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RecruitingNCT07131319Updated Jun 25, 2026

SFRT+Tislelizumab+Platinum Chemotherapy for Unresectable Stage III NSCLC

A Phase 2/3 interventional study of Spatially Fractionated Radiotherapy (SFRT) and Tislelizumab, Carboplatin, Pemetrexed in Non-Small Cell Lung Cancer, sponsored by Second Affiliated Hospital of Nanchang University. Recruiting at 1 site in China. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2026-06-25.

Sponsored by Second Affiliated Hospital of Nanchang University · Phase 2/3, Interventional, and Treatment

From the registry’s dates

  • Started Apr 2025; still recruiting 1 year 6 months later.

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Phase
Phase 2/3
Study type
Interventional
Enrollment
30
Allocation
Not applicable
Ages
18 Years to 85 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-14

Among 41 studies testing tislelizumab in Carcinoma, Non-Small-Cell Lung — 20 open to participants now, 22 under way, 2 of them phase 3. tislelizumab · Carcinoma, Non-Small-Cell Lung.

Planned enrollment
28th of 41
30 · median 39
Started
2025
with 4 others
Phase 2/3
Only one
of the 41
Primary completion
2028-10
later than 15 of 21 live
Registered
32nd of 41
by date

Among the 41 studies testing tislelizumab in Carcinoma, Non-Small-Cell Lung, this one is the 28th largest by planned enrollment, is one of 5 that started in 2025, is the only one in phase 2/3, reaches primary completion later than 15 of the 21 other live ones, and was the 32nd registered.

Carcinoma, Non-Small-Cell Lung

7,624 studies on the registry are indexed under Carcinoma, Non-Small-Cell Lung; 1,837 are open to participants now.

Browse Carcinoma, Non-Small-Cell Lung studies →

Open to participants now

20 of the 41 studies testing tislelizumab in Carcinoma, Non-Small-Cell Lung are open now, in 1 country. Recruiting first, the newest first:

14 more — sign in →

By country, each count listing its studies:

All 20 open studies →

About tislelizumab

tislelizumab: first FDA approval 2024 (TEVIMBRA), first EMA approval 2023. What it is approved for, and how studies give it, is on its page →

Who these studies take

Of the 1,326 Carcinoma, Non-Small-Cell Lung studies recruiting now, 988 (75%) set no upper age limit and 225 (17%) stop at 75 or younger; 34 take children under 18; 40 take healthy volunteers.

This study: 18 Years to 85 Years · all sexes · no healthy volunteers.

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02

Study summary

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?

Read the detailed description

Research Title: A Clinical Study on Induction Treatment with Spatial Fractionated Radiotherapy (SFRT) Concurrent with Tislelizumab Plus Platinum-based Doublet Chemotherapy for Initially Unresectable Stage III Non-small Cell Lung Cancer (NSCLC) Research Objective: To explore the efficacy and safety of induction treatment with spatial fractionated radiotherapy (SFRT) concurrent with tislelizumab plus platinum-based doublet chemotherapy for initially unresectable stage III non-small cell lung cancer (NSCLC).

Design Type: Interventional Study Research Subjects: Patients with non-small cell lung cancer diagnosed by pathological histology or cytology, staged as stage III (T3 - 4N1 - 2M0) according to the 8th edition of AJCC, defined as initially unresectable by the multidisciplinary team (MDT), without known EGFR and ALK mutations, aged ≥ 18 years old, with an ECOG PS score of 0 - 1.

Sample Size: 30 cases

03

Conditions studied

  • Non-Small Cell Lung Cancer
04

Who can participate

Ages eligible
18 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • The patient has 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).

Exclusion criteria

Exclusion Criteria:

  • Has participated in another clinical study using research products within the past 3 weeks.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Histologically or cytologically confirmed

The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).

Your pathology report is the document that shows this.

05

Study design

Phase
Phase 2 / Phase 3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
30 participants (estimated)

Study arms

  • Experimental
    SFRT concurrent with tislelizumab and platinum - based doublet chemotherapy

    SFRT concurrent with immunochemotherapy is given q3w for 3 cycles. Here are details: Radiotherapy: Select several 1 - cm - diameter spherical areas in the primary tumor's hypoxic region, 1.5 - 2 cm apart. Each area receives a single 12 - Gy high - dose radiotherapy, precisely targeting the hypoxic part to enhance the effect. Chemotherapy \& Immunotherapy: 1 - 3 days after radiotherapy, combine 200 mg of tislelizumab with platinum - based doublet chemotherapy. NSCLC chemo - drug combos vary by pathology. For adenocarcinoma, use pemetrexed (500 mg/m² d1) + carboplatin (AUC 5, d1). For other types, use albumin - bound paclitaxel (100 mg/m² d1,8) + carboplatin (AUC 5, d1).

    Other: Spatially Fractionated Radiotherapy (SFRT) · Drug: Tislelizumab, Carboplatin, Pemetrexed · Drug: Tislelizumab, paclitaxel, Carboplatin

Interventions

  • OtherSpatially Fractionated Radiotherapy (SFRT)

    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.

  • DrugTislelizumab, Carboplatin, Pemetrexed

    Drug pages: Tislelizumab · Carboplatin · Pemetrexed

    For adenocarcinoma, pemetrexed (500 mg/m², day 1) + carboplatin (AUC 5, day 1) is used.

  • DrugTislelizumab, paclitaxel, Carboplatin

    Drug pages: Tislelizumab · Paclitaxel · Carboplatin

    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.

06

What researchers measure

Primary outcomes

  1. Surgical resection rate

    The percentage of patients who underwent surgical resection after induction treatment

    Time frame: At the end of the surgery

07

Study locations

1 of 1 sites recruiting
  • Nanchang City, Jiangxi Province
    Nanchang, Jiangxi 330000, China
    Recruiting
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Apr 2025 (actual). Primary completion is estimated for Oct 2028, 42 months after the start.

Of 56 phase 2/3 interventional studies under Carcinoma, Non-Small-Cell Lung, half reached primary completion within 53 months of starting (the median), counting those still running; a quarter within 40. This study's planned 42 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
Apr 25, 2025
First posted
Aug 20, 2025
StartActual
Apr 21, 2025
Primary completionEst.
Oct 31, 2028
CompletionEst.
Dec 31, 2028
Last update
Jun 25, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jun 25, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07131319
Lead sponsor
Second Affiliated Hospital of Nanchang University
Responsible party
Sponsor
First posted
Aug 20, 2025
Start date
Apr 21, 2025
Primary completion
Oct 31, 2028 (estimated)
Completion
Dec 31, 2028 (estimated)
Last update
Jun 25, 2026

Study contacts

jing cai Jing Cai
Contact
cjdl879@163.com
15270905381

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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Studies of the drugs tested here: Tislelizumab · Carboplatin · Pemetrexed · Paclitaxel

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