Combining chemotherapy and immunotherapy with targeted radiation for lung cancer treatment

A Prospective Cohort Study of Chemotherapy Plus Immunotherapy Combined With Stereotactic Body Radiotherapy as Neoadjuvant Therapy for Patients With Resectable Non-small Cell Lung Cancer

This study is testing a new treatment plan that combines chemotherapy and immunotherapy with targeted radiation to see if it helps patients with certain types of lung cancer before surgery.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: First People's Hospital of Hangzhou (Academic / other)
• Drugs / interventions: chemotherapy, immunotherapy
• Locations: 1 site (Hangzhou, Zhejiang)
• Trial ID: NCT06718309 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the effectiveness of combining chemotherapy and immunotherapy as neoadjuvant therapy for patients with resectable non-small cell lung cancer (NSCLC). Participants will receive one cycle of chemoimmunotherapy followed by stereotactic body radiation therapy (SBRT) to the primary lung lesion, and then two additional cycles of chemoimmunotherapy. Surgical resection of the tumor will occur within 4-6 weeks after the last treatment cycle, followed by one year of immunotherapy maintenance. The study focuses on patients with EGFR/ALK wild-type tumors that are locally advanced and resectable.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older with newly diagnosed, histologically confirmed, resectable locally advanced NSCLC who have not received prior systemic therapy.

Not a fit: Patients with EGFR/ALK mutations or those who have received prior systemic antitumor therapy or chest radiotherapy may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could improve surgical outcomes and overall survival rates for patients with resectable NSCLC.

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

Eligibility criteria

Inclusion Criteria:

1. Histologically or pathologically confirmed, newly diagnosed non-small cell lung cancer patients;
2. Age ≥18 years;
3. (Eastern Cooperative Oncology Group, ECOG) (Performance Status, PS) score 0-1;
4. According to the 8th-9th edition of (American Joint Committee on Cancer, AJCC) (stage II-IIIA, for stage IIIB included T3-4N2, T4 only included tumor \> 7cm);
5. Puncture or biopsy samples were tested EGFR/ALK negative;
6. Surgically or potentially resectable after discussion by multidisciplinary team (MDT);
7. Who has not received systemic antitumor therapy and has not received chest radiotherapy;
8. Evaluable lesions in the lung or mediastinum;
9. The organ function level should meet the following criteria one week before enrollment: 1) Bone marrow function: hemoglobin ≥80g/L, white blood cell count ≥4.0\*10\^9/L or neutrophil count ≥1.5\*10\^9/L, platelet count ≥100\*10\^9/L; 2) Liver: total serum bilirubin level ≤1.5 times the normal upper limit, when serum total bilirubin level \> 1.5 times the normal upper limit, direct bilirubin level ≤ normal upper limit, aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5 times the normal upper limit; 3) Kidney: blood creatinine level \< 1.5 times the normal upper limit or creatinine clearance ≥50ml/min, urea nitrogen ≤200mg/L; Serum albumin ≥30g/L;
10. Male/female of childbearing age agrees to use contraception during the trial period (surgical ligation or oral contraceptives/IUDs + condom contraception);
11. Sign informed consent.

Exclusion Criteria:

1. Patients with severe dysfunctions of the heart, lungs and other organs who are not suitable for surgery;
2. Patients with severe autoimmune diseases: active inflammatory bowel disease (including Crohn's disease, ulcerative colitis), rheumatoid arthritis, scleroderma, systemic lupus erythematosus, autoimmune vasculitis (such as Wegener's granuloma), etc;
3. Other malignancies within 5 years (excluding non-melanoma skin cancer and cervical cancer);
4. Patient with active infection, heart failure, heart attack, unstable angina pectoris or unstable arrhythmia within the last 6 months;
5. Congenital or acquired immunodeficiency disorders include human immunodeficiency virus (HIV) or a history of organ transplantation or allogeneic stem cell transplantation;
6. Patients treated with other immunological agents, chemotherapy agents, other drugs in clinical trials and long-term cortisol therapy were excluded;
7. Patients who are allergic or contraindicated to PD-1 inhibitors.

Where this trial is running

Hangzhou, Zhejiang

• Department of Thoracic Oncology, Hangzhou Cancer Hospital — Hangzhou, Zhejiang, China (Recruiting)

Study contacts

• Principal investigator: Lucheng Zhu, MD — Hangzhou Cancer Hospital
• Study coordinator: Yi Tang

Conditions Non-Small Cell Lung Cancer; NSCLC; locally advanced; resectable; SBRT; immunotherapy