According to the American Cancer Society, lung cancer is the second most common cancer in the U.S. In 2022, it is estimated that 236,740 new cases of lung cancer will be diagnosed in the U.S. and 130,180 deaths will be attributed to the disease. Non-small cell lung cancer accounts for about 80% to 85% of all lung cancers diagnoses and there are very few successful treatment options for these patients once the cancer spreads beyond the lungs. The development of checkpoint inhibitors in non-small cell lung cancer (NSCLC) has been revolutionary, doubling the median overall survival in some settings; however, patient response may be short lived, due to late response and/or progression after achieving an initial response.
Lung Cancer Clinical Trials
ImmunityBio is currently conducting two U.S. trials for Lung Cancer:
QUILT 2.023 – A Study of N-803 (Anktiva) in Combination with Current Standard of Care vs. Standard of Care as First-Line Treatment for Patients with Stage 3 or 4 Non-Small Cell Lung Cancer (NSCLC)
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).
s1800D – Lung Cancer Master Protocol (Lung-MAP)
In 2021, ImmunityBio was chosen by Lung Cancer Master Protocol (Lung-MAP), a public-private partnership—which includes the NCI, the National Clinical Trials Network (NCTN) Cooperative Groups (SWOG, ECOG-ACRIN, Alliance, and NRG), Friends of Cancer Research, and the Foundation for the National Institutes of Health (FNIH)—to study Anktiva in the Lung-MAP trial. The trial with Anktiva in combination with Keytruda® (pembrolizumab) will include up to 478 second-line patients with tumors that are not targetable with a drug, which accounts for the majority of NSCLC cases. In the fourth quarter of 2021, approval was received from the Institutional Review Board (IRB) overseeing the Lung-MAP study to proceed with the trial—one of the NCI’s largest lung cancer clinical trials with more than 700 sites. Enrollment has begun for this trial.