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Clinical Trials List

Protocol NumberD419QC00001
NCT Number(ClinicalTrials.gov Identfier)NCT03043872

2017-08-24 - 2019-09-30

Phase III

Terminated10

ICD-10C34

Malignant neoplasm of bronchus and lung

ICD-9162.9

Malignant neoplasm of bronchus and lung, unspecified

A Phase III, Randomized, Multicenter,Open-Label, Comparative Study to Determine the Efficacy of Durvalumab or Durvalumab and Tremelimumab in Combination With Platinum-Based Chemotherapy for the First-Line Treatment in Patients With Extensive Disease Small-Cell Lung Cancer (SCLC) (CASPIAN)

  • Trial Applicant

  • Sponsor

    AstraZeneca

  • Trial scale

    Multi-Regional Multi-Center

  • Update

    2025/08/20

Investigators and Locations

Principal Investigator Chao-Hua Chiu Division of Hematology & Oncology
Taipei Veterans General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

4 Terminated

Audit

None

Principal Investigator 魏裕峰 Division of Thoracic Medicine
E-DA Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Terminated

Principal Investigator Gee-chen Chang Division of Thoracic Medicine
Taichung Veterans General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Terminated

Principal Investigator 李建德 Division of Thoracic Medicine
CHANGHUA CHRISTIAN HOSPITAL

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Terminated

Principal Investigator 陳彥勳 Division of Hematology & Oncology
Chi Mei Medical Center

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Terminated

Principal Investigator Te-Chun Hsia Division of Thoracic Medicine
China Medical University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Terminated

Principal Investigator Shang-Yin Wu Division of Hematology & Oncology
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Terminated

Audit

None

Principal Investigator CHIN-CHOU WANG Division of Thoracic Medicine
Kaoshiung Chang Gung Memorial Hospital of the C.G.M.F.

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Terminated

Principal Investigator Te-Chun Hsia 未分科
China Medical University Hospital-Taipei

Co-Principal Investigator

Audit

None

Principal Investigator kang-Yun LEE Division of Thoracic Medicine
Taipei Medical University-Shuang Ho Hospital,Ministry of Health and Welfare

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

2 Terminated

Audit

CRO

Principal Investigator James Chih-Hsin Yang Division of Hematology & Oncology
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Terminated

Audit

None

Condition/Disease

Small-Cell Lung Cancer (SCLC)

Objectives

Primary objective of this study is to assess the efficacy of durvalumab + tremelimumab + EP treatment compared with EP and the efficacy of durvalumab + EP treatment compared with EP in terms of OS.

Test Drug

Durvalumab; Tremelimumab

Active Ingredient

Humanized anti-CTLA-4 mAb
Humanized anti-PD-1 mAb

Dosage Form

injecion

Dosage

50
20

Endpoints

Primary Outcome Measures :
Overall Survival (OS); Assessed at Interim Analysis; D + EP Compared With EP [ Time Frame: From baseline until death due to any cause. Assessed until interim analysis DCO (maximum of approximately 23 months). ]
OS was defined as the time from the date of randomization until death due to any cause. Any patient not known to have died at the time of analysis was censored based on the last recorded date on which the patient was known to be alive. Median OS was calculated using the Kaplan-Meier technique. An interim analysis of OS was pre-specified after approximately 318 OS events occurred each between the D + EP and EP groups (60% maturity), and between the D + T + EP and EP groups (60% maturity). At the interim analysis DCO (11 March 2019), comparison of OS in the D + EP versus (vs) EP groups had crossed the pre-specified boundary. Since these results were considered final in terms of formal statistical testing, they are presented here as a primary outcome measure. Analysis of OS for D + EP vs EP and for D + T + EP vs EP at the time of the global cohort final analysis is presented separately in the subsequent primary outcome measure.

OS; Assessed at Final Analysis; D + EP Compared With EP and D + T + EP Compared With EP [ Time Frame: From baseline until death due to any cause. Assessed until global cohort final analysis DCO (maximum of approximately 33 months). ]
OS was defined as the time from the date of randomization until death due to any cause. Any patient not known to have died at the time of analysis was censored based on the last recorded date on which the patient was known to be alive. Median OS was calculated using the Kaplan-Meier technique. This primary outcome measure presents OS for the analysis of D + EP vs EP and D + T + EP vs EP at the time of the global cohort final analysis DCO (27 January 2020). Analysis of D + EP vs EP at the interim analysis DCO is presented in the previous primary outcome measure. Analysis of D + T + EP vs D + EP (global cohort final analysis) is presented as a secondary outcome measure.

Inclution Criteria

Inclusion criteria
For inclusion in the study, patients should fulfill the following criteria:
1. Male or female ≥18 years at the time of Screening. In Japan, patients must be aged
≥ 20 years at the time of Screening.
2. Written informed consent and any locally required authorization (eg, Health
Insurance Portability and Accountability Act in the US, European Union [EU] Data
Privacy Directive in the EU) obtained from the patient/legal representative prior to
performing any protocol-related procedures, including screening evaluations.
3. 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.
4. Provision of an archived tumor tissue block (or at least 10 newly cut unstained
slides) where such samples exist (refer to Section 5.5 and Laboratory Manual for
details).
5. 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.
6. Life expectancy ≥12 weeks at Day 1.
7. World Health Organization (WHO)/Eastern Cooperative Oncology Group (ECOG)
Performance Status of 0 or 1 at enrollment.
8. Body weight >30 kg.
9. At least 1 lesion, not previously irradiated, that can be accurately measured at
baseline as ≥10 mm in the longest diameter (except lymph nodes which must have a
short axis ≥15 mm) with computed tomography (CT) or magnetic resonance
imaging (MRI) and that is suitable for accurate repeated measurements as per
RECIST 1.1 guidelines.
10. No prior exposure to immune-mediated therapy including, but not limited to, other
anti-CTLA-4, anti-PD-1, anti-PD-L1, and anti-programmed cell death ligand 2
(anti-PD-L2) antibodies, excluding therapeutic anticancer vaccines.
11. Adequate organ and marrow function as defined below:
 Hemoglobin ≥9.0 g/dL.
 Absolute neutrophil count ≥1.5 × 109
/L (use of granulocyte colony-stimulating
factor is not permitted at screening).
 Platelet count ≥100 × 109
/L.
 Serum bilirubin ≤1.5 × the upper limit of normal (ULN). This will not apply to
patients with confirmed Gilbert’s syndrome, who will be allowed in
consultation with their physicians.
 In patients without hepatic metastasis: ALT and AST ≤2.5 × ULN.
 In patients with hepatic metastases, ALT and AST ≤5 × ULN.
 Measured or calculated creatinine clearance: >60mL/min for patients on
cisplatin and >45mL/min for patients on carboplatin, as determined by
Cockcroft-Gault (using actual body weight):
Males:
Creatinine CL = Weight (kg) × (140 – Age)
(mL/min) 72 × Serum creatinine (mg/dL)
Females:
Creatinine CL = Weight (kg) × (140 – Age) × 0.85
(mL/min) 72 × Serum creatinine (mg/dL)
12. Evidence of post-menopausal status or negative urinary or serum pregnancy test for
female pre-menopausal patients. Women will be considered post-menopausal if
they have been amenorrheic for 12 months without an alternative medical cause.
The following age-specific requirements apply:
 Women <50 years of age would be considered post-menopausal if they have
been amenorrheic for 12 months or more following cessation of exogenous
hormonal treatments and if they have luteinizing hormone and folliclestimulating hormone levels in the post-menopausal range for the institution or
underwent surgical sterilization (bilateral oophorectomy or hysterectomy).
 Women ≥50 years of age would be considered post-menopausal if they have
been amenorrheic for 12 months or more following cessation of all exogenous
hormonal treatments, had radiation-induced menopause with last menses
>1 year ago, had chemotherapy-induced menopause with last menses >1 year ago, or underwent surgical sterilization (bilateral oophorectomy, bilateral salpingectomy or hysterectomy).

Exclusion Criteria

Exclusion criteria
Patients should not enter the study if any of the following exclusion criteria are fulfilled:
1. Involvement in the planning and/or conduct of the study (applies to both
AstraZeneca staff and/or staff at the study site).
2. Previous IP assignment in the present study.
3. 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.
4. Participation in another clinical study with an IP during the last 4 weeks.
5. Medical contraindication to etoposide-platinum (carboplatin or cisplatin)-based
chemotherapy
6. 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.
7. 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.
8. 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.
9. History of allogenic organ transplantation.
10. 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.
11. 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
12. Uncontrolled intercurrent illness, including but not limited to, ongoing or active
infection, interstitial lung disease, symptomatic congestive heart failure,
uncontrolled hypertension, unstable angina pectoris, cardiac arrhythmia, 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 patient
to give written informed consent.
13. 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 IP 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
14. History of leptomeningeal carcinomatosis.
15. History of active primary immunodeficiency.
16. Active infection including tuberculosis (clinical evaluation that includes clinical
history, physical examination and radiographic findings, and TB testing in line
with local practice), hepatitis B (known positive HBV surface antigen [HbsAg]
result), hepatitis C, or human immunodeficiency virus (positive HIV 1/2
antibodies). Patients with a past or resolved HBV infection (defined as the presence
of hepatitis B core antibody [anti-HBc] and absence of HbsAg) are eligible.
Patients positive for hepatitis C virus (HCV) antibody are eligible only if
polymerase chain reaction is negative for HCV RNA.
17. Current or prior use of immunosuppressive medication within 14 days before the
first dose of durvalumab or tremelimumab. The following are exceptions to this
criterion:
 Intranasal, inhaled, topical steroids or local steroid injections (eg, intra articular
injection).
 Systemic corticosteroids at physiologic doses not to exceed 10 mg/day of
prednisone or its equivalent.
 Steroids as premedication for hypersensitivity reactions (eg, CT scan
premedication). Premedication with steroids for chemotherapy is acceptable.
18. Receipt of live, attenuated vaccine within 30 days prior to the first dose of IP. Note:
Patients, if enrolled, should not receive live vaccine whilst receiving IP and up to 30
days after the last dose of IP.
19. Female patients who are pregnant or breastfeeding or male or female patients of
reproductive potential who are not willing to employ effective birth control from
Screening to 90 days after the last dose of durvalumab monotherapy or 180 days
after the last dose of durvalumab + tremelimumab combination therapy.
20. Known allergy or hypersensitivity to durvalumab, tremelimumab, etoposide,
carboplatin, cisplatin, or any of their excipients
21. Prior randomization or treatment in a previous durvalumab and/or tremelimumab
clinical study regardless of treatment arm assignment.
For patients who have consented to Genetics Sample the following exclusion criteria apply:
 Previous allogeneic bone marrow transplant
 Non-leukocyte depleted whole blood transfusion within 120 days of genetic sample
collection

The Estimated Number of Participants

  • Taiwan

    22 participants

  • Global

    805 participants

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