Study of Durvalumab in Combination With Platinum and Etoposide for the First Line Treatment of Patients With Extensive-stage Small Cell Lung Cancer

NCT ID: NCT04774380

Last Updated: 2025-05-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 152 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-11-11
• Study Completion Date: 2025-01-02

Brief Summary

Study to determine the safety and tolerability profile of durvalumab with platinum (cisplatin or carboplatin) plus etoposide (EP) as first-line treatment in participants with extensive-stage small-cell lung cancer.

Detailed Description

The study will be conducted in North America, Europe and Turkey.

In this single arm study participants will be treated with with durvalumab alone and concurrently with platinum-based chemotherapy and etoposide during the study period until radiological disease progression, unless there is clinical progression, unacceptable toxicity, withdrawal of consent, or another discontinuation criterion is met, as per investigator assessment.

Conditions

Extensive-stage Small Cell Lung Cancer

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Durvalumab - (cisplatin or carboplatin) - Etoposide

Participants will receive durvalumab dose A administered via intravenous (IV) infusion concurrently with platinum-based chemotherapy and etoposide every 3 weeks (q3w). Thereafter, durvalumab monotherapy will be continued every 4 weeks post-chemotherapy unless specific treatment discontinuation criteria are met.

Group Type: EXPERIMENTAL

Durvalumab

Intervention Type: DRUG

Participants will receive durvalumab via IV infusion on Day 1 of each cycle.

Cisplatin

Intervention Type: DRUG

Participants will receive cisplatin via IV administration on Day 1 of each cycle.

Carboplatin

Intervention Type: DRUG

Participants will receive carboplatin via IV administration Day 1 of each cycle.

Etoposide

Intervention Type: DRUG

Participants will receive etoposide via IV administration on days 1 to 3 of each cycle.

Interventions

Durvalumab

Participants will receive durvalumab via IV infusion on Day 1 of each cycle.

Intervention Type: DRUG

Cisplatin

Participants will receive cisplatin via IV administration on Day 1 of each cycle.

Intervention Type: DRUG

Carboplatin

Participants will receive carboplatin via IV administration Day 1 of each cycle.

Intervention Type: DRUG

Etoposide

Participants will receive etoposide via IV administration on days 1 to 3 of each cycle.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Histologically- or cytologically-documented ES-SCLC (stage IV [T any, N any, M1 a/b], or with 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 anticonvulsants for at least 1 month prior to study treatment)
• Participants must be considered suitable to receive a platinum-based chemotherapy regimen as 1st line treatment for the ES-SCLC. Chemotherapy must contain either cisplatin or carboplatin in combination with etoposide
• World Health Organization/ Eastern Cooperative Oncology Group performance status of 0 to 2 at enrollment Baseline computed tomography/ magnetic resonance imaging results of the brain, chest and abdomen (including liver and adrenal glands) within 28 days prior to the treatment initiation
• No prior exposure to immune-mediated therapy including, but not limited to, other anti- CTLA-4, anti-Programmed cell death-1 (PD-1), anti- Programmed cell death ligand-1 (PD-L1), and anti-PD-L2 (anti-PD-L2) antibodies, excluding therapeutic anticancer vaccines
• Adequate organ and marrow function
• Body weight > 30 kg
• Evidence of post-menopausal status or negative urinary or serum pregnancy test for female pre-menopausal participants

Exclusion Criteria

• History of allogeneic organ transplantation
• Active or prior documented autoimmune or inflammatory disorders, systemic lupus erythematosus, sarcoidosis syndrome, or wegener syndrome
• Uncontrolled intercurrent illness, including but not limited to, ongoing or active infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, uncontrolled cardiac arrhythmia, active interstitial lung disease, serious chronic gastrointestinal conditions associated with diarrhea, or psychiatric illness/social situations that would limit compliance with study requirement, substantially increase risk of incurring AEs or compromise the ability of the participant to give written informed consent
• History of another primary malignancy except for:

• Malignancy treated with curative intent and with no known active disease ≥ 5 years before the first dose of Investigational medicinal product (IMP) and of low potential risk for recurrence
• Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease
• Adequately treated carcinoma in situ without evidence of disease
• History of leptomeningeal carcinomatosis and active primary immunodeficiency
• Active infection including tuberculosis, hepatitis B, hepatitis C, human immunodeficiency virus
• Any unresolved toxicity Common Terminology Criteria for Adverse Events Grade ≥ 2 from previous anticancer therapy
• Known allergy or hypersensitivity to any of the study drugs or any of the study drug excipients
• Received prior systemic therapy for ES-SCLC
• Medical contraindication to platinum (cisplatin or carboplatin)-etoposide-based chemotherapy
• Any concurrent chemotherapy, IMP, biologic, or hormonal therapy for cancer treatment. Concurrent use of hormonal therapy for non-cancer-related conditions is acceptable
• Planned consolidation chest radiation therapy. Radiation therapy outside of the chest for palliative care is allowed but must be completed before first dose of the study medication
• Receipt of live attenuated vaccine within 30 days prior to the first dose of in IMP
• Major surgical procedure within 28 days prior to the first dose of IMP
• Participants who have received prior immunotherapy agents including anti-PD-1 or anti PD-L1
• Current or prior use of immunosuppressive medication within 14 days before the first dose of durvalumab
• Participation in another clinical study with an investigational product administered in the last 4 weeks
• Female participants who are pregnant or breastfeeding or male or female participants of reproductive potential who are not willing to employ effective birth control from screening to 90 days after the last dose of durvalumab and 180 days after the last dose of etoposide

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 130 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

AstraZeneca

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Research Site

Panagyurishte, , Bulgaria

Research Site

Rousse, , Bulgaria

Research Site

Sofia, , Bulgaria

Research Site

Sofia, , Bulgaria

Research Site

Sofia, , Bulgaria

Research Site

Montreal, Quebec, Canada

Research Site

Burgas, , Czechia

Research Site

Olomouc, , Czechia

Research Site

Ostrava, , Czechia

Research Site

Berlin, , Germany

Research Site

Berlin, , Germany

Research Site

Cologne, , Germany

Research Site

Gauting, , Germany

Research Site

Hamburg, , Germany

Research Site

Jena, , Germany

Research Site

Kassel, , Germany

Research Site

Ancona, , Italy

Research Site

Bari, , Italy

Research Site

Milan, , Italy

Research Site

Napoli, , Italy

Research Site

Orbassano, , Italy

Research Site

Palermo, , Italy

Research Site

Roma, , Italy

Research Site

Adapazarı, , Turkey (Türkiye)

Research Site

Ankara, , Turkey (Türkiye)

Research Site

Ankara, , Turkey (Türkiye)

Research Site

Ankara, , Turkey (Türkiye)

Research Site

Antalya, , Turkey (Türkiye)

Research Site

Bursa, , Turkey (Türkiye)

Research Site

Edirne, , Turkey (Türkiye)

Research Site

Istanbul, , Turkey (Türkiye)

Research Site

Istanbul, , Turkey (Türkiye)

Research Site

Izmir, , Turkey (Türkiye)

Research Site

Malatya, , Turkey (Türkiye)

Research Site

Pamukkale, , Turkey (Türkiye)

Countries

Bulgaria; Canada; Czechia; Germany; Italy; Turkey (Türkiye)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Related Links

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Other Identifiers

2020-005537-32

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

D419QC00007

Identifier Type: -

Identifier Source: org_study_id