Trial · NCT06712355
Safety and Efficacy of BNT327, an Investigational Therapy in Combination With Chemotherapy for Patients With Untreated Small-cell Lung Cancer
NCT06712355, Phase 3, Recruiting, BioNTech SE
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Safety and Efficacy of BNT327, an Investigational Therapy in Combination With Chemotherapy for Patients With Untreated Small-cell Lung Cancer. Trials, record NCT06712355. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT06712355
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Safety and Efficacy of BNT327, an Investigational Therapy in Combination With Chemotherapy for Patients With Untreated Small-cell Lung Cancer
- NCT number
- NCT06712355
- Status
- Recruiting
- Phases
- Phase 3
- Enrollment
- 621 participants, estimated
- Lead sponsor
- BioNTech SE
- Conditions
- Extensive-stage Small-cell Lung Cancer
- Interventions
- Pumitamig, Atezolizumab, Etoposide, Carboplatin (or cisplatin if carboplatin is not tolerated)
- First posted
- 2024-12-02
- Last updated
- 2026-10-14
Source ClinicalTrials.gov
Registered outcomes14
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Overall survival (OS) | Up to approximately 46 months | OS defined as the time from randomization to death from any cause. |
| Secondary | Progression-free survival (PFS) | Up to approximately 46 months | PFS defined as the time from randomization to first objective tumor progression (progressive disease per Response Evaluation Criteria in Solid Tumors version 1.1 \[RECIST v1.1\]), or death from any cause, whichever occurs first. |
| Secondary | Objective response rate (ORR) | Up to approximately 46 months | ORR defined as the proportion of participants in whom a complete response (CR) or partial response (PR) (based on investigator's assessment per RECIST v1.1) is observed as best overall response with confirmation. |
| Secondary | Duration of response (DOR) | Up to approximately 46 months | DOR defined as the time from onset of objective response (confirmed CR or PR based on investigator's assessment 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. |
| Secondary | PFS rate based on investigator's assessment | At 6, 12, and 18 months | |
| Secondary | OS rate | At 6, 12, 18, and 24 months | |
| Secondary | Occurrence of treatment-emergent adverse events (TEAEs) including Grade ≥3, serious, and fatal TEAEs by relationship | From the first dose of study treatment to the 90-Day Follow-up Visit | TEAEs graded according to (US) National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0 |
| Secondary | Occurrence of dose delay, infusion interruption and discontinuation of study treatment due to TEAEs (including related TEAEs) | From first to last dose of study treatment, i.e., up to 2 years | |
| Secondary | 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) | Up to approximately 46 months | Global health status/QoL scale ranges in score from 0 to 100 with a high scale score representing a higher response level (e.g., high score for global health status/QoL is high QoL: high score for symptom scale/item is high symptomatology or problems). |
| Secondary | Change from baseline in EORTC QLQ-C30 physical functioning | Up to approximately 46 months | Physical functioning scale ranges in score from 0 to 100 with a high scale score representing a higher response level (e.g., high score for functional scale is high/healthy level of functioning). |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT06712355
GET https://conductscience.org/api/trials/v1/NCT06712355/registered