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Recruiting

NCT Number: NCT06718309

Chemotherapy Plus Immunotherapy Combined With SBRT as Neoadjuvant Therapy for Patients With Resectable NSCLC

In this study, patients with EGFR/ALK wild-type, resectable locally advanced NSCLC are expected to receive 1 cycle of chemoimmunotherapy as neoadjuvant therapy, followed by SBRT to the primary lung lesion, and chemoimmunotherapy for 2 cycles. Surgical treatment will be given within 4-6 weeks after the last cycle of chemoimmunotherapy, then immunotherapy maintenance for 1 year.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Department of Thoracic Oncology, Hangzhou Cancer Hospital

Hangzhou, Zhejiang, 310002, China

Location status: Recruiting

Location contact

Lihui Fang

CONTACT

[email protected]

86-571-56006035

Lucheng Zhu, MD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Histologically or pathologically confirmed, newly diagnosed non-small cell lung cancer patients;
  • Age ≥18 years;
  • (Eastern Cooperative Oncology Group, ECOG) (Performance Status, PS) score 0-1;
  • 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);
  • Puncture or biopsy samples were tested EGFR/ALK negative;
  • Surgically or potentially resectable after discussion by multidisciplinary team (MDT);
  • Who has not received systemic antitumor therapy and has not received chest radiotherapy;
  • Evaluable lesions in the lung or mediastinum;
  • 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;
  • Male/female of childbearing age agrees to use contraception during the trial period (surgical ligation or oral contraceptives/IUDs + condom contraception);
  • Sign informed consent.

Exclusion criteria

  • Patients with severe dysfunctions of the heart, lungs and other organs who are not suitable for surgery;
  • 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;
  • Other malignancies within 5 years (excluding non-melanoma skin cancer and cervical cancer);
  • Patient with active infection, heart failure, heart attack, unstable angina pectoris or unstable arrhythmia within the last 6 months;
  • Congenital or acquired immunodeficiency disorders include human immunodeficiency virus (HIV) or a history of organ transplantation or allogeneic stem cell transplantation;
  • Patients treated with other immunological agents, chemotherapy agents, other drugs in clinical trials and long-term cortisol therapy were excluded;
  • Patients who are allergic or contraindicated to PD-1 inhibitors.

Treatment and study plan

Chemotherapy

Drug

Patients with squamous cell carcinoma can choose paclitaxel + cisplatin/carboplatin and patients with nonsquamous cell carcinoma can choose pemetrexed + cisplatin/carboplatin. The chemotherapy treatment lasts 3 cycles.

Immunotherapy

Drug

Investigators choose PD-1 or PD-L1 according to drug indication and the immunotherapy lasts 3 cycles preoperatively and 1 year after surgery.

Radical resection of lung cancer

Procedure

Radical resection of lung cancer with lymph node dissection

SBRT

Radiation

SBRT for primary lung lesion 8Gy*3F after first cycle of chemoimmunotherapy

Primary outcomes

  1. Pathological complete response (pCR)

    Time frame: Assessed up to 24 weeks

    Pathological complete response for surgical patients

Secondary outcomes

  1. Major pathologic response (MPR)

    Time frame: Assessed up to 24 weeks

    No more than 10% residual viable tumour in the resected tumour (up to 24 weeks)

  2. 1-year event-free survival (1 year EFS)

    Time frame: Assessed up to 100 months

    Interval between the start of neoadjuvant treatment and any progression of disease precluding surgical resection, progression of disease in the absence of surgery, progression or recurrence after surgery, or death from any cause, whichever occurred first

  3. The R0 resection rate

    Time frame: Assessed up to 24 weeks

    The proportion of patients who had complete surgical resection [R0]

  4. Incidence of treatment-related adverse events

    Time frame: assessed up to 100 months

    The incidence of adverse events ≥ grade 3 during perioperative period

Study contacts

Contact information is provided by the study sponsor or research team.

Sponsors and collaborators

Lead sponsor

First People's Hospital of Hangzhou

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2027
Study completion
2029
First posted
Dec 5, 2024
Registry last updated
Dec 5, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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