BNT327 and Chemotherapy for Small-cell Lung Cancer

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

Recruiting Phase 3 Interventional Study
Extensive-stage Small-cell Lung Cancer
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
Ready to participate?

Review the details below, then apply to join this clinical trial.

At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
621 (estimated)
Sponsor
BioNTech SE · Industry
Who this trial is looking for

This trial is looking for patients with untreated extensive-stage small-cell lung cancer. Participants will receive either BNT327 combined with chemotherapy or a different combination of treatments to see which works better.

Are You a Good Fit for This Trial?
Rules you out Symptomatic brain metastasesUncontrolled hypertensionPoorly controlled diabetes

You may be able to join if

  • I have been diagnosed with extensive-stage small-cell lung cancer.
  • I have not had previous treatment for my cancer.
  • I have at least one measurable tumor for the study.
  • I have a performance status of 0 or 1.
  • I have normal blood and organ function.

You may not be able to join if

  • I have small-cell lung cancer with mixed histologies.
  • I have received certain types of treatment in the last 2 to 4 weeks.
  • I have been treated with specific anti-cancer drugs before.
  • I have untreated brain metastases that are causing symptoms.
  • I have uncontrolled high blood pressure or poorly controlled diabetes.
  • I have a serious or non-healing wound.
  • I have a significant risk of bleeding.
  • I have symptoms that require urgent medical attention.

Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.

Think this trial could be right for you?

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About This Trial

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).

Trial Locations
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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…
Contacts

BioNTech clinical trials patient information

+49 6131 9084

patients@biontech.de

CONTACT