Endostar in Combination With Chemoradiotherapy in Patient With Advanced Non-small Cell Lung Cancer

Affiliated Hospital of North Sichuan Medical College

Status and phase: Unknown; Phase 3; Phase 2

Conditions: Quality of Life

Treatments: Drug: Endostar for one cycle; Drug: Endostar for two cycles; Combination Product: concurrent chemoradiotherapy (CCRT)

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03588494

NSOG001

Details and patient eligibility

About

To investigate the safety and efficacy recombinant human endostatin(endostar) durative transfusion combined with cocurrent chemoradiotherapy in advanced non-small cell lung cancer(NSCLC).

Enrollment: 318 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 1. Male or female patients, age: 18-70 years of age
• 2. Pathology was diagnosed as non-small cell lung cancer. According to the Tumor Node Metastasis（TNM）stage of the 8th edition of the International Association for the Study of Lung Cancer in 2017, And the pathological stage was identified as stage IIIa-b.
• 3. No previous chest radiotherapy and radiotherapy, immunotherapy or biological therapy.
• 4. Eastern Cooperative Oncology Group (ECOG) test scored 0-1.
• 5. Serum hemoglobin ≥ 100g/L, platelet ≥ 100 × 109/L, absolute number of neutrophils ≥ 1.5 × 109/L.
• 6. Serum creatinine ≤ 1.25 times the upper limit of normal(UNL) or creatinine clearance ≥ 60 mL/min.
• 7. Serum bilirubin ≤ 1.5 times UNL, Aspartate aminotransferase (AST) and adenosine triphosphate (ALT) ≤ 2.5 times UNL, alkaline phosphatase ≤ 5 times UNL.
• 8. Forced vital capacity rate of one second（FEV1）>0.8 litre.
• 9. Coagulation function is normal
• 10. lesions are measurable according to the Response Evaluation Criteria in Solid Tumors Version 1.1(RECIST1.1)standard
• 11. Sign the inform consent form with good compliance

Exclusion criteria

• 1. Carcinoid or small cell lung cancer
• 2. Patients with any distant metastasis
• 3. patients with previous or current malignancy, except for skin non-melanoma or carcinoma in situ in the cervix
• 4. Any other disease or condition is a contraindication to chemoradiation (eg, active infection, 6 months after myocardial infarction, symptomatic heart disease including unstable angina, congestive heart failure or uncontrolled arrhythmia, immunosuppressive therapy).
• 5. Pregnancy or breastfeeding women
• 6. Women who may be pregnant but are unwilling to take appropriate contraception
• 7. Hereditary bleeding or coagulopathy

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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318 participants in 3 patient groups

concurrent chemoradiotherapy (CCRT)

Active Comparator group

Description:

Chemotherapy: Cisplatin (50 mg/m2) on days 1, 8, 29, and 36 and etoposide (50mg/m2) on days 1～5 and 29～33. Radiotherapy: Thoracic radiotherapy (TRT) started with a linear accelerator (6MV-X) on the first day of chemotherapy.A minimum dose of 60 Gy (2 Gy per fraction, Monday～Friday) was delivered, and a range of 60-66 Gy in 2 Gy fractions was allowed.

Treatment:

Combination Product: concurrent chemoradiotherapy (CCRT)

W1-CCRT

Experimental group

Description:

Endostar(15 mg/m2) was durative transfused every 24 hours for 5 days during the normalization window of the first chemoradiotherapy cycle(days -5～-1). Chemotherapy: Cisplatin (50 mg/m2) on days 1, 8, 29, and 36 and etoposide (50mg/m2) on days 1～5 and 29～33. Radiotherapy: Thoracic radiotherapy (TRT) started with a linear accelerator (6MV-X) on the first day of chemotherapy.A minimum dose of 60 Gy (2 Gy per fraction, Monday～Friday) was delivered, and a range of 60-66 Gy in 2 Gy fractions was allowed.

Treatment:

Drug: Endostar for one cycle

Combination Product: concurrent chemoradiotherapy (CCRT)

W2-CCRT

Experimental group

Description:

Endostar(15 mg/m2) was durative transfused every 24 hours for 5 days during the normalization window of the first and the second chemoradiotherapy cycles(days -5～-1 and 24～28). Chemotherapy: Cisplatin (50 mg/m2) on days 1, 8, 29, and 36 and etoposide (50mg/m2) on days 1～5 and 29～33. Radiotherapy: Thoracic radiotherapy (TRT) started with a linear accelerator (6MV-X) on the first day of chemotherapy.A minimum dose of 60 Gy (2 Gy per fraction, Monday～Friday) was delivered, and a range of 60-66 Gy in 2 Gy fractions was allowed.

Treatment:

Drug: Endostar for two cycles

Combination Product: concurrent chemoradiotherapy (CCRT)