Evaluating BAT3306 with chemotherapy compared to Keytruda in advanced 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.
This study is testing a new treatment called BAT3306 combined with chemotherapy to see if it works better than Keytruda for people with advanced lung cancer who haven't been treated before.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 676 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Bio-Thera Solutions Industry-sponsored |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (Wuhan, Hubei) |
| Trial ID | NCT06280196 on ClinicalTrials.gov |
What this trial studies
This multi-center, double-blind, randomized study aims to evaluate the pharmacokinetics, efficacy, and safety of BAT3306 in combination with pemetrexed and carboplatin, compared to Keytruda® in patients with previously untreated Stage IV non-small cell lung carcinoma (nsNSCLC). Participants will be monitored for clinical equivalence and potential benefits of BAT3306 over the established treatment. The study will include a diverse patient population to ensure robust data collection and analysis.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with a confirmed diagnosis of Stage IV non-small cell lung carcinoma without specific genetic mutations.
Not a fit: Patients with predominantly squamous cell histology NSCLC or those with specific genetic alterations like EGFR mutations may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new treatment option for patients with advanced lung cancer, potentially improving outcomes compared to existing therapies.
How similar studies have performed: Other studies have shown promising results with similar approaches, but the specific combination of BAT3306 and chemotherapy in this context is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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, per the investigator's evaluation.
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
Where this trial is running
Wuhan, Hubei
- Union Hospital Tongji Medical College Huazhong University of Science & Technology — Wuhan, Hubei, China (Recruiting)
Study contacts
- Principal investigator: Xiaorong Dong, Dr. — Wuhan Union Hospital, China
- Study coordinator: Yu Sun, PM
- Email: yusun@bio-thera.com
- Phone: 86-15040223137
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.