More than 235,000 people will be diagnosed with lung cancer in the U.S. in 2021 and more than 131,000 people will die from it this year, according to The American Cancer Association. It is by far the leading cause of cancer death among men and women, making up almost 25% of all cancer deaths. About 80% to 85% of lung cancers are non-small cell lung cancer (NSCLC). The main types of NSCLC are: 1) adenocarcinoma, which is the most common type of lung cancer in both smokers and non-smokers and is found on the outside of the lungs; 2) squamous cell carcinoma, which starts in flat cells that line the airways, is often linked to a history of smoking; and 3) large cell carcinoma, which can appear in any part of the lung and tends to grow and spread faster than the other types of NSCLC.
Lung Cancer Clinical Trials
ImmunityBio is currently conducting two U.S. trials for Lung Cancer:
This is a Phase 3, open-label, 3-cohort, randomized study to compare the safety and effectiveness of N-803 (Anktiva) in combination with the current standard of care (experimental arms) versus standard of care alone (control arms), as first-line treatment for subjects with stage 3 or 4 advanced or metastatic NSCLC. Treatment will continue for up to 2 years, or until the patient experiences confirmed progressive disease or unacceptable toxicity, withdraws consent, or if the investigator feels that it is no longer in the patient’s best interest to continue treatment. Patients will be followed for disease progression, post-therapies, and survival through 24 months after the first dose of study drug. When fully enrolled, this trial will involve 1,538 subjects.
Select Eligibility Criteria:
- Eligible subjects for this trial must have confirmation that the following mutations are not present: EGFR, ALK Translocation, BRAF, ROS1, and NTRK.
- Subjects previously treated for Stage 1 or 2 NSCLC are eligible and subjects previously treated for Stage 3 NSCLC who have progressed may still be eligible.
- You can review a list of all eligibility criteria at ClinicalTrials.gov (link below).
This is a Phase IIb, multicohort, open-label multicenter study of combination immunotherapies in patients who have previously received treatment with PD-1/PD-L1 immune checkpoint inhibitors. This trial is enrolling both non-small cell lung cancer (Cohorts 1-5) and small cell lung cancer (Cohort 1) patients. All patients in Cohorts 1-4 will receive the combination treatment of PD-1/PD-L1 checkpoint inhibitor plus N-803 (Anktiva) for up to 17 cycles. Each cycle is six weeks in duration. Some patients who experience disease progression while on study in Cohorts 1-4 may roll over into Cohort 5 and receive combination therapy with a PD-1/PD-L1 checkpoint inhibitor, N-803, and PD-L1 t-haNK cellular therapy for up to an additional 17 cycles. Each cycle is six weeks in duration. All patients will receive N-803 once every 3 weeks. Patients will also receive the same checkpoint inhibitor that they received during their previous therapy. Radiologic evaluation will occur at the end of each treatment cycle. Treatment will continue for up to 2 years, or until the patient experiences confirmed progressive disease or unacceptable toxicity, withdraws consent, or if the Investigator feels it is no longer in the patient’s best interest to continue treatment. Patients will be followed for disease progression, post-therapies, and survival through 24 months past administration of the first dose of study drug. When fully enrolled, this trial will involve up to 600 participants.