An Open Label, Multicenter Phase 2 Study of Durvalumab (MEDI4736) + Olaparib as Maintenance Therapy in Patients With Extensive Stage Small-Cell Lung Cancer

Li Zhang, MD1 site in 1 country60 target enrollmentAugust 21, 2021

ConditionsLung Cancer Small Cell Lung Cancer Durvalumab

InterventionsDurvalumab, etoposide, and cisplatin/carboplatin followed by durvalumab and olaparib

DrugsDurvalumab, etoposide, and cisplatin/carboplatin followed by durvalumab and olaparib

Overview

Phase: Phase 2
Intervention: Durvalumab, etoposide, and cisplatin/carboplatin followed by durvalumab and olaparib
Conditions: Lung Cancer
Sponsor: Li Zhang, MD
Enrollment: 60
Locations: 1
Primary Endpoint: APF12-Alive and Progression Free
Last Updated: 4 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 and safety of combining durvalumab with EP followed by durvalumab + olaparib maintenance therapy as first-line treatment in patients with extensive-disease small-cell lung cancer (SCLC).

Detailed Description

This study is planned to enroll approximately 60 eligible patients in China. Patients who fulfill all the inclusion criteria and none of the exclusion criteria will receive 4 cycles of EP with durvalumab, then durvalumab + olaparib will be administered post-chemotherapy until confirmed progressive disease (PD).Tumor assessments will be performed at Screening as baseline with follow-up at Week 6 ±1 week from the date of the first cycle treatment, at Week 12 ±1 week from the date of the first cycle treatment, and then every 8 weeks ±1 week until confirmed objective disease progression. The primary endpoint is APF12, which is defined as the Proportion of patients alive and progression free at 12 months from the first date of the first-line treatment.

Registry

clinicaltrials.gov

Start Date

August 21, 2021

End Date

November 2023

Last Updated

4 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Li Zhang, MD

Responsible Party

Sponsor Investigator

Principal Investigator

Li Zhang, MD

Professor

Sun Yat-sen University

Eligibility Criteria

Inclusion Criteria

•Male or female ≥18 years at the time of screening.
•Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
•Written informed consent and any locally required authorization obtained from the patient/legal representative prior to performing any protocol-related procedures, including screening evaluations.
•Histologically or cytologically documented extensive disease (American Joint Committee on Cancer Stage (7th edition) IV SCLC \[T any, N any, M1 a/b\]), or T3-4 due to multiple lung nodules that are too extensive or have tumor/nodal volume that is too large to be encompassed in a tolerable radiation plan.
•Brain metastases; must be asymptomatic or treated and stable off steroids and anti-convulsants for at least 1 month prior to study treatment. Patients with suspected brain metastases at screening should have a CT/MRI of the brain prior to study entry.
•Provision of an archived tumor tissue block (or at least 15 newly cut unstained slides) where such samples exist.
•Patients must be considered suitable to receive a platinum based chemotherapy regimen as 1st line treatment for the ED-SCLC. Chemotherapy must contain either cisplatin or carboplatin in combination with etoposide.
•Life expectancy ≥16 weeks at Day
•World Health Organization (WHO)/Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 2 at enrollment. PS2 patients are permitted to receive first-line treatment, and PS score should be reassessed after first-line treatment. Then patients who are assessed as PS2 at the completion of chemotherapy+durvalumab will be excluded.
•Body weight \>30 kg.

Exclusion Criteria

•Previous IP assignment in the present study.
•Concurrent enrollment in another clinical study, unless it is an observational (non interventional) clinical study or during the follow up period of an interventional study.
•Participation in another clinical study with an IP during the last 4 weeks.
•Patients unable to swallow orally administered medication and patients with gastrointestinal disorders likely to interfere with absorption of the study medication.
•Medical contraindication to etoposide platinum (carboplatin or cisplatin) based chemotherapy.
•Any history of radiotherapy to the chest prior to systemic therapy or planned consolidation chest radiation therapy. Radiation therapy outside of the chest for palliative care (ie, bone metastasis) is allowed but must be completed before first dose of the study medication.
•Any concurrent chemotherapy, IP, biologic, or hormonal therapy for cancer treatment. Concurrent use of hormonal therapy for non-cancer related conditions (eg, hormone replacement therapy) is acceptable.
•Major surgical procedure (as defined by the investigator) within 28 days prior to the first dose of IP. Note: Local surgery of isolated lesions for palliative intent is acceptable.
•History of allogeneic organ transplantation.
•Has a paraneoplastic syndrome (PNS) of autoimmune nature, requiring systemic treatment (systemic steroids or immunosuppressive agents) or has a clinical symptomatology suggesting worsening of PNS.