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

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Status and phase

Active, not recruiting
Phase 3


Small Cell Lung Carcinoma Extensive Disease


Drug: Carboplatin
Drug: Tremelimumab
Drug: Etoposide
Drug: Durvalumab
Drug: Cisplatin

Study type


Funder types



2016-001203-23 (EudraCT Number)

Details and patient eligibility


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

Full description

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.


987 patients




18 to 130 years old


No Healthy Volunteers

Inclusion criteria

  1. 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.
  2. Suitable to receive a platinum-based chemotherapy regimen as 1st line treatment.
  3. Life expectancy ≥12 weeks at Day 1.
  4. ECOG 0 or 1 at enrolment.
  5. No prior exposure to immune-mediated therapy excluding therapeutic anticancer vaccines.

Exclusion criteria

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

Trial design

Primary purpose




Interventional model

Parallel Assignment


None (Open label)

987 participants in 3 patient groups

Arm 1
Experimental group
durvalumab+tremelimumab+EP (carboplatin or cisplatin + etoposide)
Drug: Cisplatin
Drug: Durvalumab
Drug: Etoposide
Drug: Carboplatin
Drug: Tremelimumab
Arm 2
Experimental group
durvalumab+EP (carboplatin or cisplatin + etoposide)
Drug: Cisplatin
Drug: Durvalumab
Drug: Etoposide
Drug: Carboplatin
Arm 3
Active Comparator group
EP (carboplatin or cisplatin + etoposide)
Drug: Cisplatin
Drug: Etoposide
Drug: Carboplatin

Trial documents

Trial contacts and locations



Data sourced from

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