120 Participants Needed

Pembrolizumab + Chemotherapy for Small Cell Lung Cancer

Recruiting at 49 trial locations
TF
Overseen ByToll Free Number
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial is testing new drugs combined with existing treatments and chemotherapy to see if they can better treat patients with severe, widespread lung cancer by boosting the immune system and enhancing chemotherapy effects.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the study team or your doctor to understand how your medications might interact with the trial treatments.

Is the combination of pembrolizumab and chemotherapy safe for humans?

Pembrolizumab, when combined with chemotherapy, has been studied in various cancers and is generally considered safe, though it can cause side effects like fatigue, nausea, and loss of appetite. In combination with lenvatinib, common side effects include high blood pressure, diarrhea, and weight loss.12345

What makes the drug pembrolizumab combined with chemotherapy unique for treating small cell lung cancer?

This treatment is unique because it combines pembrolizumab, an immunotherapy drug that helps the immune system attack cancer cells, with chemotherapy drugs like etoposide and platinum compounds, offering a new approach for patients with extensive-stage small-cell lung cancer who have not been treated before.12678

What data supports the effectiveness of this drug for small cell lung cancer?

Research shows that pembrolizumab, when combined with chemotherapy drugs like etoposide and platinum compounds, has shown antitumor activity and improved survival in patients with extensive-stage small-cell lung cancer. Additionally, similar combinations with other drugs like durvalumab have also demonstrated significant improvements in overall survival.26789

Who Is on the Research Team?

MD

Medical Director

Principal Investigator

Merck Sharp & Dohme LLC

Are You a Good Fit for This Trial?

This trial is for adults with extensive-stage small cell lung cancer who need first-line therapy. They must not be pregnant or breastfeeding, agree to contraception, have good organ function and performance status, and no prior treatments for SCLC. Exclusions include previous immunotherapy, certain heart conditions, uncontrolled diseases, recent major surgery, active infections like HIV/Hepatitis B/C, and other factors that could affect participation.

Inclusion Criteria

I am not pregnant or breastfeeding and meet the birth control requirements.
I am a man willing to use contraception and not donate sperm.
My small cell lung cancer is at stage IV.
See 6 more

Exclusion Criteria

I haven't had a major heart issue or blood clot in the past year.
I have a history of or currently have a neurological disorder related to cancer.
Your heart's electrical activity (QT interval) is longer than normal.
See 29 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive pembrolizumab, investigational agents, and chemotherapy for first-line treatment of ES-SCLC

12 weeks
4 cycles of chemotherapy, each cycle lasting 3 weeks

Maintenance Treatment

Participants continue receiving pembrolizumab and investigational agents until disease progression or discontinuation

Up to 2 years

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 5 years

What Are the Treatments Tested in This Trial?

Interventions

  • Boserolimab
  • Carboplatin
  • Cisplatin
  • Etoposide
  • Lenvatinib
  • MK-4830
  • MK-5890
  • Pembrolizumab
Trial Overview The study tests new drugs (MK-4830, boserolimab/MK-5890 & lenvatinib/MK-7902) combined with pembrolizumab & chemotherapy in treating ES-SCLC. It's an exploratory trial without formal hypothesis testing to assess the safety and effectiveness of these combinations as a first treatment option.
How Is the Trial Designed?
3Treatment groups
Experimental Treatment
Group I: Pembrolizumab + MK-4830 + ChemotherapyExperimental Treatment5 Interventions
Group II: Pembrolizumab + Lenvatinib + ChemotherapyExperimental Treatment5 Interventions
Group III: Pembrolizumab + Boserolimab + ChemotherapyExperimental Treatment5 Interventions

Boserolimab is already approved in European Union, United States, Canada, Japan for the following indications:

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Approved in European Union as KEYTRUDA for:
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Approved in United States as KEYTRUDA for:
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Approved in Canada as KEYTRUDA for:
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Approved in Japan as KEYTRUDA for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

Merck Sharp & Dohme Corp.

Lead Sponsor

Trials
2,287
Recruited
4,582,000+
Chirfi Guindo profile image

Chirfi Guindo

Merck Sharp & Dohme Corp.

Chief Medical Officer

Engineering degree 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 Corp.

Chief Executive Officer since 2021

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

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

Published Research Related to This Trial

Combination treatments using platinum compounds and etoposide show median survival rates of 7 to 10 months for extensive-stage and 15 to 20 months for limited-stage small cell lung cancer, indicating their effectiveness in improving patient outcomes.
Adding paclitaxel to platinum/etoposide regimens has shown promising results in early studies, with good activity and manageable toxicity, and ongoing phase III trials aim to clarify its role in enhancing treatment efficacy.
The current role and future prospects of paclitaxel in the treatment of small cell lung cancer.Hainsworth, JD., Greco, FA.[2015]
In a real-life study of 121 patients with advanced non-squamous non-small cell lung cancer, the combination of pembrolizumab and chemotherapy resulted in a median progression-free survival of 9 months and overall survival of 20.6 months, demonstrating its efficacy as a first-line treatment.
The treatment was generally well-tolerated, with manageable side effects; however, 17.5% of patients experienced grade 3-4 adverse events, and there were two treatment-related deaths, indicating the need for careful monitoring during therapy.
Pembrolizumab plus pemetrexed-carboplatin combination in first-line treatment of advanced non-squamous non-small cell lung cancer: a multicenter real-life study (CAP29).Renaud, E., Ricordel, C., Corre, R., et al.[2023]
In the CASPIAN study involving 805 patients with extensive-stage small-cell lung cancer (ES-SCLC), the combination of durvalumab and platinum-etoposide significantly improved overall survival compared to platinum-etoposide alone, with a median survival of 12.9 months versus 10.5 months.
However, adding tremelimumab to durvalumab and platinum-etoposide did not provide a significant survival benefit, indicating that durvalumab plus platinum-etoposide should be considered the new standard of care for first-line treatment of ES-SCLC.
Durvalumab, with or without tremelimumab, plus platinum-etoposide versus platinum-etoposide alone in first-line treatment of extensive-stage small-cell lung cancer (CASPIAN): updated results from a randomised, controlled, open-label, phase 3 trial.Goldman, JW., Dvorkin, M., Chen, Y., et al.[2021]

Citations

The current role and future prospects of paclitaxel in the treatment of small cell lung cancer. [2015]
A phase II study of pembrolizumab and paclitaxel in patients with relapsed or refractory small-cell lung cancer. [2020]
Pembrolizumab plus pemetrexed-carboplatin combination in first-line treatment of advanced non-squamous non-small cell lung cancer: a multicenter real-life study (CAP29). [2023]
Durvalumab, with or without tremelimumab, plus platinum-etoposide versus platinum-etoposide alone in first-line treatment of extensive-stage small-cell lung cancer (CASPIAN): updated results from a randomised, controlled, open-label, phase 3 trial. [2021]
Pembrolizumab or Placebo Plus Etoposide and Platinum as First-Line Therapy for Extensive-Stage Small-Cell Lung Cancer: Randomized, Double-Blind, Phase III KEYNOTE-604 Study. [2021]
Neoadjuvant anti-programmed death-1 immunotherapy by pembrolizumab in resectable non-small cell lung cancer: First clinical experience. [2022]
Optimizing the use of lenvatinib in combination with pembrolizumab in patients with advanced endometrial carcinoma. [2023]
FDA Approval Summary: Pembrolizumab for Treatment of Metastatic Non-Small Cell Lung Cancer: First-Line Therapy and Beyond. [2022]
Pembrolizumab for the treatment of thoracic malignancies: current landscape and future directions. [2017]
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