Grade ≥3), adverse events of special interest (AESIs), treatment-related TEAEs, treatment-emergent serious adverse events (SAE), and treatment-related treatment emergent SAEs

For substudies A and B. AEs graded according to Common Terminology Criteria for Adverse Events (CTCAE v5.0) in the combination treatment regimen.

Time frame
From the first dose of the investigational medicinal product (IMP) to the 90-day Follow-Up Visit
2

Phase 2 - Occurrence of dose interruption, reduction, and discontinuation of IMP due to TEAEs (including related TEAEs)

For substudies A and B.

Time frame
From the first dose of IMP to the 90-day Follow-Up Visit
3

Phase 2 - Objective response rate (ORR)

For substudies A and B. ORR is defined as the proportion of participants in whom a confirmed complete response (CR) or confirmed partial response (PR) (per Response Evaluation Criteria in Solid Tumors version 1.1 \[RECIST v1.1\] based on the investigator's assessment) is observed as best overall response.

Time frame
Up to approximately 2 years
4

Phase 2 - Best percentage change from baseline in tumor size

For substudies A and B. Based on investigator's tumor assessment according to RECIST v1.1.

Time frame
Up to approximately 2 years

Secondary outcomes

1

Phase 3 - Overall survival (OS)

For substudies A and B. OS defined as the time from randomization to death from any cause

Time frame
Up to approximately 5 years
2

Phase 2 - Duration of Response (DOR)

For substudies A and B. DOR defined as the time from first objective response (CR or PR per RECIST v1.1) to first occurrence of objective tumor progression (progressive disease per RECIST v1.1) or death from any cause, whichever occurs first.

Time frame
Up to approximately 2 years
3

Phase 2 - Disease Control Rate (DCR)

For substudies A and B. DCR defined as the proportion of participants in whom a confirmed CR or confirmed PR or stable disease (per RECIST v1.1, stable disease assessed at least 6 weeks after randomization) is observed as best overall response.

Time frame
Up to approximately 2 years
4

Phase 3 - PFS assessed by investigator

For substudies A and B. PFS defined as the time from randomization to first documented tumor progression (progressive disease per RECIST v1.1), or death from any cause, whichever occurs first.

Time frame
Up to approximately 5 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

BioNTech SE

Lead sponsor

Bristol-Myers Squibb

Collaborator

Source ClinicalTrials.gov
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