SBRT Followed by Neoadjuvant Immunochemotherapy in Resectable Stage IB to III Non-small Cell Lung Cancer (SACTION01)

  • STATUS
    Recruiting
  • End date
    Apr 30, 2024
  • participants needed
    46
  • sponsor
    Sun Yat-sen University
Updated on 30 May 2022
platelet count
carcinoma
squamous cell carcinoma
serum bilirubin level
neutrophil count
EGFR
stereotactic body radiation therapy
cancer chemotherapy
pd-1 inhibitor
lung carcinoma

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 IB (tumors > 4cm) to III non-small cell lung cancer (NSCLC) prior to surgery.

Details
Condition Carcinoma, Non-Small-Cell Lung
Treatment SBRT, tislelizumab
Clinical Study IdentifierNCT05319574
SponsorSun Yat-sen University
Last Modified on30 May 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Patient has histologically or cytologically proven clinical stages I (tumors ≥ 4 cm), II, and IIIA NSCLC and is considered eligible for surgical resection with curative intent. Besides, T3-4N2 stage III 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)
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

Exclusion Criteria

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)
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
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