Dose-painting Radiation for LA-NSCLC (DPRLC)

University of Electronic Science and Technology of China (UESTC)

Status: Enrolling

Conditions: Non-small Cell Lung Cancer Stage II; Non-small Cell Lung Cancer Stage III

Treatments: Radiation: Dose-Painting Radiation

Study type: Interventional

Funder types: Other

Identifiers

NCT05031533

SCCHEC202108

Details and patient eligibility

About

The study evaluated the effectiveness, safety and immune effects of dose-painting radiation in patients with locally advanced non-small cell lung cancer.

Full description

The study evaluated the effectiveness, safety and immune effects of dose-painting radiation in patients with locally advanced non-small cell lung cancer.

The primary endpoint is PFS. Secondary points contains ORR, OS, HRQoL, and safety.

Enrollment: 46 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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46 participants in 1 patient group

Assigned Interventions

Experimental group

Description:

Radiation therapy: Dose-painting radiation Systemic treatment: Choose a systemic treatment plan according to the patient's genetic testing status (1) Chemotherapy 1. Squamous cell carcinoma: Paclitaxel 135mg/m2 D1 + Cisplatin 25mg/m2 D1-3, every 21 days, a total of 2-4 cycles. 2. Non-squamous cell carcinoma (adenocarcinoma, large cell carcinoma): Pemetrexed 500mg/m2 d1 + Cisplatin 75 mg/m2 d1-3, a total of 2-4 cycles. (2) Targeted therapy: According to the patient's genetic testing status, molecular targeted therapy such as EGFR-TKI and ALK inhibitors can be selected; (3) Immunotherapy: According to the patient's genetic testing status, immunotherapy such as PD1/PD-L1 inhibitors can be selected;

Treatment:

Radiation: Dose-Painting Radiation