First-line patients with extensive disease (Stage IV) small-cell lung cancer (SCLC) MedDRA version: 20.0 Level: PT Classification code 10041068 Term: Small cell lung cancer extensive stage System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Product Name: durvalumab
Product Code: MEDI4736
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: durvalumab
CAS Number: 1428935-60-7
Current Sponsor code: MEDI4736
Conce
Sponsors
AstraZeneca AB
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Histologically or cytologically documented extensive disease (American Joint Committee on Cancer Stage IV SCLC [T any, N any, M1 a/b]), including patients 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 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. 6 .Body weight >30 kg. 7. Adequate organ and marrow function. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 590 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 394
Exclusion criteria
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. Any other concurrent chemotherapy, IP, biologic, or hormonal therapy for cancer treatment. 3. History of allogenic organ transplantation. 4. Paraneoplastic syndrome of autoimmune nature, requiring systemic treatment or clinical symptomatology suggesting worsening of PNS 5. Uncontrolled intercurrent illness 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. 6. History of another primary malignancy 7. Active infection including tuberculosis, HIV, hepatitis B anc C 8. Current or prior use of immunosuppressive medication within 14 days before the first IP dose 9. Female patients who are pregnant or breastfeeding or male or female patients of reproductive potential who are not willing to employ effective birth control.. 10. Past medical history of interstitial lung disease or any evidence of clinically active interstitial lung disease.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 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.;Secondary Objective: 1.To further assess the efficacy of durvalumab +tremelimumab + EP treatment compared with EP and the efficacy of durvalumab + EP compared with EP in terms of PFS, ORR, APF6 (PFS rate at 6 months), APF12 (PFS rate at 12 months) and OS18 (OS rate at 18 months) 2.To assess the efficacy of durvalumab + tremelimumab + EP treatment compared with durvalumab + EP in terms of PFS and OS 3.To assess the PK of durvalumab and durvalumab + tremelimumab 4.To investigate the immunogenicity of durvalumab and durvalumab + tremelimumab. 5.To assess the effect of the treatment on changes in symptoms and health-related QoL using EORTC QLQ-C30 v3 and QLQ-LC13. 6.Safety objective: To assess the safety and tolerability profile of durvalumab and durvalumab + tremelimumab in combination with EP treatment compared with EP.;Primary end point(s): 1. Overall survival (OS)- the time from the date of randomization until death due to any cause.;Timepoint(s) of evaluation of this end point: 1. 42 months after the first patient has been randomized | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1.Progression free survival (PFS) - the time from the date of randomization until the date of objective disease progression or death. 2.Objective Response Rate (ORR) -the number (%) of patients with at least 1 visit response of CR or PR. 3. Proportion of patients alive and progression free at 6 (APF6) and 12 months (APF12). 4. Proportion of patients alive at 18 months (OS18).;Timepoint(s) of evaluation of this end point: 42 months after the first patient has been randomized for all Secondary endpoints. | — |
Countries
Argentina, Austria, Brazil, Bulgaria, China, Czech Republic, France, Germany, Hungary, Israel, Italy, Japan, Korea, Republic of, Netherlands, Poland, Romania, Russian Federation, Slovakia, Spain, Taiwan, Turkey, Ukraine, United States
Contacts
Public ContactInformation Center
AstraZeneca AB
Outcome results
None listed