ClinicalTrials.gg
Not yet recruitingNCT07845916QS-NSCLCUpdated Sep 29, 2026

Quad Shot Radiotherapy Combined With Tislelizumab and Platinum-Based Chemotherapy Before Surgery for Stage II-III Non-Small Cell Lung Cancer

A Phase 2 interventional study of Quad Shot Radiotherapy and Tislelizumab in Non-Small Cell Lung Cancer, sponsored by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology. Not yet recruiting at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-09-29.

Sponsored by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology · Phase 2, Interventional, and Treatment

Updated Sep 29, 2026Newly registeredGo to Updates ↓

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Phase
Phase 2
Study type
Interventional
Enrollment
12
Allocation
Not applicable
Ages
18 Years to 75 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
37th of 41
12 · median 39
Started
2026
with 6 others
Phase 2
26 of 41
17 open now
Primary completion
2027-06
later than 12 of 21 live
Registered
41st of 41
by date

Among the 41 studies testing tislelizumab in Carcinoma, Non-Small-Cell Lung, this one is the 37th largest by planned enrollment, is one of 7 that started in 2026, is one of 26 in phase 2, reaches primary completion later than 12 of the 21 other live ones, and was the 41st registered.

Carcinoma, Non-Small-Cell Lung

7,621 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 75 Years · all sexes · no healthy volunteers.

The full table on the hub →

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 41 studies testing tislelizumab in Carcinoma, Non-Small-Cell Lung, or all of them as a file.
02

Study summary

This study aims to evaluate a new pre-surgery (neoadjuvant) treatment for patients with stage II-III non-small cell lung cancer (NSCLC). Currently, standard pre-surgery treatment involves immunotherapy combined with chemotherapy. While effective, many patients still have residual tumor cells after this standard treatment.

Radiation therapy can not only kill tumor cells but also help the immune system recognize and fight cancer. The type of radiation used in this study is called "Quad Shot" (QS) radiotherapy. It is a short, high-dose, cyclical treatment designed to boost the effects of immunotherapy with less toxicity than standard daily radiation.

Patients in this study will receive 3 cycles of QS radiotherapy combined with Tislelizumab (an immunotherapy drug) and standard platinum-based chemotherapy before surgery. The main goal of this study is to see if this combined approach can make the tumor completely disappear under a microscope (called pathological complete response, or pCR). Researchers will also monitor the safety of the treatment, side effects, and how well patients tolerate the treatment before undergoing surgery. Approximately 12 patients will be enrolled in this study.

Read the detailed description

Background:

Neoadjuvant immune checkpoint inhibitor (ICI) combined with platinum-based chemotherapy has become a standard of care for resectable stage II-III NSCLC, as demonstrated by phase III trials such as CheckMate-816, KEYNOTE-671, and RATIONALE-315. However, a significant proportion of patients still fail to achieve deep pathological responses due to mechanisms such as poor antigen release, impaired antigen presentation, and an immunosuppressive tumor microenvironment (TME).

Radiotherapy possesses immunomodulatory properties, inducing immunogenic cell death and promoting antigen release. However, traditional continuous fractionated radiotherapy may deplete circulating lymphocytes and cause normal tissue damage. The "Quad Shot" (QS) regimen is a cyclical hypofractionated radiotherapy approach (14-14.8 Gy in 4 fractions over 2 days) that has shown low toxicity in palliative settings. Its cyclical, pulsatile nature may provide repeated immune stimulation and TME remodeling, making it a promising partner for immunotherapy.

Study Design:

This is a single-arm, prospective, exploratory phase II clinical study. Patients with histologically or cytologically confirmed, untreated, resectable stage II-IIIB NSCLC (including T3-4N2 IIIB, AJCC 9th edition) will be enrolled.

Patients will receive 3 cycles of neoadjuvant treatment (every 3 weeks):

Quad Shot radiotherapy (14-14.8 Gy/4 fractions, Day 1-2) Tislelizumab (200 mg, Day 3) Platinum-based doublet chemotherapy (Day 3): Carboplatin (AUC 5) or Cisplatin (75 mg/m²) combined with Pemetrexed (500 mg/m², for non-squamous) or Paclitaxel (175 mg/m², for squamous).

Following 3 cycles of neoadjuvant therapy, patients will undergo surgery 4-6 weeks (±7 days) after the last dose. Postoperative adjuvant therapy will be administered at the investigator's discretion according to NCCN and CSCO guidelines.

Objectives and Endpoints:

The primary objective is to evaluate the antitumor efficacy of this regimen, with the primary endpoint being the pathological complete response (pCR) rate. Secondary endpoints include major pathological response (MPR) rate, R0 resection rate, objective response rate (ORR) per RECIST v1.1, event-free survival (EFS), overall survival (OS), safety (NCI CTCAE v5.0), feasibility, surgical complications (Clavien-Dindo classification), and QS radiotherapy-related toxicities.

Sample Size:

A total of 12 patients will be enrolled, with at least 10 evaluable patients included in the primary endpoint analysis to account for an estimated 2 dropouts.

Study Duration:

The estimated enrollment period is 6-12 months, with an anticipated study completion date of December 2031.

03

Conditions studied

  • Non-Small Cell Lung Cancer

Keywords

  • NSCLC
  • Neoadjuvant Therapy
  • Quad Shot Radiotherapy
  • Tislelizumab
  • Platinum-based Chemotherapy
  • Immunotherapy
  • Pathological Complete Response
04

Who can participate

Ages eligible
18 Years to 75 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

  1. Age 18-75 years, either gender.
  2. or cytologically confirmed, untreated stage II-IIIB non-small cell lung cancer (NSCLC) (including T3-4N2 IIIB, AJCC 9th edition). Baseline staging must include PET/CT (or chest + upper abdomen contrast-enhanced CT + whole body bone scan) + brain MRI. Stage III patients will be further subdivided into IIIA and IIIB per AJCC 9th edition for separate recording, evaluation, and analysis.
  3. Evaluated as resectable by a multidisciplinary team including thoracic surgeons.
  4. At least one evaluable target lesion per v1.1.
  5. Performance Status 0-1.
  6. Adequate major organ function: Neutrophils ≥ 1.5×10\^9/L; ≥ 100×10\^9/L; > 9.0 g/dL; Serum creatinine ≤ 1.5× or (CrCl) ≥ 40 mL/min; /ALT ≤ 3×ULN; Total ≤ 1.5×ULN; /APTT within normal range; ≥ 1.2L or > 40% predicted.
  7. Signed written prior to any study-related procedures.
  8. Investigator judges that the patient is able to comply with the study protocol, willing and able to follow visit schedules, treatment plans, laboratory tests, and other study procedures.
  9. Negative pregnancy test at screening (for women of ). Subjects of childbearing potential (male and female) must agree to use effective from screening until 180 days after the last dose.

Exclusion criteria

Exclusion Criteria:

  1. Known or suspected disease (except vitiligo, Type I diabetes, or hypothyroidism requiring only hormone replacement therapy with no signs of recurrence).
  2. Requires systemic therapy (>10 mg/day prednisolone or equivalent) or other drugs within 14 days prior to enrollment (inhaled or topical steroids, and physiological replacement doses of adrenal corticosteroids are allowed).
  3. History of thoracic radiotherapy.
  4. Active bleeding before treatment.
  5. Severe heart, lung, liver, or kidney dysfunction, hematopoietic system disease, cachexia, or other conditions that make the patient unable to tolerate chemoradiotherapy.
  6. History of diabetes for more than 10 years with unsatisfactory blood glucose control.
  7. History of interstitial lung disease or non-infectious pneumonitis.
  8. NSCLC patients with EGFR sensitizing mutations or ALK fusion genes.
  9. Prior or concurrent other (except cured non-melanoma skin cancer and carcinoma in situ; or malignancies in complete remission for ≥ 2 years without requiring additional anti-tumor therapy during the study period).
  10. Prior treatment with , anti-PD-L1, anti-PD-L2, anti-CTLA-4, or other drugs targeting T-cell costimulatory or immune regulatory pathways.
  11. Active (HBV DNA ≥ 2000 IU/mL or 10\^4 copies/mL) or (HCV antibody positive and HCV-RNA above the lower limit of detection).
  12. positive or diagnosed with acquired immunodeficiency syndrome (AIDS).
  13. Received within 4 weeks prior to the start of study treatment.
  14. Known or suspected allergy to the study drugs or any related drugs in this trial.
  15. Pregnant or breastfeeding women.
  16. Investigator considers that the patient has other factors that may prevent completion of the study or affect subject safety or data collection.
Terms in these criteria, in plain language(23)

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.

RECIST

The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.

“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.

ECOG performance status

A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.

0
Fully active, no restrictions.
1
Limited in strenuous activity, but walking and able to do light work, such as housework or office work.
2
Walking and able to look after yourself, but unable to work; up and about more than half of waking hours.
3
Able to look after yourself only in part; in bed or a chair more than half of waking hours.
4
Unable to look after yourself at all; in bed or a chair all day.

Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.

Platelets

Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.

Hemoglobin (Hb)

The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).

ULN (upper limit of normal)

The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.

“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.

Creatinine clearance (CrCl)

How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.

ALT and AST (liver enzymes)

Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.

Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.

Bilirubin

A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.

Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.

INR, PT and aPTT (clotting tests)

Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.

Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.

FEV1

From a breathing test (spirometry): how much air you can blow out in the first second. Often given as a percentage of what is expected for your age, height and sex.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Autoimmune disease

A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.

Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

PD-1, PD-L1 and checkpoint inhibitors

PD-1, PD-L1 and CTLA-4 are proteins that act as brakes on the immune system. Checkpoint inhibitors, such as pembrolizumab or nivolumab, block them so the immune system can attack a cancer.

PD-L1 can also be measured in a tumour sample. Some scores count stained tumour cells only (TPS); others also count certain immune cells (CPS). The study names the score and the minimum it uses.

Hepatitis B tests

Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.

Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.

Hepatitis C tests

Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.

After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

Live vaccines

Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.

05

Study design

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

Study arms

  • Experimental
    Neoadjuvant Quad Shot Radiotherapy + Tislelizumab + Chemotherapy

    Patients receive 3 cycles of neoadjuvant therapy (every 21 days). Each cycle consists of: * Quad Shot radiotherapy (14-14.8 Gy/4 fractions on Day 1-2) * Tislelizumab (200 mg, Day 3) * Platinum-based doublet chemotherapy (Day 3): Carboplatin (AUC 5) or Cisplatin (75 mg/m²), combined with Pemetrexed (500 mg/m² for non-squamous) or Paclitaxel (175 mg/m² for squamous). Surgery is performed 4-6 weeks (±7 days) after the third cycle. Postoperative adjuvant therapy is administered at the investigator's discretion according to NCCN and CSCO guidelines.

    Radiation: Quad Shot Radiotherapy · Drug: Tislelizumab · Drug: Carboplatin or cisplatin · Drug: Pemetrexed or Paclitaxel

Interventions

  • RadiationQuad Shot Radiotherapy

    3.7 Gy per fraction, twice daily (with an interval of at least 6 hours), for 4 fractions over 2 consecutive days (Days 1-2 of each cycle). Total dose of 14.8 Gy per cycle, repeated every 3 weeks for 3 cycles (cumulative dose 44.4 Gy). Delivered using IMRT or VMAT.

  • 200 mg administered via intravenous infusion on Day 3 of each 21-day cycle for 3 cycles.

  • DrugCarboplatin or cisplatin

    Drug pages: Carboplatin · Cisplatin

    Carboplatin (AUC 5) or Cisplatin (75 mg/m²) administered intravenously on Day 3 of each 21-day cycle for 3 cycles.

  • DrugPemetrexed or Paclitaxel

    Pemetrexed (500 mg/m²) for non-squamous NSCLC or Paclitaxel (175 mg/m²) for squamous NSCLC, administered intravenously on Day 3 of each 21-day cycle for 3 cycles.

06

What researchers measure

Primary outcomes

  1. Pathological Complete Response (pCR) Rate

    The proportion of patients with no residual viable tumor cells in the resected primary tumor and regional lymph nodes, as assessed by pathological review. Patients who do not undergo surgery will be considered as not achieving pCR.

    Time frame: After completion of neoadjuvant therapy and surgery (approximately 4-6 weeks after the last dose of neoadjuvant therapy)

Secondary outcomes

  1. Major Pathological Response (MPR) Rate

    The proportion of patients with ≤10% viable tumor cells in the resected specimen.

    Time frame: After completion of neoadjuvant therapy and surgery (approximately 4-6 weeks after the last dose of neoadjuvant therapy)

  2. R0 Resection Rate

    The proportion of patients achieving microscopically margin-negative resection.

    Time frame: At time of surgery

  3. Objective Response Rate (ORR) per RECIST v1.1

    The proportion of patients achieving a confirmed complete or partial response according to RECIST v1.1.

    Time frame: Up to 14 days before surgery

  4. Event-Free Survival (EFS) and 2-Year EFS Rate

    Time from enrollment to disease progression, local recurrence, distant metastasis, or death from any cause.

    Time frame: Up to 60 months after enrollment

  5. Overall Survival (OS) and 2-Year OS Rate

    Time from enrollment to death from any cause.

    Time frame: Up to 60 months after enrollment

  6. Incidence and Severity of Adverse Events (AEs), Serious Adverse Events (SAEs), and Immune-Related Adverse Events (irAEs)

    Evaluated according to NCI CTCAE v5.0.

    Time frame: From informed consent to 90 days after the last dose of study treatment

  7. Feasibility (Completion Rate of Neoadjuvant Therapy and Surgery)

    Proportion of patients completing 3 cycles of neoadjuvant therapy and undergoing surgery as planned; surgical delay rate.

    Time frame: Up to 4-6 weeks after the last dose of neoadjuvant therapy

  8. QS Radiotherapy-Related Toxicity

    Incidence and severity of radiation pneumonitis, esophagitis, dermatitis, myelosuppression, and myocarditis, graded according to NCI CTCAE v5.0.

    Time frame: Up to 90 days after the last dose of radiotherapy

07

Study locations

1 site
08

Timeline

1 registry update 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

Start is estimated for Oct 2026; primary completion for Jun 2027, 8 months later.

Of 730 non-industry phase 2 interventional studies under Carcinoma, Non-Small-Cell Lung, half reached primary completion within 56 months of starting (the median), counting those still running; a quarter within 36 and three quarters within 84. This study's planned 8 months is below that.

Counting every sponsor, half of 1,047 studies reached it within 48 months; a quarter within 30 and three quarters within 76.

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

Registered
Sep 21, 2026
First posted
Sep 29, 2026
StartEst.
Oct 10, 2026
Primary completionEst.
Jun 30, 2027
CompletionEst.
Dec 31, 2031
Last update
Sep 29, 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.
Registered
First appeared on the registry. No changes since
Sep 29, 2026
Show all 1 update
  1. Sep 29, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

09

Registry details

Key details

Study ID
NCT07845916
Responsible party
Sponsor
First posted
Sep 29, 2026
Start date
Oct 10, 2026 (estimated)
Primary completion
Jun 30, 2027 (estimated)
Completion
Dec 31, 2031 (estimated)
Last update
Sep 29, 2026

Study contacts

Kunyu Yang, MD
Contact
yangkunyu@hust.edu.cn
0086-13995595360

Oversight

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

Not currently enrolling

This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drug tested here: Tislelizumab

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