Lung Cancer Clinical Trial
A Safety Study of [177Lu]Lu-DOTA-TATE in Newly Diagnosed Extensive Stage Small Cell Lung Cancer (ES-SCLC) Patients in Combination With Carboplatin, Etoposide and Tislelizumab
Summary
This study aims to establish a safe and well tolerated dose of [177Lu]Lu-DOTA-TATE in combination with carboplatin, etoposide, and tislelizumab in induction treatment and with tislelizumab in maintenance treatment in newly diagnosed patients with Extensive Stage Small Cell Lung Cancer (ES-SCLC).
Full Description
The study for each participant consists of a Screening period, a Treatment period that includes an Induction treatment period and a Maintenance treatment period, and a Follow-up period.
During the screening period of up to 28 days before starting SCLC treatment, each participant will be assessed for somatostatin receptor (SSTR) expression by [68Ga]Ga-DOTA-TATE imaging PET/scan.
Eligible participants will be enrolled in cohorts of 3 to 6 participants to receive:
Four cycles of carboplatin area under the curve (AUC) 5 on Day 1 and etoposide 100 mg/m2 on Day 1-3, every 3 weeks at Weeks 1, 4, 7 and 10 in induction period
Tislelizumab 200 mg on Day 1 every 3 weeks in induction and maintenance period
Two administrations of [177Lu]Lu-DOTA-TATE during the induction period: on either Day 3, 4 or 5 of Week 1 and on Week 7 Day 3 period followed by 1 to 4 administrations during the maintenance period on Week 13 Day 1, Week 16 Day 1, Week 19 Day 1 and Week 22 Day 1, depending on the dose assessed.
Up to six different dose level combinations of [177Lu]Lu-DOTA-TATE will be assessed in the study as follows:
Dose Level 1 (DL1): 100 mCi of [177Lu]Lu-DOTA-TATE in the induction period and 100 mCi of [177Lu]Lu-DOTA-TATE in the maintenance period.
Dose Level 2a (DL2a): 150 mCi of [177Lu]Lu-DOTA-TATE in both the induction and the maintenance periods.
Dose Level 2b (DL2b): 150 mCi of [177Lu]Lu-DOTA-TATE in the induction period and 200 mCi of [177Lu]Lu-DOTA-TATE in the maintenance period.
Dose Level 3a (DL3a): 200 mCi of [177Lu]Lu-DOTA-TATE in both the induction and maintenance periods.
Dose Level 3b (DL3b): 200 mCi of [177Lu]Lu-DOTA-TATE in the induction period and 250 mCi of [177Lu]Lu-DOTA-TATE in the maintenance period.
Dose Level 4 (DL4): 250 mCi of [177Lu]Lu-DOTA-TATE in both the induction and maintenance periods.
An infusion of sterile 2.5% Lysine - Arginine amino acid (AA) solution will be co-administered with each [177Lu]Lu-DOTA-TATE dose for renal protection.
The dose escalation part in this study will be guided by the dose limiting toxicity (DLT) rate observed within the first 6 weeks (42 days) of treatment. In addition to DLTs the totality of safety data available at the time will be assessed for each dose escalation decision. Dose escalation/de escalation will be conducted using the Bayesian Optimal Interval Approach (BOIN).
Eligibility 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 in at least one target or non-target lesion
No prior systemic treatment for ES-SCLC
ECOG status =< 1
Provision of tumor tissue to support exploratory biomarker analysis
Life expectancy of >= 6 months
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
Active autoimmune diseases or history of autoimmune diseases that may relapse
Severe chronic or active infections (including active tuberculosis, HBV, or HCV infection) requiring systemic antibacterial, antifungal or antiviral therapy within 2 weeks before Cycle 1 Day 1
Any major surgical procedure requiring general anesthesia =< 28 days before Cycle 1 Day 1
History or 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
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There are 10 Locations for this study
Washington District of Columbia, 20007, United States More Info
Principal Investigator
Cleveland Ohio, 44106, United States More Info
Principal Investigator
Lille , 59000, France
Marseille Cedex 05 , 13885, France
Montpellier , 34298, France
Villejuif Cedex , 94800, France
Malaga Andalucia, 29010, Spain
Barcelona Catalunya, 08035, Spain
Madrid , 28009, Spain
Madrid , 28041, Spain
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