Lung Non-Small Cell Carcinoma Clinical Trial
Official title:
A Phase 2 Study of Neoadjuvant Pembrolizumab-Based Combination Immunotherapy in the Treatment of Early Stage Non-Small Cell Lung Cancer
This phase II trial studies how well pembrolizumab with or without chemotherapy works when given before surgery in treating patients with stage I-IIIA non-small cell lung cancer. Immunotherapy with pembrolizumab, may induce changes in body?s immune system and may interfere with the ability of tumor cells to grow and spread. Drugs used in chemotherapy, such as cisplatin and pemetrexed, 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 cancer prior to surgery and decrease the likelihood of the cancer returning following surgery.
PRIMARY OBJECTIVES: I. To determine the impact of neoadjuvant pembrolizumab-based combination therapy on the composition, phenotype, and function of tumor-infiltrating immune cells (TIICs) in patients with early stage non-small cell lung cancer (NSCLC). SECONDARY OBJECTIVES: I. To determine the safety and tolerability of neoadjuvant pembrolizumab alone and in combination with chemotherapy as measured by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) 5.0. II. To determine the clinical efficacy of neoadjuvant pembrolizumab alone and in combination with chemotherapy. EXPLORATORY OBJECTIVES: I. To explore the relationship between changes in TIICs and clinical efficacy in patients with early stage NSCLC treated with neoadjuvant pembrolizumab-based combination therapy. II. To characterize changes in the frequency and number of circulating immune cells induced by neoadjuvant pembrolizumab-based combination therapy in patients with early stage NSCLC. III. To determine the impact of neoadjuvant pembrolizumab-based combination therapy on the composition and phenotype of the tumor microenvironment (including tumor and stromal cells) in patients with NSCLC. III. To determine the change in T cell repertoire within the tumor and blood induced by neoadjuvant pembrolizumab-based combination therapy in patients with early stage NSCLC. IV. To explore molecular profiles to identify potentially predictive biomarkers for patients with early stage NSCLC treated with immunotherapy. OUTLINE: Patients are assigned to 1 of 2 cohorts. COHORT A: Patients receive pembrolizumab intravenously (IV) over 30 minutes on day 1. Treatment repeats every 21 days for up to 2 cycles in the absence of disease progression or unacceptable toxicity. Patients then undergo surgery within 4 weeks following study treatment. COHORT B: Patients receive pembrolizumab IV over 30 minutes and chemotherapy (cisplatin/pemetrexed) IV on day 1. Treatment repeats every 21 days for up to 2 cycles in the absence of disease progression or unacceptable toxicity. Patients then undergo surgery within 4 weeks following study treatment. After completion of study treatment, patients are followed up every 3 months for up to 2 years. ;
Status | Clinical Trial | Phase | |
---|---|---|---|
Withdrawn |
NCT04989283 -
Testing the Addition of an Immunotherapy Drug, Atezolizumab, to the Usual Chemotherapy Treatment During Radiation Therapy for Superior Sulcus Non-small Cell Lung Cancer
|
Phase 2 | |
Recruiting |
NCT05106374 -
Risk of Chemotherapy Toxicity in Older Patients With Blood Cancer or Non-small Cell Lung Cancer
|
||
Terminated |
NCT03707925 -
Bronchoscopic Laser Ablation of Peripheral Lung Tumors
|
N/A | |
Active, not recruiting |
NCT04013542 -
Ipilimumab and Nivolumab in Combination With Radiation Therapy in Treating Patients With Stage 2-3 Non-small Lung Cancer
|
Phase 1 | |
Not yet recruiting |
NCT06427369 -
An Investigational Scan (124I-hJAA-F11 PET/CT) for Diagnosing Lung Cancer
|
Phase 1 | |
Recruiting |
NCT04929041 -
Testing the Addition of Radiation Therapy to Immunotherapy for Stage IV Non-Small Cell Lung Cancer Patients Who Are PD-L1 Negative
|
Phase 2/Phase 3 | |
Recruiting |
NCT04073745 -
Single Fraction Stereotactic Body Radiation Therapy After Surgery in Treating Patients With Non-small Cell Lung Cancer
|
Phase 1 | |
Recruiting |
NCT05830058 -
Positron Emission Tomography (PET) Guided Stereotactic Body Radiation Therapy for the Treatment of Oligoprogressive Non-small Cell Lung Cancer, Melanoma, and Renal Cell Carcinoma
|
Phase 2 | |
Active, not recruiting |
NCT03637816 -
Anamorelin Hydrochloride in Reducing Anorexia in Patients With Advanced Non-small Cell Lung Cancer
|
Phase 2/Phase 3 | |
Recruiting |
NCT04298606 -
A Vaccine (CIMAvax-EGF) for the Prevention of Lung Cancer Development or Recurrence
|
Early Phase 1 | |
Recruiting |
NCT06122064 -
A Tool for Improving the Shared Decision-making Process in Patients With Non-small Cell Lung Cancer
|
N/A | |
Recruiting |
NCT05802186 -
Stereotactic Body Radiation Therapy Planning With Artificial Intelligence-Directed Dose Recommendation for Treatment of Primary or Metastatic Lung Tumors, RAD-AI Study
|
N/A | |
Recruiting |
NCT03634241 -
Pembrolizumab in Preventing Lung Cancer in Patients With Stage I-II Non-Small Cell Lung Cancer or High-Risk Pulmonary Nodules, the IMPRINT-Lung Study
|
Phase 2 | |
Recruiting |
NCT04314401 -
National Cancer Institute "Cancer Moonshot Biobank"
|
||
Recruiting |
NCT05493566 -
Low-Dose Interleukin-2 and Pembrolizumab for the Treatment of Stage IV Non-Small Cell Lung Cancer
|
Early Phase 1 | |
Suspended |
NCT05501665 -
Split Course Adaptive Radiation Therapy With Pembrolizumab With/Without Chemotherapy for Treating Stage IV Lung Cancer
|
Phase 1/Phase 2 | |
Recruiting |
NCT06225427 -
Gilteritinib for the Treatment of ALK NSCLC
|
Phase 1 | |
Withdrawn |
NCT04085081 -
Physical Activity Intervention Before and After Surgery in Older Adults With Lung Cancer and Their Family Caregivers
|
N/A | |
Active, not recruiting |
NCT03939481 -
Treatment Effects on Development of Chemotherapy-Induced Peripheral Neuropathy in Patients With Cancer
|
||
Recruiting |
NCT05672108 -
Transarterial Chemoembolization for the Treatment of Lung Cancer
|
Phase 2 |