SFRT+Tislelizumab+Platinum Chemotherapy for Unresectable Stage III NSCLC

ConditionNon-Small Cell Lung Cancer

Trial statusRecruiting

Trial phasePhase 2, Phase 3

Trial typeInterventional

Biological sexAll

Age18-85

SponsorSecond Affiliated Hospital of Nanchang University

About this trial

The aim of this clinical trial is to understand whether spatial fractionated radiotherapy (SFRT) in combination with tislelizumab and platinum-based doublet chemotherapy given concurrently as induction treatment is effective in treating initially unresectable stage Ⅲ non-small cell lung cancer (NSCLC). It will also explore the safety of this treatment modality. The main questions it aims to answer are:

Will spatial fractionated radiotherapy (SFRT) in combination with tislelizumab and platinum-based doublet chemotherapy given concurrently as induction treatment increase the surgical resection rate of patients with initially unresectable stage Ⅲ non-small cell lung cancer? What adverse reactions will patients experience when receiving spatial fractionated radiotherapy (SFRT) in combination with tislelizumab and platinum-based doublet chemotherapy given concurrently as induction treatment?

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

The patient has histologically or cytologically confirmed stage III non-small cell lung cancer (NSCLC) that is deemed unresectable after discussion in the multidisciplinary team (MDT), which is classified as T3-4N1-2M0 according to the 8th edition of the American Joint Committee on Cancer (AJCC).

Disqualifiers

Has participated in another clinical study using research products within the past 3 weeks.

Trial design

Design model

Single group

Treatments tested in this trial

Spatially Fractionated Radiotherapy (SFRT)
Other intervention
Several spherical volumes (with a diameter of 1 cm) are selected within the hypoxic area of the primary tumor. The distance between each spherical volume is 1.5 - 2 cm, and a high-dose radiotherapy of 12 Gy × 1F is delivered.
Tislelizumab, Carboplatin, Pemetrexed
Drug
For adenocarcinoma, pemetrexed (500 mg/m², day 1) + carboplatin (AUC 5, day 1) is used.
Tislelizumab, paclitaxel, Carboplatin
Drug
For NSCLC with pathological types other than adenocarcinoma, nab-paclitaxel (100 mg/m² on day 1 and day 8) + carboplatin (AUC 5, day 1) is used.

Treatment groups

30 Participants

are divided into 1 treatment group

Group A: SFRT concurrent with tislelizumab and platinum - based doublet chemotherapyExperimental treatment 3 interventions

Trial outcomes

Primary outcomes

Surgical resection rate

The percentage of patients who underwent surgical resection after induction treatment

Time frame

At the end of the surgery

Sponsors and contacts

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

Second Affiliated Hospital of Nanchang University

Lead sponsor

Source ClinicalTrials.gov

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