Tislelizumab in Combination with Chemotherapy ± Radiotherapy for Extensive-Stage Oligometastatic Small Cell Lung Cancer.

ConditionSmall Cell Lung Cancer Extensive Stage

Trial statusNot yet recruiting

Trial phasePhase 2

Trial typeInterventional

Biological sexAll

Age18+

SponsorHebei Medical University Fourth Hospital

About this trial

The goal of this clinical trial is to learn the efficacy and safety of tislelizumab in combination with chemotherapy(etoposide/cisplatin ) ± concurrent radiotherapy for extensive-stage oligometastatic small cell lung cancer. 64 Patients with Extensive-Stage Oligometastatic Small Cell Lung Cancer will be randomly divided into the experimental group (tislelizumab combined with chemotherapy and radiotherapy) and the control group (tislelizumab combined with chemotherapy).Researchers will compare treatment efficacy and safety between the two groups.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients must be ≥ 18 years old;

Signed written informed consent;

Histologically or cytologically confirmed oligometastatic extensive-stage small cell lung cancer (oligometastasis is defined as the number of distant metastatic organs≤ 3, and the number of metastases ≤ 5; The ninth edition of the AJCC/UICC/IASLC TNM Staging Criteria for Lung Cancer (Annex 1), extensive-stage SCLC for any T stage, any N stage, M1a/b/c or T3-4 cannot be included in a tolerable radiotherapy program due to multiple nodules in the lungs or excessive tumor size);

chemotherapy must include a combination of cisplatin and etoposide;

Disqualifiers

Personnel involved in the design and/or conduct of this study.

Previous receipt of investigational drug in this study.

Concurrent enrollment in another clinical study, unless it is an observational (non-interventional) clinical study or the follow-up phase of an interventional study.

There are medical contraindications to etoposide-platinum-based chemotherapy.

Trial design

Design model

Parallel

Treatments tested in this trial

radiotherapy
Radiation
Palliative radiotherapy for oligometastases can be combined with chemoradiotherapy and immunomaintenance therapy period. The investigator determines the number, timing and regimen of oligometastases according to the location, size, symptoms and patient tolerance of oligometastases
immunechemotherapy
Drug
Tislelizumab in Combination With Chemotherapy(etoposide/cisplatin )

Treatment groups

64 Participants

are divided into 2 treatment groups

Group A: experimental groupExperimental treatment 2 interventions

Group B: placebo groupPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

Progression free survival

Time frame

2years

Secondary outcomes

Overall survival

Time frame

2years

Sponsors and contacts

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

Hebei Medical University Fourth Hospital

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: