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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04774380
Recruitment Status : Active, not recruiting
First Posted : March 1, 2021
Last Update Posted : January 18, 2023
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

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.

Condition or disease Intervention/treatment Phase
Extensive-stage Small Cell Lung Cancer Drug: Durvalumab Drug: Cisplatin Drug: Carboplatin Drug: Etoposide Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 150 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase IIIb, Single-arm, Multi-center, International Study of Durvalumab in Combination With Platinum and Etoposide for the First Line Treatment of Patients With Extensive-stage Small Cell Lung Cancer (LUMINANCE)
Actual Study Start Date : November 11, 2021
Estimated Primary Completion Date : June 21, 2023
Estimated Study Completion Date : March 28, 2024


Arm Intervention/treatment
Experimental: 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.
Drug: Durvalumab
Participants will receive durvalumab via IV infusion on Day 1 of each cycle.

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

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

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




Primary Outcome Measures :
  1. Number of participants with incidence of Grade 3 and higher adverse events (AEs) [ Time Frame: Until disease progression (Approximately upto 1.6 Years) ]
    Assessment of incidence of Grade 3 and higher adverse events to evaluate safety and tolerability profile of durvalumab + EP treatment.

  2. Number of participants with incidence of Immune mediated adverse events (imAEs) [ Time Frame: Until disease progression (Approximately upto 1.6 Years) ]
    Assessment of imAEs to evaluate safety and tolerability profile of durvalumab + EP treatment.


Secondary Outcome Measures :
  1. Progression-free survival (PFS) [ Time Frame: From screening until disease progression (Approximately 2 Years) ]
    Assessment of efficacy of durvalumab + EP treatment by evaluating PFS according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1). The PFS is the time from the first date of treatment until the date of objective disease progression or death (by any cause in the absence of progression) regardless of whether the participant withdraws from Investigational medicinal product (IMP) or receives another anticancer therapy prior to progression.

  2. Objective response rate (ORR) [ Time Frame: From screening until disease progression (Approximately 2 Years) ]
    Assessment of the efficacy of durvalumab + EP treatment by evaluating ORR according to RECIST 1.1. The ORR will be assessed based on Investigator-assessed response to treatment of complete response (CR) and partial response (PR), per RECIST1.1.

  3. Duration of response (DoR) [ Time Frame: From screening until disease progression (Approximately 2 Years) ]
    Assessment of the efficacy of durvalumab + EP treatment by evaluating DoR according to RECIST 1.1. The DoR is time from the date of first documented response per RECIST1.1 until the first date of documented progression per RECIST1.1 or death in the absence of disease progression.

  4. Percentage of participants remaining in response, 12 months from the time of first documented objective response (DoR12) [ Time Frame: From screening until disease progression (Approximately 2 Years) ]
    Assessment of the efficacy of durvalumab + EP treatment by evaluating DoR12 according to RECIST 1.1.

  5. Percentage of participants alive and progression-free at 12 months from first date of treatment (PFS12) [ Time Frame: From screening until disease progression (Approximately 2 Years) ]
    Assessment of the efficacy of durvalumab + EP treatment by evaluating PFS12 according to RECIST 1.1.

  6. Overall (OS) [ Time Frame: From screening until death due to any cause (Approximately 2 Years) ]
    Assessment of the efficacy of durvalumab + EP treatment by evaluating OS according to RECIST 1.1. The OS is the time from the first date of treatment until death due to any cause.

  7. Percentage of participants alive at 12 months from first date of treatment (OS12) [ Time Frame: From screening until disease progression (Approximately 2 Years) ]
    Assessment of the efficacy of durvalumab + EP treatment by evaluating OS12 according to RECIST 1.1.

  8. Number of participants with adverse events and serious adverse events [ Time Frame: From Cycle 1 (3 weeks [21 days]) until disease progression (Approximately 2 Years) ]
    Assessment of adverse events and serious adverse events to evaluate safety and tolerability profile of durvalumab + EP treatment.

  9. Number of participants with adverse events of special interests [ Time Frame: From Cycle 1 (3 weeks [21 days]) until disease progression (Approximately 2 Years) ]
    Assessment of adverse events of special interests to evaluate safety and tolerability profile of durvalumab + EP treatment.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 130 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04774380


Locations
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Bulgaria
Research Site
Panagyurishte, Bulgaria, 4500
Research Site
Ruse, Bulgaria, 7002
Research Site
Sofia, Bulgaria, 1303
Research Site
Sofia, Bulgaria, 1330
Research Site
Sofia, Bulgaria, 1407
Canada, Quebec
Research Site
Montreal, Quebec, Canada, H4A 3J1
Czechia
Research Site
Burgas, Czechia, 180 81
Research Site
Olomouc, Czechia, 779 00
Research Site
Ostrava, Czechia, 703 00
Germany
Research Site
Berlin, Germany, 12351
Research Site
Berlin, Germany, 13125
Research Site
Gauting, Germany, 82131
Research Site
Hamburg, Germany, 20251
Research Site
Jena, Germany, 07747
Research Site
Kassel, Germany, 34125
Research Site
Köln, Germany, 51109
Italy
Research Site
Ancona, Italy, 60126
Research Site
Bari, Italy, 70124
Research Site
Milano, Italy, 20141
Research Site
Napoli, Italy, 80131
Research Site
Orbassano, Italy, 10043
Research Site
Palermo, Italy, 90146
Research Site
Roma, Italy, 00168
Turkey
Research Site
Adapazari, Turkey, 54290
Research Site
Ankara, Turkey, 06010
Research Site
Ankara, Turkey, 06100
Research Site
Ankara, Turkey, 06800
Research Site
Antalya, Turkey, 07070
Research Site
Bursa, Turkey, 16059
Research Site
Edirne, Turkey, 22030
Research Site
Istanbul, Turkey, 34098
Research Site
Istanbul, Turkey, 34722
Research Site
Izmir, Turkey, 35100
Research Site
Malatya, Turkey, 44280
Research Site
Pamukkale, Turkey, 20070
Sponsors and Collaborators
AstraZeneca
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Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT04774380    
Other Study ID Numbers: D419QC00007
2020-005537-32 ( EudraCT Number )
First Posted: March 1, 2021    Key Record Dates
Last Update Posted: January 18, 2023
Last Verified: January 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description:

Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All requests will be evaluated as per the AZ disclosure commitment:

https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.

Supporting Materials: Study Protocol
Statistical Analysis Plan (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.

URL: https://astrazenecagroup-dt.pharmacm.com/DT/Home

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by AstraZeneca:
Chemotherapy
Aggressive malignancy
Programmed cell death ligand-1
Platinum-based chemotherapy
Additional relevant MeSH terms:
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Lung Neoplasms
Small Cell Lung Carcinoma
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Cisplatin
Carboplatin
Etoposide
Durvalumab
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Immunological