450 Participants Needed

Pembrolizumab + Chemotherapy for Non-Small Cell Lung Cancer

Recruiting at 39 trial locations
TF
Overseen ByToll Free Number
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, if you are on immunosuppressive therapy or have had recent chemotherapy or biological cancer therapy, you may need to stop or adjust those treatments before starting the trial.

What data supports the effectiveness of the drug Pembrolizumab combined with chemotherapy for non-small cell lung cancer?

Research shows that adding pembrolizumab to chemotherapy significantly improves survival and response rates in patients with advanced non-small cell lung cancer, with manageable side effects.12345

Is the combination of Pembrolizumab and chemotherapy safe for humans?

Pembrolizumab, when used with chemotherapy, has been generally safe but can cause side effects like pneumonitis (lung inflammation) in 1%-5% of patients and rare cases of type 1 diabetes (a condition where the body can't produce insulin). These side effects are part of the immune-related adverse events that can occur with this treatment.15678

What makes the drug combination of Pembrolizumab and chemotherapy unique for treating non-small cell lung cancer?

This drug combination is unique because Pembrolizumab, an immune system booster, is used alongside chemotherapy to improve survival rates in non-small cell lung cancer patients compared to chemotherapy alone. Pembrolizumab targets the PD-1 pathway, enhancing the body's immune response against cancer cells.156910

What is the purpose of this trial?

The purpose of this study is to assess the efficacy and safety of pembrolizumab (MK-3475) with or without chemotherapy in combination with vibostolimab (MK-7684), boserolimab (MK-5890), MK-4830, MK-0482, I-DXd, or HER3-DXd in treatment-naïve participants with advanced squamous or non-squamous NSCLC.This study is one of the pembrolizumab substudies being conducted under one pembrolizumab umbrella master protocol (MK-3475-U01/KEYMAKER-U01).

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) who haven't had treatment before. They should not be eligible for approved targeted therapies, have good organ function, and agree to use contraception. Pregnant or breastfeeding individuals, those with certain heart conditions, active infections, recent major surgery or live vaccines are excluded.

Inclusion Criteria

Is able to complete all screening procedures within the 35-day screening window
I agree to use birth control and not donate sperm during and up to 6 months after treatment.
I can provide a recent or archived tumor sample not previously treated with radiation.
See 5 more

Exclusion Criteria

I am allergic to carboplatin, paclitaxel, pemetrexed, or their ingredients.
I have a GI condition or liver issues that could affect medication absorption.
I have been diagnosed with small cell lung cancer.
See 28 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive pembrolizumab with or without chemotherapy in combination with investigational agents for up to 2 years

Up to 2 years
Every 3 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 24 months

Treatment Details

Interventions

  • Boserolimab
  • Carboplatin
  • MK-4830
  • MK-5890
  • Paclitaxel
  • Pembrolizumab
  • Pemetrexed
  • Vibostolimab
Trial Overview The study tests the effectiveness and safety of pembrolizumab combined with chemotherapy plus one of four investigational agents (vibostolimab, boserolimab, MK-4830, or MK-0482) in patients with untreated advanced NSCLC. It's part of a larger research project exploring pembrolizumab treatments.
Participant Groups
11Treatment groups
Experimental Treatment
Group I: Part B: Pembrolizumab + I-DXdExperimental Treatment2 Interventions
On Day 1 of each 3-week cycle, participants with squamous and nonsquamous NSCLC will receive pembrolizumab 200 mg IV for up to 2 years, PLUS I-DXd in escalating doses until progressive disease or toxicity.
Group II: Part B: Pembrolizumab + Carboplatin + I-DXdExperimental Treatment3 Interventions
On Day 1 of each 3-week cycle, participants will receive pembrolizumab 200 mg IV for up to 2 years, PLUS carboplatin AUC 5-6 up to 4 cycles PLUS I-DXd IV in escalating doses until PD or toxicity.
Group III: Part B: Pembrolizumab + Carboplatin + HER3-DXdExperimental Treatment3 Interventions
On Day 1 of each 3-week cycle, participants will receive pembrolizumab 200 mg IV for up to 2 years, PLUS carboplatin AUC 5-6 up to 4 cycles PLUS HER3-DXd IV in escalating doses until PD or toxicity.
Group IV: Part A: Pembrolizumab+Vibostolimab+Carboplatin + PemetrexedExperimental Treatment4 Interventions
On Day 1 of each 3-week cycle, participants with nonsquamous NSCLC receive pembrolizumab 200 mg IV PLUS vibostolimab IV PLUS carboplatin AUC 5 IV PLUS pemetrexed 500 mg/m\^2 IV in Cycles 1-4, followed by maintenance treatment of pembrolizumab 200 mg IV PLUS vibostolimab IV PLUS pemetrexed 500 mg/m\^2 IV in Cycles 5-35 (total treatment duration: up to approximately 2 years).
Group V: Part A: Pembrolizumab+Vibostolimab+Carboplatin + PaclitaxelExperimental Treatment4 Interventions
On Day 1 of each 3-week cycle, participants with squamous NSCLC receive pembrolizumab 200 mg intravenously (IV) PLUS vibostolimab IV PLUS carboplatin Area Under the Concentration-Time Curve (AUC) 6 IV PLUS paclitaxel 200 mg/m\^2 IV in Cycles 1-4, followed by maintenance treatment of pembrolizumab 200 mg IV PLUS vibostolimab IV in Cycles 5-35 (total treatment duration: up to approximately 2 years).
Group VI: Part A: Pembrolizumab+MK-4830+Carboplatin+PemetrexedExperimental Treatment4 Interventions
On Day 1 of each 3-week cycle, participants with nonsquamous NSCLC receive pembrolizumab 200 mg IV PLUS MK-4830 IV PLUS carboplatin AUC 5 IV PLUS pemetrexed 500 mg/m\^2 IV in Cycles 1-4, followed by maintenance treatment of pembrolizumab 200 mg IV PLUS MK-4830 IV PLUS pemetrexed 500 mg/m\^2 IV in Cycles 5-35 (total treatment duration: up to approximately 2 years).
Group VII: Part A: Pembrolizumab+MK-4830+Carboplatin+PaclitaxelExperimental Treatment4 Interventions
On Day 1 of each 3-week cycle, participants with squamous NSCLC receive pembrolizumab 200 mg IV PLUS MK-4830 IV PLUS carboplatin AUC 6 IV PLUS paclitaxel 200 mg/m\^2 IV in Cycles 1-4, followed by maintenance treatment of pembrolizumab 200 mg IV PLUS MK-4830 IV in Cycles 5-35 (total treatment duration: up to approximately 2 years).
Group VIII: Part A: Pembrolizumab+MK-0482+Carboplatin+PemetrexedExperimental Treatment3 Interventions
On Day 1 of each 3-week cycle, participants with nonsquamous NSCLC receive pembrolizumab 200 mg IV PLUS MK-0482 IV PLUS carboplatin AUC 5 IV PLUS pemetrexed 500 mg/m\^2 IV in Cycles 1-4, followed by maintenance treatment of pembrolizumab 200 mg IV PLUS MK-0482 IV PLUS pemetrexed 500 mg/m\^2 IV in Cycles 5-35 (total treatment duration: up to approximately 2 years).
Group IX: Part A: Pembrolizumab+MK-0482+Carboplatin+PaclitaxelExperimental Treatment3 Interventions
On Day 1 of each 3-week cycle, participants with squamous NSCLC receive pembrolizumab 200 mg IV PLUS MK-0482 IV PLUS carboplatin AUC 6 IV PLUS paclitaxel 200 mg/m\^2 IV in Cycles 1-4, followed by maintenance treatment of pembrolizumab 200 mg IV PLUS MK-0482 IV in Cycles 5-35 (total treatment duration: up to approximately 2 years).
Group X: Part A: Pembrolizumab+Boserolimab+Carboplatin+PemetrexedExperimental Treatment4 Interventions
On Day 1 of each 3-week cycle, participants with nonsquamous NSCLC receive pembrolizumab 200 mg IV PLUS carboplatin AUC 5 IV PLUS pemetrexed 500 mg/m\^2 IV PLUS boserolimab IV on Day 1 every 6 weeks (every other 3-week cycle) (Q6W) in Cycles 1-4, followed by maintenance treatment of pembrolizumab 200 mg IV Q3W PLUS pemetrexed 500 mg/m\^2 IV Q3W PLUS boserolimab IV Q6W from Cycles 5 up to Cycle 35 (total treatment duration: up to approximately 2 years).
Group XI: Part A: Pembrolizumab+Boserolimab+Carboplatin+PaclitaxelExperimental Treatment4 Interventions
On Day 1 of each 3-week cycle, participants with squamous NSCLC receive pembrolizumab 200 mg IV PLUS carboplatin AUC 6 IV PLUS paclitaxel 200 mg/m\^2 IV PLUS boserolimab IV on Day 1 every 6 weeks (every other 3-week cycle) (Q6W) in Cycles 1-4, followed by maintenance treatment of pembrolizumab 200 mg IV Q3W PLUS boserolimab IV Q6W from Cycles 5 up to Cycle 35 (total treatment duration: up to approximately 2 years).

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

🇪🇺
Approved in European Union as KEYTRUDA for:
  • Melanoma
  • Non-small cell lung cancer
  • Head and neck cancer
  • Urothelial carcinoma
  • Colorectal cancer
  • Gastric cancer
  • Hepatocellular carcinoma
  • Renal cell carcinoma
  • Endometrial carcinoma
🇺🇸
Approved in United States as KEYTRUDA for:
  • Melanoma
  • Non-small cell lung cancer
  • Head and neck cancer
  • Urothelial carcinoma
  • Colorectal cancer
  • Gastric cancer
  • Hepatocellular carcinoma
  • Renal cell carcinoma
  • Endometrial carcinoma
  • Esophageal carcinoma
  • Cervical cancer
🇨🇦
Approved in Canada as KEYTRUDA for:
  • Melanoma
  • Non-small cell lung cancer
  • Head and neck cancer
  • Urothelial carcinoma
  • Colorectal cancer
  • Gastric cancer
  • Hepatocellular carcinoma
  • Renal cell carcinoma
  • Endometrial carcinoma
🇯🇵
Approved in Japan as KEYTRUDA for:
  • Melanoma
  • Non-small cell lung cancer
  • Head and neck cancer
  • Urothelial carcinoma
  • Colorectal cancer
  • Gastric cancer
  • Hepatocellular carcinoma
  • Renal cell carcinoma

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

Daiichi Sankyo

Industry Sponsor

Trials
443
Recruited
493,000+
Hiroyuki Okuzawa profile image

Hiroyuki Okuzawa

Daiichi Sankyo

Chief Executive Officer

Degree in Social Sciences from Hitotsubashi University

Yuki Abe profile image

Yuki Abe

Daiichi Sankyo

Chief Medical Officer since 2023

MD

Findings from Research

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 KEYNOTE-407 study involving 1107 patients with untreated metastatic squamous non-small-cell lung cancer, the addition of pembrolizumab to chemotherapy significantly improved overall survival and quality of life without increasing severe toxicity.
Patients receiving pembrolizumab reported better health-related quality of life scores at weeks 9 and 18 compared to those receiving placebo, indicating that pembrolizumab enhances patient well-being while maintaining effective cancer treatment.
Health-Related Quality of Life With Carboplatin-Paclitaxel or nab-Paclitaxel With or Without Pembrolizumab in Patients With Metastatic Squamous Non-Small-Cell Lung Cancer.Mazieres, J., Kowalski, D., Luft, A., et al.[2020]
In a phase II study involving 167 patients with stage IV squamous non-small-cell lung cancer, the combination of necitumumab with paclitaxel-carboplatin chemotherapy resulted in a higher objective response rate (48.9%) compared to chemotherapy alone (40.0%).
The safety profile of necitumumab was consistent with other EGFR monoclonal antibodies, with increased rates of hypomagnesemia and rash, but overall adverse events were low, indicating that necitumumab can be safely combined with chemotherapy for improved treatment outcomes.
An Open-Label, Randomized, Controlled Phase II Study of Paclitaxel-Carboplatin Chemotherapy With Necitumumab Versus Paclitaxel-Carboplatin Alone in First-Line Treatment of Patients With Stage IV Squamous Non-Small-Cell Lung Cancer.Spigel, DR., Luft, A., Depenbrock, H., et al.[2022]

References

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]
Health-Related Quality of Life With Carboplatin-Paclitaxel or nab-Paclitaxel With or Without Pembrolizumab in Patients With Metastatic Squamous Non-Small-Cell Lung Cancer. [2020]
An Open-Label, Randomized, Controlled Phase II Study of Paclitaxel-Carboplatin Chemotherapy With Necitumumab Versus Paclitaxel-Carboplatin Alone in First-Line Treatment of Patients With Stage IV Squamous Non-Small-Cell Lung Cancer. [2022]
Pembrolizumab plus chemotherapy for first-line treatment of metastatic nonsquamous non-small-cell lung cancer: a network meta-analysis. [2022]
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]
Recurrent and atypical immune checkpoint inhibitor-induced pneumonitis. [2023]
Programmed Cell Death-1 Inhibitor-Induced Type 1 Diabetes Mellitus. [2022]
Pulmonary Sarcoidosis Activation following Neoadjuvant Pembrolizumab plus Chemotherapy Combination Therapy in a Patient with Non-Small Cell Lung Cancer: A Case Report. [2022]
Pembrolizumab monotherapy for non-small cell lung cancer (NSCLC): can patient stratification be improved in the UK Tayside population? A retrospective cohort study. [2023]
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