Health TrialsbyHealthPanel

A Study Evaluating BAT3306 Compared With Keytruda® in NSCLC Cancer Participants

ConditionCarcinoma, Non-Small-Cell Lung
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-75
SponsorBio-Thera Solutions

About this trial

Comparing the PK similarity of BAT3306 and Keytruda; in NSCLC participants who were completely removed by surgery as an auxiliary treatment

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Male or female, aged ≥18 and ≤75 years on the day of signing the Informed Consent Form (ICF);

Participants are able to give voluntary informed consent and understand the study and are willing to follow and complete all the test procedures;

Pathologically confirmed non-small cell lung cancer (NSCLC) after surgery, with a clear histological type and a pathology report provided;

Disqualifiers

Presence of EGFR gene mutation;

Pathological diagnosis of small cell lung cancer or mixed tumors with small cell components, large cell neuroendocrine carcinoma (LCNEC), or sarcomatoid tumors;

Prior treatment with anti-PD-1, anti-PD-L1/2, anti-CD137, CTLA-4 modulators, or any other immunomodulatory agents.

Severe acute or chronic infection, including any active infection requiring systemic anti-infective therapy within 2 weeks prior to randomization;

Trial design

Design model

Parallel

Treatments tested in this trial

  • BAT3306

    Drug

    One vial of 4 mL of concentrate contains 100 mg of BAT3306

  • US-Keytruda®

    Drug

    One vial of 4 mL of concentrate contains 100 mg of pembrolizumab

Treatment groups

140 Participants
are divided into 2 treatment groups
Group A: BAT3306Experimental treatment 1 intervention
Group B: US-Keytruda® armActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

PK equivalence

To compare the pharmacokinetic (PK) similarity of BAT3306 versus US-Keytruda® as adjuvant therapy in participants with completely resected NSCLC：AUC0-τ, ss

Time frame
Cycle 1 day 1, day 2, day 3, day 5, day 8, day 15, day 22(each cycle is 21 days)

Secondary outcomes

1

PK equivalence

To evaluate the PK characteristics of BAT3306 and US-Keytruda® in participants with completely resected NSCLC：Cthough

Time frame
Cycle 1，2，3，4，5，6，8，12，18（each cycle is 21 days）
2

immunogenicity equivalence

To evaluate the immunogenicity of BAT3306 and US-Keytruda® in participants with completely resected NSCLC:Anti-drug antibody (ADA) positive rate at Weeks 2, 4,12,18,24

Time frame
Weeks 2, 4,12,18,24
3

Vital signs

Number of cases with abnormal vital signs results

Time frame
The third week of every 4 cycles and EOT（No more than 18 cycles）（each cycle is 21 days)
4

Physical examination

Number of cases with abnormal Physical examination results

Time frame
The third week of every 4 cycles and EOT（No more than 18 cycles）（each cycle is 21 days)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Bio-Thera Solutions

Lead sponsor

Source ClinicalTrials.gov
Apply now