Durvalumab Plus Chemotherapy in ES-SCLC (Oriental)

NCT04449861 | Completed Phase 3 Results

• 1 other identifier: D419BR00018
• Study Type: interventional
• Target: 166
• Locations: 1 country
• Sites: 30

Brief Summary

This will be an open-label, single-arm, multicenter, Phase IIIb study to determine the safety of durvalumab + etoposide and cisplatin or carboplatin as first-line treatment in patients with extensive stage small-cell lung cancer.

Conditions

Small Cell Lung Carcinoma Extensive Disease

Outcome Measures

Primary Outcomes (2)

• Percentage of Participants With Grade ≥3 AEs

  19 months

• Percentage of Participants With Immune-mediated Adverse Events (imAEs)

  An immune-mediated adverse event (imAE) is defined as an AESI that is associated with drug exposure and is consistent with an immune-mediated mechanism of action and where there is no clear alternate aetiology.

  19 months

Secondary Outcomes (10)

• Median Progression Free Survival (PFS)

  19 months

• Proportion of Patients Alive and Progression Free at 12 Months (APF12)

  12 months

• Objective Response Rate (ORR)

  19 months

• Median Overall Survival (OS)

  19 months

• Proportion of Patients Alive at 12 Months (OS12)

  12 months

Study Arms (1)

Durvalumab plus 4-6 cycles chemotherapy

EXPERIMENTAL

Participants will receive treatment with durvalumab + etoposide and either cisplatin or carboplatin (EP) for 4 to 6 cycles. Durvalumab will be administered at a dose of 1500 mg every 3 weeks (Q3W) with first-line chemotherapy (EP) and will continue to be administered as monotherapy every 4 weeks (Q4W) post-chemotherapy until progressive disease (PD). Prophylactic cranial irradiation (PCI) is allowed at the investigators' discretion as per SoC guidance for ES-SCLC. Patients will attend a safety follow up visit 90 days after last dose of durvalumab.

Drug: Durvalumab plus chemotherapy

Interventions

Durvalumab plus chemotherapy DRUG

Drug: Durvalumab IV infusions every 3 weeks for 4-6 cycles and every 4 weeks thereafter until PD or other discontinuation criteria. Drug: Carboplatin 4-6 cycles every 3 weeks Drug: Cisplatin 4-6 cycles every 3 weeks Drug: Etoposide 4-6 cycles every 3 weeks

Durvalumab plus 4-6 cycles chemotherapy

Eligibility Criteria

• Age: 18 Years - 130 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• Previous IP assignment in the present study.
• Medical contraindication to etoposide-platinum (carboplatin or cisplatin)-based chemotherapy.
• 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.
• Received prior systemic therapy for ES-SCLC. Patients who have received prior chemoradiotherapy for limited-stage SCLC must have been treated with curative intent and experienced a treatment-free interval of at least 6 months since last chemotherapy, radiotherapy, or chemoradiotherapy cycle from diagnosis of ES-SCLC
• Any condition that, in the opinion of the treating physician, would interfere with evaluation of the study drug or interpretation of patient safety.
• 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.
• 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.
• Active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease \[eg, colitis or Crohn's disease\], diverticulitis with the exception of diverticulosis, systemic lupus erythematosus, sarcoidosis syndrome, or Wegener syndrome \[granulomatosis with polyangiitis, Graves' disease, rheumatoid arthritis, hypophysitis, and uveitis, etc\]). The following are exceptions to this criterion:
• Patients with vitiligo or alopecia
• Patients with hypothyroidism (eg, following Hashimoto syndrome) and stable on hormone replacement
• Any chronic skin condition that does not require systemic therapy
• Patients without active disease in the last 5 years may be included but only after consultation with the Study Physician
• Patients with celiac disease controlled by diet alone

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (30)

Research Site

Baoding, 071000, China

Location

Research Site

Changchun, 130012, China

Location

Research Site

Chengdu, 610041, China

Location

Research Site

Dalian, 116001, China

Location

Research Site

Dongyang, 322100, China

Location

Research Site

Guangdong, 510120, China

Location

Research Site

Guangzhou, 510080, China

Location

Research Site

Guangzhou, 510280, China

Location

Research Site

Haerbin, 150081, China

Location

Research Site

Hangzhou, 310016, China

Location

Research Site

Hangzhou, 310022, China

Location

Research Site

Hefei, 230000, China

Location

Research Site

Huai'an, 223000, China

Location

Research Site

Jiangyin, 214400, China

Location

Research Site

Jinan, 250117, China

Location

Research Site

Jinhua, 321099, China

Location

Research Site

Nanchang, 330000, China

Location

Research Site

Nanjing, 210032, China

Location

Research Site

Ningbo, 315000, China

Location

Research Site

Qingdao, 266100, China

Location

Research Site

Shanghai, 200025, China

Location

Research Site

Shanghai, 200040, China

Location

Research Site

Shenzhen, 518020, China

Location

Research Site

Taizhou, 318000, China

Location

Research Site

Tianjin, 300060, China

Location

Research Site

Whenzhou, 325000, China

Location

Research Site

Wuhan, 430022, China

Location

Research Site

Wuxi, 214023, China

Location

Research Site

Yangzhou, 225012, China

Location

Research Site

Zhengzhou, 450000, China

Location

Related Links

• Redacted CSR synopsis
• Redacted Statistical Analysis Plan
• Redacted Clinical Study Protocol

MeSH Terms

Interventions

durvalumab; Drug Therapy

Intervention Hierarchy (Ancestors)

Therapeutics

Results Point of Contact

• Title: Ying Cheng, MD
• Organization: Jilin Cancer Hospital

jl.cheng@163.com

NA

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 6, 2020
• First Posted: June 29, 2020
• Study Start: December 7, 2020
• Primary Completion: March 30, 2023
• Study Completion: March 30, 2023
• Last Updated: November 27, 2024
• Results First Posted: November 27, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
• Access Criteria: When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

Locations

CN (30)