Overview

This study is aimed at patients with unresectable NSCLC who take nintedanib during sequential radiotherapy to explore the incidence of radiation pneumonitis above grade 2 in the nintedanib combined with radiotherapy mode and observe safety. And will further explore the progression-free survival (PFS) and overall survival (OS) of patients treated with nintedanib in combination with radiotherapy and immunotherapy.

Primary objective: To evaluate the safety of nintedanib combined with sequential radiotherapy in patients with unresectable NSCLC and the incidence of radiation pneumonitis above grade 2. Secondary objective: To evaluate the changes in lung function, progression-free survival (PFS) and overall survival (OS) in patients with unresectable NSCLC after nintedanib combined with sequential radiotherapy.

Patients need to receive induction therapy, chemotherapy and/or immunotherapy for at least one cycle. Then they will receive sequential radiotherapy and nintedanib for 6 months. Finally, they will receive immunotherapy maintenance therapy for 16 cycles.

Eligibility

Inclusion Criteria:

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1. Men or women who are over 18 years old (including 18 years old) when signing the informed consent form;

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       2) Non-small cell lung cancer was confirmed by histology and could not be
          resected, and EGFR/ALK driver gene was confirmed negative by gene mutation
          examination;

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       3) At least one measurable lesion with imaging examination (according to
          RECIST1.1) is examined by spiral CT or MR, and the length and diameter of the
          lesion are ≥ 10 mm;

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4) within 3 days before treatment, the score according to ECOG is 0 ~ 1;

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5) Life expectancy ≥3 months;

• 6)The vital organs function well,
• 7)The subjects volunteered to join the study and signed the informed consent form, with good compliance and cooperation with the follow-up.

Exclusion Criteria:

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1. Complicated with severe respiratory diseases: pulmonary fibrosis, active tuberculosis, etc.
   • 2)Persons with mental disorder, blood system diseases, autoimmune diseases and serious primary diseases of heart, brain, liver and kidney;

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       3) Hemorrhagic events that require blood transfusion, invasive intervention or
          hospitalization occur within 3 months before the first administration, or there
          are bleeding symptoms and need intervention treatment (such as hemoptysis,
          hematuria and bloody stool), or high-risk factors with bleeding risk (such as
          tumor surrounding or invading important blood vessels, obvious necrosis or
          cavity around tumor, esophageal varices, etc.);

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       4) Thrombosis or embolic diseases, abnormal blood coagulation function and
          bleeding tendency;

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       5) Known or suspected to be allergic to the study drug and its auxiliary
          materials;

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       6) The baseline pregnancy test of pregnant and lactating women or fertile women is
          positive.

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       7) According to the researcher's judgment, the subjects have other factors that
          may lead to the forced termination of this study.