Combining immunotherapy and chemotherapy for advanced lung cancer treatment

Preoperative Neoadjuvant Immunotherapy Combined With Chemotherapy for Newly Diagnosed Stage Ⅲ Unresectable Non-small Cell Lung Cancer: a Open-label, Single-arm Prospective Clinical Trial

This study is testing if combining a new immunotherapy drug with chemotherapy can help people with advanced lung cancer feel better and improve their treatment outcomes.

Quick facts

• Phase: Phase 4
• Study type: Interventional
• Enrollment: 30 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: The Affiliated Hospital of Qingdao University (Academic / other)
• Drugs / interventions: chemotherapy, prednisone, Tislelizumab
• Locations: 1 site (Qingdao, Shandong)
• Trial ID: NCT06357598 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the effectiveness and safety of Tislelizumab, an immunotherapy drug, combined with chemotherapy in patients with newly diagnosed stage III unresectable non-small cell lung cancer (NSCLC). It is an open-label, single-arm prospective study that aims to determine how this combination treatment can improve patient outcomes. Participants will receive Tislelizumab along with either Pemetrexed or Nab-paclitaxel and Carboplatin or Cisplatin, followed by surgery if feasible. The study focuses on patients who are not candidates for complete surgical resection due to the advanced nature of their cancer.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 75 with stage III unresectable non-small cell lung cancer who have not had prior treatment.

Not a fit: Patients with EGFR or ALK mutations may not benefit from this study as they are excluded from participation.

Why it matters

Potential benefit: If successful, this approach could improve treatment outcomes and survival rates for patients with advanced lung cancer.

How similar studies have performed: Other studies have shown promising results with similar combinations of immunotherapy and chemotherapy in lung cancer, suggesting potential for success in this approach.

Eligibility criteria

Inclusion Criteria:

1. Age :18 Years to 75 Years;
2. ECOG physical score status of 0 or 1 points;
3. Expected survival time ≥ 6 months;
4. According to the eighth edition of the AJCC/UICC TNM staging system, patients were pathological diagnosed with Stage III NSCLC and had one of the following conditions: 1) A complete resection (R0) would not be possible, based on evaluation within a multidisciplinary team, including an experienced thoracic surgeon; 2) Multiple ipsilateral mediastinal lymph nodes metastasized into large masses or multistation metastases (IIIA: T1-2N2 or IIIB: T3-4N2); 3) Contralateral hilar or mediastinal lymph nodes, or ipsilateral or contralateral scalene or supraclavicular lymph nodes metastasis (IIIB: T1-2N3; IIIC: T3-4N3); 4) The lesion invaded the heart, aorta, or esophagus (IIIA: T4N0-1).
5. EGFR mutation or ALK mutation was negative;
6. Patients with at least one evaluable or measurable lesions as per RECIST version 1.1;
7. Patients were newly diagnosed with non-small cell lung cancer, without radiotherapy, chemotherapy, surgery or molecule-targeted treatment.
8. Patients must have enough cardiopulmonary function for the expected pulmonary resections for lung cancer.
9. The main organ function meets the following criteria:1) Blood routine:a. ANC ≥ 1.5×109/L; b. PLT ≥ 100×109/L; c. HB ≥ 90 g/L; 2) Blood biochemistry:TBIL ≤ 1.5×ULN;ALT、AST≤ 2.5×ULN;sCr≤1.5×ULN; 3) Blood coagulation: INR≤1.5×ULN and APTT≤1.5×ULN，endogenous creatinine clearance rate≥45ml/min(Cockcroft-Gault formula);
10. Pregnancy test (serum or urine) has to be performed for woman of childbearing age within 7 days before enrolment and the test result must be negative. They shall take appropriate methods for contraception during the study until the 3 months post the last administration of study drug. For men, (previous surgical sterilization accepted), shall agree to take appropriate methods of contraception during the study until the 3 months post the last administration of study drug;
11. Patient has to voluntarily join the study and sign the Informed Consent Form for the study.

Exclusion Criteria:

1. Patients with autoimmune disease, or a history of autoimmune disease within 2 years prior to the first use of the study drug including but not limited to the following: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, pituitary inflammation, vasculitis, myocarditis, nephritis, hyperthyroidism, hypothyroidism which can be included after hormone replacement therapy; Subjects with childhood asthma have been completely alleviated and without any intervention or vitiligo in adulthood can be included;
2. Subjects with congenital or acquired immunodeficiency such as HIV infection, active hepatitis B (HBV DNA ≥ 2000 IU/mL), hepatitis C (hepatitis C antibody is positive);
3. Subjects with a condition requiring other immunosuppressive medications before 7 days of study drug administration firstly, not including inhaled corticosteroids or physiological doses of systemic treatment with either corticosteroids (\> 10 mg daily prednisone equivalents);
4. Has received a live vaccine within 4 weeks of planned start of study therapy;
5. Other malignancies have been diagnosed within 5 years prior to the first use of the study drug (excluding skin basal cell carcinoma that has been cured, skin squamous cell carcinoma, and / or carcinoma in situ that has undergone radical resection);
6. Patients with a current or history of pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiologic pneumonia, drug-induced pneumonia and severe impairment of lung function;
7. Patients with serious or uncontrollable systemic diseases, such as:

   Patients with hypertension that is difficult to control (systolic blood pressure ≥140 mmHg and diastolic blood pressure ≥90 mmHg); Patients with myocardial ischemia and myocardial infarction above class II (including QT interval prolongation, for man ≥ 450 ms, for woman ≥ 470 ms);
8. Severe infection within 4 weeks before the first administration (such as intravenous drip of antibiotics, antifungal drugs or antiviral drugs), or fever of unknown origin (\> 38.5 ℃) within 4 weeks before the first administration;
9. Allogeneic organ transplantation (except corneal transplantation) or allogeneic hematopoietic stem cell transplantation;
10. Pregnant or nursing women;
11. Patients with a history of hypersensitivity to any of the study drugs, similar drugs, or excipients;
12. Participated in other clinical trials within 4 weeks;
13. Patients has received the following therapies: anti-PD-1, anti-PD-L1, or anti-PD-L2 drugs or drugs that target another stimulator or synergistically inhibit T cell receptors (e.g., CTLA-4, OX-40, CD137);
14. The investigator believes that there are any conditions that may damage the subject or result in the subject being unable to meet or perform the research request.

Where this trial is running

Qingdao, Shandong

• the Affiliated Hospital of Qingdao University — Qingdao, Shandong, China (Recruiting)

Study contacts

• Principal investigator: Wenjie Jiao, PhD — The Affiliated Hospital of Qingdao University

Conditions Non-small-cell Lung Cancer; Immunotherapy; Chemotherapy