614 Participants Needed

Sacituzumab Tirumotecan + Pembrolizumab for Lung Cancer

(TroFuse-007 Trial)

Recruiting at 230 trial locations
TF
Overseen ByToll Free Number
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
Prior Safety DataThis treatment has passed at least one previous human trial

Trial Summary

Will I have to stop taking my current medications?

The trial requires that you do not take strong inhibitors or inducers of CYP3A4 (a liver enzyme) at least 14 days before starting the study and throughout the study. If you are on such medications, you may need to stop or switch them.

What data supports the effectiveness of the drug Sacituzumab Tirumotecan + Pembrolizumab for lung cancer?

Pembrolizumab, a part of the treatment, has shown effectiveness in treating non-small cell lung cancer (NSCLC) by improving survival rates and slowing disease progression, as demonstrated in several clinical trials. It is approved for use in patients with certain types of lung cancer, showing significant benefits compared to traditional chemotherapy.12345

Is the combination of Sacituzumab Tirumotecan and Pembrolizumab safe for humans?

Pembrolizumab, also known as Keytruda, has been used in various cancer treatments and is generally considered safe, but it can cause immune-related side effects like type 1 diabetes and thyroid issues. The safety profile of pembrolizumab in combination with other drugs has been consistent with known safety data, but specific safety data for Sacituzumab Tirumotecan in combination with pembrolizumab is not provided in the available research.12346

What makes the drug Sacituzumab Tirumotecan + Pembrolizumab unique for lung cancer treatment?

This drug combines Sacituzumab Tirumotecan, an antibody-drug conjugate targeting cancer cells, with Pembrolizumab, an immune checkpoint inhibitor that helps the immune system attack cancer, offering a novel approach by combining targeted therapy with immunotherapy for lung cancer.12478

What is the purpose of this trial?

The primary objective of the study is to compare sacituzumab tirumotecan combined with pembrolizumab to pembrolizumab alone with respect to overall survival (OS). The primary hypothesis is that the combination of sacituzumab tirumotecan and pembrolizumab is superior to pembrolizumab alone with respect to OS.All participants who have completed the first course of pembrolizumab may be eligible for up to an additional 9 cycles of pembrolizumab monotherapy if there is blinded independent central review (BICR)-verified progressive disease by Response Evaluation Criteria In Solid Tumors version 1.1 (RECIST 1.1) after initial treatment.

Research Team

MD

Medical Director

Principal Investigator

Merck Sharp & Dohme LLC

Eligibility Criteria

This trial is for adults with advanced non-small cell lung cancer (NSCLC) showing high PD-L1 expression in tumors. Candidates must have a life expectancy of over 3 months, controlled HIV if present, and no need for EGFR-, ALK-, or ROS1-targeted primary therapy. They should be physically able to perform daily activities with little or no assistance.

Inclusion Criteria

I am fully active or restricted in physically strenuous activity but can do light work.
My lung cancer is confirmed by lab tests.
My cancer is not suitable for EGFR, ALK, or ROS1-targeted treatments.
See 3 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive sacituzumab tirumotecan and pembrolizumab or pembrolizumab alone for 18 cycles

108 weeks
Every 6 weeks (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

48 months

Open-label extension (optional)

Participants may receive up to an additional 9 cycles of pembrolizumab monotherapy if there is progressive disease

54 weeks

Treatment Details

Interventions

  • MK-2870
  • Pembrolizumab
Trial Overview The study aims to see if MK-2870 combined with pembrolizumab improves survival compared to using pembrolizumab alone in patients. Participants who show disease progression after initial treatment may receive additional cycles of pembrolizumab monotherapy.
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: Pembrolizumab + Sacituzumab tirumotecanExperimental Treatment2 Interventions
Participants receive sacituzumab tirumotecan via intravenous (IV) infusion on Days 1, 15 and 29 of each 6-week cycle + 400 mg Pembrolizumab every 6 weeks (q6w) via IV infusion on Day 1 of each 6-week cycle for 18 cycles. Additionally, participants receive diphenhydramine (or equivalent), an H2 antagonist of investigator's choice, acetaminophen (or equivalent), and dexamethasone (or equivalent) per each drug's product label prior to the first 4 infusions of sacituzumab tirumotecan. At subsequent infusions, the H2 antagonist and dexamethasone are optional, at the discretion of the investigator.
Group II: PembrolizumabActive Control1 Intervention
Participants receive 400 mg Pembrolizumab via IV infusion q6w on Day 1 of each 6-week cycle for 18 cycles

MK-2870 is already approved in China for the following indications:

🇨🇳
Approved in China as Sacituzumab Tirumotecan for:
  • Unresectable locally advanced or metastatic triple-negative breast cancer

Find a Clinic Near You

Who Is Running the Clinical Trial?

Merck Sharp & Dohme LLC

Lead Sponsor

Trials
4,096
Recruited
5,232,000+
Chirfi Guindo profile image

Chirfi Guindo

Merck Sharp & Dohme LLC

Chief Marketing Officer since 2022

Degree in Engineering from Ecole Centrale de Paris, MBA from New York University Stern School of Business

Robert M. Davis profile image

Robert M. Davis

Merck Sharp & Dohme LLC

Chief Executive Officer since 2021

JD from Northwestern University Pritzker School of Law, MBA from Northwestern University Kellogg Graduate School of Management, Bachelor's in Finance from Miami University

Findings from Research

In a phase II trial involving 15 patients with resectable non-small cell lung cancer (NSCLC), neoadjuvant treatment with pembrolizumab showed a major pathologic response in 27% of patients, indicating promising antitumor activity before surgery.
The treatment was found to be feasible and safe, with only 33% of patients experiencing moderate adverse events, and no postoperative mortality, suggesting that pembrolizumab does not compromise surgical outcomes.
Neoadjuvant anti-programmed death-1 immunotherapy by pembrolizumab in resectable non-small cell lung cancer: First clinical experience.Eichhorn, F., Klotz, LV., Kriegsmann, M., et al.[2022]
Pembrolizumab, a PD-1 inhibitor, has demonstrated clinical effectiveness in treating various solid tumors, particularly in patients with PD-L1-positive non-small-cell lung cancer and unresectable/metastatic melanoma.
Early-phase trials and ongoing studies are focused on further confirming the clinical benefits of pembrolizumab in thoracic malignancies, highlighting its potential as a significant treatment option in cancer therapy.
Pembrolizumab for the treatment of thoracic malignancies: current landscape and future directions.Karim, S., Leighl, N.[2017]
The ongoing KEYNOTE-495/KeyImPaCT study is evaluating the effectiveness of pembrolizumab combined with other therapies in advanced non-small cell lung cancer (NSCLC), with results showing varying objective response rates (ORR) based on tumor characteristics, ranging from 0-12% in low T-cell-inflamed groups to 50-60% in high T-cell-inflamed groups.
The study confirms that assessing T-cell-inflamed gene expression profiles (TcellinfGEP) and tumor mutational burden (TMB) can help identify which patients are more likely to benefit from pembrolizumab-based treatments, while the safety profiles of the combinations remain consistent with previous findings.
Biomarker-directed, pembrolizumab-based combination therapy in non-small cell lung cancer: phase 2 KEYNOTE-495/KeyImPaCT trial interim results.Gutierrez, M., Lam, WS., Hellmann, MD., et al.[2023]

References

Neoadjuvant anti-programmed death-1 immunotherapy by pembrolizumab in resectable non-small cell lung cancer: First clinical experience. [2022]
Pembrolizumab for the treatment of thoracic malignancies: current landscape and future directions. [2017]
Biomarker-directed, pembrolizumab-based combination therapy in non-small cell lung cancer: phase 2 KEYNOTE-495/KeyImPaCT trial interim results. [2023]
FDA Approval Summary: Pembrolizumab for Treatment of Metastatic Non-Small Cell Lung Cancer: First-Line Therapy and Beyond. [2022]
[Prolonged response with paclitaxel after immunotherapy by pembrolizumab in lung cancer]. [2017]
Pembrolizumab: An Immunotherapeutic Agent Causing Endocrinopathies. [2020]
Efficacy and safety of necitumumab and pembrolizumab combination therapy in patients with Stage IV non-small cell lung cancer. [2021]
KEYNOTE-022: Pembrolizumab with trametinib in patients with BRAF wild-type melanoma or advanced solid tumours irrespective of BRAF mutation. [2022]
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