Trilaciclib + Lurbinectedin for Small Cell Lung Cancer
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 2
Recruiting
Sponsor: UNC Lineberger Comprehensive Cancer Center
Must not be taking: Investigational drugs
Disqualifiers: Active infection, Pregnant, Breastfeeding, others
No Placebo Group
Prior Safety Data
Breakthrough Therapy
Approved in 2 Jurisdictions
Trial Summary
What is the purpose of this trial?Lung cancer is by far the leading cause of cancer death among both men and women worldwide and the second most common cancer in terms of new cases. Small cell lung cancer (SCLC) is the deadliest form of lung cancer. The standard first-line treatment is the combination of carboplatin, etoposide, and atezolizumab. While response rates for this regimen are high (roughly 60%), the duration of response is short, typically 4 months. Following progression after the 1st line treatment of SCLC, there is no consensus regarding subsequent therapy. Lurbinectedin is FDA approved and is increasingly preferred in clinical practice. Toxicity was significant, but appeared favorable compared to historic results with topotecan, leading to the adoption of this therapy for second-line SCLC. The toxicity profile was dominated by myelosuppression.
This study investigates the effect of Trilaciclib on myelosuppression rate in subjects with platinum refractory extensive stage (ES)- SCLC receiving Lurbinectedin as well as the clinical synergy of Trilaciclib and Lurbinectedin combination.
Will I have to stop taking my current medications?
The trial protocol does not specify if you must stop taking your current medications, but it mentions that certain medications or treatments are prohibited. It's best to discuss your current medications with the trial team to see if any are not allowed.
What data supports the effectiveness of the drug Lurbinectedin for Small Cell Lung Cancer?
Lurbinectedin has shown promising results in treating small cell lung cancer, especially for patients who have relapsed after initial treatment. In a phase II trial, it demonstrated a response rate of 35.2% and was approved by the FDA as a second-line treatment for this condition.
12345Is the combination of Trilaciclib and Lurbinectedin safe for humans?
Lurbinectedin has been approved for treating small cell lung cancer and has shown a favorable safety profile in studies, with manageable side effects at the approved dose. Safety data from trials involving various solid tumors indicate that the drug is generally safe for human use.
34567What makes the drug lurbinectedin unique for treating small cell lung cancer?
Lurbinectedin is unique because it is a marine-derived drug that specifically inhibits transcription (the process of copying DNA into RNA), which is often abnormal in small cell lung cancer. It was the first systematic therapy approved for this condition and has shown promising results both alone and in combination with other drugs.
45689Eligibility Criteria
Adults over 18 with small cell lung cancer who've had previous platinum and PD1/PDL1 treatments can join. They need measurable disease, good performance status (able to carry out daily activities), and must consent to participate. Excluded are those on recent investigational drugs, certain medications, pregnant/breastfeeding women, anyone allergic to the study drugs or their components, or with active infections needing treatment.Inclusion Criteria
I am fully active or can carry out light work.
I am 18 years old or older.
Written informed consent obtained to participate in the study and HIPAA authorization for release of personal health information.
+2 more
Exclusion Criteria
Treatment with any investigational drug within 4 weeks prior to start of treatment.
A known allergy or sensitivity to either study drug or its excipients.
Subject is receiving prohibited medications or treatments as listed in the protocol.
+2 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants receive Trilaciclib and Lurbinectedin to assess the effect on myelosuppression rate in subjects with platinum refractory extensive stage SCLC
Up to 8 months
Follow-up
Participants are monitored for safety and effectiveness after treatment, including overall survival and progression-free survival
Up to 5 years
Participant Groups
The trial is testing Trilaciclib's ability to reduce myelosuppression (a decrease in bone marrow activity) in patients taking Lurbinectedin for extensive stage small cell lung cancer after other treatments have failed. It aims to see if combining these two drugs improves patient outcomes.
1Treatment groups
Experimental Treatment
Group I: Trilaciclib and LurbinectedinExperimental Treatment2 Interventions
Subjects with platinum refractory extensive stage small cell lung cancer receiving laciclib and Lurbinectedin
Lurbinectedin is already approved in United States, European Union for the following indications:
🇺🇸 Approved in United States as Zepzelca for:
- Metastatic small-cell lung cancer (SCLC) with disease progression on or after platinum-based chemotherapy
🇪🇺 Approved in European Union as Zepzelca for:
- Metastatic small-cell lung cancer (SCLC) with disease progression on or after platinum-based chemotherapy
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Lineberger Comprehensive Cancer Center at University of North Carolina Chapel HillChapel Hill, NC
Loading ...
Who Is Running the Clinical Trial?
UNC Lineberger Comprehensive Cancer CenterLead Sponsor
G1 Therapeutics, Inc.Industry Sponsor
References
Comparative Effectiveness of Lurbinectedin for the Treatment of Relapsed Small Cell Lung Cancer in the Post-Platinum Setting: A Real-World Canadian Synthetic Control Arm Analysis. [2023]Based on findings from a single-arm, phase 2 basket trial (NCT02454972), lurbinectedin may be an effective treatment for individuals with small cell lung cancer (SCLC) who progressed on or after platinum-based chemotherapy.
Lurbinectedin in small cell lung cancer. [2022]Few treatment options are available for patients with small cell lung cancer (SCLC) in progression after a first-line therapy. A novel therapeutic approach is represented by lurbinectedin, a synthetic derivative of trabectedin that works by inhibiting oncogenic transcription and promoting apoptosis in tumor cells. A phase II basket trial demonstrated the activity of lurbinectedin at the dose of 3.2 mg/m2 in patients with SCLC who had failed a previous chemotherapy, with a response rate of 35.2%, a median progression-free survival (mPFS) of 3.5 months, and a median overall survival (mOS) of 9.3 months. Common severe adverse events (grades 3-4) were hematological disorders, including anemia (9%), leukopenia (29%), neutropenia (46%), and thrombocytopenia (7%). On the basis of the positive results of this phase II study, on June 2020, lurbinectedin was approved by the Food and Drug Administration as second line for SCLC patients in progression on or after platinum-based therapy. The subsequent phase III trial comparing the combination of lurbinectedin plus doxorubicin vs. CAV (cyclophosphamide, Adriamycin, and vincristine) or topotecan did not demonstrate an improvement in overall survival, although the experimental arm showed a superior safety profile. Combinations of lurbinectedin with other drugs, cytotoxic agents and immune checkpoint inhibitors, are currently under investigation. The results of these studies should better define the optimal clinical application of lurbinectedin.
SLFN11 biomarker status predicts response to lurbinectedin as a single agent and in combination with ATR inhibition in small cell lung cancer. [2022]Lurbinectedin recently received FDA accelerated approval as a second line treatment option for metastatic small cell lung cancer (SCLC). However, there are currently no established biomarkers to predict SCLC sensitivity or resistance to lurbinectedin or preclinical studies to guide rational combinations.
Treatment of Small Cell Lung Cancer with Lurbinectedin: A Review. [2022]Lurbinectedin was approved on June 15, 2020 by the Food and Drug Administration with the brand name ZEPZELCA as the first systematic approved therapy for patients having Small Cell Lung Cancer (SCLC).
Lurbinectedin in the treatment of relapsed small cell lung cancer. [2021]Lurbinectedin is a marine-derived drug that inhibits transcription, a process that is frequently dysregulated in small cell lung cancer. The activity of lurbinectedin has been studied in many solid tumors, showing not only promising results but also a favorable safety profile. In relapsed small cell lung cancer, the drug has shown encouraging activity both as a single agent and in combination with doxorubicin, paclitaxel or irinotecan. The USA FDA has recently granted accelerated approval to lurbinectedin monotherapy in this setting. This article provides an update on available data and ongoing studies of lurbinectedin in small cell lung cancer, including Phase I combination trials, the basket Phase II trial and the ATLANTIS Phase III trial.
Lurbinectedin: First Approval. [2021]The oncogenic transcription inhibitor lurbinectedin (ZEPZELCA™) is being developed by PharmaMar as a treatment for various cancers. The drug has been granted orphan drug status for the treatment of small cell lung cancer (SCLC) by regulatory authorities in multiple countries worldwide and was approved in the USA in June 2020 for the treatment of adult patients with metastatic SCLC with disease progression on or after platinum-based chemotherapy. The US FDA and international regulators, including the Australian Therapeutic Goods Administration, are collaborating on the review of lurbinectedin under the Project Orbis initiative. Clinical investigation in other solid cancers is ongoing. This article summarizes the milestones in the development of lurbinectedin leading to this first approval for the treatment of metastatic SCLC.
Pooled Safety Analysis of Single-Agent Lurbinectedin in Patients With Advanced Solid Tumours. [2023]Label="BACKGROUND">Lurbinectedin was approved by FDA and other health regulatory agencies for treating adults with metastatic small cell lung cancer (SCLC) with disease progression on or after platinum-based chemotherapy. Safety profile at approved dose (3.2 mg/m2 every 3 weeks) was acceptable and manageable in 105 adult SCLC patients from a phase II basket trial. This study analyses safety data from several solid tumours treated at the lurbinectedin-approved dose.
Combination lurbinectedin and doxorubicin versus physician's choice of chemotherapy in patients with relapsed small-cell lung cancer (ATLANTIS): a multicentre, randomised, open-label, phase 3 trial. [2023]Label="BACKGROUND">Lurbinectedin is a synthetic marine-derived anticancer agent that acts as a selective inhibitor of oncogenic transcription. Lurbinectedin monotherapy (3·2 mg/m2 every 3 weeks) received accelerated approval from the US Food and Drug Administration on the basis of efficacy in patients with small-cell lung cancer (SCLC) who relapsed after first-line platinum-based chemotherapy. The ATLANTIS trial assessed the efficacy and safety of combination lurbinectedin and the anthracycline doxorubicin as second-line treatment for SCLC.
Lurbinectedin: A New Treatment Option for Relapsed/Refractory Small-Cell Lung Cancer. [2021]To assess the clinical application of lurbinectedin and its role in the therapy of small-cell lung cancer (SCLC).