Phase Ib study investigating dose, safety and efficacy of [177Lu]Lu-DOTA-TATE in patients with Extensive Stage Small Cell Lung Cancer (specific form of lung tumour)

Phase 1

Conditions: Extensive-Stage Small Cell Lung Cancer
MedDRA version: 21.1Level: PTClassification code 10041068Term: Small cell lung cancer extensive stageSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Therapeutic area: Diseases [C] - Cancer [C04]

Registration Number: EUCTR2021-004155-16-DE

Lead Sponsor: ovartis Pharma AG

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 200

Inclusion Criteria

Key Inclusion Criteria:
• Participant is = 18 years on the day of signing informed consent form
• Histologically or cytologically confirmed ES-SCLC
• Presence of measurable disease (at least one target lesion) according to RECIST v1.1 assessed by conventional computed tomography (CT) scan
• SSTR positive [68Ga]Ga-DOTA-TATE imaging positron emission tomography (PET) scan demonstrating uptake equal or higher than the liver uptake (uptake intensity score 2 or above in the visual uptake scoring scale) in at least one target or non-target lesion
• No prior systemic treatment for ES-SCLC (except the first cycle of
chemotherapy with or without atezolizumab of the induction period)
• Provision of tumor tissue to support exploratory biomarker analysis
• Life expectancy of >=6 months
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 87
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 113

Exclusion Criteria

Key exclusion Criteria:
• Participant has received prior therapy with an antibody or drug against immune checkpoint pathways
• Active leptomeningeal disease or uncontrolled, untreated brain metastasis
• Any major surgical procedure requiring general anesthesia =< 28 days before Cycle 2 Day 1
• History of current diagnosis of electrocardiogram (ECG) abnormalities indicating significant risk of safety for participants participating in the study
• Known hypersensitivity to the active substances or any of the excipients of the study drugs
• Concurrent participation in another therapeutic clinical study