Trial · NCT06449209
Safety, Preliminary Effectiveness of BNT327, an Investigational Therapy for Patients With Small-cell Lung Cancer in Combination With Chemotherapy
NCT06449209, Phase 2, Active not recruiting, BioNTech SE
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Safety, Preliminary Effectiveness of BNT327, an Investigational Therapy for Patients With Small-cell Lung Cancer in Combination With Chemotherapy. Trials, record NCT06449209. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT06449209
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Safety, Preliminary Effectiveness of BNT327, an Investigational Therapy for Patients With Small-cell Lung Cancer in Combination With Chemotherapy
- NCT number
- NCT06449209
- Status
- Active not recruiting
- Phases
- Phase 2
- Enrollment
- 110 participants, estimated
- Lead sponsor
- BioNTech SE
- Conditions
- Extensive-stage Small-cell Lung Cancer, Small-cell Lung Cancer
- Interventions
- BNT327 Dose Level 1 (DL1), BNT327 Dose Level 2 (DL2), Etoposide, Carboplatin, Paclitaxel, Topotecan
- First posted
- 2024-06-07
- Last updated
- 2026-11-06
Source ClinicalTrials.gov
Registered outcomes15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Occurrence of treatment emergent adverse events (TEAEs), adverse events of special interest (AESIs), treatment-related TEAEs, treatment-related serious adverse events (SAEs) and treatment-related treatment emergent SAEs | up to 100 days after the last dose of treatment | In the combination treatment regimen according to the (US) National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0 (NCI CTCAE v5.0). By treatment arm and overall. |
| Primary | Occurrence of dose interruption, reduction, and discontinuation of study treatment due to TEAEs | up to 100 days after the last dose of treatment | By treatment arm and overall. |
| Primary | Objective Response Rate | until end-of-treatment visit, i.e., up to 24 months after the first dose of treatment | Defined as the proportion of participants in whom a confirmed complete response (CR) or partial response (PR) (per Response Evaluation Criteria in Solid Tumors version 1.1 \[RECIST 1.1\] based on the investigator's assessment) is observed as best overall response. By treatment arm. |
| Primary | Best percentage change from baseline in the tumor size | Until end-of-treatment visit, i.e., up to 24 months after the first dose of treatment | Based on the investigator's tumor assessment according to RECIST 1.1. Defined as the change from baseline in percent to the minimal tumor size until tumor progression/recurrence or death (whichever comes first). By treatment arm. |
| Primary | Proportion of participants who have achieved early tumor shrinkage | up to 2 months after first dose of treatment | Defined as ≥10% decrease in the pretreatment sum of diameters at first post-treatment tumor scan in target lesions. By treatment arm. |
| Secondary | PK assessment: Maximum concentration (Cmax) derived from serum concentration of investigational medicinal product (IMP) | from pre-dose to 21 days after study treatment | By treatment arm. Only for the first cycle. |
| Secondary | PK assessment: Area under the curve during the dosing interval (AUCtau) values derived from serum concentration of IMP | from pre-dose to 21 days after study treatment | By treatment arm. Only for the first cycle. |
| Secondary | Incidence of detectable BNT327 antidrug antibodies in serum | from pre-dose to 100 days after last dose of study treatment | By treatment arm and overall. |
| Secondary | Duration of Response | up to 24 months after completion of study treatment of the last participant | Defined as the time from first objective response (CR or PR per RECIST 1.1) to first occurrence of objective tumor progression or death from any cause, whichever occurs first based on investigator's review. |
| Secondary | Disease Control Rate | up to 24 months after completion of study treatment of the last participant | Defined as the proportion of participants in whom a confirmed CR or PR or stable disease (per RECIST 1.1, stable disease assessed at least 6 weeks after first dose) is observed as best overall response based on the investigator's review. |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 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/NCT06449209
GET https://conductscience.org/api/trials/v1/NCT06449209/registered