Could Your Patients Benefit? New Trials in Lung Cancer

Helen Leask, PhD

September 20, 2023

Several new trials in lung cancer have started enrolling in recent months. Is one of your patients eligible to participate?

Untreated advanced non–small cell lung cancer (NSCLC). Adult patients with this type of cancer whose tumors express PD-L1 > 50% can join a randomized, controlled, phase 2/3 study evaluating whether adding fianlimab (Regeneron) to cemiplimab (Libtayo) improves outcomes.

Cemiplimab is a PD-1 inhibitor already approved for this population. Fianlimab is an experimental LAG-3 inhibitor. In the current trial, one group of participants will receive an intravenous (IV) infusion of cemiplimab monotherapy every 3 weeks for up to 136 weeks. A second group will receive IV cemiplimab plus fianlimab, half of whom will start with a high dose of fianlimab; the other half will receive a low dose. Once the appropriate dose is selected, all participants taking the fianlimab-cemiplimab combination will continue with the chosen dose.

Centers in California, Florida, Ohio, and Tennessee started recruiting for the trial's 850 participants in June, along with a trial site in Australia. Objective response rate and overall survival are the primary endpoints. Quality of life (QoL) is a secondary endpoint. More details at

Untreated locally advanced or metastatic NSCLC with EGFR exon-20 insertion mutations. Adults in this clinical situation are eligible for a randomized, open-label, phase 3 trial to assess the safety and efficacy of zipalertinib (Taiho) alongside standard first-line platinum-based chemotherapy. Zipalertinib, an investigational tyrosine kinase inhibitor (TKI) designed to selectively inhibit EGFR variants with exon-20 insertion mutations, may offer a new option for patients with these rare mutations who currently have limited treatment choices.

Following a small safety study involving six to 12 people, trial participants will be randomized to 3-weekly chemotherapy (pemetrexed plus carboplatin/cisplatin) or 3-weekly chemo plus daily tablets of zipalertinib. The platinum drugs will be dropped after four cycles. Participants will continue receiving their respective regimens until disease progression or another reason for withdrawal, whichever comes first. The Gabrail Cancer and Research Center in Canton, Ohio, began recruiting 312 participants in June. The primary endpoints are progression-free survival and adverse events; overall survival and QoL are secondary measures. More details at

Untreated locally advanced or metastatic NSCLC with EGFR exon-20 insertion mutations. Individuals with this type of lung cancer are eligible for another randomized, open-label, phase 3 study comparing platinum-based chemotherapy to an experimental TKI — in this case, furmonertinib (ArriVent). For up to 3 years, participants will take daily tablets of furmonertinib in one of two doses or receive investigator's choice of platinum-based IV chemotherapy.

The study, which is seeking a total of 375 participants, opened across 17 states in June with sites planned in nine more states. Progression-free survival is the primary endpoint. Overall survival and QoL are secondary endpoints. More details at

Metastatic NSCLC. People with this diagnosis whose disease has progressed on anti-PD1/PD-L1 therapy can participate in a randomized, open-label, phase 3 study to determine whether gotistobart (OncoC4) can improve overall survival better than docetaxel (Taxotere). Last year, the FDA assigned Fast Track Designation to gotistobart monotherapy following phase 1/2 data, which demonstrated "encouraging anti-tumor activity and a manageable safety profile."

The current trial could lead to a drug approval. For approximately 1 year, participants will receive either gotistobart or docetaxel by IV infusion every 3 weeks. During stage 1 of the study, people in the gotistobart group will test two different doses and, in stage 2, all participants will receive the chosen dose.

Study sites in Alabama, California, Florida, Illinois, Kentucky, Ohio, and Pennsylvania opened in June ready to welcome approximately 600 participants. Centers are also gearing up in 11 more US states, Canada, Europe, Asia, and Australia.

Overall survival over 3 years is the primary outcome. QoL will not be tracked. More details at

Locally advanced inoperable NSCLC. Adults with this type of lung cancer are eligible for a National Cancer Institute randomized, controlled, phase 3 study to see if stereotactic body radiation therapy (SBRT) can prolong survival when added to standard treatment vs standard treatment alone. All individuals will receive standard image-guided radiation plus IV chemotherapy, followed by IV durvalumab, and one group will receive SBRT before standard treatment. Centers across 10 states started recruiting 474 participants for the trial in May.

Overall survival over 8 years and progression-free survival are the primary endpoints. QoL is a secondary outcome. More details at

Small cell lung cancer (SCLC) relapsed after platinum-based first-line chemotherapy. Adults in this position are sought for a randomized, open-label, phase 3 trial evaluating whether the investigational drug tarlatamab (Amgen) can prolong survival compared with standard of care. Currently, such patients have limited treatment options. Tarlatamab is one of the first therapies to target the delta-like ligand 3 (DLL3), which is overexpressed on the surface of SCLC cells in 80% of patients and associated with cell proliferation.

Individuals in the trial will receive either tarlatamab as an IV infusion or local standard of care, which could include lurbinectedin (Zepzelca), topotecan (Hycamtin), or amrubicin (Calsed) in some countries. The study opened in May at centers in Indiana and Tennessee and nine other countries aiming for a total enrolment of 700 people. The primary outcome is overall survival at approximately 5 years. QoL is a secondary outcome. More details at

All trial information is from the National Institutes of Health US National Library of Medicine (online at

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