Tarlatamab + Sacituzumab Govitecan for Small Cell Lung Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests two drugs, tarlatamab and sacituzumab govitecan, to determine their effectiveness in treating small-cell lung cancer (SCLC) and extra-pulmonary neuroendocrine cancer (EP-NEC), both aggressive cancers. The researchers aim to assess whether these drugs can benefit individuals whose cancer did not improve or returned after previous treatments. Suitable participants include those with SCLC or EP-NEC whose cancer has progressed despite prior treatments such as chemotherapy or immunotherapy. Participants will receive the drugs through an IV and undergo regular health check-ups to monitor progress. As a Phase 1, Phase 2 trial, this research focuses on understanding how the treatment works in people and measuring its effectiveness in an initial, smaller group.
Do I need to stop my current medications to join the trial?
The trial does not specify if you need to stop all current medications, but you cannot be on other investigational drugs or certain cancer therapies. You also cannot take medications that affect the enzyme UGT1A1 during the trial.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that both tarlatamab and sacituzumab govitecan have been tested separately in people with small cell lung cancer (SCLC) and have shown promising results. A study on sacituzumab govitecan found it to be generally well-tolerated, though some patients experienced side effects like low white blood cell counts and diarrhea. These side effects were manageable and are common with cancer treatments.
Tarlatamab has also demonstrated encouraging survival outcomes in earlier studies for extensive-stage SCLC. While specific side effects aren't mentioned, its progression to later-phase trials suggests it is considered safe enough for further testing.
The goal of combining these drugs is to enhance their benefits while monitoring safety. Both treatments have been used before, providing some confidence about their safety, but individual reactions can vary. Regular check-ups during the trial will help manage any side effects quickly.12345Why are researchers excited about this trial's treatments?
Researchers are excited about Tarlatamab and Sacituzumab Govitecan for small cell lung cancer because they offer a novel approach compared to existing treatments like chemotherapy and immunotherapy. Tarlatamab is an innovative bispecific T-cell engager, which means it helps the body's immune cells directly target and kill cancer cells more effectively. Sacituzumab Govitecan, on the other hand, is an antibody-drug conjugate that delivers a potent chemotherapy directly to the cancer cells, sparing more of the healthy cells. Together, these treatments might provide a more targeted and potentially more effective strategy for tackling small cell lung cancer.
What evidence suggests that this trial's treatments could be effective for small cell lung cancer?
Research has shown that sacituzumab govitecan delivers promising results for people with small cell lung cancer (SCLC). One study found it effective as a second-line treatment, meaning it helped when other treatments stopped working. Tarlatamab, another promising drug, demonstrated good survival rates in patients with advanced-stage small-cell lung cancer. In this trial, researchers are testing the combination of these two drugs, tarlatamab and sacituzumab govitecan, because they might work better together. Early results suggest this combination could offer new hope for those fighting aggressive cancers like SCLC and extra-pulmonary neuroendocrine cancer (EP-NEC).23467
Who Is on the Research Team?
Anish Thomas, M.D.
Principal Investigator
National Cancer Institute (NCI)
Are You a Good Fit for This Trial?
This trial is for adults over 18 with Small Cell Lung Cancer (SCLC) or Extra-pulmonary Neuroendocrine Cancer (EP-NEC) that's come back or didn't respond to treatment. They must have a certain level of physical fitness and meet specific blood test criteria, including adequate hemoglobin, neutrophil, and platelet levels.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive a small starter dose of tarlatamab followed by a full dose and sacituzumab govitecan in a repeating 4-week cycle
Follow-up
Participants are monitored for safety and effectiveness after treatment, with regular check-ups and imaging scans
Long-term follow-up
Participants who stop treatment for reasons other than cancer progression will continue CT scans every 6 weeks until disease progression
What Are the Treatments Tested in This Trial?
Interventions
- Sacituzumab Govitecan
- Tarlatamab
Trial Overview
The study tests Tarlatamab combined with Sacituzumab Govitecan in patients with SCLC or EP-NEC. Participants receive these drugs intravenously in cycles: a starter dose followed by regular doses every two weeks for up to two years unless side effects are too severe.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Maximum tolerated dose (MTD) Tarlatamab and Sacituzumab Govitecan
Dose escalated Tarlatamab and Sacituzumab Govitecan
Find a Clinic Near You
Who Is Running the Clinical Trial?
National Cancer Institute (NCI)
Lead Sponsor
Citations
Sacituzumab govitecan: a new hope for patients with ...
Phase 2 open-label study of Sacituzumab govitecan as second-line therapy in patients with extensive-stage small cell lung cancer: results from TROPiCS-03.
Efficacy outcomes between tarlatamab and real-world ...
The DeLLphi-301 trial of tarlatamab demonstrated promising survival among patients with extensive stage small-cell lung cancer (ES-SCLC), but it lacked a direct ...
Bispecific T-Cell Engager Tarlatamab and TROP2 ...
This is a Phase I/II, open label clinical trial aimed at identifying the MTD of Sacituzumab govitecan in combination with tarlatamab and ...
Phase 2 Open-Label Study of Sacituzumab Govitecan as ...
The phase 2 TROPiCS-03 study evaluated the efficacy/safety of sacituzumab govitecan (SG) as second-line treatment in patients with previously treated extensive ...
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onco-hema.healthbooktimes.org
onco-hema.healthbooktimes.org/article/144748-hope-on-the-horizon-emerging-therapies-for-sclcHope on the Horizon: Emerging Therapies for SCLC
By Sebastian Kraus. This review highlights significant clinical trial outcomes and emerging therapeutic strategies for both limited-stage ...
Sacituzumab govitecan: another emerging treatment option for ...
Sacituzumab govitecan: another emerging treatment option for patients with relapsed small cell lung cancer · Peer Review File · Associated Data.
a new hope for patients with pretreated extensive small-cell ...
Sacituzumab govitecan: a new hope for patients with pretreated extensive small-cell lung cancer (SCLC)—insights from the TROPiCS-03 trial.
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