Clinical Trials/NCT05092412

NCT05092412

Active, not recruiting

Phase 2

A First-line Multi-center, Single-arm Exploratory Study Using Low-dose Radiotherapy (LDRT) Combined With Durvalumab (MEDI4736), Etoposide, and Cisplatin/Carboplatin for Patients With Extensive-stage Small Cell Lung Cancer

You Lu3 sites in 1 country30 target enrollmentMarch 2, 2022

ConditionsLung Cancer Extensive-stage Small-cell Lung Cancer Durvalumab

InterventionsLow-dose radiotherapy Durvalumab Etoposide, and cisplatin/carboplatin

DrugsDurvalumab Etoposide, and cisplatin/carboplatin

Overview

Phase: Phase 2
Intervention: Low-dose radiotherapy
Conditions: Lung Cancer
Sponsor: You Lu
Enrollment: 30
Locations: 3
Primary Endpoint: Progression-free survival (PFS)
Status: Active, not recruiting
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this study was to evaluate the efficacy of low-dose radiotherapy (LDRT) combined with durvalumab, etoposide, and cisplatin/carboplatin in the first-line treatment of extensive-stage small cell lung cancer.

Detailed Description

This study will enrol 30 subjects at 3 sites in China. Subjects who fulfil all the inclusion criteria and none of the exclusion criteria will be enrolled and receive treatment with Durvalumab and EP for 4 cycles. Durvalumab will be administered at a dose of 1500 mg every 3 weeks (Q3W) with first-line chemotherapy and will continue to be administered as monotherapy every 4 weeks(Q4W) post-chemotherapy until progressive disease. The LDRT deals with primary tumour in a 15 Gy of 5 fractions over five days, starting from Day 1 in the first cycle. Subjects will attend safety follow up 12 weeks ±14 days after last dose of Durvalumab. The primary endpoint is mPFS.

Registry

clinicaltrials.gov

Start Date

March 2, 2022

End Date

June 30, 2025

Last Updated

2 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

You Lu

Responsible Party

Sponsor Investigator

Principal Investigator

You Lu

Professor

Sichuan University

Eligibility Criteria

Inclusion Criteria

•At the time of screening, male or female participants were ≥18 years old.
•Before carrying out any research program related procedures (including screening evaluation), obtain written informed consent and any locally required authorization from the participant or his legal representative.
•Extensive-stage disease confirmed by histology or cytology (American Joint Committee on Cancer (8th edition) stage IV SCLC \[any T, any N and M1a/b/c\]), or due to multiple lung nodules with a wide range Or the size of the tumor/nodule is too large to be included in a tolerable radiotherapy plan for stage T3-4 disease.
•Participants with brain metastases must be asymptomatic or stable with steroids and anticonvulsants for at least 1 month before study treatment. Participants with suspected brain metastases during screening should undergo brain CT/MRI before enrollment in the study.
•The participant must be considered suitable for platinum-based chemotherapy as the first-line treatment for extensive-stage small cell lung cancer. Chemotherapy must include either cisplatin or carboplatin, combined with etoposide.
•The participant must be considered suitable for thoracic radiotherapy as the first-line treatment for extensive-stage small cell lung cancer.
•Life expectancy on the first day of study treatment was ≥12 weeks.
•At the time of enrollment, the World Health Organization (WHO)/Eastern Cooperative Oncology Group (ECOG) physical status score was 0 or
•Weight\>30 kg.
•According to the requirements of RECIST1.1 guidelines, at least one lesion (never received radiotherapy before), accurately measured by computed tomography (CT) or magnetic resonance imaging (MRI) at baseline shows that its longest diameter is ≥10mm (except for lymph nodes, Its short axis must be ≥15 mm); and the lesion is suitable for repeated and accurate measurement.

Exclusion Criteria

•Participate in the design and execution of the study (applicable to researchers and/or members of the research center).
•Have previously received the distribution of experimental drug (IP) in this study.
•Enroll in another clinical study at the same time, unless it is an observational (non-interventional) clinical study or the follow-up phase of an interventional study.
•Etoposide-platinum (carboplatin or cisplatin)-based chemotherapy is medically contraindicated.
•Have a history of chest radiotherapy or plan to undergo intensive chest radiotherapy before systemic treatment. Radiotherapy outside the chest (eg, bone metastases) for the purpose of palliative care is allowed, but it must be completed before the first administration of the study drug.
•Simultaneously carry out any chemotherapy, biological products or hormone therapy for cancer treatment. The use of hormone therapy for non-cancer related conditions (eg, hormone replacement therapy) is acceptable.
•Major surgery (defined by the investigator) within 28 days before the first IP administration. Note: Local surgery on isolated lesions for the purpose of palliative care is acceptable.
•History of allogeneic organ transplantation.
•Paraneoplastic syndromes (PNS) with autoimmune properties requiring systemic treatment (systemic steroids or immunosuppressive agents) or clinical symptoms suggesting that PNS is aggravated.
•Active or previously recorded autoimmune diseases or inflammatory diseases (including inflammatory bowel disease \[eg, colitis or Crohn's disease\], diverticulitis \[except diverticulosis\], systemic lupus erythematosus, Sarcoidosis syndrome, Wegener syndrome \[granulomatous vasculitis, Graves disease, rheumatoid arthritis, hypophysitis, uveitis, etc.\]). For this standard, the following exceptions:

Arms & Interventions

Low-dose radiotherapy combined with durvalumab, etoposide, and cisplatin/carboplatin

Intervention: Low-dose radiotherapy

Low-dose radiotherapy combined with durvalumab, etoposide, and cisplatin/carboplatin

Intervention: Durvalumab

Low-dose radiotherapy combined with durvalumab, etoposide, and cisplatin/carboplatin

Intervention: Etoposide, and cisplatin/carboplatin

Outcomes

Primary Outcomes

Progression-free survival (PFS)

Time Frame: up to 2 years

The time from the date of first dosing of durvalumab to the first appearance of objective disease progression (according to RECIST1.1) or death from any cause (if it occurs before disease progression).

Secondary Outcomes

median overall survival（mOS）(up to 2 years)
Objective response rate (ORR)(up to 2 years)
6-month progression-free survival rate / 12-month progression-free survival rate (PFS6/12)(1 years)