Efficacy and Safety of Standard of Care Plus Durvalumab in Patients With Limited Disease Small Cell Lung Cancer (DOLPHIN)

NCT04602533 | Active Not Recruiting Phase 2 DMC

• 2 other identifiers: Dolphin2020-001050-22
• Study Type: interventional
• Target: 105
• Locations: 1 country
• Sites: 15

Brief Summary

Combination of concomitant Radio-Chemotherapy showed a significant improvement (Takada) of OS and PFS in limited disease SCLC patients. This clinical trial is a prospective, multicenter, randomized, open-label, parallel group phase II investigator initiated trial (ITT) to evaluate the efficacy and safety of Durvalumab in combination with Cisplatin/Etoposide/Radiotherapy in patients with limited disease small-cell lung cancer (SCLC).

Conditions

Small Cell Lung Cancer Limited Stage

Keywords

LD-SCLC; lung cancer; durvalumab

Outcome Measures

Primary Outcomes (1)

• Progression-free survival (PFS)

  Progression-free survival (PFS) after 18 months according to iRECIST

  18 months

Secondary Outcomes (8)

• Progression-free survival (PSF) after other assessments

  12 months

• Overall survival (OS)

  18 months

• Overall response rate (ORR)

  18 months

• Disease control rate (DCR)

  18 months

• Quality of Life Questionnaire - Cancer 30 (QLQ-C30)

  18 months

Study Arms (2)

Durvalumab

EXPERIMENTAL

Induction phase: Durvalumab (1500 mg once every 3 weeks) for 4-6 cycles in combination with standard of care (Radiochemotherapy) Maintenance phase: Durvalumab (1500 mg once every 4 weeks) until PD or unacceptable toxicities.

Drug: Durvalumab

standard of care

OTHER

Induction phase: Radiochemotherapy according to guideline Maintenance: Standard of care

Drug: standard of care

Interventions

standard of care DRUG

Radiochemotherapy: Cisplatin (75 mg/m² (BSA) D1#) or alternatively Carboplatin (AUC 5 D1) and Etoposide (100 mg/m² (BSA) D1-3) once every 3 weeks for 4-6 cycles and concomitant Radiotherapy (60±6 Gy, 1.8-2 Gy/d or 45±1.5 Gy (1.5 Gy per fraction twice daily, with 4 hours or more between fractions) with start at latest at beginning of cycle 3, ideally during cycle 1) followed by prophylactic cranial irradiation (PCI, if clinically indicated and according to local standard at any time after completion of radio-chemotherapy)) A simultaneous administration of platinum-based chemotherapy (preferred Cisplatin) and radiotherapy for at least 2 cycles should be performed.

standard of care

Durvalumab DRUG

Induction phase: Durvalumab (1500 mg once every 3 weeks) for 4-6 cycles in combination with standard of care (Radiochemotherapy) Maintenance phase: Durvalumab (1500 mg once every 4 weeks) until PD or unacceptable toxicities.

Also known as: IMFINZI®

Durvalumab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed and dated informed consent of the subject must be available before start of any specific trial procedures
• Male or female ≥ 18 years
• Histological confirmed limited disease small cell lung cancer (stage 2 and 3; T1a-4, N1-3, M0 according UICC8 criteria; if primarius is not eligible as RECIST1.1 target lesion (in cases with T1a and T1b) at least one lymph node must meet RECIST1.1 criteria for target lesion (≥15 mm short axis))
• Availability of tumor tissue or fresh tumor material for translational research by central lab testing
• ECOG PS 0 - 1
• At least one measurable lesion according RECIST 1.1
• Body weight \> 30 kg
• Adequate normal organ function
• Hemoglobin ≥ 9.0 g/dL
• Absolute neutrophil count (ANC) ≥ 1.5 x109/L
• Platelet count ≥ 100 x109/L
• AST (SGOT)/ALT (SGPT) ≤ 2.5 x institutional upper limit of normal
• Serum Bilirubin ≤ 1.5 x institutional upper limit of normal
• Estimated glomerular filtration rate (eGFR) ≥ 30 mL/min for Carboplatin, ≥ 60 mL/min for Cisplatin, calculated by the Cockcroft-Gault formula
• Life expectancy of at least 12 weeks in the discretion of the investigator

You may not qualify if:

• Extensive disease small cell lung cancer (Tx, Nx, M1; stage IV)
• Major surgical process within 28 day prior first dose of IMP and/or Radiochemotherapy
• History of allogenic organ transplantation
• Active or prior documented autoimmune or inflammatory disorder (including inflammatory bowel disease \[e.g. colitis or Crohn's disease\], diverticulitis \[with the exception of diverticulosis\], systemic lupus erythematosus, Sarcoidosis syndrome or Wegener syndrome \[granulomatosis with polyangiitis\], Graves' disease, rheumatoid arthritis, hypophysitis, uveitis, etc.). The following are exceptions to this criterion:
• Patients with vitiligo or alopecia
• Patients with hypothyroidism (e.g. following Hashimoto syndrome) stable on hormone replacement
• Patients with any chronic skin condition that not required 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
• Uncontrolled intercurrent illness (i.e. active infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, interstitial lung disease, serious chronic gastrointestinal conditions (i.e. diarrhea), psychiatric illness)
• History of another primary malignancy in the last 5 years, except adequately treated nonmelanoma skin cancer, adequately treated carcinoma in situ (without evidence of disease)
• History of leptomeningeal carcinomatosis, or brain metastases
• Known HIV positive and/or 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. 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 (HCV) antibody are eligible only if polymerase chain reaction is negative for HCV RNA.
• Current or prior use of immunosuppressive medication within 14 days before the first dose.The following are exceptions to this criterion:
• Intranasal, inhaled, topical steroids, or local steroid injections (e.g., intra articular injection)

Sponsors & Collaborators

• Michael Hopp: lead
• AstraZeneca: collaborator

Study Sites (15)

Klinikverbund Allgäu gGmbH

Immenstadt im Allgäu, Bavaria, 87509, Germany

Location

Asklepios Fachkliniken Muenchen Gauting

München Gauting, Bavaria, 82131, Germany

Location

Klinikum Ernst von Bergmann

Potsdam, Brandenburg, 14467, Germany

Location

Universitätsklinikum Gießen Marburg

Giessen, Hesse, 35392, Germany

Location

Klinikum Kassel GmbH-Klinik für Onkologie und Hämatologie

Kassel, Hesse, 34125, Germany

Location

Sana-Klinikum Offenbach

Offenbach, Hesse, 63069, Germany

Location

Universitätsmedizin Rostock

Rostock, Mecklenburg-Vorpommern, 18059, Germany

Location

Universitätsklinikum Aachen

Aachen, North Rhine-Westphalia, 52074, Germany

Location

Lungenklinik Köln-Merheim

Cologne, North Rhine-Westphalia, 51109, Germany

Location

KEM GmbH

Essen, North Rhine-Westphalia, 45136, Germany

Location

Universitätsklinikum Essen

Essen, North Rhine-Westphalia, 45147, Germany

Location

Lungenklinik Hemer

Hemer, North Rhine-Westphalia, 58675, Germany

Location

Johannes Wesling Klinikum Minden

Minden, North Rhine-Westphalia, 32429, Germany

Location

Helios Kliniken Erfurt

Erfurt, Thuringia, 99089, Germany

Location

Asklepios Klinikum Hamburg

Hamburg, 21075, Germany

Location

MeSH Terms

Conditions

Lung Neoplasms

Interventions

durvalumab; Standard of Care

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Thomas Wehler, Prof

  Universitätsklinikum Gießen Marburg

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Head of Interdisciplinary Center for Clinical Studies (IZKS)

Study Record Dates

• First Submitted: October 20, 2020
• First Posted: October 26, 2020
• Study Start: December 21, 2020
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: February 27, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

DE (15)