A Phase I/III, Multi-center, Randomized, Double-blind Study of BAT3306 plus Chemotherapy versus Keytruda® plus Chemotherapy to Evaluate Pharmacokinetics, Efficacy, and Safety in Participants with Stage IV Non-squamous Non-small Cell Lung Cancer.

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-510640-32-00

Acronym

BAT-3306-002-CR

Enrollment

Registered

2024-07-16

Start date

2024-10-16

Completion date

2025-05-08

Last updated

2025-03-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stage IV Non-squamous non-small cell lung cancer

Brief summary

PK parameters, Confirmed best overall tumor response as assessed by BIRC according to RECIST Version 1.1 (tumor assessments after initiation of a new anti-cancer treatment are excluded)

Detailed description

PK parameters Ctrough, Vital signs, physical examination, electrocardiogram parameters, clinical laboratory tests, adverse events, Immunogenicity evaluation: ADA positive rate, ADA titer, and NAb, ORR based on tumor response as assessed by BIRC, and confirmed best overall response by the end of study assessed according to RECIST Version 1.1 • DoR • PFS • OS by local radiologist/Investigator after, Relationship between ADA or NAb results and drug concentrations, tumor responses and adverse events

Interventions

DRUGKEYTRUDA 25 mg/mL concentrate for solution for infusion

DRUGPemetrexed Fresenius Kabi 25 mg/ml concentrate for solution for infusion

DRUGRecombinant Humanized Anti-PD-1 Monoclonal Antibody Solution for injection

DRUGPEMBROLIZUMAB

DRUGCarboplatin Kabi 10 mg/ml Konzentrat zur Herstellung einer Infusionslösung

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
PK parameters, Confirmed best overall tumor response as assessed by BIRC according to RECIST Version 1.1 (tumor assessments after initiation of a new anti-cancer treatment are excluded)	—

Secondary

Measure	Time frame
PK parameters Ctrough, Vital signs, physical examination, electrocardiogram parameters, clinical laboratory tests, adverse events, Immunogenicity evaluation: ADA positive rate, ADA titer, and NAb, ORR based on tumor response as assessed by BIRC, and confirmed best overall response by the end of study assessed according to RECIST Version 1.1 • DoR • PFS • OS by local radiologist/Investigator after, Relationship between ADA or NAb results and drug concentrations, tumor responses and adverse events	—

Measure

Time frame

—

Countries

Slovakia

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026