Tarlatamab + Standard Therapy for Small Cell Lung Cancer
(DeLLphi-312 Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial examines the effectiveness of a new treatment, tarlatamab, when combined with other standard cancer drugs for extensive-stage small cell lung cancer. Researchers aim to determine if adding tarlatamab can extend survival compared to using standard drugs alone. For individuals with small cell lung cancer that is too widespread for radiation treatment and who are about to begin their first line of drug therapy, this trial may be suitable. As a Phase 3 trial, it represents the final step before FDA approval, providing an opportunity to contribute to a potentially groundbreaking treatment.
Do I need to stop my current medications to join the trial?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that tarlatamab offers a good balance of benefits and risks for patients with small-cell lung cancer (SCLC), meaning its advantages outweigh potential downsides. In some studies, patients tolerated tarlatamab well, though side effects like cytokine release syndrome (CRS) and nerve damage were reported during the first treatment cycle. CRS occurs when the immune system releases too many proteins into the blood too quickly, and nerve damage can affect the nervous system. These side effects mostly appeared during the initial treatment period.
The other treatments in the study—durvalumab, carboplatin, and etoposide—are already used in cancer care and are known to be safe. They are generally well-tolerated, but like many cancer drugs, they can cause side effects such as tiredness, nausea, and low blood cell counts.
Overall, while tarlatamab has some initial side effects, its potential benefits for treating SCLC are promising. Combining it with durvalumab, carboplatin, and etoposide aims to improve treatment results.12345Why are researchers excited about this study treatment for small cell lung cancer?
Researchers are excited about Tarlatamab for small cell lung cancer because it offers a novel approach by targeting the DLL3 protein, which is often present on cancer cells but not on normal cells. Unlike traditional treatments like carboplatin and etoposide, which attack rapidly dividing cells indiscriminately, Tarlatamab is designed to selectively engage the immune system to attack cancer cells, potentially leading to fewer side effects. Additionally, the combination of Tarlatamab with durvalumab, an immune checkpoint inhibitor, may enhance the immune response against the cancer, offering a promising new avenue for patients with limited options.
What evidence suggests that this trial's treatments could be effective for small cell lung cancer?
Studies have shown that tarlatamab is a promising treatment for small cell lung cancer. In this trial, some participants will receive tarlatamab combined with durvalumab, carboplatin, and etoposide. Research indicates that tarlatamab extends patient survival compared to standard chemotherapy. One study found that 42.9% of patients treated with tarlatamab experienced tumor shrinkage or symptom improvement. Tarlatamab, a type of immunotherapy, enhances the immune system's ability to locate and destroy cancer cells. These findings suggest that tarlatamab could offer significant benefits for patients with small cell lung cancer.26789
Who Is on the Research Team?
MD
Principal Investigator
Amgen
Are You a Good Fit for This Trial?
This trial is for individuals with a diagnosis of extensive stage small-cell lung cancer who are receiving treatment for the first time. Specific eligibility criteria details are not provided, but typically participants must be adults with good organ function and no conflicting health conditions.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive tarlatamab in combination with durvalumab, carboplatin, and etoposide for 4 cycles followed by tarlatamab and durvalumab
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Carboplatin
- Durvalumab
- Etoposide
- Tarlatamab
Trial Overview
The study aims to test the effectiveness of adding Tarlatamab to a standard treatment regimen (Durvalumab, Carboplatin, Etoposide) in improving overall survival rates compared to the standard treatment alone in patients with ES-SCLC.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
Participants will receive tarlatamab in combination with durvalumab, carboplatin and etoposide for 4 cycles followed by tarlatamab and durvalumab.
Participants will receive durvalumab, carboplatin and etoposide for 4 cycles followed by durvalumab.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Amgen
Lead Sponsor
Robert A. Bradway
Amgen
Chief Executive Officer since 2012
MBA from Harvard Business School
Paul Burton
Amgen
Chief Medical Officer since 2023
MD from University of London, PhD in Molecular and Cellular Biology from Imperial College London
AstraZeneca
Industry Sponsor
Sir Pascal Soriot
AstraZeneca
Chief Executive Officer since 2012
Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris
Dr. Cristian Massacesi
AstraZeneca
Chief Medical Officer since 2021
MD from Marche Polytechnic University, Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology
Pascal Soriot
AstraZeneca
Chief Executive Officer since 2012
Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris
Cristian Massacesi
AstraZeneca
Chief Medical Officer since 2021
MD from Marche Polytechnic University, Medical Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology
Citations
Efficacy outcomes between tarlatamab and real-world ...
The study findings suggest that tarlatamab offers potential clinical benefits relative to comparator treatments.
Real-World Outcomes of Tarlatamab in Small Cell Lung ...
After a median follow-up of 6.7 months, the overall response rate (ORR) was 42.9% in SCLC patients. Conclusions. Tarlatamab is a promising treatment option for ...
Real world outcomes of patients treated with tarlatamab in ...
Majority (90%) had received prior PDL-1 therapy. 25% (5/20) of patients received prior gamma knife and in addition 10% (2/20) received whole ...
4.
academic.oup.com
academic.oup.com/oncolo/advance-article/doi/10.1093/oncolo/oyaf256/8239322?searchresult=1Efficacy outcomes between tarlatamab and real-world ...
Tarlatamab, a bispecific T-cell engager immunotherapy, showed durable response with promising survival outcomes in patients with previously treated small ...
Tarlatamab Prolongs OS Over Chemotherapy Among ...
Treatment with tarlatamab resulted in significantly longer overall survival (OS) than chemotherapy. Treatment with tarlatamab also had a significant benefit ...
Real-World Outcomes of Tarlatamab in Small Cell Lung ...
We observed higher rates of CRS and ICANS during the first treatment cycle suggesting that real-world safety outcomes may differ from clinical trial data.
Safety and activity of tarlatamab in combination with a PD ...
These studies showed a good benefit–risk profile for tarlatamab in previously-treated small-cell lung cancer (SCLC), leading to global ...
Real-world efficacy and safety of tarlatamab in patients with ...
We report a real-world case series of safety and efficacy data for patients treated with standard of care tarlatamab at MD Anderson Cancer Center.
Tarlatamab for Patients with Previously Treated Small-Cell ...
Tarlatamab, administered as a 10-mg dose every 2 weeks, showed antitumor activity with durable objective responses and promising survival outcomes
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