A study to examine pharmacokinetics, effectiveness, and safety of BAT3306 plus chemotherapy and compare with EU-Keytruda® and US-Keytruda® in participants aged greater than or equal to 18 years with Stage IV non squamous non-small cell lung cancer

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. - NIL

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/12/078579

Enrollment

676

Registered

2024-12-26

Start date

Unknown

Completion date

Unknown

Last updated

2025-02-03

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

Conditions

Health Condition 1: C349- Malignant neoplasm of unspecifiedpart of bronchus or lung

Interventions

Intervention1: BAT3306, EU-Keytruda®, and US-Keytruda®: BAT3306, EU-Keytruda®, and US-Keytruda®, 100 mg/4.0 ml, Concentrate for solution for infusion BAT3306, EU-Keytruda®, and US-Keytruda® must be a

Eligibility

Inclusion criteria

Inclusion criteria: Participants are eligible to be included in the study only if all of the following criteria are met: 1. Male or female, age =18 years on the day of signing informed consent. 2. Participants are able to give voluntary informed consent and understand the study and are willing to follow and complete all the test procedures. 3. Life expectancy =3 months. 4. Eastern Cooperative Oncology Group (ECOG) performance status =1. 5. Histologically/cytologically confirmed diagnosis of Stage IV (AJCC 8th edition) nsNSCLC. 6. Tumors without EGFR mutation/ROS1 rearrangement /ALK rearrangement.

Exclusion criteria

Exclusion criteria: Participant must be excluded from participating in the study if the participant: Medical Conditions 1. Is pregnant or a nursing female. 2. Has predominantly squamous cell histology NSCLC. Mixed tumors will be categorized by the predominant cell type; if small cell elements are present, the participant is ineligible. 3. Is currently participating and receiving an investigational agent or has participated in a study of an investigational agent and received an investigational agent or used an investigational device within 4 weeks prior to administration of the first dose of study intervention.

Design outcomes

Primary

Measure	Time frame
1. To compare the pairwise PK similarities between BAT3306 and EU-Keytruda®, BAT3306 and US-Keytruda®, and between EU-Keytruda® and US-Keytruda® in participants with nsNSCLC 2. To compare the efficacy of BAT3306 and pooled EU-Keytruda® and US-Keytruda® given with chemotherapy as first line treatment using ORR assessed by BIRC to show clinical equivalence in participants with nsNSCLCTimepoint: 1. PK parameters at Cycle 6, 1st cycle at Cycle 1 2. Confirmed best overall tumor response rate up to Week 24	—

Measure

Time frame

1. To compare the pairwise PK similarities between BAT3306 and EU-Keytruda®, BAT3306 and US-Keytruda®, and between EU-Keytruda® and US-Keytruda® in participants with nsNSCLC 2. To compare the efficacy of BAT3306 and pooled EU-Keytruda® and US-Keytruda® given with chemotherapy as first line treatment using ORR assessed by BIRC to show clinical equivalence in participants with nsNSCLCTimepoint: 1. PK parameters at Cycle 6, 1st cycle at Cycle 1 2. Confirmed best overall tumor response rate up to Week 24

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Secondary

Measure	Time frame
1. To evaluate the PK characteristics of BAT3306, EU-Keytruda®, & US-Keytruda® in participants with nsNSCLCTimepoint: 1. PK parameters at Cycle 1 & Cycle 6;2. To evaluate the immunogenicity of BAT3306 & pooled EU-Keytruda® & US-Keytruda® in participants with nsNSCLCTimepoint: 2. Immunogenicity evaluation at Week 2, Week 4, Week 12, Week 18, Week 24, Week 36, Week 54 & EOT;3. To further evaluate the efficacy of BAT3306 & pooled EU-Keytruda® & US Keytruda® given with chemotherapyTimepoint: At Week 6, Week 12, Week 18, & Week 24	—

Measure

Time frame

1. To evaluate the PK characteristics of BAT3306, EU-Keytruda®, & US-Keytruda® in participants with nsNSCLCTimepoint: 1. PK parameters at Cycle 1 & Cycle 6;2. To evaluate the immunogenicity of BAT3306 & pooled EU-Keytruda® & US-Keytruda® in participants with nsNSCLCTimepoint: 2. Immunogenicity evaluation at Week 2, Week 4, Week 12, Week 18, Week 24, Week 36, Week 54 & EOT;3. To further evaluate the efficacy of BAT3306 & pooled EU-Keytruda® & US Keytruda® given with chemotherapyTimepoint: At Week 6, Week 12, Week 18, & Week 24

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Countries

China, Georgia, India, Philippines, Slovakia, Thailand, Turkey

Contacts

Public ContactJinu Jose

IQVIA RDS (India) Private Limited

jinu.jose@iqvia.com9886203019

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026