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Carcinoma, Non-Small-Cell LungPhase 2SACTION01NCT05319574

SBRT Followed by Neoadjuvant Immunochemotherapy in Resectable Stage II to III Non-small Cell Lung Cancer

A Phase 2 study testing SBRT and Tislelizumab in people with Carcinoma, Non-Small-Cell Lung, run by Sun Yat-sen University at 1 site in China.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

The purpose of this study is to find out the effectiveness stereotactic body radiation therapy (SBRT) followed by two cycles of Tislelizumab (PD-1 inhibitor) with chemotherapy as treatment for operable stage II to III non-small cell lung cancer (NSCLC) prior to surgery. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Carcinoma, Non-Small-Cell Lung
What is being tested?
SBRT and Tislelizumab
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
46 participants
Where
1 siteChina
Study dates
24 Apr 2022to 31 May 2029
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patient has histologically or cytologically proven clinical stages II and III NSCLC (according to the 8th AJCC edition) and is considered eligible for surgical resection with curative intent. Besides, T3-4N2 stage IIIB disease deemed potentially resectable by MDT group is also allowed.
  • Measureable disease, as defined by RECIST v1.1.
  • Written informed consent and HIPAA obtained from the subject prior to performing any protocol-related procedures.
  • EGFR mutational status should be tested in all non-squamous carcinoma, and only patients with non-EGFR-TKI sensitizing mutation (19del or L858R) are allowed. For squamous cell carcinoma, EGFR mutational test is not required.
  • Age > 18 years at time of study entry
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
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  • Adequate normal organ and marrow function as defined below:
  • Haemoglobin ≥ 9.0 g/dL
  • Absolute neutrophil count (ANC) ≥ 1.5 x 109/L (> 1500 per mm3)
  • Platelet count ≥ 100 x 109/L (>100,000 per mm3)
  • Serum bilirubin ≤ 1.5 x institutional upper limit of normal (ULN). This will not apply to subjects with confirmed Gilbert's syndrome (persistent or recurrent hyperbilirubinemia that is predominantly unconjugated in the absence of hemolysis or hepatic pathology), who will be allowed only in consultation with their physician.
  • AST (SGOT)/ALT (SGPT), and alkaline phosphatase ≤ 2.5 x institutional upper limit of normal (ULN).
  • Serum creatinine CL>40 mL/min by the Cockcroft-Gault formula (Cockcroft and Gault 1976) or by 24-hour urine collection for determination of creatinine clearance:
  • Evidence of post-menopausal status or negative urinary or serum pregnancy test for female pre-menopausal patients. Women will be considered post-menopausal if they have been amenorrheic for 12 months without an alternative medical cause. The following age-specific requirements apply:
  • Women <50 years of age would be considered post-menopausal if they have been amenorrheic for 12 months or more following cessation of exogenous hormonal treatments and if they have luteinizing hormone and follicle-stimulating hormone levels in the post-menopausal range for the institution or underwent surgical sterilization (bilateral oophorectomy or hysterectomy).
  • Women ≥50 years of age would be considered post-menopausal if they have been amenorrheic exogenous hormonal treatments, had radiation-induced menopause with last menses >1 year ago, had chemotherapy-induced menopause with last menses >1 year ago, or underwent surgical sterilization (bilateral oophorectomy, bilateral salpingectomy or hysterectomy).
  • Subject is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up.
  • No prior therapy for their lung cancer.

Who cannot join

  • Participation in another clinical study with an investigational product during the last 3 weeks.
  • History of another primary malignancy except for:
  • Malignancy treated with curative intent and with no known active disease ≥3 years before the first dose of study drug and of low potential risk for recurrence.
  • Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease.
  • Adequately treated carcinoma in situ without evidence of disease eg, cervical cancer in situ, in-situ urinary bladder cancer , treated localized prostate cancer and ductal carcinoma-in situ.
  • Indolent hematological malignancies
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  • Current or prior use of immunosuppressive medication within 14 days before the first dose of durvalumab, with the exceptions of intranasal,inhaled, topical steroids, or local steroid injections (e.g., intra articular injection), corticosteroids or systemic corticosteroids at physiological doses, which are not to exceed 10 mg/day of prednisone, or an equivalent corticosteroid, and steroids as premedication for hypersensitivity reactions (e.g., CT scan premedication).
  • Any unresolved toxicity (CTCAE grade 2) from therapy for a prior malignancy with the exception of alopecia, vitiligo, and the laboratory values defined in the inclusion criteria.
  • Patients with Grade ≥2 neuropathy will be evaluated on a case-by-case basis after consultation with the Study Physician.
  • Subjects with irreversible toxicity that is not reasonably expected to be exacerbated by the investigational product may be included (e.g., hearing loss, peripherally neuropathy).
  • Any prior Grade ≥3 immune-related adverse event (irAE) while receiving any previous immunotherapy agent, or any unresolved irAE >Grade 1.
  • Active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease [e.g., colitis or Crohn's disease systemic lupus erythematosus, Sarcoidosis syndrome, or Wegener syndrome [granulomatosis with polyangiitis, Graves' disease, rheumatoid arthritis, hypophysitis, uveitis, etc]). No active diverticulitis within the previous 3 months. The following are exceptions to this criterion:
  • Patients with vitiligo or alopecia
  • Patients with hypothyroidism (e.g., following Hashimoto syndrome) stable on hormone replacement
  • Any chronic skin condition that does not require systemic therapy
  • Patients without active disease in the last 5 years may be included but only after consultation with the study physician
  • Patients with celiac disease controlled by diet alone
  • Active or prior documented inflammatory bowel disease (e.g., Crohn's disease, ulcerative colitis).
  • History of active primary immunodeficiency.
  • History of allogeneic organ transplant.
  • History of hypersensitivity to tislelizumab or any excipient.
  • Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, cardiac arrhythmia, serious chronic gastrointestinal conditions associated with diarrhea, or psychiatric illness/social situations that would limit compliance with study requirement, substantially increase risk of incurring AEs or compromise the ability of the patient to give written informed consent.
  • Active infection including tuberculosis (clinical evaluation that includes clinical history, physical examination and radiographic findings, and TB testing in line with local practice), hepatitis B (known positive HBV surface antigen (HBsAg) result), hepatitis C, or human immunodeficiency virus (positive HIV 1/2 antibodies). Patients with a past or resolved HBV infection (defined as the presence of hepatitis B core antibody [anti-HBc] and absence of HBsAg) are eligible. Patients positive for hepatitis C (HCV) antibody are eligible only if polymerase chain reaction is negative for HCV RNA.
  • History of leptomeningeal carcinomatosis.
  • Any condition that, in the opinion of the investigator, would interfere with evaluation of study treatment or interpretation of patient safety or study results
  • Subjects with uncontrolled seizures.
  • History of interstitial lung disease, idiopathic pulmonary fibrosis, pneumonitis (including drug induced), or evidence of active pneumonitis on screening chest CT scan.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Sun Yat-sen University Cancer Center

    Guangzhou, Guangdong, 510060

Other trials in China

About this study

Official title: Preoperative Stereotactic Body Radiotherapy and Platinum-based Doublet Chemotherapy Plus Tislelizumab (Immunotherapy) for Operable Stage II to III EGFR Wild-type Non-small Cell Lung Cancer

The purpose of this study is to find out the effectiveness stereotactic body radiation therapy (SBRT) followed by two cycles of Tislelizumab (PD-1 inhibitor) with chemotherapy as treatment for operable stage II to III non-small cell lung cancer (NSCLC) prior to surgery.

Being tested
SBRT, Tislelizumab
Keywords
Non small cell lung cancer, Neoadjuvant, Immunotherapy, SBRT
Medical subject headings
Carcinoma, Non-Small-Cell Lung

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SBRTRadiation

    Also called stereotactic body radiation therapy

    Stereotactic body radiation therapy delivered with a fixed dose (8Gy) in 3 daily fractions 1-7 days before the first cycle of immunochemotherapy

  • TislelizumabDrug

    200mg q3w for two cycles administrated concurrently with chemotherapy

Study groups in NCT05319574
Study groupRoleWhat they receive
Neoadjuvant SBRT plus immunochemotherapyExperimentalStereotactic body radiation therapy (8Gy*3d) followed by Tislelizumab (200mg) with platinum-based doublet chemotherapy administered pre-operatively every 3 weeks for 2 cycles before surgical resection
Receives: Radiation: SBRT; Drug: Tislelizumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Major Pathological Response (MPR)

    MPR is defined as ≤10% residual viable tumor in the resected specimen

    Measured: From date of enrollment until one month after resection

Secondary outcomes (3)

  1. Pathologic Complete response (PCR)

    PCR is defined as no residual viable tumor in the resected specimen

    Measured: From date of enrollment until one month after resection

  2. Resected rate

    Resected rate is defined as the percentage of patients that undergo surgical resection after neoadjuvant treatment

    Measured: From date of enrollment to an average of 18 weeks after the first dose

  3. Disease-free survival

    Disease recurrence or death from any cause assessed using history, physical examination and CT scanning, histologically or cytologically confirmed whenever possible

    Measured: From date of SBRT start date until the date of first documented progression or date of death from any cause, whichever came first, assessed every 6 months for 2 years , then yearly thereafter till year 5

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Apr 2022
  2. Study start24 Apr 2022
  3. Primary completion25 Jun 2023
  4. Study completion31 May 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
46 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05319574
Sponsor's protocol ID
SYSUCC B2022-159-01
Acronym
SACTION01
Status last verified
Oct 2026
First submitted
1 Apr 2022
Last updated
13 Oct 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Zhao ZR, Liu SL, Zhou T, Chen G, Long H, Su XD, Zhang X, Fu JH, Lin P, Zhang LJ, Rong TH, Wu JD, Li ZC, Su HL, Chen JY, Yang YP, Lin YB, Xi M, Yang H. Stereotactic body radiotherapy with sequential tislelizumab and chemotherapy as neoadjuvant therapy in patients with resectable non-small-cell lung cancer in China (SACTION01): a single-arm, single-centre, phase 2 trial. Lancet Respir Med. 2024 Dec;12(12):988-996. doi: 10.1016/S2213-2600(24)00215-7. Epub 2024 Sep 18.

    PubMed 39305910

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing SBRT and Tislelizumab in people with Carcinoma, Non-Small-Cell Lung, run by Sun Yat-sen University at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 18 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 13 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Major Pathological Response (MPR) (time frame: From date of enrollment until one month after resection). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05319574, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2026; AzTrials last refreshed its copy on 7 Nov 2026.

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