Alotinib Plus Durvalumab-Platinum-Etoposide in First-line Treatment Extensive Small-cell Lung Cancer

• Status: Not yet recruiting
• Trial end date: 2022-11-04
• Target enrollment: 0
• Participant gender: All

Summary

Small Cell Lung cancer (SCLC) is a highly aggressive tumor that accounts for about 15 percent of all lung cancer cases. SCLC disease progresses rapidly, and about 2/3 of the patients have extensive stage (ES-SCLC) at the time of diagnosis, with extremely poor prognosis. However, the overall survival (OS) of ES-SCLC patients was not significantly prolonged, with platinum combined with etoposide chemotherapy as the standard treatment. In recent years, the emergence of Immune checkpoint inhibitor (ICI) has made the treatment of ES-SCLC appear at the dawn. In Impower133 study, Atezolizumab combined with chemotherapy significantly prolonged OS(median OS 12.3 months vs 10.3 months, HR=0.70, 95%CI 0.54-0.91, P = 0.007). Durvalumab combined with chemotherapy (CASPIAN study) is the first study in 20 years in which the total survival time of ES-SCLC treated by first-line therapy is 13 months, and there is no significant increase in adverse reactions compared with chemotherapy. Therefore, in 2019, NCCN also recommended Atezolizumab or Durvalumab+ EC regimens as a category 1 preferred option for first-line treatment of ES-SCLC.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Henan Cancer Hospital
• Treatments: Antibodies, Monoclonal; Durvalumab; Etoposide; Etoposide phosphate

Criteria

Inclusion Criteria:

• Histologically confirmed primary treatment of ES-SCLC (small cell lung cancer) in male or female patients aged ≥18 and <75 years.

• The ECOG energy status is 0 or 1.

• Appropriate hematologic and terminal organ functions.

Exclusion Criteria:

• Prior to systemic treatment, the patient had a history of chest radiation therapy or planned to undergo intensive chest radiation therapy.

• Spinal cord compression not explicitly treated by surgery and/or radiation, or previously diagnosed and treated, with no evidence of clinical stabilization of >2 weeks prior to randomization. Active brain metastases (stable brain metastases may be admitted after treatment) occurred within one month prior to enrollment.

• Uncontrolled or symptomatic hypercalcemia, active tuberculosis, major cardiovascular disease.

• A history of autoimmune diseases, idiopathic pulmonary fibrosis, organized pneumonia, HIV positive, active hepatitis B, radiographic findings of tumor infiltration of the large vessels in the chest and significant pulmonary cavitation lesions, a previous history of hypertensive crisis or hypertensive encephalopathy.

• History of hemoptysis within 1 month prior to randomization (≥0.5 TSP of bright red blood per episode).

• Major surgery within 28 days or needle core biopsy or other minor surgical procedures within 7 days.