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Report for Clinical Trial NCT03867175

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

A Randomized Trial of Consolidative Immunotherapy With vs Without Thoracic Radiotherapy and / or Stereotactic Body Radiation Therapy (SBRT) After First-Line Systemic Therapy for Metastatic NSCLC

This phase III trial studies immunotherapy and stereotactic body radiation therapy to see how well it works compared with immunotherapy alone after first-line systemic therapy (therapy that goes throughout the body) in treating patients with stage IV non-small cell lung cancer. 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. Stereotactic body radiation therapy uses special equipment to position a patient and deliver radiation to tumors with high precision. This method can kill tumor cells with fewer doses over a shorter period and cause less damage to normal tissue. Giving immunotherapy with stereotactic body radiation therapy may work better than immunotherapy alone in treating patients with non-small cell lung cancer.

NCT03867175 Metastatic Lung Cancer Stage IV Lung Cancer
MeSH:Lung Neoplasms
HPO:Neoplasm of the lung

2 Interventions

Name: Stereotactic Body Radiation Therapy

Description: Patients undergo 3-10 treatments of stereotactic body radiation therapy (SBRT)
Type: Radiation
Group Labels: 1

Arm 1 Stereotactic Body Radiation Therapy/Pembrolizumab

Name: Pembrolizumab

Description: Patients undergo 3-10 treatments of SBRT. Patients also receive pembrolizumab IV over 30 minutes every 3-4 weeks for 1 year at the discretion of the treating physician.
Type: Biological
Group Labels: 2

Arm 1 Stereotactic Body Radiation Therapy/Pembrolizumab Arm 2 Pembrolizumab


Primary Outcomes

Description: Will be determined using the product-limit method of Kaplan and Meier. Will compare unadjusted median PFS between the 2 arms using a log-rank test. Will also use a proportional hazards model to compare progression-free survival between the two groups, adjusting for key covariates such as age, performance (Eastern Cooperative Oncology Group) status, response to initial systemic therapy versus (vs) stable disease, the presence or absence of brain metastases, PD-L1 [programmed death-ligand ] expression (< 1% vs > 50%), tumor histology (adenocarcinoma vs non-adenocarcinoma), and number of disease sites treated (1-3 sites vs 4-6 sites).

Measure: Progression-free survival (PFS) after completion of first line systemic therapy

Time: Up to 5 years

Secondary Outcomes

Description: Will be reported with an exact 95% confidence interval.

Measure: Overall Survival

Time: Up to 5 years

Description: In patients not receiving radiation, the investigators will assess progression at their known sites of disease prior to beginning first line systemic chemotherapy.

Measure: Time of Progression

Time: Baseline up to 5 years

Description: Investigators will assess the rate of failures inside and outside of radiation treatment.

Measure: Rate of Failure

Time: Baseline up to 5 years

Description: Investigators will assess the development of new sites of disease during or after immunotherapy

Measure: Number of Participants with New Sites of Disease

Time: Baseline up to 5 years

Description: All safety measures, including acute and late toxicity, will be reported using descriptive statistics (mean, median, standard deviation, proportions, and 95% confidence intervals). This will include calculating frequency/risk of adverse events by treatment site. Potential toxicities reported would include pneumonitis, esophagitis, chest wall pain, dermatologic toxicity, renal dysfunction, gastrointestinal toxicity including nausea, vomiting, and diarrhea, hepatotoxicity, and abdominal pain. These toxicities would be assessed according to site of irradiation by the treating physician and graded as per Common Terminology Criteria for Adverse Events 5.

Measure: Incidence of adverse events

Time: Up to 5 years

Purpose: Treatment

Allocation: Randomized

Parallel Assignment


There are 2 SNPs

SNPs


1 L858R

- Patients with major activating mutations in EGFR (del19, L858R, and T790M) or ROS 1 or ALK gene rearrangements are excluded. --- L858R ---


2 T790M

- Patients with major activating mutations in EGFR (del19, L858R, and T790M) or ROS 1 or ALK gene rearrangements are excluded. --- L858R --- --- T790M ---



HPO Nodes


HPO: