Targeted radiation treatment for advanced lung cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study evaluates the effectiveness and safety of dose-painting radiation therapy in patients with locally advanced non-small cell lung cancer (NSCLC). It aims to assess the immune effects of this targeted approach, focusing on progression-free survival as the primary endpoint. Secondary endpoints include overall response rate, overall survival, health-related quality of life, and safety profiles. The study involves patients who are inoperable and have measurable lesions suitable for radical radiotherapy.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. The patient or the legal representative of the patient can sign a written informed consent, and can understand and agree to follow the research requirements;
2. The age at the time of signing the informed consent form is between 18 and 75 years old;
3. It is diagnosed as non-small cell lung cancer by histology, and is suitable for radical radiotherapy:
4. Stage II-Ⅲ (AJCC 8th edition \[Rice et al., 2017\]) inoperable NSCLC patients (not medically suitable for surgery or refuse surgical intervention);
5. Measurable lesions that meet the definition of RECISTv1.1;
6. ECOG physical status ≤ 2;
7. Survival expectancy ≥ 3 months;
8. Hemoglobin ≥100g/L, WBC≥4×109/L, platelet ≥100×109/L (or follow the standards of each center);
9. Liver function: ALT, AST\<1.5 times the upper limit of normal (ULN), total bilirubin\<1.5×ULN;
10. Renal function: serum creatinine \<1.5×ULN;
11. Pulmonary function: FEV1\>50%, the percentage of DLCO (lung diffusion function) measured value and predicted value\>80% mild to moderate lung function impairment.
12. The patient has good compliance with the treatment and follow-up.

Exclusion Criteria:

1. There is evidence of distant metastasis (M1, AJCC 8th edition \[Rice et al., 2017\]);
2. There is pleural effusion, pericardial effusion or ascites that is not clinically controlled and requires repeated drainage or medical intervention (within 2 weeks before randomization);
3. Intolerance or resistance to the chemotherapy, targeted, and immunotherapy specified in the experimental protocol;
4. Have received radiotherapy and surgical treatment;
5. There were other active malignant tumors ≤ 2 years before enrollment, except for the specific cancers under study in this study and locally recurring cancers that have been cured (eg, resected basal cell or squamous cell skin cancer, superficial Bladder cancer, carcinoma in situ of the cervix or breast);
6. A history of interstitial lung disease, non-infectious pneumonia or uncontrolled systemic diseases, including pulmonary fibrosis, acute lung diseases, etc.;
7. Has suffered from other malignant tumors;
8. Subjects who have received other drug trials within the past month;
9. Pregnant or lactating women and women who refuse contraception during the treatment observation period;
10. People with a history of severe allergies or idiosyncratic physique;
11. Those with a history of severe lung or heart disease;
12. Refusal or inability to sign the informed consent to participate in the trial;
13. Drug or alcohol addicts;
14. Personality or mental illness, lack of capacity for civil conduct or limited capacity for civil conduct.

Where it's running

• Sichuan Cancer Hospital & Institute
  Chengdu, Sichuan, China Recruiting
• Yunnan Cancer Hospital
  Kunming, China Recruiting
• Chongqing university three Gorges hospital
  Wanzhou, China Recruiting
• General Hospital of Ningxia Medical University
  Yingchuan, China Recruiting

Study contacts

• Study coordinator: Jiahua Lyu, Doctor
• Email: winlttljh@163.com
• Phone: +86-17713539529

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.