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Durvalumab ± Tremelimumab in Combination With Platinum Based Chemotherapy in Untreated Extensive-Stage Small Cell Lung Cancer (CASPIAN)

Trial Status: Closed to Accrual

This is a phase III, randomized, open-label, multicenter, global study to determine the efficacy and safety of combining durvalumab ± tremelimumab with platinum based chemotherapy (EP) followed by durvalumab ± tremelimumab maintenance therapy versus EP alone as first-line treatment in patients with extensive-stage small-cell lung cancer

Inclusion Criteria

  • Histologically or cytologically documented extensive disease. Brain metastases; must be asymptomatic or treated and stable off steroids and anti-convulsants for at least 1 month prior to study treatment.
  • Suitable to receive a platinum-based chemotherapy regimen as 1st line treatment.
  • Life expectancy ≥12 weeks at Day 1.
  • ECOG 0 or 1 at enrolment.
  • No prior exposure to immune-mediated therapy excluding therapeutic anticancer vaccines.

Exclusion Criteria

  • Any history of radiotherapy to the chest prior to systemic therapy or planned consolidation chest radiation therapy (except paliative care outside of the chest).
  • Paraneoplastic syndrome of autoimmune nature, requiring systemic treatment or clinical symptomatology suggesting worsening of PNS
  • Active infection including tuberculosis, HIV, hepatitis B anc C
  • Active or prior documented autoimmune or inflammatory disorders
  • Uncontrolled intercurrent illness, including but not limited to interstitial lung disease.

Alabama

Birmingham
University of Alabama at Birmingham Cancer Center
Status: ADMINISTRATIVELY_COMPLETE

Arizona

Scottsdale
Mayo Clinic in Arizona
Status: CLOSED_TO_ACCRUAL

California

Los Angeles
Translational Research In Oncology - US Inc (TRIO-US)
Status: CLOSED_TO_ACCRUAL
UCLA / Jonsson Comprehensive Cancer Center
Status: COMPLETED
Contact: Lia Etheridge
Phone: 310-825-7174

Connecticut

New Haven
Yale University
Status: CLOSED_TO_ACCRUAL

New York

New York
NYP / Columbia University Medical Center / Herbert Irving Comprehensive Cancer Center
Status: ADMINISTRATIVELY_COMPLETE

Ohio

Cleveland
Case Comprehensive Cancer Center
Status: COMPLETED

Washington

Seattle
Fred Hutch / University of Washington Cancer Consortium
Status: CLOSED_TO_ACCRUAL

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.

All patients will be randomized in a 1:1:1 ratio in a stratified manner according to the

planned platinum-based therapy for Cycle 1 (cisplatin or carboplatin) to receive treatment

with durvalumab + tremelimumab + EP (Arm 1), durvalumab + EP (Arm 2), or standard of care- EP

(Arm 3). Arm 1 and Arm 2 patients receive the treatment until confirmed disease progression

while Arm 3 patients receive up to 6 cycles of EP and prophylactic cranial irradiation if

clinically indicated, at the Investigators' discretion.Patients who have discontinued

treatment due to toxicity or symptomatic deterioration, clinical progression, or who have

commenced subsequent anticancer therapy will be followed up until confirmed disease

progression and for survival.

Targeted population are adult patients (aged ≥18 years) with 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.

Patients must have WHO/ECOG performance status of 0 or 1.

Tumor assessments will be performed at Screening as baseline with follow-up at Week 6 ±1 week

from the date of randomization, at Week 12 ±1 week from the date of randomization, and then

every 8 weeks ±1 week until confirmed objective disease progression.

An independent data monitoring committee (IDMC) comprised of independent experts will be

convened to confirm the safety and tolerability of the proposed dose and schedule of

durvalumab ± tremelimumab in combination with platinum based chemotherapy at two early stages

of enrolment.

Trial Phase Phase III

Trial Type Treatment

Lead Organization
AstraZeneca Pharmaceuticals LP

  • Primary ID D419QC00001
  • Secondary IDs NCI-2017-00703, 2016-001203-23
  • Clinicaltrials.gov ID NCT03043872