Is NCT06712355 recruiting in Fort Wayne, IN?

Yes, NCT06712355 is currently recruiting participants at its Fort Wayne, IN location. This extensive-stage small-cell lung cancer clinical trial is actively enrolling qualified participants.

Is participation in this Fort Wayne clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

Extensive-stage Small-cell Lung Cancer Clinical Trial in Fort Wayne, IN

Q: How do I join the extensive-stage small-cell lung cancer clinical trial in Fort Wayne?

To join this clinical trial in Fort Wayne, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

About This Extensive-stage Small-cell Lung Cancer Study in Fort Wayne

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).

Sponsor: BioNTech SE

Who Can Participate

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.

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Fort Wayne?

Yes, this clinical trial (NCT06712355) has an active research site in Fort Wayne, IN that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Extensive-stage Small-cell Lung Cancer Treatment Options in Fort Wayne, IN

If you're searching for extensive-stage small-cell lung cancer treatment options in Fort Wayne, IN, this clinical trial (NCT06712355) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Fort Wayne research site is actively enrolling participants for this clinical trial. You'll receive care from experienced extensive-stage small-cell lung cancer specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all extensive-stage small-cell lung cancer clinical trials near you to find additional studies recruiting in your area.

Extensive-stage Small-cell Lung Cancer Clinical Trial in Fort Wayne, IN

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