150 Participants Needed

Chemotherapy + Immunotherapy for Lung Cancer

Recruiting at 10 trial locations
MH
Overseen ByMissak Haigentz, MD
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: Rutgers, The State University of New Jersey
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

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?

Research shows that combining pembrolizumab with chemotherapy, including pemetrexed and a platinum-based drug like carboplatin, significantly improves survival rates in patients with advanced non-small cell lung cancer compared to chemotherapy alone.12345

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, Jr., MD | Rutgers ...

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

Patients may have ANY PD-L1 expression Tumor Proportion Score (TPS) status
My cancer is not small cell carcinoma.
My brain scans show no worsening after treatment for brain metastases.
See 9 more

Exclusion Criteria

My cancer does not have treatable mutations like EGFR (except exon 20), BRAF (V600), MET Exon14, ALK, or ROS1.
I have a history of cancer.
I haven't had any cancer except for skin cancer in the last 5 years.
See 2 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Induction

Alternating cycles of induction chemoimmunotherapy and immunotherapy alone

18-30 weeks
Visits every 3-6 weeks

Maintenance

Maintenance cycles with Pemetrexed and Pembrolizumab or Pembrolizumab alone

Up to 2 years

Follow-up

Participants are monitored for safety and effectiveness after treatment

36 months

Treatment Details

Interventions

  • 5Fluorouracil
  • Carboplatin
  • Paclitaxel
  • Pembrolizumab
  • Pemetrexed
Trial Overview The study tests alternating cycles of chemoimmunotherapy (chemo drugs like Paclitaxel combined with Pembrolizumab) and immunotherapy alone as initial treatments. It aims to see if changing treatment types can better manage advanced cancers.
Participant Groups
3Treatment groups
Experimental Treatment
Group I: Squamous Lung CancerExperimental Treatment3 Interventions
A Cycles consist of either: * Paclitaxel Based: Carboplatin/Paclitaxel/Pembrolizumab OR * nab-Paclitaxel Based: Carboplatin/nab Paclitaxel/Pembrolizumab These A Cycles will be given for up to four cycles (standard) B Cycles consist of Pembrolizumab alone
Group II: Non-Squamous Lung CancerExperimental Treatment3 Interventions
* A Cycles consist of Carboplatin/Pemetrexed/Pembrolizumab (up to four cycles standard) * B Cycles consist of Pembrolizumab alone Maintenance Cycles (Cycle 5 and beyond): Pemetrexed in combination with Pembrolizumab; Alternatively, Pembrolizumab alone, for up to 2 years since enrollment (standard)
Group III: Head and Neck Squamous Cell CarcinomaExperimental Treatment3 Interventions
* A Cycles consist of Carboplatin/5-Fluorouracil/Pembrolizumab (up to six cycles standard) * B Cycles consist of Pembrolizumab alone Maintenance Cycles (Cycle 7 and beyond): Pembrolizumab alone, for up to two years since enrollment (standard)

5Fluorouracil is already approved in United States, Canada, European Union for the following indications:

🇺🇸
Approved in United States as Efudex for:
  • Actinic keratosis
  • Basal cell carcinoma
🇨🇦
Approved in Canada as Efudex for:
  • Actinic keratosis
  • Basal cell carcinoma
🇺🇸
Approved in United States as Adrucil for:
  • Anal Cancer
  • Breast Cancer
  • Cervical Cancer
  • Colorectal Cancer
  • Nasopharyngeal Carcinoma
  • Pancreatic Cancer
  • Stomach Cancer
🇪🇺
Approved in European Union as Fluorouracil for:
  • 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

Trials
471
Recruited
81,700+

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 patients with metastatic non-small-cell lung cancer (NSCLC) expressing PD-L1 in ≥50% of tumor cells, pembrolizumab significantly improves progression-free and overall survival compared to traditional platinum-based chemotherapy.
Combining pembrolizumab with standard chemotherapy (pemetrexed and a platinum drug) enhances survival outcomes regardless of PD-L1 expression, indicating a broader efficacy of this combination therapy.
Combined Checkpoint Inhibition and Chemotherapy: New Era of 1st-Line Treatment for Non-Small-Cell Lung Cancer.Wang, C., Kulkarni, P., Salgia, R.[2020]
In the phase III KEYNOTE-189 study, pembrolizumab combined with pemetrexed and platinum-based chemotherapy significantly improved overall survival (OS) and progression-free survival (PFS) in patients with untreated metastatic nonsquamous non-small-cell lung cancer, with a hazard ratio of 0.56 for OS and 0.49 for PFS after a median follow-up of 31 months.
The treatment was associated with a high objective response rate (ORR) of 48.3% compared to 19.9% for the placebo group, and among patients who completed 35 cycles of pembrolizumab, the ORR was even higher at 85.7%, indicating strong efficacy with manageable toxicity.
Pemetrexed plus platinum with or without pembrolizumab in patients with previously untreated metastatic nonsquamous NSCLC: protocol-specified final analysis from KEYNOTE-189.Rodríguez-Abreu, D., Powell, SF., Hochmair, MJ., 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]
Combined Checkpoint Inhibition and Chemotherapy: New Era of 1st-Line Treatment for Non-Small-Cell Lung Cancer. [2020]
Pemetrexed plus platinum with or without pembrolizumab in patients with previously untreated metastatic nonsquamous NSCLC: protocol-specified final analysis from KEYNOTE-189. [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]
Pemetrexed Induced Life-threatening Anaphylaxis. [2020]
Pemetrexed (Alimta): a new antifolate for non-small-cell lung cancer. [2017]
Recurrent and atypical immune checkpoint inhibitor-induced pneumonitis. [2023]
Toxic epidermal necrolysis related to pemetrexed and carboplatin with vitamin B12 and folic acid supplementation for advanced non-small cell lung cancer. [2015]
Long-term survival follow-up of atezolizumab in combination with platinum-based doublet chemotherapy in patients with advanced non-small-cell lung cancer. [2022]