Durvalumab With Consolidative Radiochemotherapy and Ablative Stereotactic Radiotherapy in Oligometastatic ES-SCLC

ConditionExtensive-stage Small-cell Lung Cancer

Trial statusRecruiting

Trial phasePhase 2

Trial typeInterventional

Biological sexAll

Age18+

SponsorUniversität des Saarlandes

About this trial

Open-label, single-arm, prospective multicenter phase II clinical trial to determine the efficacy of immunotherapy with durvalumab concomitant with radiochemotherapy, followed by durvalumab maintenance therapy in combination with stereotactic radiotherapy in extensive stage SCLC

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Histologically confirmed first diagnosis of ES-SCLC according to the Veterans Administration Lung Study Group (VALG) Staging System for SCLC1 (disease extension that cannot be treated within one radiation field).

Primary tumor with or without mediastinal or supraclavicular lymph node metastases (counts as one lesion if it can be treated within one radiation field).

Up to four distant tumor lesions/metastases that can be treated with stereotactic radiotherapy (stereotactic radiotherapy of lung metastases in addition to radiochemotherapy of primary tumor should previously be discussed with the principal investigator).

No cytologically confirmed malignant pleural effusion (in case of suspected malignant pleural effusion in imaging, pleurocentesis for cytological assessment is required).

Disqualifiers

Participation in another clinical study with an investigational product during the last 4 weeks.

Concurrent enrolment in another clinical study, unless it is an observational (non-interventional) clinical study or during the follow-up period of an interventional study.

Prior systemic anticancer therapy (chemotherapy, immunotherapy, targeted therapy), apart from two cycles of etoposide/platinum + durvalumab (prior chemotherapy/ immunotherapy/ targeted therapy for other malignancy treated with curative intent ≥5 years ago is no exclusion criterion).

Any unresolved toxicity NCI CTCAE Grade ≥2 from previous chemo-immunotherapy (2 cycles of platinum/etoposide + durvalumab) with the exception of alopecia, vitiligo, and the laboratory values defined in the inclusion criteria

Trial design

Design model

Single group

Treatments tested in this trial

Thoracic Radiochemotherapy
Radiation
Radiotherapy to the primary tumor including mediastinal lymph node metastases is delivered in single fractions of 1.8Gy once daily up to a cumulative dose of 63.0Gy by intensity modulated radiation therapy (IMRT) or volumetric modulated arc therapy (VMAT).
durvalumab
Drug
Durvalumab is administered in fixed dose 1500mg in q3w cycles concomitant to chemotherapy and q4w cycles during maintenance treatment
Stereotactic radiotherapy of further tumor locations
Radiation
Stereotactic radiotherapy is delivered to the up to four further tumor locations during durvalumab maintenance therapy and will be performed according to local standards with established dose and fractionation schemes in ablative doses depending on the affected organ system.
Chemotherapy
Drug
Concomitant chemotherapy consists of further two cycles platinum/etoposide q3w (summarized cycle 3-4).

Treatment groups

43 Participants

are divided into 1 treatment group

Group A: TreatmentExperimental treatment 4 interventions

Trial outcomes

Primary outcomes

Progression-free survival (PFS) rate

Efficacy of a treatment scheme consisting of thoracic radiotherapy concomitant to platinum/etoposide/durvalumab therapy followed by stereotactic radiotherapy concomitant to durvalumab maintenance to improve the one year PFS rate using investigator assessments according to RECIST 1.1

Time frame

12 month

Secondary outcomes

overall survival (OS)

One-year OS rate

Time frame

12 month

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Universität des Saarlandes

Lead sponsor

Source ClinicalTrials.gov

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