101 Participants Needed

Pembrolizumab + Chemotherapy for Non-Small Cell Lung Cancer

Recruiting at 524 trial locations
AJ
Overseen ByAminah Jatoi, MD
Age: 65+
Sex: Any
Trial Phase: Phase 2
Sponsor: Alliance for Clinical Trials in Oncology
Must be taking: Pembrolizumab
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 studies the side effects of pembrolizumab with or without chemotherapy in treating patients with stage IV non-small cell lung cancer that has come back (recurrent) and has spread to other places in the body (advanced). Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Drugs used in chemotherapy, such as pemetrexed and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving pembrolizumab with or without chemotherapy may shrink the tumor in older patients with non-small cell lung cancer.

Do I need to stop my current medications to join the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What safety data exists for the combination of Pembrolizumab and Chemotherapy in treating non-small cell lung cancer?

Pembrolizumab, when combined with chemotherapy drugs like carboplatin and pemetrexed, has been studied for safety in treating non-small cell lung cancer. Some patients may experience side effects such as pneumonitis (lung inflammation) and scleroderma-like changes (skin thickening), but these are not common. Safety analyses have been conducted to monitor adverse events, including those affecting the kidneys.12345

How is the drug combination of pembrolizumab, carboplatin, and pemetrexed unique for treating non-small cell lung cancer?

This drug combination is unique because it combines pembrolizumab, an immune system booster, with chemotherapy drugs carboplatin and pemetrexed, leading to better survival rates for patients with non-small cell lung cancer compared to chemotherapy alone. It is effective regardless of PD-L1 expression, a protein that can affect how well the immune system fights cancer.12367

What data supports the effectiveness of the drug combination of pembrolizumab, carboplatin, and pemetrexed for non-small cell lung cancer?

Research shows that combining pembrolizumab with carboplatin and pemetrexed improves response rates and survival in patients with advanced non-small cell lung cancer compared to chemotherapy alone.238910

Who Is on the Research Team?

AJ

Aminah Jatoi, MD

Principal Investigator

Mayo Clinic

Are You a Good Fit for This Trial?

This trial is for patients aged 70 or older with advanced non-small cell lung cancer that has returned and spread. Participants must have proper organ function, no untreated brain metastases, be off corticosteroids, speak English to complete questionnaires, and not plan other cancer treatments within 3 months of joining.

Inclusion Criteria

Your bilirubin level in the blood is within a certain range, unless you have Gilbert's disease, in which case it can be slightly higher.
I have no cancer treatments planned for the next 3 months.
Your platelet count is at least 100,000 per cubic millimeter.
See 11 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive pembrolizumab with or without chemotherapy every 21 days

Up to 6 months
Every 21 days

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 5 years
Annually

What Are the Treatments Tested in This Trial?

Interventions

  • Carboplatin
  • Pembrolizumab
  • Pemetrexed
Trial Overview The study tests pembrolizumab (an immunotherapy drug) alone or combined with chemotherapy drugs pemetrexed and carboplatin in elderly patients. It aims to see if these treatments can shrink tumors by helping the immune system attack the cancer or by stopping tumor growth.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Group I: Group B (pembrolizumab, pemetrexed, carboplatin)Experimental Treatment6 Interventions
Group II: Group A (pembrolizumab)Experimental Treatment4 Interventions

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

🇺🇸
Approved in United States as Paraplatin for:
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Approved in European Union as Carboplatin for:
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Approved in Canada as Carboplatin for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

Alliance for Clinical Trials in Oncology

Lead Sponsor

Trials
521
Recruited
224,000+

National Cancer Institute (NCI)

Collaborator

Trials
14,080
Recruited
41,180,000+

Published Research Related to This Trial

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 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]
Pemetrexed (Alimta) shows a response rate of 16%-23% as a single agent for non-small-cell lung cancer (NSCLC) and a higher response rate of 38.9%-44.8% when combined with cisplatin, leading to a median survival of 8.9-10.9 months.
The main side effect of pemetrexed is neutropenia, but this can be mitigated with vitamin B12 and folate supplements, highlighting the importance of supportive care in enhancing treatment safety.
Pemetrexed (Alimta): a new antifolate for non-small-cell lung cancer.Ettinger, DS.[2017]

Citations

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]
Neoadjuvant anti-programmed death-1 immunotherapy by pembrolizumab in resectable non-small cell lung cancer: First clinical experience. [2022]
Pemetrexed (Alimta): a new antifolate for non-small-cell lung cancer. [2017]
24-Month Overall Survival from KEYNOTE-021 Cohort G: Pemetrexed and Carboplatin with or without Pembrolizumab as First-Line Therapy for Advanced Nonsquamous Non-Small Cell Lung Cancer. [2022]
Toxic epidermal necrolysis related to pemetrexed and carboplatin with vitamin B12 and folic acid supplementation for advanced non-small cell lung cancer. [2015]
Recurrent and atypical immune checkpoint inhibitor-induced pneumonitis. [2023]
Safety of pemetrexed plus platinum in combination with pembrolizumab for metastatic nonsquamous non-small cell lung cancer: A post hoc analysis of KEYNOTE-189. [2023]
[Pemetrexed-induced scleroderma-like changes in the lower legs]. [2015]
Pulmonary Sarcoidosis Activation following Neoadjuvant Pembrolizumab plus Chemotherapy Combination Therapy in a Patient with Non-Small Cell Lung Cancer: A Case Report. [2022]
10.United Statespubmed.ncbi.nlm.nih.gov
Combined Checkpoint Inhibition and Chemotherapy: New Era of 1st-Line Treatment for Non-Small-Cell Lung Cancer. [2020]
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