A Study to Evaluate PK, Efficacy, and Safety of BAT3306 Plus Chemo and Compare With Keytruda®(EU/US) in Participants With IV nqNSCLC

Carcinoma, Non-Small-Cell Lung Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06280196
• Other study ID #: BAT-3306-002-CR
• Status: Not yet recruiting
• Phase: Phase 3
• Start date: August 15, 2024
• Est. completion date: October 30, 2028

Study information

• Verified date: March 2024
• Source: Bio-Thera Solutions
• Contact: Yu Sun, PM
• Phone: 86-15040223137
• Email: yusun[@]bio-thera.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To compare the pairwise PK similarities between BAT3306, EU-Keytruda, and US-Keytruda, all administered with pemetrexed and carboplatin.

Description:

This is a multi-center, double-blind, randomized study that includes PK and clinical equivalence comparisons, aimed at comparing BAT3306 with Keytruda® in previously untreated participants with Stage IV nsNSCLC.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 676
• Est. completion date: October 30, 2028
• Est. primary completion date: July 30, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Participants are eligible to be included in the study only if all 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:

• Participant must be excluded from participating in the study if the participant:

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.

4. Before the first dose of study intervention:

• Had received prior systemic antineoplastic chemotherapy and targeted, biological therapy

• Had prior treatment with any other anti-PD-1, PD-L1 or PD-L2 agent or an antibody targeting other immuno-regulatory receptors or mechanisms. Examples of such antibodies include (but are not limited to) antibodies against TIGIT, IDO, PD-L1, CTLA-4, and LAG3.

• Has participated in any other BAT3306 study and has been treated with BAT3306.

• Had major surgery <3 weeks prior to first dose

• Received radiation therapy to the lung that is > 30 Gy within 6 months of the first dose of study intervention.

• Completed palliative radiotherapy within 14 days of the first dose of study intervention.

5. Is expected to require any other form of antineoplastic therapy while participating in the study. and so on

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung

Intervention

Drug:
• BAT3306
One vial of 4 mL of concentrate contains 100 mg of BAT3306
• EU-Keytruda®
One vial of 4 mL of concentrate contains 100 mg of pembrolizumab
• US-Keytruda®
One vial of 4 mL of concentrate contains 100 mg of pembrolizumab
• Pemetrexed
500 mg/m2 on Day 1 of each 21-day cycle of the study
• Carboplatin
Target AUC of 5 mg/mL/min on Day 1 of each 21-day cycle up to 4 cycles

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bio-Thera Solutions

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	clinical equivalence	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 nsNSCLC. Confirmed best overall tumor response rate as assessed by BIRC according to RECIST Version 1.1 (tumor assessments after initiation of a new anti-cancer treatment are excluded)	Week 3,5,7,9,12,15,EOT
Secondary	safety of BAT3306-AE	The Investigator and any qualified designees are responsible for detecting, documenting, and reporting events that meet the definition of an AE or SAE and remain responsible for following up AE that are serious, considered related to the study intervention or the study, or that caused the participant to discontinue the study.	From signed ICF to 90days after the last drug administration