Pembrolizumab + Chemotherapy + Radiation for Lung Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores a combination of treatments for individuals with stage II-IIIB non-small cell lung cancer that cannot be surgically removed. The researchers aim to determine the safest and most effective dose of pembrolizumab (an immunotherapy drug) when combined with the chemotherapy drugs paclitaxel and carboplatin, along with radiation therapy. Participants should have non-small cell lung cancer that requires chemoradiation and has not spread to the brain. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this novel combination therapy.
Will I have to stop taking my current medications?
The trial protocol does not specify if you need to stop taking your current medications. However, if you are on systemic steroid therapy or any immunosuppressive therapy, you must stop these at least 7 days before starting the trial treatment.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that pembrolizumab is usually well-tolerated in many cancer treatments. In a study with 2,799 patients, researchers found its safety to be manageable, although some side effects occurred. Its use in several types of cancer suggests a reliable safety record.
Paclitaxel and carboplatin, two chemotherapy drugs in the study, can cause side effects like a low white blood cell count. These effects are common in cancer treatments and usually manageable. The FDA has approved them for non-small cell lung cancer, indicating a known safety profile.
The radiation therapies involved, 3D conformal radiation and intensity-modulated radiation therapy (IMRT), are standard treatments for lung cancer. They have been widely used and can cause side effects like fatigue and skin irritation, but they are generally considered safe and effective.
Overall, while each treatment may have potential side effects, previous studies and approvals suggest they are generally well-tolerated.12345Why are researchers excited about this trial's treatments?
Researchers are excited about this treatment combination for lung cancer because it brings together pembrolizumab, a cutting-edge immunotherapy drug, with traditional chemotherapy and radiation. Unlike standard treatments which mainly involve chemotherapy and radiation, pembrolizumab works by helping the immune system recognize and attack cancer cells more effectively. This approach has the potential to enhance the overall effectiveness of treatment, potentially leading to better outcomes for patients. Additionally, the combination aims to maximize cancer cell destruction while minimizing damage to healthy tissues, offering hope for improved quality of life during treatment.
What evidence suggests that this trial's treatments could be effective for lung cancer?
In this trial, participants will receive a combination of pembrolizumab, paclitaxel, carboplatin, and radiation therapy to treat non-small cell lung cancer (NSCLC). Research has shown that using pembrolizumab with chemotherapy more than doubles the average survival time compared to chemotherapy alone. This means patients lived longer with this treatment. Studies also indicate that this combination helps prevent the cancer from spreading or worsening for a longer period. Additionally, this treatment plan has proven safe and effective for both main types of NSCLC. These findings suggest that this approach could be a strong option for targeting lung cancer cells.678910
Who Is on the Research Team?
Salma Jabbour, MD
Principal Investigator
Rutgers Cancer Institute of New Jersey
Are You a Good Fit for This Trial?
This trial is for adults with stage II-IIIB non-small cell lung cancer who haven't had prior treatments that conflict with the study. They must have good organ function, no active infections or autoimmune diseases, not be pregnant or breastfeeding, and agree to use contraception. People with certain medical conditions or those who've received specific treatments recently are excluded.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Chemoradiation
Patients receive paclitaxel and carboplatin intravenously and undergo radiation therapy for 6 weeks
Pembrolizumab Treatment
Patients receive pembrolizumab intravenously every 21 days for up to 18 courses
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- 3-Dimensional Conformal Radiation Therapy
- Carboplatin
- Intensity-Modulated Radiation Therapy
- Paclitaxel
- Pembrolizumab
3-Dimensional Conformal Radiation Therapy is already approved in United States, European Union, Canada, Japan, China, Switzerland for the following indications:
- Various types of cancer, including gynecologic cancers
- Various types of cancer, including gynecologic cancers
- Various types of cancer, including gynecologic cancers
- Various types of cancer, including gynecologic cancers
- Various types of cancer, including gynecologic cancers
- Various types of cancer, including gynecologic cancers
Find a Clinic Near You
Who Is Running the Clinical Trial?
Rutgers, The State University of New Jersey
Lead Sponsor
Merck Sharp & Dohme LLC
Industry Sponsor
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
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
National Cancer Institute (NCI)
Collaborator
Rutgers Cancer Institute of New Jersey
Collaborator