Lu-DOTA-TATE + Chemotherapy + Immunotherapy for Small Cell Lung Cancer
Trial Summary
What is the purpose of this trial?
This study aims to establish a safe and well tolerated dose of \[177Lu\]Lu-DOTA-TATE in combination with carboplatin, etoposide and atezolizumab in this setting and to assess preliminary efficacy of this combination treatment versus the combination of carboplatin, etoposide, and atezolizumab.The study will be essential to assess a new potential therapeutic option in participants with this aggressive cancer type.
Will I have to stop taking my current medications?
The trial information does not specify if you need to stop taking your current medications. However, if you have severe infections requiring treatment or are on certain immune therapies, you may need to stop those before joining.
What data supports the effectiveness of the drug Lu-DOTA-TATE for treating small cell lung cancer?
Research shows that Lu-DOTA-TATE, a radiolabeled somatostatin analog, has been effective in treating various neuroendocrine tumors, including small cell lung cancer, by targeting specific receptors on tumor cells. It has shown promising results in tumor regression and survival in animal models and has been used successfully in patients with other types of neuroendocrine tumors.12345
Is Lu-DOTA-TATE safe for use in humans?
Lu-DOTA-TATE has been used as a treatment for neuroendocrine tumors, and studies have focused on its early efficacy and toxicity, indicating it has been evaluated for safety in humans. However, specific safety data for its use in combination with chemotherapy and immunotherapy for small cell lung cancer is not provided in the available research.36789
What makes the Lu-DOTA-TATE + Chemotherapy + Immunotherapy treatment unique for small cell lung cancer?
This treatment is unique because it combines a radiopharmaceutical, [177Lu]Lu-DOTA-TATE, which targets somatostatin receptors on cancer cells, with chemotherapy and immunotherapy, potentially enhancing the overall effectiveness against small cell lung cancer. The use of [177Lu]Lu-DOTA-TATE is novel in this context, as it has primarily been used for neuroendocrine tumors, and its combination with other therapies could offer a new approach for this aggressive cancer type.2381011
Research Team
Novartis Pharmaceuticals
Principal Investigator
Novartis Pharmaceuticals
Eligibility Criteria
This trial is for adults over 18 with newly diagnosed ES-SCLC who haven't had treatment yet. They need a positive PET scan showing SSTR and at least one measurable tumor lesion. People can't join if they have brain metastasis, autoimmune diseases, severe infections, recent major surgery, ECG abnormalities that pose risks, known drug hypersensitivity or are in another clinical study.Inclusion Criteria
Exclusion Criteria
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment - Induction
Participants receive [177Lu]Lu-DOTA-TATE in combination with carboplatin, etoposide, and atezolizumab
Treatment - Maintenance
Participants continue treatment with [177Lu]Lu-DOTA-TATE and atezolizumab
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- [177Lu]Lu-DOTA-TATE (Radioisotope Therapy)
- Carboplatin (Alkylating agents)
- Etoposide (Topoisomerase I inhibitors)
- Tislelizumab (Monoclonal Antibodies)
Find a Clinic Near You
Who Is Running the Clinical Trial?
Novartis Pharmaceuticals
Lead Sponsor
Dr. Vas Narasimhan
Novartis Pharmaceuticals
Chief Executive Officer since 2018
MD from Harvard Medical School
Dr. Shreeram Aradhye
Novartis Pharmaceuticals
Chief Medical Officer since 2021
MD