Recruiting NCT06712355

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

Phase III Interventional Extensive-stage Small-cell Lung Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied: The protocol lists: Pumitamig, Atezolizumab, Etoposide, Carboplatin (or cisplatin if carboplatin is not tolerated).
Who it may be relevant to: Registry conditions: Extensive-stage Small-cell Lung Cancer. Basic parameters: from 18 years · All.
What needs checking: Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place: United States, Australia, China, France, Germany +9
Next step: Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

A Phase III, Multisite, Double-blinded Randomized Trial of BNT327 in Combination With Chemotherapy (Etoposide/Carboplatin) Compared to Atezolizumab in Combination With Chemotherapy (Etoposide/Carboplatin) in Participants With First-line Extensive-stage Small-cell Lung Cancer

Overview

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).

Detailed description

There are two stages in this study: Stage 1 will have two treatment arms and one control arm, and Stage 2 will have a treatment arm and a control arm. The control arms in Stages 1 and 2 are the same.

Each stage of the study consists of a screening period (up to 21 days), an induction period followed by a maintenance period (until confirmed disease progression, intolerable toxicity, participant withdrawal, study termination or up to 2 years \[whichever occurs first\]), and a follow-up (FU) period for all participants (2 safety FU visits and survival FU visits).

In Stage 1, eligible participants will be randomized (1:1:1) to the arms. In Stage 2, participants will then be randomized (1:1) to the arms. The randomization will be stratified based on the following factors:

1. Brain or liver metastases per investigator assessment (presence versus absence); 2. Smoking status (smoker versus never-smoker); and 3. Geography.

Participants will be allowed to switch to cisplatin if carboplatin is not tolerated at the investigator's discretion.

Interventions

Drug Pumitamig
Intravenous infusion
Drug Atezolizumab
Intravenous infusion
Drug Etoposide
Intravenous infusion and capsules
Drug Carboplatin (or cisplatin if carboplatin is not tolerated)
Intravenous infusion

Primary outcome measures

Overall survival (OS) [Time frame: Up to approximately 46 months]

Secondary outcome measures (12)

Progression-free survival (PFS) [Time frame: Up to approximately 46 months]
Objective response rate (ORR) [Time frame: Up to approximately 46 months]
Duration of response (DOR) [Time frame: Up to approximately 46 months]
PFS rate based on investigator's assessment [Time frame: At 6, 12, and 18 months]
OS rate [Time frame: At 6, 12, 18, and 24 months]
Occurrence of treatment-emergent adverse events (TEAEs) including Grade ≥3, serious, and fatal TEAEs by relationship [Time frame: From the first dose of study treatment to the 90-Day Follow-up Visit]
Occurrence of dose delay, infusion interruption and discontinuation of study treatment due to TEAEs (including related TEAEs) [Time frame: From first to last dose of study treatment, i.e., up to 2 years]
Change from baseline in European Organisation for Research and Treatment of Cancer (EORTC) Quality-of-Life Core 30 questionnaire (QLQ-C30) Global Health status/Quality-of-Life score (Items 29 and 30) [Time frame: Up to approximately 46 months]
Change from baseline in EORTC QLQ-C30 physical functioning [Time frame: Up to approximately 46 months]
Change from baseline in coughing scale of the EORTC Quality-of-Life-Lung cancer 29 questionnaire (QLQ-LC29) [Time frame: Up to approximately 46 months]
Change from baseline in shortness of breath scale of the EORTC QLQ-LC29 [Time frame: Up to approximately 46 months]
Change from baseline in coughed up blood item of the EORTC QLQ-LC29 [Time frame: Up to approximately 46 months]

Eligibility criteria

Inclusion criteria

Have histologically or cytologically confirmed ES-SCLC (using the AJCC \[American Joint Committee on Cancer\] tumor node metastasis staging system combined with Veterans Administration Lung Study Group \[VALG\]'s two stage classification scheme). For AJCC tumor node metastasis staging system: 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.
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.
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 (ECOG) performance status of 0 or 1.
Adequate hematologic and organ function as defined in the protocol.

Exclusion criteria

Have histologically or cytologically confirmed SCLC with combined histologies.
Have received any of the following therapies or drugs within the noted time intervals prior to study treatment:

Within 2 weeks: small molecule agents with half-life of <7 days; radiation outside the thoracic cavity including whole brain radiation. Of note, other local radiation for brain lesions (not whole brain) is allowed; local radiation for bone lesions is allowed. Palliative bone radiation or brain stereotactic radiosurgery would not require a washout period, but participants should recover from radiotherapy-related toxicity.
Within 4 weeks: radiation involving the thoracic cavity; small molecule targeted agents with half-life of ≥7 days; monoclonal antibodies, antibody-drug conjugates, radioimmunoconjugates, or T-cell or other cell-based therapies.
Have received prior treatment with anti-vascular endothelial growth factor (VEGF) monoclonal antibody, or programmed death (ligand)-1 (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 the following central nervous system metastases:

Participants with untreated brain metastases that are symptomatic or large (e.g., greater than 2 cm).
Participants with treated central nervous system (CNS) metastases who are not neurologically stable or on steroids (at a dosage greater than 10 mg/Day of prednisone or an equivalent dose of other corticosteroid) within 7 days before initiating study treatment of this study.
Participants with known leptomeningeal metastases.
Have uncontrolled hypertension or poorly controlled diabetes prior to study treatment.
Have a serious or non-healing wound, or (incompletely healed) bone fracture. This includes history of abdominal fistula, tracheoesophageal fistula, gastrointestinal perforation, or intra-abdominal abscess for which an interval of 6 months must pass before study entry. In addition, the participant must have undergone correction (or spontaneous healing) of the perforation/fistula and/or the underlying process causing the fistula/perforation.
Have a significant risk of hemorrhage (per investigator clinical judgment) as defined in the protocol.
Have superior vena cava syndrome or symptoms of spinal cord compression that requires urgent medical intervention.

NOTE: Other protocol defined Inclusion/Exclusion criteria apply.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation: Randomized
Model: Parallel assignment
Masking: Quadruple blind
Primary purpose: Treatment

Study locations

United States · 36 centers

ACRC Arizona Clinical Research Center — Tucson
Clermont Oncology Center — Clermont
Cancer Care Centers of Brevard, Inc — Palm Bay
Northside Hospital Atlanta — Atlanta
Illinois Cancer Specialists — Niles
Fort Wayne Medical Oncology and Hematology, Inc — Fort Wayne
McFarland Clinic — Ames
Helen G. Nassif Community Cancer Center — Cedar Rapids
… and 28 more centers

China · 34 centers

Jilin Cancer Hospital — Changchun
Affiliated Hospital of Hebei University — Baoding
Beijing Friendship Hospital, Capital Medical University — Beijing
Peking Union Medical College Hospital — Beijing
Beijing Chest Hospital,Capital Medical University — Beijing
The First Affiliated Hospital of Bengbu Medical College — Bengbu
Fujian Provincial Cancer Hospital — Fuzhou
Guangdong General Hospital — Guangzhou
… and 26 more centers

Turkey (Türkiye) · 22 centers