NCT04730999

Efficacy and Safety Study of a New Therapeutic Strategy in the Treatment of Extended-Disease Small-Cell Lung Cancer

A Phase II, Single Arm Study of CarbopLatin Plus Etoposide With Bevacizumab and Atezolizumab in Patients With exTEnded-disease Small-cell Lung Cancer (SCLC)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 54 (actual)
• Sponsor: Gruppo Oncologico Italiano di Ricerca Clinica · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Small cell lung cancer (SCLC) is an aggressive type of neuroendocrine tumor with the majority of patients (about 60-70%) being diagnosed with metastatic disease and with a median survival ranging from 7 to 12 months. Combination chemotherapy (CT), namely a platinum and etoposide-based regimen, represents the cornerstone of treatment for extended disease (ED) SCLC. Despite this the duration of response is short and nearly all patients develop disease relapse or progression. The recent approval of atezolizumab in combination with carboplatin and etoposide as first line in patients with ED SCLC is surely a step forward in the understanding the molecular landscape and treatment of this complex tumor, but new therapeutic approaches need to be explored. This trial aims to assess the efficacy in terms of 1 year survival a new therapeutic strategy that combines to the standard CT (carboplatin and etoposide), two drugs indicated in the tratment of several types of tumors: bevacizumab and atezolizomab. The treatment will start with an induction phase during which eligible patients will receive, by intravenous way, a combination of the above mentioned drugs according to a specific administration regimen. This phase will last about 18 weeks. Therafter the treatment will proceed with a maintenence phase lasting for a maximum of 54 weeks during which the patients will receive only atezolizumab and bevacizumab, by intravenous way, according to a specific administration regimen. Treatment will be discontnued in case of disease progression, unacceptable toxicity, patient refusal or loss of clinical benefit (for atezolizumab). During the study period the patients will undergo to periodic visits and laboratory, radiologic assessments to monitor the efficacy and the safety of the ongoing treatment.

Conditions

• Small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	Etoposide	Induction phase: 100 mg/sqm on days 1-3, for a maximum of 6 cycles (each one of 21 days duration). Intravenous administration. Treatment will continue until progression of disease, unacceptable toxicity, patient refusal.
DRUG	Carboplatin	Induction phase: AUC 5 on day 1 for a maximum of 6 cycles (each one of 21 days duration). Intravenous administration. Treatment will continue until progression of disease, unacceptable toxicity, patient refusal.
DRUG	Bevacizumab	Induction phase: 7.5 mg/kg on day 1, for a maximum of 6 cycles (each one of 21 days duration). Intravenous administration. Maintenance phase: 7.5 mg/kg on day 1, for a maximum of 12 cycles (each one of 21 days duration). Intravenous administration. In both phases, the treatment will continue until progression of disease, unacceptable toxicity, patient refusal.
DRUG	Atezolizumab	Induction phase: flat dosing of 1200 mg on day 1, for a maximum of 6 cycles ( each one of 21 days duration). Intravenous administration. Maintenance phase: flat dosing of 1200 mg on day 1, for a maximum of 12 cycles (each one of 21 days duration). Intravenous administration. In both phases, the treatment will continue until progression of disease, unacceptable toxicity, patient refusal, loss of clinical benefit.

Timeline

• Start date: 2020-07-01
• Primary completion: 2023-06-01
• Completion: 2024-06-19
• First posted: 2021-01-29
• Last updated: 2024-07-05

Locations

14 sites across 1 country: Italy