Targeted radiation treatment for advanced lung cancer

A Prospective Study on the Efficacy, Safety and Immune Effects of Dose-painting Radiation for Locally Advanced Non-small Cell Lung Cancer(LA-NSCLC)

This study is testing a special type of targeted radiation treatment for people with advanced lung cancer to see if it helps them live longer and feel better.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 46 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Sichuan Cancer Hospital and Research Institute (other)
• Drugs / interventions: chemotherapy, immunotherapy, radiation
• Locations: 4 sites (Chengdu, Sichuan and 3 other locations)
• Trial ID: NCT05031533 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 75 with inoperable stage II-III non-small cell lung cancer who can tolerate radical radiotherapy.

Not a fit: Patients with operable lung cancer or those who do not meet the health and functional criteria may not benefit from this study.

Why it matters

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

How similar studies have performed: While dose-painting radiation is a novel approach, similar studies have shown promise in improving outcomes for patients with localized tumors.

Eligibility criteria

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 this trial is running

Chengdu, Sichuan and 3 other locations

• 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

Conditions: Non-small Cell Lung Cancer Stage III, Non-small Cell Lung Cancer Stage II, radiotherapy, dose-painting radiation, non-small cell lung cancer