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Combining a new radioligand therapy with standard chemotherapy for extensive stage small cell lung cancer

A Phase Ib/II Dose Finding Study Assessing Safety and Efficacy of [177Lu]Lu-DOTA-TATE in Newly Diagnosed Extensive Stage Small Cell Lung Cancer (ES-SCLC) in Combination With Carboplatin, Etoposide, and Atezolizumab in Induction and With Atezolizumab in Maintenance Phase

Phase1; Phase2 Interventional Novartis · NCT05142696

This study is testing a new treatment that combines a special radioligand therapy with standard chemotherapy to see if it helps people with extensive stage small cell lung cancer feel better.

Quick facts

PhasePhase1; Phase2
Study typeInterventional
Enrollment200 (estimated)
Ages18 Years to 100 Years
SexAll
SponsorNovartis Industry-sponsored
Drugs / interventionsatezolizumab, chemotherapy
Locations23 sites (Washington, District of Columbia and 22 other locations)
Trial IDNCT05142696 on ClinicalTrials.gov

What this trial studies

This study evaluates the safety and efficacy of the radioligand therapy [177Lu]Lu-DOTA-TATE in combination with carboplatin, etoposide, and atezolizumab for patients with newly diagnosed extensive stage small cell lung cancer (ES-SCLC). Participants will undergo a screening period to assess somatostatin receptor expression, followed by a dose escalation phase to determine the optimal dose of [177Lu]Lu-DOTA-TATE. The study will then randomize approximately 140 participants to receive either the experimental combination treatment or the standard chemotherapy regimen alone. The goal is to establish a new therapeutic option for this aggressive cancer type.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older with histologically confirmed extensive stage small cell lung cancer and measurable disease.

Not a fit: Patients with prior systemic treatment for ES-SCLC or those with active autoimmune diseases may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new effective option for patients with extensive stage small cell lung cancer.

How similar studies have performed: While the combination of radioligand therapy with standard chemotherapy is a novel approach, similar studies have shown promise in other cancer types.

Eligibility criteria

Show full inclusion / exclusion 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
* No prior systemic treatment for ES-SCLC (except the first cycle of chemotherapy with or without atezolizumab of the induction period
* 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 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

Where this trial is running

Washington, District of Columbia and 22 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Extensive Stage Small Cell Lung CancerES-SCLCRadioligand therapyRLT[177Lu]Lu-DOTA-TATELutatheraLutetium oxodotreotideLutetium Lu 177 dotatate
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.