Hypofractionated Chemoradiotherapy With Tislelizumab and Surufatinib for Unresectable Stage III NSCLC

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorSun Yat-sen University

About this trial

This phase II trial employs a prospective, randomized, parallel-group design to evaluate the efficacy and safety of hypofractionated radiotherapy combined with tislelizumab and surufatinib. Eligible patients are randomly assigned to one of two arms: Experimental Group A receives hypofractionated chemoradiotherapy plus concurrent tislelizumab and surufatinib, followed by consolidation therapy with tislelizumab plus surufatinib; Experimental Group B receives the same hypofractionated chemoradiotherapy plus concurrent tislelizumab alone, followed by tislelizumab consolidation.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Males or females aged 18 to 75 years or older;

Patients must have histologically or cytologically confirmed non-small cell lung cancer (NSCLC);

Unresectable Stage III disease according to AJCC 8th staging system;

Negative for known driver gene mutations;

Disqualifiers

Concurrent enrolment in another clinical study, unless it is an observational(non-interventional) clinical study;

Mixed small cell and non-small cell lung cancer histology;

Recent major surgery within 4 weeks prior to entry into the study (excluding the placement of vascular access;

Active or prior documented autoimmune disease within the past 2 years;

Trial design

Design model

Parallel

Treatments tested in this trial

  • Radiotherapy

    Radiation

    Split-course hypofractionated thoracic radiotherapy

  • Concurrent chemotherapy

    Drug

    Weekly nab-paclitaxel and cisplatin during radiotherapy

  • Tislelizumab

    Drug

    Tislelizumab 200mg every three weeks during and following radiotherapy

  • Surufatinib

    Drug

    Surufatinib during and following radiotherapy

Treatment groups

160 Participants
are divided into 2 treatment groups
Group A: Study group AExperimental treatment 4 interventions
Group B: Study group BExperimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

Progression-free survival

The time from randomization to the first documented disease progression or death from any cause, whichever occurs first.

Time frame
18-month

Secondary outcomes

1

Overall survival

The time from randomization to death from any cause, censored at the last follow-up date.

Time frame
18-month
2

Treatment related toxicity

Graded by CTCAE 5.0

Time frame
18-month

Other outcomes

Sponsors and contacts

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