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

NCT05319574 | Active Not Recruiting Phase 2

• 1 other identifier: SYSUCC B2022-159-01
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Carcinoma, Non-Small-Cell Lung

Keywords

Non small cell lung cancer; Neoadjuvant; Immunotherapy; SBRT

Outcome Measures

Primary Outcomes (1)

• Major Pathological Response (MPR)

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

  From date of enrollment until one month after resection

Secondary Outcomes (3)

• Pathologic Complete response (PCR)

  From date of enrollment until one month after resection

• Resected rate

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

• Disease-free survival

  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

Study Arms (1)

Neoadjuvant SBRT plus immunochemotherapy

EXPERIMENTAL

Stereotactic 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

Radiation: SBRT; Drug: Tislelizumab

Interventions

SBRT RADIATION

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

Also known as: stereotactic body radiation therapy

Neoadjuvant SBRT plus immunochemotherapy

Tislelizumab DRUG

200mg q3w for two cycles administrated concurrently with chemotherapy

Neoadjuvant SBRT plus immunochemotherapy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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).

You may not qualify if:

• 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
• 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).
• 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

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (1)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, 510060, China

Location

Related Publications (1)

• 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.

  PMID: 39305910 DERIVED

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Radiosurgery; tislelizumab

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Radiotherapy; Therapeutics; Stereotaxic Techniques; Neurosurgical Procedures; Surgical Procedures, Operative; Investigative Techniques

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof.

Study Record Dates

• First Submitted: April 1, 2022
• First Posted: April 8, 2022
• Study Start: April 24, 2022
• Primary Completion: June 25, 2023
• Study Completion (Estimated): May 31, 2026
• Last Updated: June 12, 2025

Record last verified: 2025-06

Locations

CN (1)