BL-M14D1 + Atezolizumab for Small Cell Lung Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new treatment combination for individuals with extensively spread small cell lung cancer who have not yet received treatment. The trial compares the effects of the experimental drug BL-M14D1 and Atezolizumab against standard treatment options to determine which is more effective and safer. Ideal participants are those diagnosed with extensive-stage small cell lung cancer who have not previously received specific chemotherapies. As a Phase 3 trial, this study serves as the final step before potential FDA approval, providing participants an opportunity to contribute to groundbreaking advancements in cancer treatment.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that combining BL-M14D1 and Atezolizumab has promising effects against tumors. Researchers tested this combination on patients who had tried several other treatments. The safety profile is considered manageable, meaning most side effects can be controlled.
In a previous study, nearly all patients (98.4%) experienced side effects related to the treatment. Severe side effects occurred in 74% of the patients. Notably, there was one report of a serious lung condition (grade 3 interstitial lung disease) and one death related to the treatment.
Atezolizumab has FDA approval for other uses, which provides some reassurance about its safety. However, BL-M14D1 is still under study for safety and effectiveness. Participants should consider this when deciding to join the trial.12345Why are researchers excited about this trial's treatments?
Researchers are excited about the combination of BL-M14D1 and Atezolizumab for small cell lung cancer because it offers a novel approach compared to traditional treatments like chemotherapy regimens with carboplatin and etoposide. BL-M14D1 introduces a unique active ingredient that may enhance the immune system's ability to target cancer cells, potentially improving outcomes when used alongside Atezolizumab, an immunotherapy that helps the immune system detect and fight cancer. This combination aims to provide a more targeted attack on cancer cells, potentially leading to better effectiveness and fewer side effects than standard chemotherapy.
What evidence suggests that this trial's treatments could be effective for small cell lung cancer?
Research has shown that BL-M14D1 may help treat small cell lung cancer. In studies with patients who had already tried several treatments, BL-M14D1 helped 62% of them, and 71.1% showed some improvement. On average, patients' cancer did not worsen for over seven months. In this trial, some participants will receive a combination of BL-M14D1 and Atezolizumab, a drug already used for this cancer, which has been shown to help patients live longer. This combination might increase these benefits, offering new hope for those with advanced small cell lung cancer.23456
Who Is on the Research Team?
Junliang Cai, MD
Principal Investigator
SystImmune Inc.
Are You a Good Fit for This Trial?
This trial is for adults with newly diagnosed extensive-stage small cell lung cancer who have not received prior treatment. Participants must be healthy enough for chemo and immunotherapy, have at least one tumor that can be measured, good organ function, and be able to carry out daily activities.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Induction Therapy
Participants receive carboplatin, etoposide, and atezolizumab for 4 cycles
Maintenance Therapy
Participants receive atezolizumab with or without lurbinectedin until discontinuation criteria are met
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Atezolizumab
- BL-M14D1
Trial Overview
The study compares a new drug combo (BL-M14D1 plus Atezolizumab) against the standard treatment (Carboplatin, Etoposide, and Atezolizumab followed by Atezolizumab and Lurbinectedin). Patients are randomly assigned to either group.
How Is the Trial Designed?
3
Treatment groups
Experimental Treatment
Active Control
BL-M14D1: Administered on days 1 of every 21 days Atezolizumab: Administered dose on days 1 of every 21 days
BL-M14D1: Administered on days 1 of every 21 days Atezolizumab: Administered dose on days 1 of every 21 days
Medications used in the Control Arm should be administered per local label or institutional guidelines. Induction therapy (4 cycles): Carboplatin (AUC of 5 mg/mL\*min IV) on Day 1 of each 21-day cycle Etoposide (100 mg/m2 IV) on Days 1 through 3 of each 21-day cycle Atezolizumab (1200 mg) IV on Day 1 of each 21-day cycle Maintenance therapy (continues until discontinuation criteria are met): Atezolizumab (1200 mg) IV on Day 1 of each 21-day cycle Lurbinectedin (3.2 mg/m2) IV on Day 1 of each 21-day cycle (to be added only if approved in region and as per PI discretion)
Find a Clinic Near You
Who Is Running the Clinical Trial?
SystImmune Inc.
Lead Sponsor
Citations
BL-M14D1 Plus Atezolizumab vs Standard of Care ...
The objective of the study is to evaluate the efficacy and safety of BL-M14D1 in combination with Atezolizumab compared to Standard-of-Care ...
SystImmune Announces First Patient Dosed in Global ...
These results demonstrated promising anti-tumor activity and a manageable safety profile in heavily pre-treated patients with small cell lung ...
Phase I study of BL-M14D1, a novel DLL3-directed ...
BL-M14D1 has demonstrated a promising efficacy with an ORR/cORR of 71.1%/57.8% and mPFS of 7.2 months in heavily pre-treated SCLC.
BL-M14D1 Plus Atezolizumab vs Standard of Care in First- ...
The objective of the study is to evaluate the efficacy and safety of BL-M14D1 in combination with Atezolizumab compared to Standard-of-Care ...
SystImmune Reports Phase 1 Data for BL-M14D1 ...
"These initial Phase 1 results for BL-M14D1 demonstrate compelling anti-tumor activity, including a 62% confirmed response rate and encouraging ...
BL-M14D1 - Drug Targets, Indications, Patents
These results demonstrated promising anti-tumor activity and a manageable safety profile in heavily pre-treated patients with small cell lung ...
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