Chemotherapy + Immunotherapy for Lung Cancer
Trial Summary
What is the purpose of this trial?
The purpose of the research is to evaluate a new schedule of alternating cycles of induction chemoimmunotherapy (chemotherapy plus pembrolizumab) and immunotherapy (pembrolizumab) alone for the initial treatment of patients with advanced lung or head and neck cancers.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications. However, you must not have received prior systemic chemotherapy or immunotherapy for advanced metastatic NSCLC or recurrent/metastatic head and neck cancer. Some low-dose chemotherapeutics for non-malignant conditions may be allowed with review, and you must not be on immunosuppressive medication within 7 days prior to randomization.
What data supports the effectiveness of the drug combination used in the Chemotherapy + Immunotherapy for Lung Cancer trial?
Is the combination of chemotherapy and immunotherapy generally safe for lung cancer patients?
The combination of chemotherapy and immunotherapy, such as pembrolizumab with carboplatin and pemetrexed, is generally considered safe for lung cancer patients, but there are some risks. Pemetrexed can cause severe allergic reactions in rare cases, and pembrolizumab may lead to pneumonitis (lung inflammation) in 1%-5% of patients. These treatments are usually well-tolerated, but it's important to be aware of these potential side effects.15678
What makes the chemotherapy and immunotherapy drug combination unique for lung cancer?
This treatment combines chemotherapy drugs with pembrolizumab, an immunotherapy drug, which has shown to improve survival rates in advanced non-small cell lung cancer compared to chemotherapy alone. The combination works by using chemotherapy to kill cancer cells and pembrolizumab to help the immune system attack the cancer, offering a more effective approach than traditional treatments.125910
Research Team
Missak Haigentz, MD
Principal Investigator
Rutgers Cancer Institute of New Jersey
Eligibility Criteria
This trial is for adults with advanced lung or head and neck cancers. Participants must have a certain level of physical fitness (ECOG 0-2) and measurable disease. They should not be pregnant, breastfeeding, or have severe infections, organ transplants, autoimmune diseases requiring treatment in the past 2 years, known specific cancer mutations, or pre-existing severe lung conditions.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Induction
Alternating cycles of induction chemoimmunotherapy and immunotherapy alone
Maintenance
Maintenance cycles with Pemetrexed and Pembrolizumab or Pembrolizumab alone
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- 5Fluorouracil
- Carboplatin
- Paclitaxel
- Pembrolizumab
- Pemetrexed
5Fluorouracil is already approved in United States, Canada, European Union for the following indications:
- Actinic keratosis
- Basal cell carcinoma
- Actinic keratosis
- Basal cell carcinoma
- Anal Cancer
- Breast Cancer
- Cervical Cancer
- Colorectal Cancer
- Nasopharyngeal Carcinoma
- Pancreatic Cancer
- Stomach Cancer
- Actinic keratosis
- Basal cell carcinoma
- Anal Cancer
- Breast Cancer
- Cervical Cancer
- Colorectal Cancer
- Nasopharyngeal Carcinoma
- Pancreatic Cancer
- Stomach Cancer
Find a Clinic Near You
Who Is Running the Clinical Trial?
Rutgers, The State University of New Jersey
Lead Sponsor